Aranesp

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 

 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 10 micrograms solution for injection in pre-filled syringe. 
Aranesp 15 micrograms solution for injection in pre-filled syringe. 
Aranesp 20 micrograms solution for injection in pre-filled syringe. 
Aranesp 30 micrograms solution for injection in pre-filled syringe. 
Aranesp 40 micrograms solution for injection in pre-filled syringe. 
Aranesp 50 micrograms solution for injection in pre-filled syringe. 
Aranesp 60 micrograms solution for injection in pre-filled syringe. 
Aranesp 80 micrograms solution for injection in pre-filled syringe. 
Aranesp 100 micrograms solution for injection in pre-filled syringe. 
Aranesp 130 micrograms solution for injection in pre-filled syringe. 
Aranesp 150 micrograms solution for injection in pre-filled syringe. 
Aranesp 300 micrograms solution for injection in pre-filled syringe. 
Aranesp 500 micrograms solution for injection in pre-filled syringe. 
 
Aranesp 10 micrograms solution for injection in pre-filled pen. 
Aranesp 15 micrograms solution for injection in pre-filled pen. 
Aranesp 20 micrograms solution for injection in pre-filled pen. 
Aranesp 30 micrograms solution for injection in pre-filled pen. 
Aranesp 40 micrograms solution for injection in pre-filled pen. 
Aranesp 50 micrograms solution for injection in pre-filled pen. 
Aranesp 60 micrograms solution for injection in pre-filled pen. 
Aranesp 80 micrograms solution for injection in pre-filled pen. 
Aranesp 100 micrograms solution for injection in pre-filled pen. 
Aranesp 130 micrograms solution for injection in pre-filled pen. 
Aranesp 150 micrograms solution for injection in pre-filled pen. 
Aranesp 300 micrograms solution for injection in pre-filled pen. 
Aranesp 500 micrograms solution for injection in pre-filled pen. 
 
Aranesp 25 micrograms solution for injection in vial. 
Aranesp 40 micrograms solution for injection in vial. 
Aranesp 60 micrograms solution for injection in vial. 
Aranesp 100 micrograms solution for injection in vial. 
Aranesp 200 micrograms solution for injection in vial. 
Aranesp 300 micrograms solution for injection in vial. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Aranesp 10 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). 
Aranesp 15 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 15 micrograms of darbepoetin alfa in 0.375 mL (40 mcg/mL). 
Aranesp 20 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). 
Aranesp 30 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). 
Aranesp 40 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). 
Aranesp 50 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). 
Aranesp 60 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). 
Aranesp 80 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). 



 

 

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Aranesp 100 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). 
Aranesp 130 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). 
Aranesp 150 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). 
Aranesp 300 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). 
Aranesp 500 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). 
 
Aranesp 10 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). 
Aranesp 15 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 15 micrograms of darbepoetin alfa in 0.375 mL (40 mcg/mL). 
Aranesp 20 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL). 
Aranesp 30 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL). 
Aranesp 40 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL). 
Aranesp 50 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL). 
Aranesp 60 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL). 
Aranesp 80 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL). 
Aranesp 100 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL). 
Aranesp 130 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL). 
Aranesp 150 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL). 
Aranesp 300 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL). 
Aranesp 500 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL). 
 
Aranesp 25 micrograms solution for injection in vial 
Each vial contains 25 micrograms of darbepoetin alfa in 1 mL (25 mcg/mL). 
Aranesp 40 micrograms solution for injection in vial  
Each vial contains 40 micrograms of darbepoetin alfa in 1 mL (40 mcg/mL). 
Aranesp 60 micrograms solution for injection in vial 
Each vial contains 60 micrograms of darbepoetin alfa in 1 mL (60 mcg/mL). 
Aranesp 100 micrograms solution for injection in vial 
Each vial contains 100 micrograms of darbepoetin alfa in 1 mL (100 mcg/mL). 
Aranesp 200 micrograms solution for injection in vial  
Each vial contains 200 micrograms of darbepoetin alfa in 1 mL (200 mcg/mL). 
Aranesp 300 micrograms solution for injection in vial  
Each vial contains 300 micrograms of darbepoetin alfa in 1 mL (300 mcg/mL). 
 
Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). 
 



 

 

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Excipient with known effect: 
 
Aranesp 10 micrograms solution for injection in pre-filled syringe 
Each pre-filled syringe contains 1.52 mg of sodium in 0.4 mL. 
Aranesp 15 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 1.42 mg of sodium in 0.375 mL. 
Aranesp 20 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 1.90 mg of sodium in 0.5 mL. 
Aranesp 30 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 1.14 mg of sodium in 0.3 mL. 
Aranesp 40 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 1.52 mg of sodium in 0.4 mL. 
Aranesp 50 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 1.90 mg of sodium in 0.5 mL. 
Aranesp 60 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 1.14 mg of sodium in 0.3 mL. 
Aranesp 80 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 1.52 mg of sodium in 0.4 mL. 
Aranesp 100 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 1.90 mg of sodium in 0.5 mL. 
Aranesp 130 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 2.46 mg of sodium in 0.65 mL. 
Aranesp 150 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 1.14 mg of sodium in 0.3 mL. 
Aranesp 300 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 2.27 mg of sodium in 0.6 mL. 
Aranesp 500 micrograms solution for injection in pre-filled syringe  
Each pre-filled syringe contains 3.79 mg of sodium in 1 mL. 
 
Aranesp 10 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 1.52 mg of sodium in 0.4 mL. 
Aranesp 15 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 1.42 mg of sodium in 0.375 mL. 
Aranesp 20 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 1.90 mg of sodium in 0.5 mL. 
Aranesp 30 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 1.14 mg of sodium in 0.3 mL. 
Aranesp 40 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 1.52 mg of sodium in 0.4 mL. 
Aranesp 50 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 1.90 mg of sodium in 0.5 mL. 
Aranesp 60 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 1.14 mg of sodium in 0.3 mL. 
Aranesp 80 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 1.52 mg of sodium in 0.4 mL. 
Aranesp 100 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 1.90 mg of sodium in 0.5 mL. 
Aranesp 130 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 2.46 mg of sodium in 0.65 mL. 
Aranesp 150 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 1.14 mg of sodium in 0.3 mL. 
Aranesp 300 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 2.27 mg of sodium in 0.6 mL. 
Aranesp 500 micrograms solution for injection in pre-filled pen 
Each pre-filled pen contains 3.79 mg of sodium in 1 mL. 
 



 

 

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Aranesp 25 micrograms solution for injection in vial 
Each vial contains 3.79 mg of sodium. 
Aranesp 40 micrograms solution for injection in vial 
Each vial contains 3.79 mg of sodium. 
Aranesp 60 micrograms solution for injection in vial 
Each vial contains 3.79 mg of sodium. 
Aranesp 100 micrograms solution for injection in vial 
Each vial contains 3.79 mg of sodium. 
Aranesp 200 micrograms solution for injection in vial 
Each vial contains 3.79 mg of sodium. 
Aranesp 300 micrograms solution for injection in vial 
Each vial contains 3.79 mg of sodium. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection) in pre-filled syringe. 
Solution for injection (injection) in pre-filled pen (SureClick). 
Solution for injection (injection) in vial. 
 
Clear, colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and 
paediatric patients (see section 4.2). 
 
Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving 
chemotherapy. 
 
4.2 Posology and method of administration 
 
Aranesp treatment should be initiated by physicians experienced in the above mentioned indications. 
 
Posology 
 
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients 
 
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a 
physician’s evaluation of the individual patient’s clinical course and condition is necessary. Aranesp 
should be administered either subcutaneously or intravenously in order to increase haemoglobin to not 
greater than 12 g/dL (7.5 mmol/L). Subcutaneous use is preferable in patients who are not receiving 
haemodialysis to avoid the puncture of peripheral veins.  
 
Patients should be monitored closely to ensure that the lowest approved effective dose of Aranesp is 
used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin 
concentration below or at 12 g/dL (7.5 mmol/L). Caution should be exercised with escalation of 
Aranesp doses in patients with chronic renal failure. In patients with a poor haemoglobin response to 
Aranesp, alternative explanations for the poor response should be considered (see sections 4.4 
and 5.1). 
 



 

 

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Due to intra-patient variability, occasional individual haemoglobin values for a patient above and 
below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed 
through dose management, with consideration for the haemoglobin target range of 
10 g/dL (6.2 mmol/L) to 12 g/dL (7.5 mmol/L). A sustained haemoglobin level of greater than 
12 g/dL (7.5 mmol/L) should be avoided; guidance for appropriate dose adjustment for when 
haemoglobin values exceeding 12 g/dL (7.5 mmol/L) are observed are described below. A rise in 
haemoglobin of greater than 2 g/dL (1.25 mmol/L) over a four week period should be avoided. If it 
occurs, appropriate dose adjustment should be made as provided. 
 
Treatment with Aranesp is divided into two stages, correction and maintenance phase. Guidance is 
given separately for adult and paediatric patients. 
 
Adult patients with chronic renal failure 
 
Correction phase: 
 
The initial dose by subcutaneous or intravenous administration is 0.45 mcg/kg body weight, as a single 
injection once weekly. Alternatively, in patients not on dialysis, the following initial doses can also be 
administered subcutaneously as a single injection: 0.75 mcg/kg once every two weeks or 1.5 mcg/kg 
once monthly. If the increase in haemoglobin is inadequate (less than 1 g/dL (0.6 mmol/L) in four 
weeks) increase the dose by approximately 25%. Dose increases must not be made more frequently 
than once every four weeks. 
 
If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in four weeks reduce the dose by 
approximately 25%. If the haemoglobin exceeds 12 g/dL (7.5 mmol/L), a dose reduction should be 
considered. If the haemoglobin continues to increase, the dose should be reduced by 
approximately 25%. If after a dose reduction, haemoglobin continues to increase, the dose should be 
temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be 
reinitiated at approximately 25% lower than the previous dose. 
 
The haemoglobin should be measured every one or two weeks until it is stable. Thereafter the 
haemoglobin can be measured at longer intervals. 
 
Maintenance phase: 
 
In dialysis patients, Aranesp may continue to be administered as a single injection once weekly or 
once every two weeks. Dialysis patients converting from once weekly to once every other week dosing 
with Aranesp should initially receive a dose equivalent to twice the previous once weekly dose. 
 
In patients not on dialysis, Aranesp may continue to be administered as a single injection once weekly 
or once every two weeks or once monthly. For patients treated with Aranesp once every two weeks, 
after the target haemoglobin has been achieved, Aranesp may then be administered subcutaneously 
once monthly using an initial dose equal to twice the previous once every two week dose. 
 
Dosing should be titrated as necessary to maintain the haemoglobin target. 
 
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that 
the dose is adjusted by approximately 25%. 
 
If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in four weeks reduce the dose by 
approximately 25%, depending on the rate of increase. If the haemoglobin exceeds 
12 g/dL (7.5 mmol/L), a dose reduction should be considered. If the haemoglobin continues to 
increase, the dose should be reduced by approximately 25%. If after a dose reduction, haemoglobin 
continues to increase, the dose should be temporarily withheld until the haemoglobin begins to 
decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous 
dose.  
 



 

 

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After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks. 
Dose changes in the maintenance phase of treatment should not be made more frequently than every 
two weeks. 
 
When changing the route of administration the same dose must be used and the haemoglobin 
monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the 
haemoglobin at the desired level.  
 
Clinical studies have demonstrated that adult patients receiving r-HuEPO one, two or three times 
weekly may be converted to once weekly or once every other week Aranesp. The initial weekly dose 
of Aranesp (mcg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) 
by 200. The initial every other week dose of Aranesp (mcg/every other week) can be determined by 
dividing the total cumulative dose of r-HuEPO administered over a two-week period by 200. Because 
of individual variability, titration to optimal therapeutic doses is expected for individual patients. 
When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two 
weeks and the same route of administration should be used. 
 
Paediatric population with chronic renal failure 
 
Treatment of paediatric patients younger than 1 year of age has not been studied in randomised clinical 
trials (see section 5.1). 
 
Correction phase: 
 
For patients ≥ 1 year of age, the initial dose by subcutaneous or intravenous administration is 
0.45 mcg/kg body weight, as a single injection once weekly. Alternatively, in patients not on dialysis, 
an initial dose of 0.75 mcg/kg may be administered subcutaneously as a single injection once every 
two weeks. If the increase in haemoglobin is inadequate (less than 1 g/dL (0.6 mmol/L) in four weeks) 
increase the dose by approximately 25%. Dose increases must not be made more frequently than once 
every four weeks.  
 
If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in four weeks reduce the dose by 
approximately 25%, depending on the rate of increase. If the haemoglobin exceeds 
12 g/dL (7.5 mmol/L), a dose reduction should be considered. If the haemoglobin continues to 
increase, the dose should be reduced by approximately 25%. If after a dose reduction, haemoglobin 
continues to increase, the dose should be temporarily withheld until the haemoglobin begins to 
decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous 
dose.  
 
The haemoglobin should be measured every one or two weeks until it is stable. Thereafter the 
haemoglobin can be measured at longer intervals.  
 
Correction of anaemia in paediatric patients with once monthly Aranesp dosing frequency has not 
been studied. 
 
Maintenance phase: 
 
For paediatric patients ≥ 1 year of age, in the maintenance phase, Aranesp may continue to be 
administered as a single injection once weekly or once every two weeks. Patients < 6 years of age may 
need higher doses for maintenance of haemoglobin than patients above that age. Dialysis patients 
converting from once weekly to once every other week dosing with Aranesp should initially receive a 
dose equivalent to twice the previous once weekly dose.  
 
In patients ≥ 11 years of age not on dialysis, once the target haemoglobin has been achieved with once 
every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial 
dose equal to twice the previous once every two week dose.  
 



 

 

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Clinical data in paediatric patients has demonstrated that patients receiving r-HuEPO two or three 
times weekly may be converted to once weekly Aranesp, and those receiving r-HuEPO once weekly 
may be converted to once every other week Aranesp. The initial weekly paediatric dose of Aranesp 
(mcg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 240. The 
initial every other week dose of Aranesp (mcg/every other week) can be determined by dividing the 
total cumulative dose of r-HuEPO administered over a two-week period by 240. Because of individual 
variability, titration to optimal therapeutic doses is expected for individual patients. When substituting 
Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same 
route of administration should be used. 
 
Dosing should be titrated as necessary to maintain the haemoglobin target.  
 
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that 
the dose is adjusted by approximately 25%.  
 
If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in four weeks reduce the dose by 
approximately 25%, depending on the rate of increase. If the haemoglobin exceeds 
12 g/dL (7.5 mmol/L), a dose reduction should be considered. If the haemoglobin continues to 
increase, the dose should be reduced by approximately 25%. If after a dose reduction, haemoglobin 
continues to increase, the dose should be temporarily withheld until the haemoglobin begins to 
decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous 
dose.  
 
Patients starting dialysis during treatment with Aranesp should be closely monitored for adequate 
control of their haemoglobin. 
 
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks. 
Dose changes in the maintenance phase of treatment should not be made more frequently than every 
two weeks. 
 
When changing the route of administration the same dose must be used and the haemoglobin 
monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the 
haemoglobin at the desired level.  
 
Treatment of symptomatic chemotherapy-induced anaemia in cancer patients 
 
Aranesp should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin 
concentration ≤ 10 g/dL (6.2 mmol/L)) in order to increase haemoglobin to not greater than 
12 g/dL (7.5 mmol/L). Anaemia symptoms and sequelae may vary with age, gender, and overall 
burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is 
necessary.  
 
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and 
below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed 
through dose management, with consideration for the haemoglobin target range of 
10 g/dL (6.2 mmol/L) to 12 g/dL (7.5 mmol/L). A sustained haemoglobin level of greater than 
12 g/dL (7.5 mmol/L) should be avoided; guidance for appropriate dose adjustments for when 
haemoglobin values exceeding 12 g/dL (7.5 mmol/L) are observed are described below.  
 
The recommended initial dose is 500 mcg (6.75 mcg/kg) given once every three weeks, or once 
weekly dosing can be given at 2.25 mcg/kg body weight. If the clinical response of the patient 
(fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective.  
 
Aranesp therapy should be discontinued approximately four weeks after the end of chemotherapy. 
 



 

 

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Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced 
by 25 to 50% in order to ensure that the lowest approved dose of Aranesp is used to maintain 
haemoglobin at a level that controls the symptoms of anaemia. Appropriate dose titration between 
500 mcg, 300 mcg, and 150 mcg should be considered.  
 
Patients should be monitored closely, if the haemoglobin exceeds 12 g/dL (7.5 mmol/L), the dose 
should be reduced by approximately 25 to 50%. Treatment with Aranesp should be temporarily 
discontinued if haemoglobin levels exceed 13 g/dL (8.1 mmol/L). Therapy should be reinitiated at 
approximately 25% lower than the previous dose after haemoglobin levels fall to 
12 g/dL (7.5 mmol/L) or below.  
 
If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in 4 weeks, the dose should be reduced 
by 25 to 50%. 
 
Method of administration 
 
Aranesp may be administered subcutaneously by the patient or a carer after being trained by a doctor, 
nurse or pharmacist. 
 
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in 
pre-filled syringe 
Aranesp is administered either subcutaneously or intravenously as described in the posology. 
Rotate the injection sites and inject slowly to avoid discomfort at the site of injection. 
Aranesp is supplied ready for use in a pre-filled syringe.  
 
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in 
pre-filled pen 
Aranesp in a pre-filled pen is only for subcutaneous administration. 
Rotate the injection sites to avoid discomfort at the site of injection. 
Aranesp is supplied ready for use in a pre-filled pen. 
 
Aranesp 25, 40, 60, 100, 200, 300 micrograms solution for injection in vial 
Aranesp is administered either subcutaneously or intravenously as described in the posology. 
Rotate the injection sites and inject slowly to avoid discomfort at the site of injection. 
Aranesp is supplied ready for use in a vial. 
 
The instructions for use, handling and disposal are given in section 6.6.  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Poorly controlled hypertension.  
 
4.4 Special warnings and precautions for use 
 
General  
 
In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the 
administered ESA should be clearly recorded (or stated) in the patient file. 
 
Blood pressure should be monitored in all patients, particularly during initiation of Aranesp therapy. If 
blood pressure is difficult to control by initiation of appropriate measures, the haemoglobin may be 
reduced by decreasing or withholding the dose of Aranesp (see section 4.2). Cases of severe 
hypertension, including hypertensive crisis, hypertensive encephalopathy, and seizures, have been 
observed in CRF patients treated with Aranesp. 
 



 

 

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In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and 
during treatment and supplementary iron therapy may be necessary. 
 
Non-response to therapy with Aranesp should prompt a search for causative factors. Deficiencies of 
iron, folic acid or vitamin B12 reduce the effectiveness of ESAs and should therefore be corrected. 
Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe 
aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis may also compromise 
the erythropoietic response. A reticulocyte count should be considered as part of the evaluation. If 
typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of 
the bone marrow should be considered. If the bone marrow is consistent with PRCA, testing for 
anti-erythropoietin antibodies should be performed. 
 
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic 
epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association 
with epoetin treatment. More severe cases have been observed with long-acting epoetins.  
At the time of prescription patients should be advised of the signs and symptoms and monitored 
closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Aranesp should 
be withdrawn immediately and an alternative treatment considered. If the patient has developed a 
severe cutaneous skin reaction such as SJS or TEN due to the use of Aranesp, treatment with Aranesp 
must not be restarted in this patient at any time. 
 
Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in 
association with ESAs, including Aranesp. This has been predominantly reported in patients with CRF 
treated subcutaneously. These antibodies have been shown to cross-react with all erythropoietic 
proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should 
not be switched to Aranesp (see section 4.8). 
 
A paradoxical decrease in haemoglobin and development of severe anaemia associated with low 
reticulocyte counts should prompt to discontinue treatment with epoetin and perform 
anti-erythropoietin antibody testing. Cases have been reported in patients with hepatitis C treated with 
interferon and ribavirin, when epoetins are used concomitantly. Epoetins are not approved in the 
management of anaemia associated with hepatitis C. 
 
Active liver disease was an exclusion criteria in all studies of Aranesp, therefore no data are available 
from patients with impaired liver function. Since the liver is thought to be the principal route of 
elimination of darbepoetin alfa and r-HuEPO, Aranesp should be used with caution in patients with 
liver disease. 
 
Aranesp should also be used with caution in those patients with sickle cell anaemia. 
 
Misuse of Aranesp by healthy persons may lead to an excessive increase in packed cell volume. This 
may be associated with life-threatening complications of the cardiovascular system. 
 
The needle cap of the pre-filled syringe or pre-filled pen contains dry natural rubber (a derivative of 
latex), which may cause allergic reactions. 
 
Aranesp should be used with caution in patients with epilepsy. Convulsions have been reported in 
patients receiving Aranesp. 
 
The reported risk of thrombotic vascular events (TVEs) should be carefully weighed against the 
benefits to be derived from treatment with darbepoetin alfa particularly in patients with pre-existing 
risk factors for TVE, including obesity and prior history of TVEs (e.g., deep venous thrombosis, 
pulmonary embolism, and cerebral vascular accident). 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
‘sodium-free’. 
 



 

 

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Chronic renal failure patients 
 
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the 
upper limit of the target haemoglobin concentration recommended in section 4.2. In clinical studies, an 
increased risk of death, serious cardiovascular or cerebrovascular events including stroke, and vascular 
access thrombosis was observed when ESAs were administered to target a haemoglobin of greater 
than 12 g/dL (7.5 mmol/L).  
 
Caution should be exercised with escalation of Aranesp doses in patients with chronic renal failure, 
since high cumulative epoetin doses may be associated with an increased risk of mortality, serious 
cardiovascular and cerebrovascular events. In patients with a poor haemoglobin response to epoetins, 
alternative explanations for the poor response should be considered (see sections 4.2 and 5.1). 
 
Controlled clinical trials have not shown significant benefits attributable to the administration of 
epoetins when haemoglobin concentration is increased beyond the level necessary to control 
symptoms of anaemia and to avoid blood transfusion.  
 
Supplementary iron therapy is recommended for all patients with serum ferritin values 
below 100 mcg/L or whose transferrin saturation is below 20%. 
 
Serum potassium levels should be monitored regularly during Aranesp therapy. Potassium elevation 
has been reported in a few patients receiving Aranesp, though causality has not been established. If an 
elevated or rising potassium level is observed then consideration should be given to ceasing Aranesp 
administration until the level has been corrected. 
 
Cancer patients 
 
Effect on tumour growth 
 
Epoetins are growth factors that primarily stimulate red blood cell production. Erythropoietin 
receptors may be expressed on the surface of a variety of tumour cells. As with all growth factors, 
there is a concern that epoetins could stimulate the growth of tumours. In several controlled studies, 
epoetins have not been shown to improve overall survival or decrease the risk of tumour progression 
in patients with anaemia associated with cancer.  
 
In controlled clinical studies, use of Aranesp and other ESAs have shown: 
 
 shortened time to tumour progression in patients with advanced head and neck cancer receiving 

radiation therapy when administered to target a haemoglobin of greater than 
14 g/dL (8.7 mmol/L), ESAs are not indicated for use in this patient population. 

 
 shortened overall survival and increased deaths attributed to disease progression at 4 months in 

patients with metastatic breast cancer receiving chemotherapy when administered to target a 
haemoglobin of 12-14 g/dL (7.5-8.7 mmol/L).  

 
 increased risk of death when administered to target a haemoglobin of 12 g/dL (7.5 mmol/L) in 

patients with active malignant disease receiving neither chemotherapy nor radiation therapy. 
ESAs are not indicated for use in this patient population. 

 
 an observed 9% increase in risk for PD or death in the epoetin alfa plus SOC group from a 

primary analysis and a 15% increased risk that cannot be statistically ruled out in patients with 
metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin 
concentration range of 10 to 12 g/dL (6.2 to 7.5 mmol/L). 

 
 non-inferiority of darbepoetin alfa to placebo for overall survival and progression free survival 

in patients with advanced stage non-small cell lung cancer receiving chemotherapy when 
administered to a target haemoglobin of 12 g/dL (7.5 mmol/L) (see section 5.1).  



 

 

12

 
In view of the above, in some clinical situations blood transfusion should be the preferred treatment 
for the management of anaemia in patients with cancer. The decision to administer recombinant 
erythropoietins should be based on a benefit-risk assessment with the participation of the individual 
patient, which should take into account the specific clinical context. Factors that should be considered 
in this assessment should include the type of tumour and its stage; the degree of anaemia; 
life-expectancy; the environment in which the patient is being treated; and patient preference (see 
section 5.1). 
 
In patients with solid tumours or lymphoproliferative malignancies, if the haemoglobin value exceeds 
12 g/dL (7.5 mmol/L), the dosage adaptation described in section 4.2 should be closely respected, in 
order to minimise the potential risk of thromboembolic events. Platelet counts and haemoglobin level 
should also be monitored at regular intervals. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
The clinical results obtained so far do not indicate any interaction of darbepoetin alfa with other 
substances. However, there is potential for an interaction with substances that are highly bound to red 
blood cells e.g. cyclosporin, tacrolimus. If Aranesp is given concomitantly with any of these 
treatments, blood levels of these substances should be monitored and the dosage adjusted as the 
haemoglobin rises. 
 
4.6 Pregnancy and lactation 
 
Pregnancy 
 
There are no adequate and well-controlled studies with Aranesp in pregnant women. 
 
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal 
development, parturition or postnatal development. No alteration of fertility was detected. 
 
Caution should be exercised when prescribing Aranesp to pregnant women. 
 
Breast-feeding 
 
It is unknown whether Aranesp is excreted in human milk. A risk to the suckling child cannot be 
excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain 
from Aranesp therapy taking into account the benefit of breast-feeding for the child and the benefit of 
therapy for the woman. 
 
4.7 Effects on ability to drive and use machines 
 
Aranesp has no or negligible influence on the ability to drive and use machines.  
 
4.8 Undesirable effects 
 
Summary of the safety profile  
 
Identified adverse reactions associated with Aranesp are hypertension, stroke, thromboembolic events, 
convulsions, allergic reactions, rash/erythema and pure red cell aplasia (PRCA); see section 4.4. 
 
Injection site pain was reported as attributable to treatment in studies where Aranesp was administered 
via subcutaneous injection. The injection site discomfort was generally mild and transient in nature 
and occurred predominantly after the first injection.  
 



 

 

13

Tabulated list of adverse reactions 
 
Incidence of adverse reactions are listed below by system organ class and frequency. Frequencies are 
defined as: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare 
(≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available 
data). 
 
Data are presented separately for CRF and cancer patients reflecting the different adverse reaction 
profile in these populations.  
 
Chronic renal failure patients 
 
Data presented from controlled studies included 1,357 patients, 766 who received Aranesp and 
591 patients who received r-HuEPO. In the Aranesp group, 83% were receiving dialysis and 17% 
were not receiving dialysis. Stroke was identified as an adverse reaction in an additional clinical study 
(TREAT, see section 5.1).  
 
Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: 
 
MedDRA system organ class Subject incidence Adverse reaction 
Blood and lymphatic system 
disorders 

Not known2 Pure red cell aplasia 

Immune system disorders Very common Hypersensitivitya 
Nervous system disorders Common Strokeb

Uncommon1 Convulsions 
Cardiac disorders Very common Hypertension 
Vascular disorders Uncommon Thromboembolic eventsc 

Uncommon1 Dialysis vascular access 
thrombosisd  

Skin and subcutaneous tissue 
disorders 

Common Rash/erythemae 
Not known2 SJS/TEN, erythema multiforme, 

blistering, skin exfoliation
General disorders and administration 
site conditions 

Common Injection site pain 
Uncommon1 Injection site bruising 

Injection site haemorrhage
Source: Includes 5 randomised, double-blind, active-controlled studies (970200, 970235, 980117, 980202, and 
980211) except for the adverse reaction of stroke which was identified as an adverse reaction in the TREAT 
study (study 20010184). 
1 Adverse reactions identified in the post-marketing environment. Per the Guideline on Summary of Product 
Characteristics (Revision 2, September 2009), frequency of adverse reactions identified in the post-marketing 
setting was determined using the “Rule of three”. 
2 Frequency cannot be estimated from the available data. 
a Hypersensitivity events includes all events under the hypersensitivity SMQ. 
b Stroke events includes PT haemorrhagic stroke, ischaemic stroke, cerebrovascular accident, and stroke in 
evolution. 
c Thromboembolic events adverse reaction includes PT embolism arterial, thrombophlebitis, thrombosis, venous 
thrombosis limb. 
d Dialysis vascular access thrombosis includes all adverse reactions under the dialysis vascular access thrombosis 
AMQ 
e Rash/erythema adverse reaction includes PT rash, rash pruritic, rash macular, rash generalised, erythema. 
 
Cancer patients 
 
Adverse reactions were determined based on pooled data from eight randomised, double-blind, 
placebo-controlled studies of Aranesp with a total of 4,630 patients (Aranesp 2,888, placebo 1,742). 
Patients with solid tumours (e.g., lung, breast, colon, ovarian cancers) and lymphoid malignancies 
(e.g., lymphoma, multiple myeloma) were enrolled in the clinical studies. 
 



 

 

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Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: 
 
MedDRA system organ class Subject incidence Adverse reaction 
Immune system disorders Very common Hypersensitivitya 
Nervous system disorders Uncommon1 Convulsions 
Cardiac disorders Common Hypertension 
Vascular disorders Common  Thromboembolic eventsb, 

including pulmonary embolism
Skin and subcutaneous tissue 
disorders 

Common Rash/erythemac 
Not known2 SJS/TEN, erythema multiforme, 

blistering, skin exfoliation
General disorders and administration 
site conditions 

Common Oedemad 
Common Injection site paine 
Uncommon1 Injection site bruising 

Injection site haemorrhage
1 ADRs identified in the post marketing environment. Per the Guideline on Summary of Product Characteristics 
(Revision 2, September 2009), frequency of ADRs identified in the post marketing setting was determined using 
the “Rule of three”. 
2 Frequency cannot be estimated from the available data. 
Source: includes 8 randomised, double-blind, placebo-controlled studies (980291-schedule 1 and 2, 980297, 
990114, 20000161, 20010145, 20030232, and 20070782) 
a Hypersensitivity events includes all events under the hypersensitivity SMQ. 
b Thromboembolic events adverse reactions includes PT embolism, thrombosis, deep vein thrombosis, jugular 
vein thrombosis, venous thrombosis, arterial thrombosis, pelvic venous thrombosis, peripheral embolism, 
pulmonary embolism, as well as thrombosis in device from SOC product issues. 
c Rash adverse reactions includes PT rash, rash pruritic, rash generalised, rash papular, erythema, exfoliative 
rash, rash maculo-papular, rash vesicular as well as rash pustular from SOC Infections and Infestations. 
d Oedema: includes PT Oedema Peripheral, Oedema, Generalised Oedema, Oedema due to Cardiac Disease, 
Face oedema 
e Injection site pain adverse reaction includes PT injection site pain, administration site pain, catheter site pain, 
infusion site pain and vessel puncture site pain. 
 
Description of selected adverse reactions 
 
Chronic renal failure patients 
 
Stroke was reported as common in CRF patients in TREAT (see section 5.1). 
 
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) 
associated with Aranesp therapy have been reported predominantly in patients with CRF treated 
subcutaneously. In case PRCA is diagnosed, therapy with Aranesp must be discontinued and patients 
should not be switched to another recombinant erythropoietic protein (see section 4.4). 
 
The frequency of all hypersensitivity reactions was estimated from clinical trial data as very common 
in CRF patients. Hypersensitivity reactions were also very common in the placebo groups. There have 
been reports, from post-marketing experience, of serious hypersensitivity reactions including 
anaphylactic reaction, angioedema, allergic bronchospasm, skin rash and urticaria associated with 
darbepoetin alfa. 
 
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic 
epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported (see 
section 4.4). 
 
Convulsions have been reported in patients receiving darbepoetin alfa (see section 4.4). The frequency 
is estimated from clinical trial data as uncommon in CRF patients.  
 



 

 

15

In CRF patients on haemodialysis, events of vascular access thrombosis (such as vascular access 
complication, arteriovenous fistula thrombosis, graft thrombosis, shunt thrombosis, arteriovenous fistula 
site complication, etc.) have been reported in post-marketing data. The frequency is estimated from 
clinical trial data as uncommon.  
 
Cancer patients 
 
Hypertension has been observed in cancer patients in post-marketing experience (see section 4.4). The 
frequency is estimated from clinical trial data as common in cancer patients and was also common in 
the placebo groups. 
 
Hypersensitivity reactions have been observed in cancer patients in post-marketing experience. The 
frequency of all hypersensitivity reactions was estimated from clinical trial data as very common in 
cancer patients. Hypersensitivity reactions were also very common in the placebo groups. There have 
been reports of serious hypersensitivity reactions including anaphylactic reaction, angioedema, allergic 
bronchospasm, skin rash and urticaria associated with darbepoetin alfa.  
 
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic 
epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported (see 
section 4.4). 
 
Convulsions have been reported in patients receiving darbepoetin alfa in post-marketing experience 
(see section 4.4). The frequency is estimated from clinical trial data as uncommon in cancer patients. 
Convulsions were common in the placebo groups. 
 
Paediatric chronic renal failure population 
 
In all paediatric CRF studies, there were no additional adverse reactions identified for paediatric 
patients compared to those previously reported for adult patients (see section 5.1).  
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
The maximum amount of Aranesp that can be safely administered in single or multiple doses has not 
been determined. Therapy with Aranesp can result in polycythaemia if the haemoglobin is not 
carefully monitored and the dose appropriately adjusted. Cases of severe hypertension have been 
observed following overdose with Aranesp (see section 4.4). 
 
In the event of polycythaemia, Aranesp should be temporarily withheld (see section 4.2). If clinically 
indicated, phlebotomy may be performed. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anti-anaemic preparations, other anti-anaemic preparations, ATC Code: 
B03XA02. 
 



 

 

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Mechanism of action 
 
Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of 
erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor 
cells in the bone marrow. The production of erythropoietin primarily occurs in and is regulated by the 
kidney in response to changes in tissue oxygenation. Production of endogenous erythropoietin is 
impaired in patients with chronic renal failure and the primary cause of their anaemia is due to 
erythropoietin deficiency. In patients with cancer receiving chemotherapy the etiology of anaemia is 
multifactorial. In these patients, erythropoietin deficiency and a reduced response of erythroid 
progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia. 
 
Pharmacodynamic effects 
 
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone. 
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and 
recombinant human erythropoietins (r-HuEPO) have three. The additional sugar residues are 
molecularly indistinct from those on the endogenous hormone. Due to its increased carbohydrate 
content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater 
in vivo activity. Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for 
the erythropoietin receptor. 
 
Clinical efficacy and safety 
 
Chronic renal failure patients 
 
Patients with CRF experienced greater risks for death and serious cardiovascular events when 
administered ESAs to target higher versus lower haemoglobin levels (13.5 g/dL (8.4 mmol/L) versus 
11.3 g/dL (7.1 mmol/L); 14 g/dL (8.7 mmol/L) versus 10 g/dL (6.2 mmol/L) in two clinical studies. 
 
In a randomised, double-blind correction study (n = 358) comparing once every two week and once 
monthly dosing schedules in patients with CRF not on dialysis, darbepoetin alfa once monthly dosing 
was non-inferior to once every two week dosing for correcting anaemia. The median (quartile 1, 
quartile 3) time to achieve haemoglobin correction (≥ 10.0 g/dL and ≥ 1.0 g/dL increase from 
baseline) was 5 weeks for both once every two week (3, 7 weeks) and once monthly dosing (3, 
9 weeks). During the evaluation period (weeks 29-33), the mean (95% CI) weekly equivalent dose was 
0.20 (0.17, 0.24) mcg/kg in the once every two week arm and 0.27 (0.23, 0.32) mcg/kg in the once 
monthly arm. 
 
In a randomised, double-blind, placebo-controlled study (TREAT) of 4,038 CRF patients not on 
dialysis with type 2 diabetes and haemoglobin levels ≤ 11 g/dL, patients received either treatment with 
darbepoetin alfa to target haemoglobin levels of 13 g/dL or placebo (with darbepoetin alfa rescue at 
haemoglobin less than 9 g/dL). The study did not meet either primary objective of demonstrating a 
reduction in risk for all-cause mortality or cardiovascular morbidity (darbepoetin alfa vs placebo; 
HR 1.05, 95% CI (0.94, 1.17)), or all-cause mortality or end stage renal disease (ESRD) (darbepoetin 
alfa vs placebo; HR 1.06, 95% CI (0.95, 1.19)). Analysis of the individual components of the 
composite endpoints showed the following HR (95% CI): death 1.05 (0.92, 1.21), congestive heart 
failure (CHF) 0.89 (0.74, 1.08), myocardial infarction (MI) 0.96 (0.75, 1.23), stroke 1.92 (1.38, 2.68), 
hospitalisation for myocardial ischaemia 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18). 
 
Pooled post-hoc analyses of clinical studies of ESAs have been performed in chronic renal 
failure patients (on dialysis, not on dialysis, in diabetic and non-diabetic patients). A tendency towards 
increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated 
with higher cumulative ESA doses independent of the diabetes or dialysis status was observed (see 
sections 4.2 and 4.4).  
 



 

 

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Paediatric population 
 
In a randomised clinical study 114 paediatric patients aged 2 to 18 with chronic kidney disease 
receiving or not receiving dialysis who were anaemic (haemoglobin < 10.0 g/dL) and not being treated 
with an ESA were administered darbepoetin alfa weekly (n = 58) or once every two weeks (n = 56) for 
the correction of anaemia. Haemoglobin concentrations were corrected to ≥ 10 g/dL in > 98% 
(p < 0.001) of paediatric patients administered darbepoetin alfa once weekly and 84% (p = 0.293) once 
every two weeks. At the time haemoglobin ≥ 10.0 g/dL was first achieved, the mean (SD) weight-
adjusted dose was 0.48 (0.24) mcg/kg (range: 0.0 to 1.7 mcg/kg) weekly for the once weekly group 
and 0.76 (0.21) mcg/kg (range: 0.3 to 1.5 mcg/kg) biweekly for the once every two week group. 
 
In a clinical study in 124 paediatric patients with chronic kidney disease receiving or not receiving 
dialysis aged 1 to 18, patients that were stable on epoetin alfa were randomised to receive either 
darbepoetin alfa administered once weekly (subcutaneously or intravenously) using a dose conversion 
ratio of 238:1 or to continue with epoetin alfa therapy at the current dose, schedule, and route of 
administration. The primary efficacy endpoint [change in haemoglobin between baseline and the 
evaluation period (week 21-28)] was comparable between the two groups. The mean haemoglobin for 
r-HuEPO and darbepoetin alfa at baseline was 11.1 (SD 0.7) g/dL and 11.3 (SD 0.6) g/dL, 
respectively. The mean haemoglobin at week 28 for r-HuEPO and darbepoetin alfa was 11.1 (SD 
1.4) g/dL and 11.1 (SD 1.1) g/dL, respectively. 
 
In an European observational registry study which enrolled 319 paediatric patients with chronic 
kidney disease (13 (4.1%) patients < 1 year of age, 83 (26.0%) patients 1-< 6 years of age, 90 (28.2%) 
patients 6-< 12 years of age, and 133 (41.7%) patients ≥ 12 years of age) receiving darbepoetin alfa, 
mean haemoglobin concentrations ranging between 11.3 and 11.5 g/dL and mean weight-adjusted 
darbepoetin alfa doses remained relatively constant (between 2.31 mcg/kg month and 2.67 mcg/kg 
month) over the study period for the entire study population. 
 
In these studies, no meaningful differences were identified between the safety profile for paediatric 
patients and that previously reported for adult patients (see section 4.8). 
 
Cancer patients receiving chemotherapy 
 
EPO-ANE-3010, a randomised, open-label, multicentre study was conducted in 2,098 anaemic women 
with metastatic breast cancer, who received first line or second line chemotherapy. This was a non 
inferiority study designed to rule out a 15% risk increase in tumour progression or death of epoetin 
alfa plus standard of care (SOC) as compared with SOC alone. At the time of clinical data cutoff, the 
median progression free survival (PFS) per investigator assessment of disease progression was 
7.4 months in each arm (HR 1.09, 95% CI: 0.99, 1.20), indicating the study objective was not met. 
Significantly fewer patients received RBC transfusions in the epoetin alfa plus SOC arm (5.8% versus 
11.4%); however, significantly more patients had thrombotic vascular events in the epoetin alfa plus 
SOC arm (2.8% versus 1.4%). At the final analysis, 1,653 deaths were reported. Median overall 
survival in the epoetin alfa plus SOC group was 17.8 months compared with 18.0 months in the SOC 
alone group (HR 1.07, 95% CI: 0.97, 1.18). The median time to progression (TTP) based on 
investigator-determined progressive disease (PD) was 7.5 months in the epoetin alfa plus SOC group 
and 7.5 months in the SOC group (HR 1.099, 95% CI: 0.998, 1.210). The median TTP based on IRC-
determined PD was 8.0 months in the epoetin alfa plus SOC group and 8.3 months in the SOC group 
(HR 1.033, 95% CI: 0.924, 1.156). 
 
In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer 
patients receiving platinum containing chemotherapy there was a significant reduction in transfusion 
requirements (p < 0.001).  
 
Clinical studies have demonstrated that darbepoetin alfa had similar effectiveness when administered 
as a single injection either once every three weeks, once every two weeks, or weekly without any 
increase in total dose requirements.  
 



 

 

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The safety and effectiveness of once every three weeks dosing of Aranesp therapy in reducing the 
requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a 
randomised, double-blind, multinational study. This study was conducted in 705 anaemic patients with 
non-myeloid malignancies receiving multi-cycle chemotherapy. Patients were randomised to receive 
Aranesp at 500 mcg once every three weeks or 2.25 mcg/kg once weekly. In both groups, the dose was 
reduced by 40% of the previous dose (e.g., for first dose reduction, to 300 mcg in the once every three 
weeks group and 1.35 mcg/kg in the once weekly group) if haemoglobin increased by more than 
1 g/dL in a 14-day period. In the once every three weeks group, 72% of patients required dose 
reductions. In the once weekly group, 75% of patients required dose reductions. This study supports 
500 mcg once every three weeks being comparable to once weekly administration with respect to the 
incidence of subjects receiving at least one red blood cell transfusion from week 5 to the end of 
treatment phase. 
 
In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic 
patients with lymphoproliferative malignancies receiving chemotherapy there was a significant 
reduction in transfusion requirements and an improvement in haemoglobin response (p < 0.001). 
Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue 
(FACT-fatigue) scale, was also observed. 
 
Erythropoietin is a growth factor that primarily stimulates red blood cell production. Erythropoietin 
receptors may be expressed on the surface of a variety of tumour cells. 
 
Survival and tumour progression have been examined in five large controlled studies involving a total 
of 2,833 patients, of which four were double-blind placebo-controlled studies and one was an 
open-label study. Two of the studies recruited patients who were being treated with chemotherapy. 
The target haemoglobin concentration in two studies was > 13 g/dL; in the remaining three studies it 
was 12-14 g/dL. In the open-label study there was no difference in overall survival between patients 
treated with recombinant human erythropoietin and controls. In the four placebo-controlled studies the 
hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls. These studies 
have shown a consistent unexplained statistically significant excess mortality in patients who have 
anaemia associated with various common cancers who received recombinant human erythropoietin 
compared to controls. Overall survival outcome in the trials could not be satisfactorily explained by 
differences in the incidence of thrombosis and related complications between those given recombinant 
human erythropoietin and those in the control group. 
 
In a randomised, double-blind, placebo-controlled phase 3 study 2,549 adult patients with anaemia 
receiving chemotherapy for the treatment of advanced stage non-small cell lung cancer (NSCLC), 
were randomised 2:1 to darbepoetin alfa or placebo and treated to a maximum Hb of 12 g/dL. The 
results showed non-inferiority for the primary endpoint of overall survival with a median survival for 
darbepoetin alfa versus placebo of 9.5 and 9.3 months, respectively (stratified HR 0.92; 95% CI: 0.83–
1.01). The secondary endpoint of progression free survival was 4.8 and 4.3 months, respectively 
(stratified HR 0.95; 95% CI: 0.87–1.04), ruling out the pre-defined 15% risk increase. 
 
A systematic review has also been performed involving more than 9,000 cancer patients participating 
in 57 clinical trials. Meta-analysis of overall survival data produced a hazard ratio point estimate of 
1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8,167 patients).  
 
An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06; 35 trials and 
6,769 patients) was observed in patients treated with recombinant human erythropoietin. There is 
therefore consistent evidence to suggest that there may be significant harm to patients with cancer who 
are treated with recombinant human erythropoietin. The extent to which these outcomes might apply 
to the administration of recombinant human erythropoietin to patients with cancer, treated with 
chemotherapy to achieve haemoglobin concentrations less than 13 g/dL, is unclear because few 
patients with these characteristics were included in the data reviewed.  
 



 

 

19

A patient-level data analysis has also been performed on more than 13,900 cancer patients (chemo-, 
radio-, chemoradio-, or no therapy) participating in 53 controlled clinical trials involving several 
epoetins. Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in 
favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for the cancer patients 
receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 
10,441 patients). Meta-analyses also indicate consistently a significantly increased relative risk of 
thromboembolic events in cancer patients receiving recombinant human erythropoietin (see 
section 4.4).  
 
5.2 Pharmacokinetic properties 
 
Due to its increased carbohydrate content the level of darbepoetin alfa in the circulation remains above 
the minimum stimulatory concentration for erythropoiesis for longer than the equivalent molar dose of 
r-HuEPO, allowing darbepoetin alfa to be administered less frequently to achieve the same biological 
response. 
  
Chronic renal failure patients 
 
The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients 
following intravenous and subcutaneous administration. The terminal half-life of darbepoetin alfa is 
21 hours (SD 7.5) when administered intravenously. Clearance of darbepoetin alfa is 1.9 mL/hr/kg 
(SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 mL/kg). 
Bioavailability is 37% with subcutaneous administration. Following monthly administration of 
darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 mcg/kg, the terminal half-life was 
73 hours (SD 24). The longer terminal half-life of darbepoetin alfa administered subcutaneously 
compared to intravenously is due to subcutaneous absorption kinetics. In clinical studies, minimal 
accumulation was observed with either route of administration. In preclinical studies it has been 
shown that renal clearance is minimal (up to 2% of total clearance), and does not affect the serum 
half-life.  
 
Data from 809 patients receiving Aranesp in European clinical studies were analysed to assess the 
dose required to maintain haemoglobin; no difference was observed between the average weekly dose 
administered via the intravenous or subcutaneous routes of injection.  
 
The pharmacokinetics of darbepoetin alfa in paediatric patients (2 to 16 years) with CRF who were 
either receiving or not receiving dialysis was assessed for sampling periods up to 2 weeks (336 hours) 
after one or two subcutaneous or intravenous doses. Where the same sampling duration was used, 
observed pharmacokinetic data and population pharmacokinetic modelling demonstrated that the 
pharmacokinetics of darbepoetin alfa was similar for paediatric and adult patients with CRF. 
 
In a phase 1 pharmacokinetic study, following intravenous administration, an approximate 25% 
difference between paediatric and adult patients in the area under the curve from time 0 to infinity 
(AUC[0-∞]) was observed; however, this difference was less than the 2-fold range in AUC(0-∞) 
observed for the paediatric patients. AUC(0-∞) was similar between adult and paediatric patients with 
CRF following subcutaneous administration. Half-life was also similar between adult and paediatric 
patients with CRF following both intravenous and subcutaneous administration.  
 
Cancer patients receiving chemotherapy 
 
Following subcutaneous administration of 2.25 mcg/kg to adult cancer patients a mean peak 
concentration of 10.6 ng/mL (SD 5.9) of darbepoetin alfa was reached at a mean time of 91 hours 
(SD 19.7). These parameters were consistent with dose linear pharmacokinetics over a wide dose 
range (0.5 to 8 mcg/kg weekly and 3 to 9 mcg/kg every two weeks). Pharmacokinetic parameters did 
not change on multiple dosing over 12 weeks (dosing every week or every two weeks). There was an 
expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no 
unexpected accumulation upon repeated administration. A pharmacokinetic study in patients with 
chemotherapy-induced anaemia treated with 6.75 mcg/kg darbepoetin alfa administered SC every 



 

 

20

3 weeks in combination with chemotherapy was conducted which allowed for full characterisation of 
the terminal half-life. In this study, mean (SD) terminal half-life was 74 (SD 27) hours. 
 
5.3 Preclinical safety data 
 
In all studies in rats and dogs darbepoetin alfa produced marked increases in haemoglobin, 
haematocrits, red blood cell counts and reticulocytes, which correspond to the expected 
pharmacological effects. Adverse events at very high doses were all considered to be related to an 
exaggerated pharmacological effect (decreased tissue perfusion due to increased blood viscosity). 
These included myelofibrosis and splenic hypertrophy as well as broadening of the ECG-QRS 
complex in dogs but no dysrhythmia and no effect on the QT interval were observed. 
 
Darbepoetin alfa did not reveal any genotoxic potential nor did it have any effect on the proliferation 
of non-haematological cells in vitro or in vivo. In the chronic toxicity studies no tumourigenic or 
unexpected mitogenic responses were observed in any tissue type. The carcinogenic potential of 
darbepoetin alfa has not been evaluated in long-term animal studies. 
 
In studies performed in rats and rabbits no clinically relevant evidence of harmful effects with respect 
to pregnancy, embryonal/ foetal development, parturition or postnatal development was observed. 
Placental transfer was minimal. No alteration of fertility was detected.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium phosphate monobasic 
Sodium phosphate dibasic 
Sodium chloride 
Polysorbate 80 
Water for injections 
 
6.2 Incompatibilities 
 
In the absence of incompatibility studies, this medicinal product must not be mixed or administered as 
an infusion with other medicinal products. 
 
6.3 Shelf life 
 
3 years.  
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C - 8°C).  
Do not freeze.  
Keep the container in the outer carton in order to protect from light.  
 
For the purpose of ambulatory use, Aranesp may be removed from storage once for a maximum single 
period of seven days at room temperature (up to 25ºC). Once removed from the refrigerator and has 
reached room temperature (up to 25ºC) it must either be used within 7 days or disposed of. 
 
6.5 Nature and contents of container 
 
Aranesp 10 micrograms solution for injection in pre-filled syringe 
0.4 mL solution for injection (25 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 



 

 

21

Aranesp 15 micrograms solution for injection in pre-filled syringe 
0.375 mL solution for injection (40 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
Aranesp 20 micrograms solution for injection in pre-filled syringe 
0.5 mL solution for injection (40 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
Aranesp 30 micrograms solution for injection in pre-filled syringe 
0.3 mL solution for injection (100 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
Aranesp 40 micrograms solution for injection in pre-filled syringe 
0.4 mL solution for injection (100 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
Aranesp 50 micrograms solution for injection in pre-filled syringe 
0.5 mL solution for injection (100 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
Aranesp 60 micrograms solution for injection in pre-filled syringe 
0.3 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
Aranesp 80 micrograms solution for injection in pre-filled syringe 
0.4 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
Aranesp 100 micrograms solution for injection in pre-filled syringe 
0.5 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
Aranesp 130 micrograms solution for injection in pre-filled syringe 
0.65 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
Aranesp 150 micrograms solution for injection in pre-filled syringe 
0.3 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
Aranesp 300 micrograms solution for injection in pre-filled syringe 
0.6 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
Aranesp 500 micrograms solution for injection in pre-filled syringe 
1 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with 
stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes. 
 
The syringes may be presented in either blistered (1- and 4-pack), with or without an automatic needle 
guard or non-blistered packaging (1-pack only).  
 
The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex). See 
section 4.4. 
 
Aranesp 10 micrograms solution for injection in pre-filled pen 
0.4 mL solution for injection (25 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
Aranesp 15 micrograms solution for injection in pre-filled pen 
0.375 mL solution for injection (40 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
Aranesp 20 micrograms solution for injection in pre-filled pen 
0.5 mL solution for injection (40 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
Aranesp 30 micrograms solution for injection in pre-filled pen 
0.3 mL solution for injection (100 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 



 

 

22

Aranesp 40 micrograms solution for injection in pre-filled pen 
0.4 mL solution for injection (100 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
Aranesp 50 micrograms solution for injection in pre-filled pen 
0.5 mL solution for injection (100 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
Aranesp 60 micrograms solution for injection in pre-filled pen 
0.3 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
Aranesp 80 micrograms solution for injection in pre-filled pen 
0.4 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
Aranesp 100 micrograms solution for injection in pre-filled pen 
0.5 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
Aranesp 130 micrograms solution for injection in pre-filled pen 
0.65 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
Aranesp 150 micrograms solution for injection in pre-filled pen 
0.3 mL solution for injection (500 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
Aranesp 300 micrograms solution for injection in pre-filled pen 
0.6 mL solution for injection (500 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass 
syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
Aranesp 500 micrograms solution for injection in pre-filled pen 
1 mL solution for injection (500 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe 
and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens. 
 
The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex). See section 4.4. 
 
Aranesp 25 micrograms solution for injection in vial 
1 mL solution for injection (25 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer 
laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials. 
Aranesp 40 micrograms solution for injection in vial 
1 mL solution for injection (40 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer 
laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials. 
Aranesp 60 micrograms solution for injection in vial 
1 mL solution for injection (60 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer 
laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials. 
Aranesp 100 micrograms solution for injection in vial 
1 mL solution for injection (100 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer 
laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials. 
Aranesp 200 micrograms solution for injection in vial 
1 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer 
laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials. 
Aranesp 300 micrograms solution for injection in vial 
1 mL solution for injection (300 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer 
laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The carton contains a package leaflet with the full instructions for use and handling. 
 
The Aranesp (SureClick) pre-filled pen delivers the complete dose of each presentation. 
 



 

 

23

Aranesp is a sterile but unpreserved product. Do not administer more than one dose. Any medicinal 
product remaining should be disposed of. 
 
Before administration the Aranesp solution should be inspected for visible particles. Only solutions 
which are colourless, clear or slightly opalescent, should be injected. Do not shake. Allow the 
container to reach room temperature before injecting.  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
Aranesp 10 micrograms solution for injection pre-filled syringe 
EU/1/01/185/001 1 Pack Blister 
EU/1/01/185/002 4 Pack Blister 
EU/1/01/185/033 1 Pack Unblistered 
EU/1/01/185/074 1 blister pack with needle guard 
EU/1/01/185/075 4 blister pack with needle guard 
Aranesp 15 micrograms solution for injection pre-filled syringe 
EU/1/01/185/003 1 Pack Blister 
EU/1/01/185/004 4 Pack Blister 
EU/1/01/185/034 1 Pack Unblistered 
EU/1/01/185/076 1 blister pack with needle guard 
EU/1/01/185/077 4 blister pack with needle guard 
Aranesp 20 micrograms solution for injection pre-filled syringe 
EU/1/01/185/005 1 Pack Blister 
EU/1/01/185/006 4 Pack Blister 
EU/1/01/185/035 1 Pack Unblistered 
EU/1/01/185/078 1 blister pack with needle guard 
EU/1/01/185/079 4 blister pack with needle guard 
Aranesp 30 micrograms solution for injection pre-filled syringe 
EU/1/01/185/007 1 Pack Blister 
EU/1/01/185/008 4 Pack Blister 
EU/1/01/185/036 1 Pack Unblistered 
EU/1/01/185/080 1 blister pack with needle guard 
EU/1/01/185/081 4 blister pack with needle guard 
Aranesp 40 micrograms solution for injection pre-filled syringe 
EU/1/01/185/009 1 Pack Blister 
EU/1/01/185/010 4 Pack Blister 
EU/1/01/185/037 1 Pack Unblistered 
EU/1/01/185/082 1 blister pack with needle guard 
EU/1/01/185/083 4 blister pack with needle guard 
Aranesp 50 micrograms solution for injection pre-filled syringe 
EU/1/01/185/011 1 Pack Blister 
EU/1/01/185/012 4 Pack Blister 
EU/1/01/185/038 1 Pack Unblistered 
EU/1/01/185/084 1 blister pack with needle guard 
EU/1/01/185/085 4 blister pack with needle guard 



 

 

24

Aranesp 60 micrograms solution for injection pre-filled syringe 
EU/1/01/185/013 1 Pack Blister 
EU/1/01/185/014 4 Pack Blister 
EU/1/01/185/039 1 Pack Unblistered 
EU/1/01/185/086 1 blister pack with needle guard 
EU/1/01/185/087 4 blister pack with needle guard 
Aranesp 80 micrograms solution for injection pre-filled syringe 
EU/1/01/185/015 1 Pack Blister 
EU/1/01/185/016 4 Pack Blister 
EU/1/01/185/040 1 Pack Unblistered 
EU/1/01/185/088 1 blister pack with needle guard 
EU/1/01/185/089 4 blister pack with needle guard 
Aranesp 100 micrograms solution for injection pre-filled syringe 
EU/1/01/185/017 1 Pack Blister 
EU/1/01/185/018 4 Pack Blister 
EU/1/01/185/041 1 Pack Unblistered 
EU/1/01/185/090 1 blister pack with needle guard 
EU/1/01/185/091 4 blister pack with needle guard 
Aranesp 130 micrograms solution for injection pre-filled syringe 
EU/1/01/185/069 1 Pack Blister 
EU/1/01/185/070 4 Pack Blister 
EU/1/01/185/071 1 Pack Unblistered 
EU/1/01/185/092 1 blister pack with needle guard 
EU/1/01/185/093 4 blister pack with needle guard 
Aranesp 150 micrograms solution for injection pre-filled syringe 
EU/1/01/185/019 1 Pack Blister 
EU/1/01/185/020 4 Pack Blister 
EU/1/01/185/042 1 Pack Unblistered 
EU/1/01/185/094 1 blister pack with needle guard 
EU/1/01/185/095 4 blister pack with needle guard 
Aranesp 300 micrograms solution for injection pre-filled syringe 
EU/1/01/185/021 1 Pack Blister 
EU/1/01/185/022 4 Pack Blister 
EU/1/01/185/043 1 Pack Unblistered 
EU/1/01/185/096 1 blister pack with needle guard 
EU/1/01/185/097 4 blister pack with needle guard 
Aranesp 500 micrograms solution for injection pre-filled syringe 
EU/1/01/185/031 1 Pack Blister 
EU/1/01/185/032 4 Pack Blister 
EU/1/01/185/044 1 Pack Unblistered 
EU/1/01/185/098 1 blister pack with needle guard 
EU/1/01/185/099 4 blister pack with needle guard 
Aranesp 10 micrograms solution for injection pre-filled pen 
EU/1/01/185/045 – 1 pack 
EU/1/01/185/057 – 4 pack 
Aranesp 15 micrograms solution for injection pre-filled pen 
EU/1/01/185/046 – 1 pack 
EU/1/01/185/058 – 4 pack 
Aranesp 20 micrograms solution for injection pre-filled pen 
EU/1/01/185/047 – 1 pack 
EU/1/01/185/059 – 4 pack 
Aranesp 30 micrograms solution for injection pre-filled pen 
EU/1/01/185/048 – 1 pack 
EU/1/01/185/060 – 4 pack 
Aranesp 40 micrograms solution for injection pre-filled pen 
EU/1/01/185/049 – 1 pack 
EU/1/01/185/061 – 4 pack 



 

 

25

Aranesp 50 micrograms solution for injection pre-filled pen 
EU/1/01/185/050 – 1 pack 
EU/1/01/185/062 – 4 pack 
Aranesp 60 micrograms solution for injection pre-filled pen 
EU/1/01/185/051 – 1 pack 
EU/1/01/185/063 – 4 pack 
Aranesp 80 micrograms solution for injection pre-filled pen 
EU/1/01/185/052 – 1 pack 
EU/1/01/185/064 – 4 pack 
Aranesp 100 micrograms solution for injection pre-filled pen 
EU/1/01/185/053 – 1 pack 
EU/1/01/185/065 – 4 pack 
Aranesp 130 micrograms solution for injection pre-filled pen 
EU/1/01/185/072 – 1 pack 
EU/1/01/185/073 – 4 pack 
Aranesp 150 micrograms solution for injection pre-filled pen 
EU/1/01/185/054 – 1 pack 
EU/1/01/185/066 – 4 pack 
Aranesp 300 micrograms solution for injection pre-filled pen 
EU/1/01/185/055 – 1 pack 
EU/1/01/185/067 – 4 pack 
Aranesp 500 micrograms solution for injection pre-filled pen 
EU/1/01/185/056 – 1 pack 
EU/1/01/185/068 – 4 pack 
Aranesp 25 micrograms solution for injection vial 
EU/1/01/185/100 1 Pack  
EU/1/01/185/101 4 Pack  
Aranesp 40 micrograms solution for injection vial 
EU/1/01/185/102 1 Pack  
EU/1/01/185/103 4 Pack  
Aranesp 60 micrograms solution for injection vial 
EU/1/01/185/104 1 Pack  
EU/1/01/185/105 4 Pack  
Aranesp 100 micrograms solution for injection vial 
EU/1/01/185/106 1 Pack  
EU/1/01/185/107 4 Pack  
Aranesp 200 micrograms solution for injection vial 
EU/1/01/185/108 1 Pack  
EU/1/01/185/109 4 Pack  
Aranesp 300 micrograms solution for injection vial 
EU/1/01/185/110 1 Pack  
EU/1/01/185/111 4 Pack  
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 8 June 2001 
Date of latest renewal: 19 May 2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu  



 

 

26

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR 
BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT  

 



 

 

27

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
Amgen Manufacturing Limited 
PO Box 4060, Road 31 km 24.6 
Juncos, PR 00777-4060 
Puerto Rico 
 
Name and address of the manufacturers responsible for batch release  
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Amgen Technology (Ireland) Unlimited Company 
Pottery Road 
Dun Laoghaire  
Co Dublin 
Ireland 
 
Amgen NV 
Telecomlaan 5-7 
1831 Diegem 
Belgium 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic safety update reports (PSURs)  
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT  
 
 Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP. 
 



 

 

28

An updated RMP should be submitted: 
 At the request of the European Medicines Agency;  
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 Additional risk minimisation measures for Aranesp solution for injection in pre-filled pen 
 
The MAH shall agree the final educational material with the national competent authority where the 
pre-filled pen is marketed. Healthcare professionals prescribing Aranesp pre-filled pen will be 
provided educational materials to facilitate training patients on the correct self-administration of 
Aranesp. 
 
The healthcare professional’s educational material should contain the following key elements: 
 Training checklist 

- provides structured training steps for healthcare professionals to train patients/caregivers 
on the specific preparation and administration steps that they will need to perform using a 
dummy pen, while following the instructions for use located in the package leaflet. 

- reminds the healthcare professionals to verify that the patients/caregivers can demonstrate 
using the dummy pen confidently and competently to be able to prepare and administer 
the medicine successfully when at home. 

- includes information on how to receive further checklists or demonstration device(s). 
 A demonstration device 
 A poster-size instructions for use (for patients/caregivers with diminished eyesight) 

- includes the instructions for use located in the package leaflet in a way that 
patients/caregivers with diminished eyesight are informed on how to handle the pen and 
administer Aranesp appropriately. 

 
 



 

 

29

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 

 

30

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 

 

31

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 10 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.4 mL pre-filled syringe contains 10 micrograms darbepoetin alfa (25 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

32

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/001 1 pack 
EU/1/01/185/002 4 pack 
EU/1/01/185/074 1 pack with needle guard 
EU/1/01/185/075 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 10 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



 

 

33

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 10 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.4 ml 
 



 

 

34

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 10 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.4 ml 

 



 

 

35

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 10 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.4 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

36

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 10 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.4 mL pre-filled syringe contains 10 micrograms darbepoetin alfa (25 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

37

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/033  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 10 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

38

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 10 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.4 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

39

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 15 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.375 mL pre-filled syringe contains 15 micrograms darbepoetin alfa (40 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

40

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/003 1 pack 
EU/1/01/185/004 4 pack 
EU/1/01/185/076 1 pack with needle guard 
EU/1/01/185/077 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 15 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN



 

 

41

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 15 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.375 ml  
 



 

 

42

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 15 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.375 ml  
 

 



 

 

43

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 15 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.375 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

44

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 15 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.375 mL pre-filled syringe contains 15 micrograms darbepoetin alfa (40 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

45

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/034 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 15 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

46

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 15 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.375 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

47

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 20 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.5 mL pre-filled syringe contains 20 micrograms darbepoetin alfa (40 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

48

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/005 1 pack 
EU/1/01/185/006 4 pack 
EU/1/01/185/078 1 pack with needle guard 
EU/1/01/185/079 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 20 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

49

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 20 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.5 ml 
 



 

 

50

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 20 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.5 ml 
 

 



 

 

51

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 20 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

52

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 20 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.5 mL pre-filled syringe contains 20 micrograms darbepoetin alfa (40 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

53

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/035 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 20 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

54

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 20 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

55

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 30 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.3 mL pre-filled syringe contains 30 micrograms darbepoetin alfa (100 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

56

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/007 1 pack 
EU/1/01/185/008 4 pack 
EU/1/01/185/080 1 pack with needle guard 
EU/1/01/185/081 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 30 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN



 

 

57

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 30 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.3 ml 
 



 

 

58

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 30 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.3 ml 
 

 



 

 

59

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 30 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

60

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 30 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.3 mL pre-filled syringe contains 30 micrograms darbepoetin alfa (100 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

61

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/036 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 30 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

62

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 30 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

63

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 40 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.4 mL pre-filled syringe contains 40 micrograms darbepoetin alfa (100 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

64

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/009 1 pack 
EU/1/01/185/010 4 pack 
EU/1/01/185/082 1 pack with needle guard 
EU/1/01/185/083 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 40 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

65

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 40 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.4 ml  
 



 

 

66

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 40 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.4 ml  
 

 



 

 

67

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 40 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.4 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

68

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 40 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.4 mL pre-filled syringe contains 40 micrograms darbepoetin alfa (100 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

69

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/037 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 40 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

70

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 40 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.4 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

71

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 50 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.5 mL pre-filled syringe contains 50 micrograms darbepoetin alfa (100 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

72

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/011 1 pack 
EU/1/01/185/012 4 pack 
EU/1/01/185/084 1 pack with needle guard 
EU/1/01/185/085 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 50 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

73

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 50 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.5 ml  
 



 

 

74

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 50 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.5 ml  
 

 



 

 

75

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 50 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

76

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 50 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.5 mL pre-filled syringe contains 50 micrograms darbepoetin alfa (100 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

77

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/038 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 50 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

78

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 50 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

79

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 60 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.3 mL pre-filled syringe contains 60 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

80

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/013 1 pack 
EU/1/01/185/014 4 pack 
EU/1/01/185/086 1 pack with needle guard 
EU/1/01/185/087 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 60 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN



 

 

81

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 60 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.3 ml  
 



 

 

82

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 60 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.3 ml  

 



 

 

83

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 60 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

84

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 60 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.3 mL pre-filled syringe contains 60 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

85

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/039 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 60 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

86

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 60 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

87

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 80 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.4 mL pre-filled syringe contains 80 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

88

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/015 1 pack 
EU/1/01/185/016 4 pack 
EU/1/01/185/088 1 pack with needle guard 
EU/1/01/185/089 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 80 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



 

 

89

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 80 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.4 ml  
 



 

 

90

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 80 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.4 ml  
 

 



 

 

91

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 80 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.4 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

92

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 80 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.4 mL pre-filled syringe contains 80 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

93

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/040 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 80 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

94

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 80 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.4 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

95

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 100 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.5 mL pre-filled syringe contains 100 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

96

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/017 1 pack 
EU/1/01/185/018 4 pack 
EU/1/01/185/090 1 pack with needle guard 
EU/1/01/185/091 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 100 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



 

 

97

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 100 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.5 ml  
 



 

 

98

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 100 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.5 ml  
 

 



 

 

99

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 100 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

100

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 100 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.5 mL pre-filled syringe contains 100 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

101

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/041 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 100 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

102

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 100 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

103

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 130 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.65 mL pre-filled syringe contains 130 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

104

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/069 1 pack 
EU/1/01/185/070 4 pack 
EU/1/01/185/092 1 pack with needle guard 
EU/1/01/185/093 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 130 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



 

 

105

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 130 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.65 ml  
 



 

 

106

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 130 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.65 ml  
 

 



 

 

107

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 130 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.65 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

108

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 130 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.65 mL pre-filled syringe contains 130 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

109

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/071 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 130 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

110

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 130 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.65 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

111

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 150 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.3 mL pre-filled syringe contains 150 micrograms darbepoetin alfa (500 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

112

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/019 1 pack 
EU/1/01/185/020 4 pack 
EU/1/01/185/094 1 pack with needle guard 
EU/1/01/185/095 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 150 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



 

 

113

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 150 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.3 ml  
 



 

 

114

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 150 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.3 ml  
 

 



 

 

115

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 150 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

116

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 150 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.3 mL pre-filled syringe contains 150 micrograms darbepoetin alfa (500 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

117

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/042 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 150 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

118

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 150 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

119

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 300 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.6 mL pre-filled syringe contains 300 micrograms darbepoetin alfa (500 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

120

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/021 1 pack 
EU/1/01/185/022 4 pack 
EU/1/01/185/096 1 pack with needle guard 
EU/1/01/185/097 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 300 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



 

 

121

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 300 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.6 ml  
 



 

 

122

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 300 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
0.6 ml  
 

 



 

 

123

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 300 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.6 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

124

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 300 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.6 mL pre-filled syringe contains 300 micrograms darbepoetin alfa (500 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

125

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/043 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 300 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

126

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 300 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.6 ml  
 
 
6. OTHER 
 
Amgen Europe B.V. 



 

 

127

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITH TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 500 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 1 mL pre-filled syringe contains 500 micrograms darbepoetin alfa (500 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
4 single use pre-filled syringes. 
1 single use pre-filled syringe with automatic needle guard. 
4 single use pre-filled syringes with automatic needle guards. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

128

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/031 1 pack 
EU/1/01/185/032 4 pack 
EU/1/01/185/098 1 pack with needle guard 
EU/1/01/185/099 4 pack with needle guard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 500 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



 

 

129

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 500 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
1 ml 
 



 

 

130

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 500 µg injection 
Darbepoetin alfa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
IV/SC 
1 ml 

 



 

 

131

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITH TRAY  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 500 µg 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

132

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED SYRINGE CARTON WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 500 micrograms solution for injection in pre-filled syringe 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 1 mL pre-filled syringe contains 500 micrograms darbepoetin alfa (500 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use pre-filled syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

133

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/044 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 500 syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

134

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 500 µg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

135

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 10 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.4 mL pre-filled pen contains 10 micrograms darbepoetin alfa (25 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

136

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/045 1 pack 
EU/1/01/185/057 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 10 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

137

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 10 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.4 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

138

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 15 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.375 mL pre-filled pen contains 15 micrograms darbepoetin alfa (40 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

139

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/046 1 pack 
EU/1/01/185/058 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 15 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

140

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 15 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.375 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

141

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 20 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.5 mL pre-filled pen contains 20 micrograms darbepoetin alfa (40 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

142

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/047 1 pack 
EU/1/01/185/059 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 20 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

143

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 20 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

144

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 30 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.3 mL pre-filled pen contains 30 micrograms darbepoetin alfa (100 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

145

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/048 1 pack 
EU/1/01/185/060 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 30 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

146

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 30 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

147

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 40 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.4 mL pre-filled pen contains 40 micrograms darbepoetin alfa (100 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

148

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/049 1 pack 
EU/1/01/185/061 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 40 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

149

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 40 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.4 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

150

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 50 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.5 mL pre-filled pen contains 50 micrograms darbepoetin alfa (100 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

151

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/050 1 pack 
EU/1/01/185/062 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 50 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

152

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 50 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

153

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 60 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.3 mL pre-filled pen contains 60 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

154

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/051 1 pack 
EU/1/01/185/063 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 60 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

155

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 60 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

156

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 80 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.4 mL pre-filled pen contains 80 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

157

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/052 1 pack 
EU/1/01/185/064 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 80 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

158

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 80 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.4 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

159

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 100 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.5 mL pre-filled pen contains 100 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

160

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/053 1 pack 
EU/1/01/185/065 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 100 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

161

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 100 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

162

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 130 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.65 mL pre-filled pen contains 130 micrograms darbepoetin alfa (200 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

163

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/072 1 pack 
EU/1/01/185/073 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 130 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

164

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 130 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.65 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

165

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 150 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.3 mL pre-filled pen contains 150 micrograms darbepoetin alfa (500 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

166

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/054 1 pack 
EU/1/01/185/066 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 150 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

167

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 150 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

168

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 300 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 0.6 mL pre-filled pen contains 300 micrograms darbepoetin alfa (500 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

169

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/055 1 pack 
EU/1/01/185/067 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 300 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

170

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 300 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.6 ml  
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

171

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PRE-FILLED PEN CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 500 micrograms solution for injection in pre-filled pen 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 1 mL pre-filled pen contains 500 micrograms darbepoetin alfa (500 micrograms/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
SureClick x1 
1 single use pre-filled pen 
This box containing 1 pre-filled pen, is part of a 4-multipack 
SureClick x4 
4 single use pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 



 

 

172

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/056 1 pack 
EU/1/01/185/068 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aranesp 500 pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

173

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 500 µg injection 
Darbepoetin alfa 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 
6. OTHER 
 
Amgen Europe B.V.  



 

 

174

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
VIAL CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 25 micrograms solution for injection in vial 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 1 mL vial contains 25 micrograms darbepoetin alfa. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use vial 
4 single use vials 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

175

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/100 1 pack 
EU/1/01/185/101 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

176

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 25 mcg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 
6. OTHER 
 



 

 

177

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
VIAL CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 40 micrograms solution for injection in vial 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 1 mL vial contains 40 micrograms darbepoetin alfa. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use vial 
4 single use vials 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

178

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/102 1 pack 
EU/1/01/185/103 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

179

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 40 mcg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 
6. OTHER 
 



 

 

180

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
VIAL CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 60 micrograms solution for injection in vial 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 1 mL vial contains 60 micrograms darbepoetin alfa. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use vial 
4 single use vials 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

181

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/104 1 pack 
EU/1/01/185/105 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

182

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 60 mcg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 
6. OTHER 
 



 

 

183

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
VIAL CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 100 micrograms solution for injection in vial 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 1 mL vial contains 100 micrograms darbepoetin alfa. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use vial 
4 single use vials 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

184

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/106 1 pack 
EU/1/01/185/107 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

185

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 100 mcg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 
6. OTHER 
 



 

 

186

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
VIAL CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 200 micrograms solution for injection in vial 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 1 mL vial contains 200 micrograms darbepoetin alfa. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use vial 
4 single use vials 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

187

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/108 1 pack 
EU/1/01/185/109 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

188

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 200 mcg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 
6. OTHER 
 



 

 

189

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
VIAL CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aranesp 300 micrograms solution for injection in vial 
Darbepoetin alfa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each 1 mL vial contains 300 micrograms darbepoetin alfa. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, 
water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 single use vial 
4 single use vials 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous or subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 



 

 

190

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061  
4817 ZK Breda 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/01/185/110 1 pack 
EU/1/01/185/111 4 pack 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

 

191

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Aranesp 300 mcg injection 
Darbepoetin alfa 
IV/SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 
6. OTHER 
 



 

 

192

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



 

 

193

Package leaflet: Information for the user 
 

Aranesp 10 micrograms solution for injection in pre-filled syringe 
Aranesp 15 micrograms solution for injection in pre-filled syringe 
Aranesp 20 micrograms solution for injection in pre-filled syringe 
Aranesp 30 micrograms solution for injection in pre-filled syringe 
Aranesp 40 micrograms solution for injection in pre-filled syringe 
Aranesp 50 micrograms solution for injection in pre-filled syringe 
Aranesp 60 micrograms solution for injection in pre-filled syringe 
Aranesp 80 micrograms solution for injection in pre-filled syringe 

Aranesp 100 micrograms solution for injection in pre-filled syringe 
Aranesp 130 micrograms solution for injection in pre-filled syringe 
Aranesp 150 micrograms solution for injection in pre-filled syringe 
Aranesp 300 micrograms solution for injection in pre-filled syringe 
Aranesp 500 micrograms solution for injection in pre-filled syringe 

darbepoetin alfa 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Aranesp is and what it is used for 
2. What you need to know before you use Aranesp 
3. How to use Aranesp 
4. Possible side effects 
5. How to store Aranesp 
6. Contents of the pack and other information  
7. Instructions for injecting with the Aranesp pre-filled syringe 
 
 
1. What Aranesp is and what it is used for 
 
Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia. Anaemia is when your 
blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and 
shortness of breath.  
 
Aranesp works in exactly the same way as the natural hormone erythropoietin. Erythropoietin is 
produced in your kidneys and encourages your bone marrow to produce more red blood cells. The 
active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster 
Ovary Cells (CHO-K1).  
 
If you have chronic renal failure  
 
Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney 
failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural 
hormone erythropoietin which can often cause anaemia.  
 
Because it will take your body some time to make more red blood cells, it will be about four weeks 
before you notice any effect. Your normal dialysis routine will not affect the ability of Aranesp to treat 
your anaemia. 



 

 

194

 
If you are receiving chemotherapy 
 
Aranesp is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers 
(non-myeloid malignancies) who are receiving chemotherapy. 
 
One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood 
cells. Towards the end of your chemotherapy course, particularly if you have had a lot of 
chemotherapy, your red blood cell count may fall making you anaemic. 
 
 
2. What you need to know before you use Aranesp 
 
Do not use Aranesp: 
- if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in 

section 6). 
- if you have been diagnosed with high blood pressure which is not being controlled with other 

medicines prescribed by your doctor. 
 
Warnings and precautions  
 
Talk to your doctor, pharmacist or nurse before using Aranesp. 
 
Please tell your doctor if you are suffering or have suffered from: 
- high blood pressure which is being controlled with medicines prescribed by your doctor; 
- sickle cell anaemia; 
- epileptic fits (seizures);  
- convulsions (fits or seizures);  
- liver disease; 
- significant lack of response to medicines used to treat anaemia; 
- an allergy to latex (the needle cap on the pre-filled syringe contains a derivative of latex); or 
- hepatitis C. 
 
Special warnings: 
- If you have symptoms which include unusual tiredness and a lack of energy this could mean 

you have pure red cell aplasia (PRCA), which has been reported in patients. PRCA means that 
the body has stopped or reduced the production of red blood cells which causes severe anaemia. 
If you experience these symptoms you should contact your doctor who will determine the best 
course of action to treat your anaemia.  

 
- Take special care with other products that stimulate red blood cell production: Aranesp is one of 

a group of products that stimulate the production of red blood cells like the human protein 
erythropoietin does. Your healthcare professional should always record the exact product you 
are using. 

 
- If you are a patient with chronic renal failure, and particularly if you do not respond properly to 

Aranesp, your doctor will check your dose of Aranesp because repeatedly increasing your dose 
of Aranesp if you are not responding to treatment may increase the risk of having a problem of 
the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death. 

 
- Your doctor should try to keep your haemoglobin between 10 and 12 g/dL. Your doctor will 

check that your haemoglobin does not exceed a certain level, as high haemoglobin 
concentrations could put you at risk of having a problem of the heart or the blood vessels and 
could increase risk of myocardial infarction, stroke and death. 

 



 

 

195

- If you have symptoms which include severe headache, drowsiness, confusion, problems with 
your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood 
pressure. If you experience these symptoms you should contact your doctor. 

 
- If you are a cancer patient you should be aware that Aranesp may act as a blood cell growth 

factor and in some circumstances may have a negative impact on your cancer. Depending on 
your individual situation a blood transfusion may be preferable. Please discuss this with your 
doctor. 

 
- Misuse by healthy people can cause life-threatening problems with the heart or blood vessels. 
 
- Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal 

necrolysis (TEN) have been reported in association with epoetin treatment. SJS/TEN can appear 
initially as reddish target-like spots or circular patches often with central blisters on the trunk. 
Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These 
serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may 
progress to widespread peeling of the skin and life-threatening complications.  
If you develop a serious rash or another of these skin symptoms, stop taking Aranesp and 
contact your doctor or seek medical attention immediately. 

 
Other medicines and Aranesp 
 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the 
number of red cells in your blood. It is important to tell your doctor if you are taking either of these 
medicines. 
 
Using Aranesp with food and drink 
 
Food and drink do not affect Aranesp. 
 
Pregnancy and breast-feeding 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Aranesp has not been tested in pregnant women. It is important to tell your doctor if you: 
 are pregnant;  
 think you may be pregnant; or 
 plan to get pregnant.  
 
It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if 
you use Aranesp. 
 
Driving and using machines 
 
Aranesp should not affect your ability to drive or use machinery. 
 
Aranesp contains sodium 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
‘sodium-free’. 
 
 



 

 

196

3. How to use Aranesp 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.  
 
Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 
10 g/dL or less. Your doctor will tell you how much and how often you must take Aranesp in order to 
maintain a haemoglobin level between 10 and 12 g/dL. This may vary depending on whether you are 
an adult or a child.  
 
Injecting Aranesp yourself 
 
Your doctor may decide that it is best for you or a carer to inject Aranesp. Your doctor, nurse or 
pharmacist will show you how to inject yourself with the pre-filled syringe. Do not try to inject 
yourself if you have not been trained. Never inject Aranesp into a vein yourself.  
 
If you have chronic renal failure 
 
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, Aranesp is given as a 
single injection, either under your skin (subcutaneous) or into a vein (intravenous). 
 
In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will 
be either: 
 0.75 micrograms once every two weeks, or 
 0.45 micrograms once weekly. 
For adult patients not on dialysis, 1.5 micrograms/kg once monthly may also be used as the initial 
dose. 
 
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, once your anaemia is 
corrected you will continue to receive Aranesp given as a single injection, either once a week or once 
every two weeks. For all adults and paediatric patients ≥ 11 years of age not on dialysis, Aranesp 
could also be given as an injection once monthly. 
 
Your doctor will take regular blood samples to measure how your anaemia is responding and may 
adjust your dose once every four weeks as necessary in order to maintain long term control of your 
anaemia. 
 
Your doctor will use the lowest effective dose to control the symptoms of your anaemia. 
 
If you do not respond adequately to Aranesp, your doctor will check your dose and will inform you if 
you need to change doses of Aranesp. 
 
Your blood pressure will also be checked regularly, particularly at the beginning of your treatment. 
 
In some cases, your doctor may recommend that you take iron supplements. 
 
Your doctor may decide to change the way that your injection is given (either under the skin or into a 
vein). If this changes you will start on the same dose as you have been receiving and your doctor will 
take blood samples to make sure that your anaemia is still being managed correctly. 
 
If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by 
gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection 
once weekly or once every two weeks. The route of injection is the same as with r-HuEPO but your 
doctor will tell you how much you should take, and when, and may adjust your dose if necessary. 
 



 

 

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If you are receiving chemotherapy 
 
Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.  
 
In order to correct your anaemia, your initial dose will be 
 500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your 

body weight), or 
 2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight. 
 
Your doctor will take regular blood samples to measure how your anaemia is responding and may 
adjust your dose as necessary. Your treatment will continue until approximately four weeks after the 
end of your chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp. 
 
In some cases, your doctor may recommend that you take iron supplements. 
 
If you use more Aranesp than you should 
 
You could have serious problems if you use more Aranesp than you need, such as very high blood 
pressure. You should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell 
in any way you should contact your doctor, nurse or pharmacist immediately. 
 
If you forget to use Aranesp 
 
Do not use a double dose to make up for a forgotten dose.  
 
If you have forgotten a dose of Aranesp, you should contact your doctor to discuss when you should 
inject the next dose. 
 
If you stop using Aranesp 
 
If you want to stop using Aranesp, you should discuss it with your doctor first. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
The following side effects have been experienced by some patients taking Aranesp: 
 
Chronic renal failure patients 
 
Very common: may affect more than 1 in 10 people 
 High blood pressure (hypertension) 
 Allergic reactions 
 
Common: may affect up to 1 in 10 people 
 Stroke 
 Pain around the area injected  
 Rash and/or redness of the skin 
 
Uncommon: may affect up to 1 in 100 people 
 Blood clots (thrombosis) 
 Convulsions (fits and seizures) 
 Bruising and bleeding at the site of injection  
 Blood clots in a dialysis access 
 



 

 

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Not known: frequency cannot be estimated from available data 
 Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy) 
 
Cancer patients 
 
Very common: may affect more than 1 in 10 people 
 Allergic reactions 
 
Common: may affect up to 1 in 10 people 
 High blood pressure (hypertension) 
 Blood clots (thrombosis) 
 Pain around the area injected  
 Rash and/or redness of the skin 
 Fluid retention (oedema) 
 
Uncommon: may affect up to 1 in 100 people 
 Convulsions (fits and seizures) 
 Bruising and bleeding at the site of injection 
 
All patients 
 
Not known: frequency cannot be estimated from available data 
 Serious allergic reactions which may include: 

 Sudden life-threatening allergic reactions (anaphylaxis) 
 Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in 

swallowing or breathing (angioedema) 
 Shortness of breath (allergic bronchospasm) 
 Skin rash 
 Hives (urticaria) 

 Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have 
been reported in association with epoetin treatment. These can appear as reddish target-like 
macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of 
mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.  
Stop using Aranesp if you develop these symptoms and contact your doctor or seek medical 
attention immediately. See also section 2. 

 
Reporting of side effects 
 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Aranesp 
 
Keep this medicine out of the sight and reach of children.  
 
Do not use this medicine after the expiry date which is stated on the carton and on the pre-filled 
syringe label after EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C - 8°C). Do not freeze. Do not use Aranesp if you think it has been frozen. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 



 

 

199

When your syringe has been removed from the refrigerator and left at room temperature for 
approximately 30 minutes before injection it must either be used within 7 days or disposed of. 
 
Do not use this medicine if you notice the pre-filled syringe contents are cloudy or there are particles 
in it. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Aranesp contains 
 
- The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by gene-

technology). The pre-filled syringe contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 
300 or 500 micrograms of darbepoetin alfa.  

- The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium 
chloride, polysorbate 80 and water for injections. 

 
What Aranesp looks like and contents of the pack 
 
Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled syringe.  
 
Aranesp is available in packs of 1 or 4 pre-filled syringes. The syringes are provided either with 
(1- and 4-pack) or without (1-pack) a blister-wrapping. Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Amgen Europe B.V.  
Minervum 7061  
4817 ZK Breda  
The Netherlands 
 
Marketing Authorisation Holder  
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Manufacturer 
Amgen Technology (Ireland) Unlimited Company 
Pottery Road 
Dun Laoghaire 
Co Dublin 
Ireland 
 
Manufacturer 
Amgen NV 
Telecomlaan 5-7 
1831 Diegem 
Belgium 
 



 

 

200

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
s.a. Amgen n.v. 
Tel/Tél: +32 (0)2 7752711 
 

Lietuva 
Amgen Switzerland AG Vilniaus filialas 
Tel: +370 5 219 7474 

България 
Амджен България ЕООД 
Тел.: +359 (0)2 424 7440 

Luxembourg/Luxemburg 
s.a. Amgen  
Belgique/Belgien 
Tel/Tél: +32 (0)2 7752711 

Česká republika 
Amgen s.r.o. 
Tel: +420 221 773 500 

Magyarország 
Amgen Kft. 
Tel.: +36 1 35 44 700 

Danmark 
Amgen, filial af Amgen AB, Sverige 
Tlf: +45 39617500 
 

Malta 
Amgen B.V. 
The Netherlands 
Tel: +31 (0)76 5732500 
 

Deutschland 
AMGEN GmbH  
Tel.: +49 89 1490960  
 

Nederland 
Amgen B.V. 
Tel: +31 (0)76 5732500 

Eesti 
Amgen Switzerland AG Vilniaus filialas 
Tel: +372 586 09553 

Norge 
Amgen AB 
Tel: +47 23308000 

Ελλάδα 
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.  
Τηλ.: +30 210 3447000 
 

Österreich 
Amgen GmbH  
Tel: +43 (0)1 50 217  
 

España 
Amgen S.A.  
Tel: +34 93 600 18 60  
 

Polska 
Amgen Biotechnologia Sp. z o.o. 
Tel.: +48 22 581 3000 

France 
Amgen S.A.S.  
Tél: +33 (0)9 69 363 363  

Portugal 
Amgen Biofarmacêutica, Lda. 
Tel: +351 21 4220606 

Hrvatska 
Amgen d.o.o. 
Tel: +385 (0)1 562 57 20 

România 
Amgen România SRL 
Tel: +4021 527 3000 

Ireland 
Amgen Ireland Limited 
Tel: +353 1 8527400 
 

Slovenija 
AMGEN zdravila d.o.o. 
Tel: +386 (0)1 585 1767 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Amgen Slovakia s.r.o. 
Tel: +421 2 321 114 49 



 

 

201

Italia 
Amgen S.r.l 
Tel: +39 02 6241121 

Suomi/Finland 
Amgen AB, sivuliike Suomessa/Amgen AB, filial 
i Finland 
Puh/Tel: +358 (0)9 54900500 
 

Kύπρος 
C.A. Papaellinas Ltd 
Τηλ.: +357 22741 741 

Sverige 
Amgen AB  
Tel: +46 (0)8 6951100 

Latvija 
Amgen Switzerland AG Rīgas filiāle 
Tel: +371 257 25888 
 

United Kingdom 
Amgen Limited 
Tel: +44 (0)1223 420305 

 
This leaflet was last revised in 
 
Other sources of information  
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 
 
 
7. Instructions for injecting with the Aranesp pre-filled syringe  
 
This section contains information on how to give yourself an injection of Aranesp. It is important that 
you do not try to give yourself the injection unless you have received training from your doctor, nurse 
or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist 
for assistance. 
 
How do you or the person injecting you, use the Aranesp pre-filled syringe? 
 
Your doctor has prescribed an Aranesp pre-filled syringe for injection into the tissue just under the 
skin. Your doctor, nurse or pharmacist will tell you how much Aranesp you need and how frequently 
it should be injected.  
 
Equipment: 
 
To give yourself an injection you will need: 
 
 a new Aranesp pre-filled syringe; and 
 alcohol wipes or similar. 
 
What should I do before I give myself a subcutaneous injection of Aranesp? 
 
1. Remove the pre-filled syringe from the refrigerator. Leave the pre-filled syringe at room 

temperature for approximately 30 minutes. This will make the injection more comfortable. Do 
not warm Aranesp in any other way (for example, do not warm it in a microwave or in hot 
water). Additionally, do not leave the syringe exposed to direct sunlight. 

 
2. Do not shake the pre-filled syringe. 
 
3. Do not remove the cap from the syringe until you are ready to inject. 
 
4. Check that it is the correct dose that your doctor has prescribed. 
 



 

 

202

5. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed 
the last day of the month shown. 

 
6. Check the appearance of Aranesp. It must be a clear, colourless or slightly pearly liquid. If it is 

cloudy or there are particles in it, you must not use it. 
 
7. Wash your hands thoroughly. 
 
8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.  
 
How do I prepare my Aranesp injection? 
 
Before you inject Aranesp you must do the following: 
 
1. To avoid bending the needle, gently pull the cap from the needle 

without twisting as shown in pictures 1 and 2.  
2. Do not touch the needle or push the plunger. 
3. You may notice a small air bubble in the pre-filled syringe. You do not 

have to remove the air bubble before injecting. Injecting the solution 
with the air bubble is harmless. 

4. You can now use the pre-filled syringe. 

 
Where should I give my injection? 
 

 

The best places to inject yourself are the top of your thighs and the 
abdomen. If someone else is injecting for you, they can also use the back 
of your arms. 
 
You may change the injection site if you notice the area is red or sore. 

 
How do I give my injection? 
 
1. Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between 

your thumb and forefinger. 
 
2. Insert the needle fully into the skin as shown by your doctor, nurse or pharmacist. 
 
3. Inject the prescribed dose subcutaneously as directed by your doctor, nurse or pharmacist. 
 
4. Push the plunger with a slow constant pressure, always keeping your skin pinched, until the 

syringe is empty. 
 
5. Remove the needle and let go of your skin. 
 
6. If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. Do not rub 

the injection site. If needed, you may cover the injection site with a plaster. 
 
7. Only use each syringe for one injection. Do not use any Aranesp that is left in the syringe. 
 
Remember: If you have any problems, please do not be afraid to ask your doctor or nurse for help and 
advice. 
 



 

 

203

Disposing of used syringes 
 
 Do not put the cap back on used needles, as you may accidentally prick yourself. 
 Keep used syringes out of the reach and sight of children. 
 The used pre-filled syringe should be disposed of in accordance with local requirements. Ask 

your pharmacist how to dispose of medicines no longer required. These measures will help to 
protect the environment.  



 

 

204

Package leaflet: Information for the user 
 

Aranesp 10 micrograms solution for injection in pre-filled pen (SureClick) 
Aranesp 15 micrograms solution for injection in pre-filled pen (SureClick) 
Aranesp 20 micrograms solution for injection in pre-filled pen (SureClick) 
Aranesp 30 micrograms solution for injection in pre-filled pen (SureClick) 
Aranesp 40 micrograms solution for injection in pre-filled pen (SureClick) 
Aranesp 50 micrograms solution for injection in pre-filled pen (SureClick) 
Aranesp 60 micrograms solution for injection in pre-filled pen (SureClick) 
Aranesp 80 micrograms solution for injection in pre-filled pen (SureClick) 

Aranesp 100 micrograms solution for injection in pre-filled pen (SureClick) 
Aranesp 130 micrograms solution for injection in pre-filled pen (SureClick) 
Aranesp 150 micrograms solution for injection in pre-filled pen (SureClick) 
Aranesp 300 micrograms solution for injection in pre-filled pen (SureClick) 
Aranesp 500 micrograms solution for injection in pre-filled pen (SureClick) 

darbepoetin alfa 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Aranesp is and what it is used for 
2. What you need to know before you use Aranesp 
3. How to use Aranesp 
4. Possible side effects 
5. How to store Aranesp 
6. Contents of the pack and other information 
 
 
1. What Aranesp is and what it is used for 
 
Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia. Anaemia is when your 
blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and 
shortness of breath.  
 
Aranesp works in exactly the same way as the natural hormone erythropoietin. Erythropoietin is 
produced in your kidneys and encourages your bone marrow to produce more red blood cells. The 
active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster 
Ovary Cells (CHO-K1).  
 
If you have chronic renal failure  
 
Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney 
failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural 
hormone erythropoietin which can often cause anaemia.  
 
Because it will take your body some time to make more red blood cells, it will be about four weeks 
before you notice any effect. Your normal dialysis routine will not affect the ability of Aranesp to treat 
your anaemia. 
 



 

 

205

If you are receiving chemotherapy 
 
Aranesp is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers 
(non-myeloid malignancies) who are receiving chemotherapy. 
 
One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood 
cells. Towards the end of your chemotherapy course, particularly if you have had a lot of 
chemotherapy, your red blood cell count may fall making you anaemic. 
 
 
2. What you need to know before you use Aranesp 
 
Do not use Aranesp: 
- if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in 

section 6). 
- if you have been diagnosed with high blood pressure which is not being controlled with other 

medicines prescribed by your doctor. 
 
Warnings and precautions 
 
Talk to your doctor, pharmacist or nurse before using Aranesp 
 
Please tell your doctor if you are suffering or have suffered from: 
- high blood pressure which is being controlled with medicines prescribed by your doctor; 
- sickle cell anaemia; 
- epileptic fits (seizures);  
- convulsions (fits or seizures);  
- liver disease; 
- significant lack of response to medicines used to treat anaemia; 
- an allergy to latex (the needle cap on the pre-filled pen contains a derivative of latex); or 
- hepatitis C. 
 
Special warnings: 
- If you have symptoms which include unusual tiredness and a lack of energy this could mean 

you have pure red cell aplasia (PRCA), which has been reported in patients. PRCA means that 
the body has stopped or reduced the production of red blood cells which causes severe anaemia. 
If you experience these symptoms you should contact your doctor who will determine the best 
course of action to treat your anaemia.  

 
- Take special care with other products that stimulate red blood cell production: Aranesp is one of 

a group of products that stimulate the production of red blood cells like the human protein 
erythropoietin does. Your healthcare professional should always record the exact product you 
are using. 

 
- If you are a patient with chronic renal failure, and particularly if you do not respond properly to 

Aranesp, your doctor will check your dose of Aranesp because repeatedly increasing your dose 
of Aranesp if you are not responding to treatment may increase the risk of having a problem of 
the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death. 

 
- Your doctor should try to keep your haemoglobin between 10 and 12 g/dL. Your doctor will 

check that your haemoglobin does not exceed a certain level, as high haemoglobin 
concentrations could put you at risk of having a problem of the heart or the blood vessels and 
could increase risk of myocardial infarction, stroke and death. 

 
- If you have symptoms which include severe headache, drowsiness, confusion, problems with 

your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood 
pressure. If you experience these symptoms you should contact your doctor. 



 

 

206

 
- If you are a cancer patient you should be aware that Aranesp may act as a blood cell growth 

factor and in some circumstances may have a negative impact on your cancer. Depending on 
your individual situation a blood transfusion may be preferable. Please discuss this with your 
doctor. 

 
- Misuse by healthy people can cause life-threatening problems with the heart or blood vessels. 
 
- Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal 

necrolysis (TEN) have been reported in association with epoetin treatment. SJS/TEN can appear 
initially as reddish target-like spots or circular patches often with central blisters on the trunk. 
Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These 
serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may 
progress to widespread peeling of the skin and life-threatening complications.  
If you develop a serious rash or another of these skin symptoms, stop taking Aranesp and 
contact your doctor or seek medical attention immediately. 

 
Other medicines and Aranesp 
 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the 
number of red cells in your blood. It is important to tell your doctor if you are taking either of these 
medicines. 
 
Using Aranesp with food and drink 
 
Food and drink do not affect Aranesp. 
 
Pregnancy and breast-feeding 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Aranesp has not been tested in pregnant women. It is important to tell your doctor if you: 
 are pregnant; 
 think you may be pregnant; or 
 plan to get pregnant.  
 
It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if 
you use Aranesp. 
 
Driving and using machines 
 
Aranesp should not affect your ability to drive or use machinery. 
 
Aranesp contains sodium 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
‘sodium-free’. 
 
 
3. How to use Aranesp 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 



 

 

207

Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 
10 g/dL or less. Your injection is to be given under the skin (subcutaneous), and so you may use the 
Aranesp pre-filled pen. Your doctor will tell you how much and how often you must take Aranesp in 
order to maintain a haemoglobin level between 10 and 12 g/dL. This may vary depending on whether 
you are an adult or a child.  
 
Injecting Aranesp yourself 
 
Your doctor has decided that the Aranesp pre-filled pen is the best way for you, a nurse or a carer to 
inject Aranesp. Your doctor, nurse or pharmacist will show you how to inject yourself with the 
pre-filled pen. Do not try to inject yourself if you have not been trained. Never inject Aranesp into a 
vein yourself. The pre-filled pen is designed to inject the area under your skin only. 
 
For instructions on use of the pre-filled pen, please read the section at the end of this leaflet. 
 
If you have chronic renal failure 
 
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, Aranesp pre-filled pen is 
given as a single injection, under your skin (subcutaneous). 
 
In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will 
be either: 
 0.75 micrograms once every two weeks, or 
 0.45 micrograms once weekly.  
For adult patients not on dialysis, 1.5 micrograms/kg once monthly may also be used as the initial 
dose. 
 
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, once your anaemia is 
corrected you will continue to receive Aranesp given as a single injection, either once a week or once 
every two weeks. For all adults and paediatric patients ≥ 11 years of age not on dialysis, Aranesp 
could also be given as an injection once monthly. 
 
Your doctor will take regular blood samples to measure how your anaemia is responding and may 
adjust your dose once every four weeks as necessary in order to maintain long term control of your 
anaemia. 
 
Your doctor will use the lowest effective dose to control the symptoms of your anaemia. 
 
If you do not respond adequately to Aranesp, your doctor will check your dose and will inform you if 
you need to change doses of Aranesp. 
 
Your blood pressure will also be checked regularly, particularly at the beginning of your treatment. 
 
In some cases, your doctor may recommend that you take iron supplements. 
 
Your doctor may decide to change the way that your injection is given (either under the skin or into a 
vein). If this changes you will start on the same dose as you have been receiving and your doctor will 
take blood samples to make sure that your anaemia is still being managed correctly. 
 
If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by 
gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection 
once weekly or once every two weeks. The route of injection is the same as with r-HuEPO but your 
doctor will tell you how much you should take, and when, and may adjust your dose if necessary. 
 
If you are receiving chemotherapy 
 
Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.  



 

 

208

 
In order to correct your anaemia, your initial dose will be 
 500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your 

body weight), or 
 2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight. 
 
Your doctor will take regular blood samples to measure how your anaemia is responding and may 
adjust your dose as necessary. Your treatment will continue until approximately four weeks after the 
end of your chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp. 
 
In some cases, your doctor may recommend that you take iron supplements. 
 
If you use more Aranesp than you should 
 
You could have serious problems if you use more Aranesp than you need, such as very high blood 
pressure. You should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell 
in any way you should contact your doctor, nurse or pharmacist immediately. 
 
If you forget to use Aranesp 
 
Do not use a double dose to make up for a forgotten dose. 
 
If you have forgotten a dose of Aranesp, you should contact your doctor to discuss when you should 
inject the next dose. 
 
If you stop using Aranesp 
 
If you want to stop using Aranesp, you should discuss it with your doctor first. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
The following side effects have been experienced by some patients taking Aranesp: 
 
Chronic renal failure patients 
 
Very common: may affect more than 1 in 10 people 
 High blood pressure (hypertension) 
 Allergic reactions 
 
Common: may affect up to 1 in 10 people 
 Stroke 
 Pain around the area injected  
 Rash and/or redness of the skin 
 
Uncommon: may affect up to 1 in 100 people 
 Blood clots (thrombosis) 
 Convulsions (fits and seizures) 
 Bruising and bleeding at the site of injection 
 Blood clots in a dialysis access 
 
Not known: frequency cannot be estimated from available data 
 Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy) 
 



 

 

209

Cancer patients 
 
Very common: may affect more than 1 in 10 people 
 Allergic reactions 
 
Common: may affect up to 1 in 10 people 
 High blood pressure (hypertension) 
 Blood clots (thrombosis) 
 Pain around the area injected  
 Rash and/or redness of the skin 
 Fluid retention (oedema) 
 
Uncommon: may affect up to 1 in 100 people 
 Convulsions (fits and seizures) 
 Bruising and bleeding at the site of injection 
 
All patients 
 
Not known: frequency cannot be estimated from available data 
 Serious allergic reactions which may include: 

 Sudden life-threatening allergic reactions (anaphylaxis) 
 Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in 

swallowing or breathing (angioedema) 
 Shortness of breath (allergic bronchospasm) 
 Skin rash 
 Hives (urticaria) 

 Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have 
been reported in association with epoetin treatment. These can appear as reddish target-like 
macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of 
mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.  
Stop using Aranesp if you develop these symptoms and contact your doctor or seek medical 
attention immediately. See also section 2. 

 
Reporting of side effects 
 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Aranesp 
 
Keep this medicine out of the sight and reach of children.  
 
Do not use this medicine after the expiry date which is stated on the carton and on the pre-filled pen 
label after EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C - 8°C). Do not freeze. Do not use Aranesp if you think it has been frozen. 
 
Keep the pre-filled pen in the outer carton in order to protect from light. 
 
When your pen has been removed from the refrigerator and left at room temperature for approximately 
30 minutes before injection it must either be used within 7 days or disposed of. 
 
Do not use this medicine if you notice the pre-filled pen contents are cloudy or there are particles in it. 



 

 

210

 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Aranesp contains 
 
- The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by gene-

technology). The pre-filled pen contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 
or 500 micrograms of darbepoetin alfa. 

- The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium 
chloride, polysorbate 80 and water for injections. 

 
What Aranesp looks like and contents of the pack 
 
Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled pen.  
 
Aranesp (SureClick) is available in packs containing 1 or 4 pre-filled pens. Not all pack sizes may be 
marketed.  
 
Marketing Authorisation Holder and Manufacturer 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Marketing Authorisation Holder  
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Manufacturer 
Amgen Technology (Ireland) Unlimited Company 
Pottery Road 
Dun Laoghaire 
Co Dublin 
Ireland 
 
Manufacturer 
Amgen NV 
Telecomlaan 5-7 
1831 Diegem 
Belgium 
 



 

 

211

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
s.a. Amgen n.v. 
Tel/Tél: +32 (0)2 7752711 
 

Lietuva 
Amgen Switzerland AG Vilniaus filialas 
Tel: +370 5 219 7474 

България 
Амджен България ЕООД 
Тел.: +359 (0)2 424 7440 

Luxembourg/Luxemburg 
s.a. Amgen  
Belgique/Belgien 
Tel/Tél: +32 (0)2 7752711 

Česká republika 
Amgen s.r.o. 
Tel: +420 221 773 500 

Magyarország 
Amgen Kft. 
Tel.: +36 1 35 44 700 

Danmark 
Amgen, filial af Amgen AB, Sverige 
Tlf: +45 39617500 
 

Malta 
Amgen B.V. 
The Netherlands 
Tel: +31 (0)76 5732500 
 

Deutschland 
AMGEN GmbH  
Tel.: +49 89 1490960  
 

Nederland 
Amgen B.V. 
Tel: +31 (0)76 5732500 

Eesti 
Amgen Switzerland AG Vilniaus filialas 
Tel: +372 586 09553 

Norge 
Amgen AB 
Tel: +47 23308000 

Ελλάδα 
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.  
Τηλ.: +30 210 3447000 
 

Österreich 
Amgen GmbH  
Tel: +43 (0)1 50 217  
 

España 
Amgen S.A.  
Tel: +34 93 600 18 60  
 

Polska 
Amgen Biotechnologia Sp. z o.o. 
Tel.: +48 22 581 3000 

France 
Amgen S.A.S.  
Tél: +33 (0)9 69 363 363  

Portugal 
Amgen Biofarmacêutica, Lda. 
Tel: +351 21 4220606 

Hrvatska 
Amgen d.o.o. 
Tel: +385 (0)1 562 57 20 

România 
Amgen România SRL 
Tel: +4021 527 3000 

Ireland 
Amgen Ireland Limited 
Tel: +353 1 8527400 
 

Slovenija 
AMGEN zdravila d.o.o. 
Tel: +386 (0)1 585 1767 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Amgen Slovakia s.r.o. 
Tel: +421 2 321 114 49 



 

 

212

Italia 
Amgen S.r.l 
Tel: +39 02 6241121 

Suomi/Finland 
Amgen AB, sivuliike Suomessa/Amgen AB, filial 
i Finland 
Puh/Tel: +358 (0)9 54900500 
 

Kύπρος 
C.A. Papaellinas Ltd 
Τηλ.: +357 22741 741 

Sverige 
Amgen AB  
Tel: +46 (0)8 6951100 

Latvija 
Amgen Switzerland AG Rīgas filiāle 
Tel: +371 257 25888 
 

United Kingdom 
Amgen Limited 
Tel: +44 (0)1223 420305 

 
This leaflet was last revised in 
 
Other sources of information  
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 
 
 
 



 

 

213

Instructions for use 
 
It is important that you do not try to give the injection unless you or your caregiver has received 
training from your healthcare provider.  
 
There are additional educational materials available to train you on how to self administer 
Aranesp pre-filled pen, a dummy demonstration device and a poster-size instructions for use for 
patients/caregivers with diminished eyesight. 

 
Guide to parts 

Before use After use 
 Red start button  
 
 
 
 
 

 

Expiry date 

Window 

Medicine 

Grey cap on 
  

 

 
 
 
 
 

Expiry date 

Yellow window 
(injection complete)

Yellow safety guard

Grey cap off 

Important: Needle is inside 

 



 

 

214

Important 

Before you use the Aranesp SureClick pre-filled pen, read this important information: 
Storing your Aranesp SureClick pre-filled pens 
 Keep the pre-filled pen and all medicines out of the reach of children. 
 Keep the pre-filled pen in the outer carton in order to protect from light or physical damage. 
 Store the pre-filled pen in the refrigerator (2ºC – 8ºC). 
 Once your pre-filled pen has been removed from the refrigerator, and left at room temperature 

(up to 25ºC) for approximately 30 minutes before injection, it must either be used within seven 
days or disposed of. 

 Do not store the pre-filled pen in extreme heat or cold. For example, avoid storing in your car 
glove box or boot.  

 Do not freeze. Do not use Aranesp if you think it has been frozen. 
Using your Aranesp SureClick pre-filled pens 
 Your healthcare provider has prescribed the Aranesp pre-filled pen for injection into the tissue 

just under the skin (subcutaneous use). 
 Do not use the pre-filled pen after the expiry date on the label. The expiry date refers to the last 

day of that month. 
 Do not shake the pre-filled pen. 
 Do not remove the grey cap from the pre-filled pen until you are ready to inject. 
 Do not use the pre-filled pen if it has been dropped on a hard surface. Part of the pre-filled pen 

may be broken even if you cannot see the break. Use a new pre-filled pen. 
 The pen contains dry natural rubber, which is made from latex, within the grey cap. Tell your 

healthcare provider if you are allergic to latex. 
For more information or help, contact your healthcare provider. 

 



 

 

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Step 1: Prepare 
A Remove one pre-filled pen from the carton.

Carefully lift the pre-filled pen straight up out of the carton. 
Put the original carton with any unused pre-filled pens back in the refrigerator. 
Leave the pre-filled pen at room temperature for at least 30 minutes before injecting. 

 Do not put the pre-filled pen back in the refrigerator once it 
has reached room temperature. 

 Do not try to warm the pre-filled pen by using a heat source 
such as hot water or microwave. 

 Do not leave the pre-filled pen in direct sunlight. 
 Do not shake the pre-filled pen. 
 Do not remove the grey cap from the pre-filled pen yet. 

 
30 minutes 
 
 

 

B Inspect the pre-filled pen. 

 
Grey cap on Window Medicine

 

Make sure the medicine in the window is a clear and colourless liquid. 
 Check that it is the correct dose that your healthcare provider has prescribed. 

 Do not use the pre-filled pen if the medicine is cloudy or discoloured or contains flakes or 
particles. 

 Do not use the pre-filled pen if any part appears cracked or broken. 
 Do not use the pre-filled pen if the pre-filled pen has been dropped. 
 Do not use the pre-filled pen if the grey cap is missing or not securely attached. 
 Do not use the pre-filled pen if the expiry date printed after EXP on the label has passed. 

In all cases, use a new pre-filled pen and contact your healthcare provider.

C Gather all the materials needed for your injection.
Wash your hands thoroughly with soap and water. 
On a clean, well-lit work surface, place the: 
 New pre-filled pen 
 Alcohol wipes 
 Cotton ball or gauze pad 
 Plaster 
 Sharps disposal container 

  



 

 

216

 
D Prepare and clean your injection site.

 
 
Upper arm 

Stomach area (abdomen) 

Thigh
 

You can use: 
 Your thigh 
 Stomach area (abdomen), except for a 5 cm (2-inch) area right around your navel 
 Outer area of upper arm (only if someone else is giving you the injection) 

Clean the injection site with an alcohol wipe. Let your skin dry. 
 Do not touch this area again before injecting. 

 Choose a different site each time you give yourself an injection. If you want to use the same 
injection site, make sure it is not the same spot on the injection site you used for a previous 
injection. 

 Do not inject into areas where the skin is tender, bruised, red, or hard.  
 Avoid injecting into areas with scars or stretch marks. 

 
Important: Follow your healthcare provider’s instructions about selecting sites for injection 
appropriate to you and about changing the site for each injection. 
 



 

 

217

Step 2: Get ready 
E Pull the grey cap straight off, only when you are ready to inject.  

It is normal to see a drop of liquid at the end of the needle or yellow safety guard. 
 Do not twist or bend the grey cap. 
 Do not put the grey cap back onto the pre-filled pen. 
 Do not remove the grey cap from the pre-filled pen until you are ready to inject. 

If you are unable to inject, please contact your healthcare provider immediately. 

F Stretch or pinch your injection site to create a firm surface.
Stretch method 

  

Stretch your skin firmly by moving your thumb and fingers in opposite directions, creating an area 
about 5 cm (2-inches) wide. 

OR 
Pinch method 

 

Pinch your skin firmly between your thumb and fingers, creating an area about 5 cm (2-inches) wide. 

Important: It is important to keep your skin stretched or pinched while injecting. 



 

 

218

Step 3: Inject 
G Hold the stretch or pinch. With the grey cap off, place the pre-filled pen on your skin at 

90 degrees. 

 

Important: Do not touch the red start button yet.

H Firmly push the pre-filled pen down onto your skin until it stops moving. 

  Push down 

 
Important: You must push all the way down but do not touch the red start button until you are ready 
to inject. 

I When you are ready to inject, press the red start button. 
 

“click”  Release button 

 
 

 
 



 

 

219

J Keep pushing down on your skin. Your injection could take about 15 seconds. 

 

 “click”  

 

 

15 seconds 

 

 
 

Window turns yellow 
when the injection is 

done 

 

Note: After you remove the pre-filled pen from your skin, the 
needle will be automatically covered. 

Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks 
like the medicine is still injecting, this means you have not received a full dose. Contact your 
healthcare provider immediately. 

K Examine the injection site. 
 If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection 

site. Apply a plaster if needed. 

Step 4: Finish 
L Dispose of the used pre-filled pen and grey cap.

 

Put the used pre-filled pen in the sharps disposal container immediately after use. 
 Do not reuse the pre-filled pen. 
 Do not recycle the pre-filled pen or sharps disposal container or throw them into household 

rubbish. 
Talk with your healthcare provider about proper disposal. There may be local guidelines for disposal. 

Important: Always keep the sharps disposal container out of the sight and reach of children. 



 

 

220

Package leaflet: Information for the user 
 

Aranesp 10 micrograms solution for injection in pre-filled syringe 
Aranesp 15 micrograms solution for injection in pre-filled syringe 
Aranesp 20 micrograms solution for injection in pre-filled syringe 
Aranesp 30 micrograms solution for injection in pre-filled syringe 
Aranesp 40 micrograms solution for injection in pre-filled syringe 
Aranesp 50 micrograms solution for injection in pre-filled syringe 
Aranesp 60 micrograms solution for injection in pre-filled syringe 
Aranesp 80 micrograms solution for injection in pre-filled syringe 

Aranesp 100 micrograms solution for injection in pre-filled syringe 
Aranesp 130 micrograms solution for injection in pre-filled syringe 
Aranesp 150 micrograms solution for injection in pre-filled syringe 
Aranesp 300 micrograms solution for injection in pre-filled syringe 
Aranesp 500 micrograms solution for injection in pre-filled syringe 

darbepoetin alfa 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Aranesp is and what it is used for 
2. What you need to know before you use Aranesp 
3. How to use Aranesp 
4. Possible side effects 
5. How to store Aranesp 
6. Contents of the pack and other information  
 
 
1. What Aranesp is and what it is used for 
 
Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia. Anaemia is when your 
blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and 
shortness of breath.  
 
Aranesp works in exactly the same way as the natural hormone erythropoietin. Erythropoietin is 
produced in your kidneys and encourages your bone marrow to produce more red blood cells. The 
active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster 
Ovary Cells (CHO-K1).  
 
If you have chronic renal failure  
 
Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney 
failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural 
hormone erythropoietin which can often cause anaemia.  
 
Because it will take your body some time to make more red blood cells, it will be about four weeks 
before you notice any effect. Your normal dialysis routine will not affect the ability of Aranesp to treat 
your anaemia. 
 



 

 

221

If you are receiving chemotherapy 
 
Aranesp is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers 
(non-myeloid malignancies) who are receiving chemotherapy. 
 
One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood 
cells. Towards the end of your chemotherapy course, particularly if you have had a lot of 
chemotherapy, your red blood cell count may fall making you anaemic. 
 
 
2. What you need to know before you use Aranesp 
 
Do not use Aranesp: 
- if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in 

section 6). 
- if you have been diagnosed with high blood pressure which is not being controlled with other 

medicines prescribed by your doctor. 
 
Warnings and precautions 
 
Talk to your doctor, pharmacist or nurse before using Aranesp. 
 
Please tell your doctor if you are suffering or have suffered from: 
- high blood pressure which is being controlled with medicines prescribed by your doctor; 
- sickle cell anaemia; 
- epileptic fits (seizures);  
- convulsions (fits or seizures);  
- liver disease; 
- significant lack of response to medicines used to treat anaemia; 
- an allergy to latex (the needle cap on the pre-filled syringe contains a derivative of latex); or 
- hepatitis C. 
 
Special warnings: 
- If you have symptoms which include unusual tiredness and a lack of energy this could mean 

you have pure red cell aplasia (PRCA), which has been reported in patients. PRCA means that 
the body has stopped or reduced the production of red blood cells which causes severe anaemia. 
If you experience these symptoms you should contact your doctor who will determine the best 
course of action to treat your anaemia.  

 
- Take special care with other products that stimulate red blood cell production: Aranesp is one of 

a group of products that stimulate the production of red blood cells like the human protein 
erythropoietin does. Your healthcare professional should always record the exact product you 
are using. 

 
- If you are a patient with chronic renal failure, and particularly if you do not respond properly to 

Aranesp, your doctor will check your dose of Aranesp because repeatedly increasing your dose 
of Aranesp if you are not responding to treatment may increase the risk of having a problem of 
the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death. 

 
- Your doctor should try to keep your haemoglobin between 10 and 12 g/dL. Your doctor will 

check that your haemoglobin does not exceed a certain level, as high haemoglobin 
concentrations could put you at risk of having a problem of the heart or the blood vessels and 
could increase risk of myocardial infarction, stroke and death. 

 
- If you have symptoms which include severe headache, drowsiness, confusion, problems with 

your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood 
pressure. If you experience these symptoms you should contact your doctor. 



 

 

222

 
- If you are a cancer patient you should be aware that Aranesp may act as a blood cell growth 

factor and in some circumstances may have a negative impact on your cancer. Depending on 
your individual situation a blood transfusion may be preferable. Please discuss this with your 
doctor. 

 
- Misuse by healthy people can cause life-threatening problems with the heart or blood vessels. 
 
- Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal 

necrolysis (TEN) have been reported in association with epoetin treatment. SJS/TEN can appear 
initially as reddish target-like spots or circular patches often with central blisters on the trunk. 
Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These 
serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may 
progress to widespread peeling of the skin and life-threatening complications. If you develop a 
serious rash or another of these skin symptoms, stop taking Aranesp and contact your doctor or 
seek medical attention immediately. 

 
Other medicines and Aranesp 
 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the 
number of red cells in your blood. It is important to tell your doctor if you are taking either of these 
medicines. 
 
Using Aranesp with food and drink 
 
Food and drink do not affect Aranesp. 
 
Pregnancy and breast-feeding  
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Aranesp has not been tested in pregnant women. It is important to tell your doctor if you: 
 are pregnant;  
 think you may be pregnant; or 
 plan to get pregnant.  
 
It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if 
you use Aranesp. 
 
Driving and using machines 
 
Aranesp should not affect your ability to drive or use machinery. 
 
Aranesp contains sodium 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
‘sodium-free’. 
 
 
3. How to use Aranesp 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 



 

 

223

Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 
10 g/dL or less. Your doctor will tell you how much and how often you must take Aranesp in order to 
maintain a haemoglobin level between 10 and 12 g/dL. This may vary depending on whether you are 
an adult or a child.  
 
Injecting Aranesp yourself 
 
Your doctor may decide that it is best for you or a carer to inject Aranesp. Your doctor, nurse or 
pharmacist will show you how to inject yourself with the pre-filled syringe. Do not try to inject 
yourself if you have not been trained. Never inject Aranesp into a vein yourself.  
 
If you have chronic renal failure 
 
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, Aranesp is given as a 
single injection, either under your skin (subcutaneous) or into a vein (intravenous). 
 
In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will 
be either: 
 0.75 micrograms once every two weeks, or 
 0.45 micrograms once weekly. 
For adult patients not on dialysis, 1.5 micrograms/kg once monthly may also be used as the initial 
dose. 
 
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, once your anaemia is 
corrected you will continue to receive Aranesp given as a single injection, either once a week or once 
every two weeks. For all adults and paediatric patients ≥ 11 years of age not on dialysis, Aranesp 
could also be given as an injection once monthly. 
 
Your doctor will take regular blood samples to measure how your anaemia is responding and may 
adjust your dose once every four weeks as necessary in order to maintain long term control of your 
anaemia. 
 
Your doctor will use the lowest effective dose to control the symptoms of your anaemia. 
 
If you do not respond adequately to Aranesp, your doctor will check your dose and will inform you if 
you need to change doses of Aranesp. 
 
Your blood pressure will also be checked regularly, particularly at the beginning of your treatment. 
 
In some cases, your doctor may recommend that you take iron supplements. 
 
Your doctor may decide to change the way that your injection is given (either under the skin or into a 
vein). If this changes you will start on the same dose as you have been receiving and your doctor will 
take blood samples to make sure that your anaemia is still being managed correctly. 
 
If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by 
gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection 
once weekly or once every two weeks. The route of injection is the same as with r-HuEPO but your 
doctor will tell you how much you should take, and when, and may adjust your dose if necessary. 
 
If you are receiving chemotherapy 
 
Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.  
 



 

 

224

In order to correct your anaemia, your initial dose will be 
 500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your 

body weight), or 
 2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight. 
 
Your doctor will take regular blood samples to measure how your anaemia is responding and may 
adjust your dose as necessary. Your treatment will continue until approximately four weeks after the 
end of your chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp. 
 
In some cases, your doctor may recommend that you take iron supplements. 
 
If you use more Aranesp than you should 
 
You could have serious problems if you use more Aranesp than you need, such as very high blood 
pressure. You should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell 
in any way you should contact your doctor, nurse or pharmacist immediately. 
 
If you forget to use Aranesp 
 
Do not use a double dose to make up for a forgotten dose. 
 
If you have forgotten a dose of Aranesp, you should contact your doctor to discuss when you should 
inject the next dose. 
 
If you stop using Aranesp 
 
If you want to stop using Aranesp, you should discuss it with your doctor first. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
The following side effects have been experienced by some patients taking Aranesp: 
 
Chronic renal failure patients 
 
Very common: may affect more than 1 in 10 people 
 High blood pressure (hypertension) 
 Allergic reactions 
 
Common: may affect up to 1 in 10 people 
 Stroke 
 Pain around the area injected  
 Rash and/or redness of the skin 
 
Uncommon: may affect up to 1 in 100 people 
 Blood clots (thrombosis) 
 Convulsions (fits and seizures) 
 Bruising and bleeding at the site of injection 
 Blood clots in a dialysis access 
 
Not known: frequency cannot be estimated from available data 
 Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy) 
 



 

 

225

Cancer patients 
 
Very common: may affect more than 1 in 10 people 
 Allergic reactions 
 
Common: may affect up to 1 in 10 people 
 High blood pressure (hypertension) 
 Blood clots (thrombosis) 
 Pain around the area injected  
 Rash and/or redness of the skin 
 Fluid retention (oedema) 
 
Uncommon: may affect up to 1 in 100 people 
 Convulsions (fits and seizures) 
 Bruising and bleeding at the site of injection 
 
All patients 
 
Not known: frequency cannot be estimated from available data 
 Serious allergic reactions which may include: 

 Sudden life-threatening allergic reactions (anaphylaxis) 
 Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in 

swallowing or breathing (angioedema) 
 Shortness of breath (allergic bronchospasm) 
 Skin rash 
 Hives (urticaria) 

 Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have 
been reported in association with epoetin treatment. These can appear as reddish target-like 
macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of 
mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. 
Stop using Aranesp if you develop these symptoms and contact your doctor or seek medical 
attention immediately. See also section 2. 

 
Reporting of side effects 
 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Aranesp 
 
Keep this medicine out of the sight and reach of children.  
 
Do not use this medicine after the expiry date which is stated on the carton and on the pre-filled 
syringe label after EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C - 8°C). Do not freeze. Do not use Aranesp if you think it has been frozen. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
When your syringe has been removed from the refrigerator and left at room temperature for 
approximately 30 minutes before injection it must either be used within 7 days or disposed of. 
 



 

 

226

Do not use this medicine if you notice the pre-filled syringe contents are cloudy or there are particles 
in it. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Aranesp contains 
 
- The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by gene-

technology). The pre-filled syringe contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 
300 or 500 micrograms of darbepoetin alfa.  

- The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium 
chloride, polysorbate 80 and water for injections. 

 
What Aranesp looks like and contents of the pack 
 
Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled syringe.  
 
Aranesp is available in packs of 1 or 4 pre-filled syringes with automatic needle guard in a blister 
wrapping. Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Marketing Authorisation Holder  
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Manufacturer 
Amgen Technology (Ireland) Unlimited Company 
Pottery Road 
Dun Laoghaire 
Co Dublin 
Ireland 
 
Manufacturer 
Amgen NV 
Telecomlaan 5-7 
1831 Diegem 
Belgium 
 



 

 

227

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
s.a. Amgen n.v. 
Tel/Tél: +32 (0)2 7752711 
 

Lietuva 
Amgen Switzerland AG Vilniaus filialas 
Tel: +370 5 219 7474 

България 
Амджен България ЕООД 
Тел.: +359 (0)2 424 7440 

Luxembourg/Luxemburg 
s.a. Amgen  
Belgique/Belgien 
Tel/Tél: +32 (0)2 7752711 

Česká republika 
Amgen s.r.o. 
Tel: +420 221 773 500 

Magyarország 
Amgen Kft. 
Tel.: +36 1 35 44 700 

Danmark 
Amgen, filial af Amgen AB, Sverige 
Tlf: +45 39617500 
 

Malta 
Amgen B.V. 
The Netherlands 
Tel: +31 (0)76 5732500 
 

Deutschland 
AMGEN GmbH  
Tel.: +49 89 1490960  
 

Nederland 
Amgen B.V. 
Tel: +31 (0)76 5732500 

Eesti 
Amgen Switzerland AG Vilniaus filialas 
Tel: +372 586 09553 

Norge 
Amgen AB 
Tel: +47 23308000 

Ελλάδα 
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.  
Τηλ.: +30 210 3447000 
 

Österreich 
Amgen GmbH  
Tel: +43 (0)1 50 217 
 

España 
Amgen S.A.  
Tel: +34 93 600 18 60  
 

Polska 
Amgen Biotechnologia Sp. z o.o. 
Tel.: +48 22 581 3000 

France 
Amgen S.A.S. 
Tél: +33 (0)9 69 363 363  

Portugal 
Amgen Biofarmacêutica, Lda. 
Tel: +351 21 4220606 

Hrvatska 
Amgen d.o.o. 
Tel: +385 (0)1 562 57 20 

România 
Amgen România SRL 
Tel: +4021 527 3000 

Ireland 
Amgen Ireland Limited 
Tel: +353 1 8527400 
 

Slovenija 
AMGEN zdravila d.o.o. 
Tel: +386 (0)1 585 1767 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Amgen Slovakia s.r.o. 
Tel: +421 2 321 114 49 



 

 

228

Italia 
Amgen S.r.l 
Tel: +39 02 6241121 

Suomi/Finland 
Amgen AB, sivuliike Suomessa/Amgen AB, filial 
i Finland 
Puh/Tel: +358 (0)9 54900500 
 

Kύπρος 
C.A. Papaellinas Ltd 
Τηλ.: +357 22741 741 

Sverige 
Amgen AB  
Tel: +46 (0)8 6951100 

Latvija 
Amgen Switzerland AG Rīgas filiāle 
Tel: +371 257 25888 
 

United Kingdom 
Amgen Limited 
Tel: +44 (0)1223 420305 

 
This leaflet was last revised in 
 
Other sources of information  
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 
 
 
 
 



 

 

229

Instructions for use: 

Guide to parts 
Before use After use 

Plunger

Finger grips

Syringe label
Syringe barrel

Syringe safety guard

Needle safety spring

Grey needle cap on

 

Used plunger 

Syringe label 

Used syringe barrel 

Used needle 

Used needle safety 
spring 

Grey needle cap off 

 

 



 

 

230

Important 

Before you use an Aranesp pre-filled syringe with automatic needle guard, read this important 
information: 
 It is important that you do not try to give yourself the injection unless you have received 

training from your doctor or healthcare provider. 
 Aranesp is given as an injection into the tissue just under the skin (subcutaneous injection). 
 Tell your doctor if you have an allergy to latex. The needle cap on the pre-filled syringe 

contains a derivative of latex and may cause severe allergic reactions. 
 Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject. 

 Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new pre-filled 
syringe and call your doctor or healthcare provider. 

 Do not attempt to activate the pre-filled syringe prior to injection. 

 Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe. 

 Do not attempt to remove the peelable label on the pre-filled syringe barrel before 
administering your injection. 

Call your doctor or healthcare provider if you have any questions. 
 

Step 1: Prepare 
A Remove the pre-filled syringe tray from the package and gather the supplies needed for your 

injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container 
(not included). 

Put the original package with any unused pre-filled syringes back in the refrigerator. 
 
For a more comfortable injection, leave the pre-filled syringe at room temperature for about 
30 minutes before injecting. Wash your hands thoroughly with soap and water. 
 
On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies. 

 Do not try to warm the syringe by using a heat source such as hot water or microwave 
 Do not leave the pre-filled syringe exposed to direct sunlight
 Do not shake the pre-filled syringe  

  Keep pre-filled syringes out of the sight and reach of children 
 
B Open the tray, peeling away the cover. Grab the pre-filled syringe safety guard to remove the 

pre-filled syringe from the tray. 

 

Grab here
For safety reasons: 

 Do not grasp the plunger 
 Do not grasp the grey needle cap 



 

 

231

C Inspect the medicine and pre-filled syringe. 
 Medicine 

 

 Do not use the pre-filled syringe if:
 The medicine is cloudy or there are particles in it. It must be a clear and colourless 

liquid. 
 Any part appears cracked or broken. 
 The grey needle cap is missing or not securely attached. 
 The expiry date printed on the label has passed the last day of the month shown. 

In all cases, call your doctor or healthcare provider.
 

Step 2: Get ready 
A Wash your hands thoroughly. Prepare and clean your injection site. 

You can use: 

Upper arm 
 

Belly 

Upper thigh 

 Upper part of your thigh 
 Belly, except for a 5 cm (2-inch) area right around your belly button 
 Outer area of upper arm (only if someone else is giving you the injection) 
Clean the injection site with an alcohol wipe. Let your skin dry. 

 Do not touch the injection site before injecting 

 
Choose a different site each time you give yourself an injection. If you need to use the 
same injection site, just make sure it is not the same spot on that site you used last time.  
Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting 
into areas with scars or stretch marks.



 

 

232

B Carefully pull the grey needle cap straight out and away from your body. 

 

 

C Pinch your injection site to create a firm surface. 

 

 It is important to keep the skin pinched when injecting. 

 
Step 3: Inject 

A Hold the pinch. INSERT the needle into skin. 

 

 Do not touch the cleaned area of the skin 



 

 

233

B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”. Push all 
the way down through the snap. 

 

“SNAP”  

 

 It is important to push down through the “snap” to deliver your full dose. 
 

C RELEASE your thumb. Then LIFT the syringe off skin. 

 

After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle. 
 Do not put the grey needle cap back on used pre-filled syringes. 



 

234 

 
Healthcare Providers only

Remove and save the pre-filled syringe label. 

Turn the plunger to move the label into a position where you can remove the syringe label. 
 

Step 4: Finish 
A Discard the used pre-filled syringe and other supplies in a sharps disposal container. 

 

Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
Keep the syringe and sharps disposal container out of sight and reach of children. 

 Do not reuse the pre-filled syringe 
 Do not recycle pre-filled syringes or throw them into household waste 

 

B Examine the injection site. 
If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. 
Apply a plaster if needed. 
 



 

235 

Package leaflet: Information for the user 
 

Aranesp 25 micrograms solution for injection in vial 
Aranesp 40 micrograms solution for injection in vial 
Aranesp 60 micrograms solution for injection in vial 

Aranesp 100 micrograms solution for injection in vial 
Aranesp 200 micrograms solution for injection in vial 
Aranesp 300 micrograms solution for injection in vial 

darbepoetin alfa 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Aranesp is and what it is used for 
2. What you need to know before you use Aranesp 
3. How to use Aranesp 
4. Possible side effects 
5. How to store Aranesp 
6. Contents of the pack and other information  
 
 
1. What Aranesp is and what it is used for 
 
Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia. Anaemia is when your 
blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and 
shortness of breath.  
 
Aranesp works in exactly the same way as the natural hormone erythropoietin. Erythropoietin is 
produced in your kidneys and encourages your bone marrow to produce more red blood cells. The 
active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster 
Ovary Cells (CHO-K1).  
 
If you have chronic renal failure  
 
Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney 
failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural 
hormone erythropoietin which can often cause anaemia.  
 
Because it will take your body some time to make more red blood cells, it will be about four weeks 
before you notice any effect. Your normal dialysis routine will not affect the ability of Aranesp to treat 
your anaemia. 
 
If you are receiving chemotherapy 
 
Aranesp is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers 
(non-myeloid malignancies) who are receiving chemotherapy. 
 
One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood 
cells. Towards the end of your chemotherapy course, particularly if you have had a lot of 
chemotherapy, your red blood cell count may fall making you anaemic. 
 



 

236 

 
2. What you need to know before you use Aranesp 
 
Do not use Aranesp: 
- if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in 

section 6). 
- if you have been diagnosed with high blood pressure which is not being controlled with other 

medicines prescribed by your doctor. 
 
Warnings and precautions 
 
Talk to your doctor, pharmacist or nurse before using Aranesp. 
 
Please tell your doctor if you are suffering or have suffered from: 
- high blood pressure which is being controlled with medicines prescribed by your doctor; 
- sickle cell anaemia; 
- epileptic fits (seizures);  
- convulsions (fits or seizures);  
- liver disease; 
- significant lack of response to medicines used to treat anaemia; or 
- hepatitis C. 
 
Special warnings: 
- If you have symptoms which include unusual tiredness and a lack of energy this could mean 

you have pure red cell aplasia (PRCA), which has been reported in patients. PRCA means that 
the body has stopped or reduced the production of red blood cells which causes severe anaemia. 
If you experience these symptoms you should contact your doctor who will determine the best 
course of action to treat your anaemia.  

 
- Take special care with other products that stimulate red blood cell production: Aranesp is one of 

a group of products that stimulate the production of red blood cells like the human protein 
erythropoietin does. Your healthcare professional should always record the exact product you 
are using. 

 
- If you are a patient with chronic renal failure, and particularly if you do not respond properly to 

Aranesp, your doctor will check your dose of Aranesp because repeatedly increasing your dose 
of Aranesp if you are not responding to treatment may increase the risk of having a problem of 
the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death. 

 
- Your doctor should try to keep your haemoglobin between 10 and 12 g/dL. Your doctor will 

check that your haemoglobin does not exceed a certain level, as high haemoglobin 
concentrations could put you at risk of having a problem of the heart or the blood vessels and 
could increase risk of myocardial infarction, stroke and death. 

 
- If you have symptoms which include severe headache, drowsiness, confusion, problems with 

your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood 
pressure. If you experience these symptoms you should contact your doctor. 

 
- If you are a cancer patient you should be aware that Aranesp may act as a blood cell growth 

factor and in some circumstances may have a negative impact on your cancer. Depending on 
your individual situation a blood transfusion may be preferable. Please discuss this with your 
doctor. 

 



 

237 

- Misuse by healthy people can cause life-threatening problems with the heart or blood vessels. 
 
- Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal 

necrolysis (TEN) have been reported in association with epoetin treatment. SJS/TEN can appear 
initially as reddish target-like spots or circular patches often with central blisters on the trunk. 
Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These 
serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may 
progress to widespread peeling of the skin and life-threatening complications.  
If you develop a serious rash or another of these skin symptoms, stop taking Aranesp and 
contact your doctor or seek medical attention immediately. 

 
Other medicines and Aranesp 
 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the 
number of red cells in your blood. It is important to tell your doctor if you are taking either of these 
medicines. 
 
Using Aranesp with food and drink 
 
Food and drink do not affect Aranesp. 
 
Pregnancy and breast-feeding 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Aranesp has not been tested in pregnant women. It is important to tell your doctor if you: 
 are pregnant;  
 think you may be pregnant; or 
 plan to get pregnant.  
 
It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if 
you use Aranesp. 
 
Driving and using machines 
 
Aranesp should not affect your ability to drive or use machinery. 
 
Aranesp contains sodium 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
‘sodium-free’. 
 
 
3. How to use Aranesp 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.  
 
Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 
10 g/dL or less. Your doctor will tell you how much and how often you must take Aranesp in order to 
maintain a haemoglobin level between 10 and 12 g/dL. This may vary depending on whether you are 
an adult or a child.  
 
The injections will be given by a healthcare professional. 



 

238 

 
If you have chronic renal failure 
 
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, Aranesp is given as a 
single injection by a healthcare professional, either under your skin (subcutaneous) or into a vein 
(intravenous). 
 
In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will 
be either: 
 0.75 micrograms once every two weeks, or 
 0.45 micrograms once weekly.  
For adult patients not on dialysis, 1.5 micrograms/kg once monthly may also be used as the initial 
dose. 
 
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, once your anaemia is 
corrected you will continue to receive Aranesp given as a single injection, either once a week or once 
every two weeks. For all adults and paediatric patients ≥ 11 years of age not on dialysis, Aranesp 
could also be given as an injection once monthly. 
 
Your doctor will take regular blood samples to measure how your anaemia is responding and may 
adjust your dose once every four weeks as necessary in order to maintain long term control of your 
anaemia. 
 
Your doctor will use the lowest effective dose to control the symptoms of your anaemia. 
 
If you do not respond adequately to Aranesp, your doctor will check your dose and will inform you if 
you need to change doses of Aranesp. 
 
Your blood pressure will also be checked regularly, particularly at the beginning of your treatment. 
 
In some cases, your doctor may recommend that you take iron supplements. 
 
Your doctor may decide to change the way that your injection is given (either under the skin or into a 
vein). If this changes you will start on the same dose as you have been receiving and your doctor will 
take blood samples to make sure that your anaemia is still being managed correctly. 
 
If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by 
gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection 
once weekly or once every two weeks. The route of injection is the same as with r-HuEPO but your 
doctor will tell you how much you should take, and when, and may adjust your dose if necessary. 
 
If you are receiving chemotherapy 
 
Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.  
 
In order to correct your anaemia, your initial dose will be 
 500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your 

body weight), or 
 2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight. 
 
Your doctor will take regular blood samples to measure how your anaemia is responding and may 
adjust your dose as necessary. Your treatment will continue until approximately four weeks after the 
end of your chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp. 
 
In some cases, your doctor may recommend that you take iron supplements. 
 



 

239 

If you use more Aranesp than you should 
 
You could have serious problems if you receive more Aranesp than you need, such as very high blood 
pressure. You should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell 
in any way you should contact your doctor, nurse or pharmacist immediately. 
 
If you miss a dose of Aranesp 
 
Do not use a double dose to make up for a forgotten dose. 
 
If you miss a dose of Aranesp, you should contact your doctor to discuss when you should receive the 
next dose. 
 
If you stop using Aranesp 
 
If you want to stop using Aranesp, you should discuss it with your doctor first. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
The following side effects have been experienced by some patients taking Aranesp: 
 
Chronic renal failure patients 
 
Very common: may affect more than 1 in 10 people 
 High blood pressure (hypertension) 
 Allergic reactions 
 
Common: may affect up to 1 in 10 people 
 Stroke 
 Pain around the area injected  
 Rash and/or redness of the skin 
 
Uncommon: may affect up to 1 in 100 people 
 Blood clots (thrombosis) 
 Convulsions (fits and seizures) 
 Bruising and bleeding at the site of injection 
 Blood clots in a dialysis access 
 
Not known: frequency cannot be estimated from available data 
 Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy) 
 
Cancer patients 
 
Very common: may affect more than 1 in 10 people 
 Allergic reactions 
 
Common: may affect up to 1 in 10 people 
 High blood pressure (hypertension) 
 Blood clots (thrombosis) 
 Pain around the area injected  
 Rash and/or redness of the skin 
 Fluid retention (oedema) 
 



 

240 

Uncommon: may affect up to 1 in 100 people 
 Convulsions (fits and seizures) 
 Bruising and bleeding at the site of injection 
 
All patients 
 
Not known: frequency cannot be estimated from available data 
 Serious allergic reactions which may include: 

 Sudden life-threatening allergic reactions (anaphylaxis) 
 Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in 

swallowing or breathing (angioedema) 
 Shortness of breath (allergic bronchospasm) 
 Skin rash 
 Hives (urticaria) 

 Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have 
been reported in association with epoetin treatment. These can appear as reddish target-like 
macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of 
mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop 
using Aranesp if you develop these symptoms and contact your doctor or seek medical attention 
immediately. See also section 2. 

 
Reporting of side effects 
 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Aranesp 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and on the vial label after 
EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C - 8°C). Do not freeze. Do not use Aranesp if you think it has been frozen. 
 
Keep the vial in the outer carton in order to protect from light. 
 
When your vial has been removed from the refrigerator and left at room temperature for 
approximately 30 minutes before injection it must either be used within 7 days or disposed of. 
 
Do not use this medicine if you notice the vial contents are cloudy or there are particles in it. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 



 

241 

6. Contents of the pack and other information  
 
What Aranesp contains 
 
- The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by gene-

technology). The vial contains either 25, 40, 60, 100, 200 or 300 micrograms of darbepoetin 
alfa. 

- The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium 
chloride, polysorbate 80 and water for injections. 

 
What Aranesp looks like and contents of the pack 
 
Aranesp is a clear, colourless or slightly pearly solution for injection in vial.  
 
Aranesp is available in packs of 1 or 4 vials. Not all pack sizes may be marketed.  
 
Marketing Authorisation Holder and Manufacturer 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Marketing Authorisation Holder  
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Manufacturer 
Amgen Technology (Ireland) Unlimited Company 
Pottery Road 
Dun Laoghaire 
Co Dublin 
Ireland 
 
Manufacturer 
Amgen NV 
Telecomlaan 5-7 
1831 Diegem 
Belgium 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
s.a. Amgen n.v. 
Tel/Tél: +32 (0)2 7752711 
 

Lietuva 
Amgen Switzerland AG Vilniaus filialas 
Tel: +370 5 219 7474 

България 
Амджен България ЕООД 
Тел.: +359 (0)2 424 7440 

Luxembourg/Luxemburg 
s.a. Amgen  
Belgique/Belgien 
Tel/Tél: +32 (0)2 7752711 

Česká republika 
Amgen s.r.o. 
Tel: +420 221 773 500 

Magyarország 
Amgen Kft. 
Tel.: +36 1 35 44 700 



 

242 

Danmark 
Amgen, filial af Amgen AB, Sverige 
Tlf: +45 39617500 
 

Malta 
Amgen B.V. 
The Netherlands 
Tel: +31 (0)76 5732500 
 

Deutschland 
AMGEN GmbH  
Tel.: +49 89 1490960  
 

Nederland 
Amgen B.V. 
Tel: +31 (0)76 5732500 

Eesti 
Amgen Switzerland AG Vilniaus filialas 
Tel: +372 586 09553 

Norge 
Amgen AB 
Tel: +47 23308000 

Ελλάδα 
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.  
Τηλ.: +30 210 3447000 
 

Österreich 
Amgen GmbH  
Tel: +43 (0)1 50 217  
 

España 
Amgen S.A.  
Tel: +34 93 600 18 60  
 

Polska 
Amgen Biotechnologia Sp. z o.o. 
Tel.: +48 22 581 3000 

France 
Amgen S.A.S.  
Tél: +33 (0)9 69 363 363  

Portugal 
Amgen Biofarmacêutica, Lda. 
Tel: +351 21 4220606 

Hrvatska 
Amgen d.o.o. 
Tel: +385 (0)1 562 57 20 

România 
Amgen România SRL 
Tel: +4021 527 3000 

Ireland 
Amgen Ireland Limited 
Tel: +353 1 8527400 
 

Slovenija 
AMGEN zdravila d.o.o. 
Tel: +386 (0)1 585 1767 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Amgen Slovakia s.r.o. 
Tel: +421 2 321 114 49 

Italia 
Amgen S.r.l 
Tel: +39 02 6241121 

Suomi/Finland 
Amgen AB, sivuliike Suomessa/Amgen AB, filial 
i Finland 
Puh/Tel: +358 (0)9 54900500 
 

Kύπρος 
C.A. Papaellinas Ltd 
Τηλ.: +357 22741 741 

Sverige 
Amgen AB  
Tel: +46 (0)8 6951100 

Latvija 
Amgen Switzerland AG Rīgas filiāle 
Tel: +371 257 25888 
 

United Kingdom 
Amgen Limited 
Tel: +44 (0)1223 420305 

 



 

243 

This leaflet was last revised in 
 
Other sources of information  
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET