Neulasta

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Neulasta 6 mg solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The 
concentration is 10 mg/mL based on protein only**. 
 
* Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with 
polyethylene glycol (PEG). 
** The concentration is 20 mg/mL if the PEG moiety is included. 
 
The potency of this product should not be compared to the potency of another pegylated or 
non-pegylated protein of the same therapeutic class. For more information, see section 5.1. 
 
Excipients with known effect 
Each pre-filled syringe contains 30 mg sorbitol (E420) (see section 4.4). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection). 
Solution for injection (injection) with on-body injector (Onpro kit). 
 
Clear, colourless solution for injection. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients 
treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia 
and myelodysplastic syndromes). 
 
4.2 Posology and method of administration 
 
Neulasta therapy should be initiated and supervised by physicians experienced in oncology and/or 
haematology. 
 
Posology 
 
One 6 mg dose (a single pre-filled syringe) of Neulasta is recommended for each chemotherapy cycle, 
given at least 24 hours after cytotoxic chemotherapy. 
 
Special populations 
 
Paediatric population 
 
The safety and efficacy of Neulasta in children has not yet been established. Currently available data 
are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made. 
 



 

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Patients with renal impairment 
 
No dose change is recommended in patients with renal impairment, including those with end-stage 
renal disease. 
 
Method of administration 
 
Neulasta is injected subcutaneously via: 
 a pre-filled syringe for manual administration; or 
 a pre-filled syringe with on-body injector for automatic administration. 
 
Neulasta 6 mg solution for injection in pre-filled syringe 
 
The manually administered injections should be given into the thigh, abdomen or upper arm. 
 
Neulasta 6 mg solution for injection in pre-filled syringe with on-body injector 
 
The on-body injector must be filled using the co-packed pre-filled syringe. The on-body injector 
should be applied to intact, non-irritated skin on the back of the arm or abdomen. The back of the arm 
may only be used if there is a caregiver available to monitor the status of the on-body injector. 
Approximately 27 hours after the on-body injector is applied to the patient’s skin, Neulasta will be 
delivered over approximately 45 minutes. Once filled, the on-body injector should be used for 
immediate application and can be applied on the same day as the administration of cytotoxic 
chemotherapy, as long as application is timed to ensure the on-body injector delivers Neulasta at least 
24 hours after administration of cytotoxic chemotherapy. 
 
The on-body injector must only be used with the co-packed pre-filled syringe. The co-packed 
pre-filled syringe contains additional solution to compensate for residual liquid retained in the on-body 
injector after delivery. If the pre-filled syringe co-packed with the on-body injector is used for 
manually administering a subcutaneous injection, the patient will receive more than the recommended 
dose. If the pre-filled syringe for manual administration is used with the on-body injector, the patient 
may receive less than the recommended dose. 
 
For instructions on handling of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade 
name of the administered product should be clearly recorded in the patient file. 
 
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for 
pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1). 
However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it 
should be used with caution in this patient population. 
 
G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some 
non-myeloid cells in vitro. 
 



 

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The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic 
syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should 
not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast 
transformation of chronic myeloid leukaemia from AML. 
 
The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with 
cytogenetics t(15;17) have not been established. 
 
The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose 
chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic 
chemotherapy beyond established dosage regimens. 
 
Pulmonary adverse events 
 
Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF 
administration. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher 
risk (see section 4.8). 
 
The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological 
signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil 
count may be preliminary signs of acute respiratory distress syndrome (ARDS). In such circumstances 
pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment 
given (see section 4.8). 
 
Glomerulonephritis 
 
Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, 
events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and 
pegfilgrastim. Urinalysis monitoring is recommended. 
 
Capillary leak syndrome 
 
Capillary leak syndrome has been reported after G-CSF administration and is characterised by 
hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients who develop symptoms of 
capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, 
which may include a need for intensive care (see section 4.8). 
 
Splenomegaly and splenic rupture 
 
Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal 
cases, have been reported following administration of pegfilgrastim (see section 4.8). Therefore, 
spleen size should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of 
splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip 
pain. 
 
Thrombocytopenia and anaemia 
 
Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full 
dose myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of 
platelet count and haematocrit is recommended. Special care should be taken when administering 
single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia. 
 



 

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Myelodysplastic syndrome and acute myeloid leukaemia in breast and lung cancer patients  
 
In the post-marketing observational study setting, pegfilgrastim in conjunction with chemotherapy 
and/or radiotherapy has been associated with development of myelodysplastic syndrome (MDS) and 
acute myeloid leukaemia (AML) in breast and lung cancer patients (see section 4.8). Monitor patients 
treated in these settings for signs and symptoms of MDS/AML.  
 
Medication error as a result of device failure 
 
There is a risk of medication error, particularly a partial or missed dose of pegfilgrastim, in the event 
of a device failure or malfunction with the on-body injector. In the event of a partial or missed dose, 
patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection 
than if the dose had been correctly delivered. The healthcare professional must ensure the patient 
receives appropriate training about the on-body injector and understands that if they suspect a device 
failure or malfunction the patient must immediately inform a healthcare professional as they may need 
a replacement dose. Comprehensive instructions for use for healthcare professionals and patients are 
given in the package leaflet. The patient should also be given the Patient Alert Card. 
 
Sickle cell anaemia 
 
Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or 
sickle cell disease (see section 4.8). Therefore, physicians should use caution when prescribing 
pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical 
parameters and laboratory status and be attentive to the possible association of this medicine with 
splenic enlargement and vaso-occlusive crisis. 
 
Leukocytosis 
 
White blood cell (WBC) counts of 100 × 109/L or greater have been observed in less than 1% of 
patients receiving pegfilgrastim. No adverse events directly attributable to this degree of leukocytosis 
have been reported. Such elevation in white blood cells is transient, typically seen 24 to 48 hours after 
administration and is consistent with the pharmacodynamic effects of this medicine. Consistent with 
the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular 
intervals during therapy. If leukocyte counts exceed 50 × 109/L after the expected nadir, this medicine 
should be discontinued immediately. 
 
Hypersensitivity 
 
Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have 
been reported in patients treated with pegfilgrastim. Permanently discontinue pegfilgrastim in patients 
with clinically significant hypersensitivity. Do not administer pegfilgrastim to patients with a history 
of hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate 
therapy should be administered, with close patient follow-up over several days. 
 
Stevens-Johnson syndrome 
 
Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in 
association with pegfilgrastim treatment. If the patient has developed SJS with the use of 
pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.  
 
Immunogenicity 
 
As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of 
antibodies against pegfilgrastim is generally low. Binding antibodies do occur as expected with all 
biologics; however, they have not been associated with neutralising activity at present. 
 



 

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Aortitis 
 
Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients. The 
symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory 
markers (e.g. c-reactive protein and white blood cell count). In most cases aortitis was diagnosed by 
CT scan and generally resolved after withdrawal of G-CSF. See also section 4.8. 
 
Other warnings 
 
The safety and efficacy of Neulasta for the mobilisation of blood progenitor cells in patients or healthy 
donors has not been adequately evaluated. 
 
The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may 
cause allergic reactions. 
 
The on-body injector uses an acrylic adhesive. For patients who have reactions to acrylic adhesives, 
use of this product may result in an allergic reaction. 
 
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been 
associated with transient positive bone-imaging findings. This should be considered when interpreting 
bone-imaging results. 
 
Sorbitol 
 
The additive effect of concomitantly administered products containing sorbitol (or fructose) and 
dietary intake of sorbitol (or fructose) should be taken into account. 
 
Sodium 
 
This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially 
‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ 
pegfilgrastim should be administered at least 24 hours after administration of cytotoxic chemotherapy. 
In clinical trials, Neulasta has been safely administered 14 days before chemotherapy. Concomitant 
use of Neulasta with any chemotherapy agent has not been evaluated in patients. In animal models 
concomitant administration of Neulasta and 5-fluorouracil (5-FU) or other antimetabolites has been 
shown to potentiate myelosuppression. 
 
Possible interactions with other haematopoietic growth factors and cytokines have not been 
specifically investigated in clinical trials. 
 
The potential for interaction with lithium, which also promotes the release of neutrophils, has not been 
specifically investigated. There is no evidence that such an interaction would be harmful. 
 
The safety and efficacy of Neulasta have not been evaluated in patients receiving chemotherapy 
associated with delayed myelosuppression e.g. nitrosoureas. 
 
Specific interaction or metabolism studies have not been performed, however, clinical trials have not 
indicated an interaction of Neulasta with any other medicinal products. 
 



 

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4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of pegfilgrastim in pregnant women. Studies in 
animals have shown reproductive toxicity (see section 5.3). Pegfilgrastim is not recommended during 
pregnancy and in women of childbearing potential not using contraception. 
 
Breast-feeding 
 
There is insufficient information on the excretion of pegfilgrastim/metabolites in human milk, a risk to 
the newborns/infants cannot be excluded. A decision must be made whether to discontinue 
breast-feeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of 
breast-feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative 
weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body 
surface area) (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Pegfilgrastim has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and 
musculoskeletal pain (common [≥ 1/100 to < 1/10]). Bone pain was generally of mild to moderate 
severity, transient and could be controlled in most patients with standard analgesics. 
 
Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, 
flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon 
[≥ 1/1,000 to < 1/100]). Serious allergic reactions, including anaphylaxis can occur in patients 
receiving pegfilgrastim (uncommon) (see section 4.4). 
 
Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as 
uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following 
administration of G-CSFs; see section 4.4 and section “Description of selected adverse reactions” 
below. 
 
Splenomegaly, generally asymptomatic, is uncommon. 
 
Splenic rupture including some fatal cases is uncommonly reported following administration of 
pegfilgrastim (see section 4.4). 
 
Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, 
pulmonary infiltrates and pulmonary fibrosis have been reported. Uncommonly, cases have resulted in 
respiratory failure or ARDS, which may be fatal (see section 4.4). 
 
Isolated cases of sickle cell crises have been reported in patients with sickle cell trait or sickle cell 
disease (uncommon in sickle cell patients) (see section 4.4). 
 



 

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Tabulated list of adverse reactions 
 
The data in the table below describe adverse reactions reported from clinical trials and spontaneous 
reporting. Within each frequency grouping, undesirable effects are presented in order of decreasing 
seriousness. 
 
MedDRA 
system organ 
class 

Adverse reactions 

Very common  
(≥ 1/10) 

Common  
(≥ 1/100 to < 1/10) 

Uncommon  
(≥ 1/1,000 to < 1/100) 

Rare  
(≥ 1/10,000 to 

< 1/1,000) 

Neoplasms 
benign, 
malignant and 
unspecified (incl 
cysts and 
polyps) 

  Myelodysplastic 
syndrome1 
Acute myeloid 
leukaemia1 
 

 

Blood and 
lymphatic 
system disorders 

 Thrombocytopenia1 

Leukocytosis1 
Sickle cell anaemia 
with crisis2 
Splenomegaly2 
Splenic rupture2

 

Immune system 
disorders 

  Hypersensitivity 
reactions 
Anaphylaxis

 

Metabolism and 
nutrition 
disorders 

  Elevations in uric acid  

Nervous system 
disorders 

Headache1    

Vascular 
disorders 

  Capillary leak 
syndrome1

Aortitis 

Respiratory, 
thoracic and 
mediastinal 
disorders 

  Acute Respiratory 
Distress Syndrome2 
Pulmonary adverse 
reactions (interstitial 
pneumonia, pulmonary 
oedema, pulmonary 
infiltrates and 
pulmonary fibrosis) 
Haemoptysis

Pulmonary 
haemorrhage 

Gastrointestinal 
disorders 

Nausea1     

Skin and 
subcutaneous 
tissue disorders 

 Dermatitis contact1 Sweet’s syndrome 
(acute febrile 
neutrophilic 
dermatosis)1,2 
Cutaneous vasculitis1,2

Stevens-Johnson 
syndrome 

Musculoskeletal 
and connective 
tissue disorders 

Bone pain Musculoskeletal pain 
(myalgia, arthralgia, 
pain in extremity, back 
pain, musculoskeletal 
pain, neck pain)

  

Renal and 
urinary 
disorders 

  Glomerulonephritis2  



 

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MedDRA 
system organ 
class 

Adverse reactions 

Very common  
(≥ 1/10) 

Common  
(≥ 1/100 to < 1/10) 

Uncommon  
(≥ 1/1,000 to < 1/100) 

Rare  
(≥ 1/10,000 to 

< 1/1,000) 

General 
disorders and 
administrative 
site conditions 

 Injection site pain1 

Application site 
reactions1 
Non-cardiac chest pain 

Injection site reactions2  

Investigations   Elevations in lactate 
dehydrogenase and 
alkaline phosphatase1 
Transient elevations in 
LFTs for ALT or AST1 

 

1 See section “Description of selected adverse reactions” below. 
2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical 
trials in adults. The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving 
Neulasta in nine randomised clinical trials. 
 
Description of selected adverse reactions 
 
Uncommon cases of Sweet’s syndrome have been reported, although in some cases underlying 
haematological malignancies may play a role. 
 
Uncommon events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim. 
The mechanism of vasculitis in patients receiving pegfilgrastim is unknown. 
 
Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain 
(common) have occurred on initial or subsequent treatment with pegfilgrastim. 
 
Application site reactions (including events such as haemorrhage, pain, discomfort, bruise, and 
erythaema) have been reported with the use of the on-body injector. 
 
Contact dermatitis and local skin reactions such as rash, pruritus, and urticaria have been reported with 
the use of the on-body injector, possibly indicating a hypersensitivity reaction to the adhesive. 
 
Common cases of leukocytosis (White Blood Count [WBC] > 100 × 109/L) have been reported (see 
section 4.4). 
 
Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated 
clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, 
with no associated clinical effects, were uncommon in patients receiving Neulasta following cytotoxic 
chemotherapy. 
 
Nausea and headaches were very commonly observed in patients receiving chemotherapy. 
 
Uncommon elevations in liver function tests (LFTs) for alanine aminotransferase (ALT) or aspartate 
aminotransferase (AST), have been observed in patients after receiving pegfilgrastim following 
cytotoxic chemotherapy. These elevations are transient and return to baseline. 
 
An increased risk of MDS/AML following treatment with Neulasta in conjunction with chemotherapy 
and/or radiotherapy has been observed in an epidemiological study in breast and lung cancer patients 
(see section 4.4). 
 
Common cases of thrombocytopenia have been reported. 
 
Cases of capillary leak syndrome have been reported in the post-marketing setting with G-CSF use. 
These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple 
chemotherapy medications or undergoing apheresis (see section 4.4). 



 

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Paediatric population 
 
The experience in children is limited. A higher frequency of serious adverse reactions in younger 
children aged 0-5 years (92%) has been observed compared to older children aged 6-11 and 
12-21 years respectively (80% and 67%) and adults. The most common adverse reaction reported was 
bone pain (see sections 5.1 and 5.2). 
 
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 
 
Single doses of 300 mcg/kg have been administered subcutaneously to a limited number of healthy 
volunteers and patients with non-small cell lung cancer without serious adverse reactions. The adverse 
events were similar to those in subjects receiving lower doses of pegfilgrastim. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: immunostimulants, colony stimulating factor; ATC Code: L03AA13 
 
Human granulocyte-colony stimulating factor (G-CSF) is a glycoprotein, which regulates the 
production and release of neutrophils from the bone marrow. Pegfilgrastim is a covalent conjugate of 
recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule. 
Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Pegfilgrastim 
and filgrastim have been shown to have identical modes of action, causing a marked increase in 
peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or 
lymphocytes. Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal 
or enhanced function as demonstrated by tests of chemotactic and phagocytic function. As with other 
haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial 
cells. G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar 
effects may be seen on some non-myeloid cells in vitro. 
 
In two randomised, double-blind, pivotal studies in patients with high-risk stage II-IV breast cancer 
undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of 
pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of 
febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 
11 daily administrations). In the absence of growth factor support, this regimen has been reported to 
result in a mean duration of grade 4 neutropenia of 5 to 7 days, and a 30-40% incidence of febrile 
neutropenia. In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration 
of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the 
filgrastim group (difference 0.23 days, 95% CI -0.15, 0.63). Over the entire study, the rate of febrile 
neutropenia was 13% of pegfilgrastim-treated patients compared with 20% of filgrastim-treated 
patients (difference 7%, 95% CI of -19%, 5%). In a second study (n = 310), which used a 
weight-adjusted dose (100 mcg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim 
group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI 
-0.36, 0.30). The overall rate of febrile neutropenia was 9% of patients treated with pegfilgrastim and 
18% of patients treated with filgrastim (difference 9%, 95% CI of -16.8%, -1.1%). 
 



 

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In a placebo-controlled, double-blind study in patients with breast cancer the effect of pegfilgrastim on 
the incidence of febrile neutropenia was evaluated following administration of a chemotherapy 
regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/m2 every 3 weeks for 
4 cycles). Nine hundred and twenty-eight patients were randomised to receive either a single dose of 
pegfilgrastim or placebo approximately 24 hours (day 2) after chemotherapy in each cycle. The 
incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared 
with placebo (1% versus 17%, p < 0.001). The incidence of hospitalisations and IV anti-infective use 
associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group 
compared with placebo (1% versus 14%, p < 0.001; and 2% versus 10%, p < 0.001). 
 
A small (n = 83), phase II, randomised, double-blind study in patients receiving chemotherapy for de 
novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, 
administered during induction chemotherapy. Median time to recovery from severe neutropenia was 
estimated as 22 days in both treatment groups. Long-term outcome was not studied (see section 4.4). 
 
In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients 
receiving 100 mcg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and 
cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils 
< 0.5 × 109/L) was observed in younger children aged 0-5 years (8.9 days) compared to older children 
aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults. Additionally a higher 
incidence of febrile neutropenia was observed in younger children aged 0-5 years (75%) compared to 
older children aged 6-11 years and 12-21 years (70% and 33%, respectively) and adults (see 
sections 4.8 and 5.2). 
 
In a phase I (n = 253) randomised, single dose, parallel-group study conducted in healthy subjects the 
exposure (mean serum concentration-time profiles) of pegfilgrastim delivered by manual injection and 
by the on-body injector were comparable. The rate (Cmax) and extent (AUC0-inf) of the absorption of 
pegfilgrastim delivered by the on-body injector were similar to those from the manual injection of the 
pre-filled syringe. The least-squares geometric mean ratios (90% CIs) (on-body injector to manual 
injection) were 0.97 (0.83, 1.14) for Cmax and 1.00 (0.84, 1.20) for AUC0-inf within the pre-specified 
bioequivalence limit of 0.80 to 1.25, and established bioequivalence between the two delivery methods 
of a single 6 mg dose of pegfilgrastim. 
 
5.2 Pharmacokinetic properties 
 
After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim 
occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during 
the period of neutropenia after myelosuppressive chemotherapy. The elimination of pegfilgrastim is 
non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose. 
Pegfilgrastim appears to be mainly eliminated by neutrophil-mediated clearance, which becomes 
saturated at higher doses. Consistent with a self-regulating clearance mechanism, the serum 
concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see figure 1). 
 



 

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Figure 1. Profile of median pegfilgrastim serum concentration and Absolute Neutrophil Count 
(ANC) in chemotherapy treated patients after a single 6 mg injection 

 

 
 
Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of pegfilgrastim is not 
expected to be affected by renal or hepatic impairment. In an open-label, single dose study (n = 31) 
various stages of renal impairment, including end-stage renal disease, had no impact on the 
pharmacokinetics of pegfilgrastim. 
 
Elderly 
 
Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is 
similar to that in adults. 
 
Paediatric population 
 
The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who 
received 100 mcg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy. The youngest 
age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) 
(47.9 ± 22.5 mcgꞏhr/mL) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcgꞏhr/mL 
and 29.3 ± 23.2 mcgꞏhr/mL, respectively) (see section 5.1). With the exception of the youngest age 
group (0-5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with 
high-risk stage II-IV breast cancer and receiving 100 mcg/kg pegfilgrastim after the completion of 
doxorubicin/docetaxel (see sections 4.8 and 5.1). 
 
5.3 Preclinical safety data 
 
Preclinical data from conventional studies of repeated dose toxicity revealed the expected 
pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, 
extramedullary haematopoiesis and splenic enlargement. 
 
There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim 
subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo 



 

13 

loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen 
when pregnant rabbits were exposed to the recommended human dose. In rat studies, it was shown that 
pegfilgrastim may cross the placenta. Studies in rats indicated that reproductive performance, fertility, 
oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by 
pegfilgrastim given subcutaneously. The relevance of these findings for humans is not known. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium acetate* 
Sorbitol (E420) 
Polysorbate 20 
Water for injections 
 
*Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide. 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products, particularly with sodium 
chloride solutions. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
 
Neulasta may be exposed to room temperature (not above 30°C) for a maximum single period of up to 
72 hours. Neulasta left at room temperature for more than 72 hours should be discarded. 
 
The pre-filled syringe for use with the on-body injector may be exposed at room temperature for no 
longer than 36 hours prior to filling the on-body injector. 
 
Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours 
does not adversely affect the stability of Neulasta. 
 
Keep the container in the outer carton in order to protect from light. 
 
6.5 Nature and contents of container 
 
Pre-filled syringe (Type I glass), with a rubber stopper, stainless steel needle and needle cap with or 
without an automatic needle guard. 
 
The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see 
section 4.4). 
 
On-body injector, the fluid path is made from polypropylene, cyclic olefin copolymer, silicone rubber 
and fluorinated ethylene propylene (FEP), with a stainless steel 28 gauge needle. The on-body injector 
contains three silver oxide batteries and includes an adhesive patch made from non-woven polyester 
tape single coated with a polyacrylate adhesive. 
 
Each pre-filled syringe for manual administration contains 0.6 mL of solution for injection. 
Each pre-filled syringe for use with the on-body injector contains 0.64 mL of solution for injection. 



 

14 

Pack size of one pre-filled syringe, in either blistered or non-blistered packaging. 
Pack size of one pre-filled syringe in blistered packaging co-packed with an on-body injector. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Before use, Neulasta solution should be inspected visually for particulate matter. Only a solution that 
is clear and colourless should be injected. 
 
The on-body injector must only be used with the Neulasta pre-filled syringe co-packed in the carton. 
The Neulasta pre-filled syringe for manual administration must not be used with the on-body injector. 
 
Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive. 
 
When administering using the manual pre-filled syringe, allow the pre-filled syringe to reach room 
temperature before injecting. 
 
Any unused 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 NUMBER(S) 
 
EU/1/02/227/001 - 1 pack blistered syringe 
EU/1/02/227/002 - 1 pack unblistered syringe 
EU/1/02/227/004 - 1 pack blistered syringe with needle guard 
EU/1/02/227/005 - 1 pack blistered syringe with blistered on-body injector 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 22 August 2002 
Date of latest renewal: 16 July 2007 
 
 
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 



 

15 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURER(S) 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 
 



 

16 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturers of the biological active substance 
 
Amgen Inc. 
One Amgen Center Drive 
Thousand Oaks 
CA 91320 
USA 
 
Amgen Manufacturing Limited 
P.O Box 4060 
Road 31 km. 24.6 
Juncos 
Puerto Rico 00777-4060 
USA 
 
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. 
 
 



 

17 

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. 
 
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 

 
The MAH shall ensure that in each Member State where Neulasta on-body injector is marketed, all 
patients/carers who are expected to use Neulasta on-body injector are provided with a patient alert card 
to be disseminated through the prescribing physicians. 

The aim of this patient alert card is to help prevent medication errors including underdose resulting in 
lack of efficacy with the on-body injector device. 

The patient alert card shall contain the following key messages: 
 how to monitor the on-body injector 
 when to expect dose delivery to begin 
 not to remove the on-body injector until after dose delivery is complete 
 how to recognise signs from the device (e.g. adhesion issues, fill indicator not moved, no 

beeping sound, status light has not flashed etc.) that there has been a failure in the delivery of 
the intended dose 

 what action to take in a suspected case of failed delivery or incomplete delivery of the dose and 
if symptoms of serious infection that may indicate a missed dose present. 

 



 

18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 

19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 

20 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON FOR BLISTERED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Neulasta 6 mg solution for injection 
pegfilgrastim 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection. 
Each pre-filled syringe contains 0.64 mL of solution that delivers 6 mg of pegfilgrastim (10 mg/mL) to 
be used with the on-body injector. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections. See leaflet for further 
information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection in a single use pre-filled syringe (0.6 mL). 
Solution for injection in a single use pre-filled syringe with automatic needle guard (0.6 mL). 
Solution for injection in a pack size of one single use pre-filled syringe (0.64 mL) and one on-body 
injector (Onpro kit). 
Pack size of one. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous use. 
Read the package leaflet before use. 
Important: read the package leaflet before handling pre-filled syringe. 
 
 
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 
 
Avoid vigorous shaking. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



 

21 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the container in the outer carton in order to protect from light. 
 
 
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/1/02/227/001 - 1 pack 
EU/1/02/227/004 - 1 pack with needle guard 
EU/1/02/227/005 - 1 pack with on-body injector 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Neulasta 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



 

22 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER PACK FOR SYRINGE WITH AUTOMATIC NEEDLE GUARD 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Neulasta 6 mg injection 
pegfilgrastim 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 

 



 

23 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER PACK FOR SYRINGE TO BE USED WITH ON-BODY INJECTOR 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Neulasta 6 mg injection 
pegfilgrastim 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
For use with the on-body injector only. 
 



 

24 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SYRINGE LABEL 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Neulasta 6 mg 
Pegfilgrastim 
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. 



 

25 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SYRINGE LABEL FOR USE WITH ON-BODY INJECTOR 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Neulasta 6 mg injection 
pegfilgrastim 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.64 ml 
 
 
6. OTHER 
 
Amgen Europe B.V. 
 



 

26 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON FOR UNBLISTERED SYRINGE 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Neulasta 6 mg solution for injection 
pegfilgrastim 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections. See leaflet for further 
information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection in a single use pre-filled syringe (0.6 mL). 
Pack size of one. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous use. 
Read the package leaflet before 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 
 
Avoid vigorous shaking. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



 

27 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the container in the outer carton in order to protect from light. 
 
 
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/1/02/227/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Neulasta 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



 

28 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
UNBLISTERED SYRINGE LABEL 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Neulasta 6 mg injection 
pegfilgrastim 
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. 
 

 



 

29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 

30 

Package leaflet: Information for the user 
 

Neulasta 6 mg solution for injection 
pegfilgrastim 

 
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 symptoms 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 Neulasta is and what it is used for 
2. What you need to know before you use Neulasta 
3. How to use Neulasta 
4. Possible side effects 
5. How to store Neulasta 
6. Contents of the pack and other information 
 
 
1. What Neulasta is and what it is used for 
 
Neulasta contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by 
biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very 
similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body. 
 
Neulasta is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence 
of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of 
cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are 
important as they help your body fight infection. These cells are very sensitive to the effects of 
chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells 
fall to a low level there may not be enough left in the body to fight bacteria and you may have an 
increased risk of infection. 
 
Your doctor has given you Neulasta to encourage your bone marrow (part of the bone which makes 
blood cells) to produce more white blood cells that help your body fight infection. 
 
 
2. What you need to know before you use Neulasta 
 
Do not use Neulasta 
 
 if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine. 
 
Warnings and precautions 
 
Talk to your doctor, pharmacist or nurse before using Neulasta: 
 
 if you experience an allergic reaction including weakness, drop in blood pressure, difficulty 

breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the 
skin that itch. 

 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. 



 

31 

 if you have an allergy to acrylic adhesives. The on-body injector uses acrylic adhesive and may 
result in an allergic reaction. 

 if you experience a cough, fever and difficulty breathing. This can be a sign of Acute 
Respiratory Distress Syndrome (ARDS). 

 if you have any of the following or combination of the following side effects: 
- swelling or puffiness, which may be associated with passing water less frequently, 

difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of 
tiredness. 

These could be symptoms of a condition called “Capillary Leak Syndrome” which causes blood 
to leak from the small blood vessels into your body. See section 4. 

 if you get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a 
problem with your spleen (splenomegaly). 

 if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary 
oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung 
infiltration). 

 if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) 
or decreased blood platelet counts, which reduces the ability of your blood to clot 
(thrombocytopenia). Your doctor may want to monitor you more closely. 

 if you have sickle cell anaemia. Your doctor may monitor your condition more closely. 
 if you are a patient with breast cancer or lung cancer, Neulasta in combination with 

chemotherapy and/or radiation therapy may increase your risk of a precancerous blood 
condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid 
leukaemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding.  

 if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the 
face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing 
these could be signs of a severe allergic reaction. 

 if you have symptoms of inflammation of aorta (the large blood vessel which transports blood 
from the heart to the body), this has been reported rarely in cancer patients and healthy donors. 
The symptoms can include fever, abdominal pain, malaise, back pain and increased 
inflammatory markers. Tell your doctor if you experience those symptoms. 

 
Your doctor will check your blood and urine regularly as Neulasta can harm the tiny filters inside your 
kidneys (glomerulonephritis). 
 
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Neulasta. Stop 
using Neulasta and seek medical attention immediately if you notice any of the symptoms described in 
section 4. 
 
You should talk to your doctor about your risks of developing cancers of the blood. If you develop or 
are likely to develop cancers of the blood, you should not use Neulasta, unless instructed by your 
doctor. 
 
Loss of response to pegfilgrastim 
 
If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, 
your doctor will investigate the reasons why including whether you have developed antibodies which 
neutralise pegfilgrastim’s activity. 
 
Other medicines and Neulasta 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 



 

32 

Pregnancy and breast-feeding 
 
Ask your doctor or pharmacist for advice before taking any medicine. Neulasta has not been tested in 
pregnant women. It is important to tell your doctor if you: 
 are pregnant; 
 think you may be pregnant; or 
 are planning to have a baby. 
 
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Neulasta. 
 
Driving and using machines 
 
Neulasta has no or negligible effect on the ability to drive or use machines. 
 
Neulasta contains sorbitol (E420) and sodium  
 
This medicine contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 50 mg/mL. 
This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially 
‘sodium-free’. 
 
 
3. How to use Neulasta 
 
Neulasta is for use in adults aged 18 and over. 
 
Always take Neulasta exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your 
skin) and it should be given at least 24 hours after your last dose of chemotherapy at the end of each 
chemotherapy cycle. 
 
Injecting Neulasta yourself 
 
Your doctor may decide that it would be more convenient for you to inject Neulasta yourself. Your 
doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been 
trained. 
 
For further instructions on how to inject yourself with Neulasta, please read the section at the end of 
this leaflet. 
 
Do not shake Neulasta vigorously as this may affect its activity. 
 
If you use more Neulasta than you should 
 
If you use more Neulasta than you should contact your doctor, pharmacist or nurse. 
 
If you forget to inject Neulasta 
 
If you are injecting yourself and have forgotten your dose of Neulasta, you should contact your doctor 
to discuss when you should inject the next dose. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 



 

33 

4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Please tell your doctor immediately if you have any of the following or combination of the following 
side effects: 
 swelling or puffiness, which may be associated with passing water less frequently, difficulty 

breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These 
symptoms generally develop in a rapid fashion. 

 
These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called 
“Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body 
and needs urgent medical attention. 
 
Very common side effects (may affect more than 1 in 10 people): 
 bone pain. Your doctor will tell you what you can take to ease the bone pain. 
 nausea and headaches. 
 
Common side effects (may affect up to 1 in 10 people): 
 rash, itchy red raised bumps (contact dermatitis/local skin reactions) have been seen with the 

on-body injector. 
 pain at the site of injection. 
 application site reactions which may include redness, bleeding, bruising, pain and discomfort 

have been seen with the on-body injector. 
 general aches and pains in the joints and muscles. 
 some changes may occur in your blood, but these will be detected by routine blood tests. Your 

white blood cell count may become high for a short period of time. Your platelet count may 
become low which might result in bruising. 

 
Uncommon side effects (may affect up to 1 in 100 people): 
 allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin 

that itch. 
 serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty 

breathing, swelling of the face). 
 increased spleen size. 
 spleen rupture. Some cases of splenic rupture were fatal. It is important that you contact your 

doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder 
pain since this may relate to a problem with your spleen. 

 breathing problems. If you have a cough, fever and difficulty breathing please tell your doctor. 
 Sweet’s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face 

and neck with fever) has occurred but other factors may play a role. 
 cutaneous vasculitis (inflammation of the blood vessels in the skin). 
 damage to the tiny filters inside your kidneys (glomerulonephritis). 
 redness at the site of injection. 
 coughing up blood (haemoptysis). 
 blood disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]). 
 
Rare side effects (may affect up to 1 in 1,000 people): 
 inflammation of aorta (the large blood vessel which transports blood from the heart to the body), 

see section 2. 
 bleeding from the lung (pulmonary haemorrhage). 
 Stevens-Johnson syndrome, which can appear as reddish target-like 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 Neulasta if you develop these 
symptoms and contact your doctor or seek medical attention immediately. See also section 2. 



 

34 

 
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 Neulasta 
 
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 syringe label 
after EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C – 8°C). 
 
You may take Neulasta out of the refrigerator and keep it at room temperature (not above 30°C) for no 
longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room 
temperature (not above 30°C) it must either be used within 3 days or disposed of. 
 
Do not freeze. Neulasta may be used if it is accidentally frozen for a single period of less than 
24 hours. 
 
Keep the container in the outer carton in order to protect from light. 
 
Do not use this medicine if you notice it is 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 to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Neulasta contains 
 
- The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 

0.6 mL of solution. 
- The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for 

injections. See section 2. 
 
What Neulasta looks like and contents of the pack 
 
Neulasta is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL). 
 
Each pack contains 1 glass pre-filled syringe with an attached stainless steel needle and needle cap. 
 
The pre-filled syringe (with or without blister wrapping) may also be provided with an automatic 
needle guard. 
 
Marketing Authorisation Holder and Manufacturer 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 



 

35 

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 
 

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 



 

36 

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

Portugal 
Amgen Biofarmacêutica, Lda. 
Tel: +351 21 422 0606 

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 

 
This leaflet was last revised in 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
 
--------------------------------------------------------------------------------------------------------------------------- 
 
Instructions for injecting with the Neulasta pre-filled syringe 
 
This section contains information on how to give yourself an injection of Neulasta. 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, pharmacist for 
assistance. 
 
How do you, or the person injecting you, use Neulasta pre-filled syringe? 
 
You will need to give yourself the injection into the tissue just under the skin. This is known as a 
subcutaneous injection. 
 
Equipment that you need 
 
To give yourself a subcutaneous injection you will need: 
 
 a pre-filled syringe of Neulasta; and 
 alcohol wipes or similar. 



 

37 

 
What should I do before I give myself a subcutaneous injection of Neulasta? 
 
1. Remove from the refrigerator. 
 
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 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. 
 
5. Check the appearance of Neulasta. It must be a clear and colourless liquid. If there are particles 

in it, you must not use it. 
 
6. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room 

temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm 
Neulasta in any other way (for example, do not warm it in a microwave or in hot water). 

 
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 Neulasta injection? 
 
Before you inject Neulasta you must do the following: 
 

1. Hold the syringe barrel and gently take the cap from the 
needle without twisting. Pull straight as shown in pictures 1 
and 2. Do not touch the needle or push the plunger. 

 
2. 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. 
 
3. You can now use the pre-filled syringe. 
 
Where should I give my injection? 
 

 

The most suitable places to inject yourself are: 
 the top of your thighs; and 
 the abdomen, except for the area around the navel. 
If someone else is injecting you, they can also use the back of your arms. 

 



 

38 

How do I give my injection? 
 
1. Clean your skin by using an alcohol wipe. 
 
2. Pinch (without squeezing) the skin using your thumb and forefinger. Insert the needle into the 

skin. 
 
3. Push the plunger down with a slow constant pressure. Push the plunger all the way down as far 

as it will go to inject all the liquid. 
 
4. After injecting the liquid, remove the needle and let go of your skin. 
 
5. If you notice a spot of blood at the injection site, dab with a cotton ball or tissues. Do not rub the 

injection site. If needed, you may cover the injection site with a plaster. 
 
6. Do not use any Neulasta that is left in the syringe. 
 
Remember 
 
Only use each syringe for one injection. If you have any problems, please ask your doctor or nurse for 
help and advice. 
 
Disposing of used syringes 
 
 Do not put the cap back on used needles. 
 
 Keep used syringes out of the sight and reach of children. 
 
 The used 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. 

 
--------------------------------------------------------------------------------------------------------------------------- 



 

39 

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 

 

 



 

40 

Important 

Before you use a Neulasta 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. 

  Neulasta 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). 

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. 
 



 

41 

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. 

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

 



 

42 

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. 
 



 

43 

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. 
 



 

44 

Healthcare providers only 
The trade name of the administered product should be clearly recorded in the patient file. 

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. 

 



 

45 

 
Package leaflet: Information for the user 

 
Neulasta 6 mg solution for injection with on-body injector 

pegfilgrastim 
 

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 symptoms 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. 
- Whilst wearing the Neulasta on-body injector it is important that you keep the Patient Alert 

Card provided by your doctor, pharmacist or nurse with you. It contains important advice on 
how to monitor your device for medication errors including under dose leading to lack of effect, 
and when to seek immediate medical attention. 

 
What is in this leaflet 
 
1. What Neulasta is and what it is used for 
2. What you need to know before you use Neulasta 
3. How to use Neulasta 
4. Possible side effects 
5. How to store Neulasta 
6. Contents of the pack and other information 
 
 
1. What Neulasta is and what it is used for 
 
Neulasta contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by 
biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very 
similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body. 
 
Neulasta is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence 
of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of 
cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are 
important as they help your body fight infection. These cells are very sensitive to the effects of 
chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells 
fall to a low level there may not be enough left in the body to fight bacteria and you may have an 
increased risk of infection. 
 
Your doctor has given you Neulasta to encourage your bone marrow (part of the bone which makes 
blood cells) to produce more white blood cells that help your body fight infection. 
 
 
2. What you need to know before you use Neulasta 
 
Do not use Neulasta 
 
 if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine. 
 



 

46 

Warnings and precautions 
 
Talk to your doctor, pharmacist or nurse before using Neulasta: 
 
 if you experience an allergic reaction including weakness, drop in blood pressure, difficulty 

breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the 
skin that itch. 

 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. 

 if you have an allergy to acrylic adhesives. The on-body injector uses acrylic adhesive and may 
result in an allergic reaction. 

 if you experience a cough, fever and difficulty breathing. This can be a sign of Acute 
Respiratory Distress Syndrome (ARDS). 

 if you have any of the following or combination of the following side effects: 
- swelling or puffiness, which may be associated with passing water less frequently, 

difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of 
tiredness. 

These could be symptoms of a condition called “Capillary Leak Syndrome” which causes blood 
to leak from the small blood vessels into your body. See section 4. 

 if you get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a 
problem with your spleen (splenomegaly). 

 if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary 
oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung 
infiltration). 

 if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) 
or decreased blood platelet counts, which reduces the ability of your blood to clot 
(thrombocytopenia). Your doctor may want to monitor you more closely. 

 if you have sickle cell anaemia. Your doctor may monitor your condition more closely. 
 if you are a patient with breast cancer or lung cancer, Neulasta in combination with 

chemotherapy and/or radiation therapy may increase your risk of a precancerous blood 
condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid 
leukaemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding.  

 if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the 
face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing 
these could be signs of a severe allergic reaction. 

 if you have symptoms of inflammation of aorta (the large blood vessel which transports blood 
from the heart to the body), this has been reported rarely in cancer patients and healthy donors. 
The symptoms can include fever, abdominal pain, malaise, back pain and increased 
inflammatory markers. Tell your doctor if you experience those symptoms. 

 
Your doctor will check your blood and urine regularly as Neulasta can harm the tiny filters inside your 
kidneys (glomerulonephritis). 
 
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Neulasta. Stop 
using Neulasta and seek medical attention immediately if you notice any of the symptoms described in 
section 4. 
 
You should talk to your doctor about your risks of developing cancers of the blood. If you develop or 
are likely to develop cancers of the blood, you should not use Neulasta, unless instructed by your 
doctor. 
 
Loss of response to pegfilgrastim 
 
If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, 
your doctor will investigate the reasons why including whether you have developed antibodies which 
neutralise pegfilgrastim’s activity. 



 

47 

 
Other medicines and Neulasta 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Pregnancy and breast-feeding 
 
Ask your doctor or pharmacist for advice before taking any medicine. Neulasta has not been tested in 
pregnant women. It is important to tell your doctor if you: 
 are pregnant; 
 think you may be pregnant; or 
 are planning to have a baby. 
 
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Neulasta. 
 
Driving and using machines 
 
Neulasta has no or negligible effect on the ability to drive or use machines. 
 
Neulasta contains sorbitol (E420) and sodium  
 
This medicine contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 50 mg/mL. 
This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially 
‘sodium-free’. 
 
 
3. How to use Neulasta 
 
Neulasta is for use in adults aged 18 and over. 
 
Always take Neulasta exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your 
skin) and it should be given at least 24 hours after your last dose of chemotherapy at the end of each 
chemotherapy cycle. 
 
Using Neulasta with the on-body injector 
 
Your doctor may decide that it would be more convenient for you to use Neulasta with the on-body 
injector. For further information on use with the on-body injector, please read the instructions for use 
at the end of this leaflet. 
 
Check the instructions at the end of this leaflet and contact your healthcare provider if: 
 during the monitoring of your on-body injector you are concerned that it is leaking; or 
 after the injection is complete you are concerned that you may not have received the full dose. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 



 

48 

4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Please tell your doctor immediately if you have any of the following or combination of the following 
side effects: 
 swelling or puffiness, which may be associated with passing water less frequently, difficulty 

breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These 
symptoms generally develop in a rapid fashion. 

 
These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called 
“Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body 
and needs urgent medical attention. 
 
Very common side effects (may affect more than 1 in 10 people): 
 bone pain. Your doctor will tell you what you can take to ease the bone pain. 
 nausea and headaches. 
 
Common side effects (may affect up to 1 in 10 people): 
 rash, itchy red raised bumps (contact dermatitis/local skin reactions) have been seen with the 

on-body injector. 
 pain at the site of injection. 
 application site reactions which may include redness, bleeding, bruising, pain and discomfort 

have been seen with the on-body injector. 
 general aches and pains in the joints and muscles. 
 some changes may occur in your blood, but these will be detected by routine blood tests. Your 

white blood cell count may become high for a short period of time. Your platelet count may 
become low which might result in bruising. 

 
Uncommon side effects (may affect up to 1 in 100 people): 
 allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin 

that itch. 
 serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty 

breathing, swelling of the face). 
 increased spleen size. 
 spleen rupture. Some cases of splenic rupture were fatal. It is important that you contact your 

doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder 
pain since this may relate to a problem with your spleen. 

 breathing problems. If you have a cough, fever and difficulty breathing please tell your doctor. 
 Sweet’s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face 

and neck with fever) has occurred but other factors may play a role. 
 cutaneous vasculitis (inflammation of the blood vessels in the skin). 
 damage to the tiny filters inside your kidneys (glomerulonephritis). 
 redness at the site of injection. 
 coughing up blood (haemoptysis). 
 blood disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]). 
 
Rare side effects (may affect up to 1 in 1,000 people): 
 inflammation of aorta (the large blood vessel which transports blood from the heart to the body), 

see section 2. 
 bleeding from the lung (pulmonary haemorrhage). 
 Stevens-Johnson syndrome, which can appear as reddish target-like 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 Neulasta if you develop these 
symptoms and contact your doctor or seek medical attention immediately. See also section 2. 



 

49 

 
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 Neulasta 
 
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 syringe label 
after EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C – 8°C). 
 
The syringe for use with the on-body injector must either be used within 36 hours after it has reached 
room temperature (not above 30°C) or disposed of. 
 
Do not freeze. Neulasta may be used if it is accidentally frozen for a single period of less than 
24 hours. 
 
Keep the container in the outer carton in order to protect from light. 
 
Do not use this medicine if you notice it is 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 to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Neulasta contains 
 
- The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 

0.6 mL of solution. 
- The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for 

injections. See section 2. 
 
What Neulasta looks like and contents of the pack 
 
Neulasta is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL). 
 
Each pack contains 1 glass pre-filled syringe with an attached stainless steel needle and needle cap. 
 
One pre-filled syringe with blister wrapping and with an on-body injector. 
 
Marketing Authorisation Holder and Manufacturer 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 



 

50 

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 
 

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 



 

51 

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

Portugal 
Amgen Biofarmacêutica, Lda. 
Tel: +351 21 422 0606 

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 

 
This leaflet was last revised in 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
 
 
--------------------------------------------------------------------------------------------------------------------------- 



 

52 

On-body injector for Neulasta 6 mg solution for injection 
Patient instructions for use 

Important information 
The on-body injector delivers your Neulasta dose with an under-the-skin (subcutaneous) injection. 
Your healthcare provider will fill the on-body injector with Neulasta and then apply it directly to your 
skin using an adhesive pad. The adhesive pad is water-resistant but you are advised to avoid 
submerging the on-body injector in water. 
 
The on-body injector is worn for 27 hours after placement and is programmed to make sure you do not 
receive Neulasta any sooner than 24 hours after your chemotherapy. The on-body injector will use 
sounds and lights to let you know its status. 
 
Allergies 
 Serious allergic reactions can happen with Neulasta. Ask your caregiver to be nearby for the 

first use. Plan to be in a place where you or your caregiver can appropriately monitor the 
on-body injector for Neulasta during the approximately 45 minute Neulasta delivery and for an 
hour after the delivery. 

 Tell your healthcare provider if you have had severe skin reactions to acrylic adhesives. If you 
have an allergic reaction during the delivery of Neulasta, remove the on-body injector by 
grabbing the edge of the adhesive pad and peeling off the on-body injector. Get emergency 
medical help right away. 

 Tell your healthcare provider if you have an allergy to latex. A pre-filled syringe is used to fill 
the on-body injector. The grey needle cap of the pre-filled syringe contains dry natural rubber, 
which is derived from latex. Latex may be transferred to your skin. 

 
Activity 
 Avoid knocking or pulling the on-body injector. Consider wearing loose clothing and take care 

when changing clothes. There is a small cannula which sits just under your skin. If the on-body 
injector has been knocked or pulled, the cannula may become dislodged. If this happens, you 
may not receive your dose of Neulasta. 

 Avoid activities and places that may interfere with monitoring during the dosing of Neulasta. 
For example AVOID, travelling, driving, or operating heavy machines during 26-29 hours 
following application of the on-body injector (this includes the 45-minute dose delivery period 
plus an hour post-delivery). 

 Do not use baths, hot tubs, whirlpool baths, or saunas while wearing the on-body injector. This 
may affect your medicine. 

 Only expose the on-body injector to temperatures between 5°C - 40°C. 
 Do not expose the on-body injector to direct sunlight. If it is exposed to direct sunlight for more 

than 1 hour, it may affect your medicine. Wear the on-body injector under your clothing. 
 Do not expose the on-body injector to the following because the on-body injector may be 

damaged and you could be injured: 
- Diagnostic imaging (e.g. CT scan, MRI, ultrasound, x-ray). 
- Radiation treatment. 
- Oxygen rich environments, such as hyperbaric chambers (a transparent chamber with an 

increase in atmospheric pressure). 
 
On-body injector becomes loose or falls off 
 Contact your healthcare provider immediately if the on-body injector comes away from your 

skin at any time before your full dose has been delivered, do not reapply it. There is a small 
cannula which sits just under your skin. If the on-body injector has been knocked or pulled, the 
cannula may become dislodged. If this happens, you may not receive your dose of Neulasta. 

 



 

53 

 
Electrical equipment 
 Keep the on-body injector at least 10 cm (4 inches) away from electrical equipment such as 

mobile phones, cordless telephones, microwaves and other common appliances. Failure to keep 
the on-body injector at least this recommended distance may interfere with its operation and can 
lead to a missed or incomplete dose of Neulasta. 

If you have any concerns or further questions on the use of this medicine, contact your healthcare 
provider. 



 

54 

 

Guide to parts for on-body injector for Neulasta 
Green flashing status light 

Cannula  
window 

 
 

 

Fill indicator 

The on-body injector is working properly. 

Red flashing status light 

Cannula  
window 

 
 

 

Fill indicator 

Important: If at any time you hear beeping, check the status light. If it is flashing red, contact your 
healthcare provider immediately as you may need a replacement dose. 

 
 

100% (full) 0% (empty) 

Fill indicator 

On-body injector placement 

 

Important: Contact your healthcare provider immediately if you have 
severe pain or skin discomfort around your on-body injector. 

 
 Apply to intact, non-irritated skin on the stomach area abdomen or 

back of the arm. Use the arm only if a caregiver can help monitor the 
on-body injector’s status. 

Abdomen 
 

Back of  
upper arm 

 



 

55 

Step 1: Monitor your on-body injector 

A For the next 27 hours, occasionally check the status light for at least 10 seconds. If the 
status light is flashing green, it is ok. 

 

27 hours

 

If the on-body injector was placed on the back of your arm, a caregiver must be available to monitor 
its status. Do not try to do this yourself, as you may accidently move it and dislodge the cannula from 
your skin leading to a missed or incomplete dose of Neulasta. 

 Be careful not to bump or knock the on-body injector off your body. 
 The on-body injector has a self-adhesive backing to attach it to the skin, do not use additional 

materials to hold it in place as this could dislodge the cannula leading to a missed or incomplete 
dose of Neulasta. 

 If the on-body injector at any time comes away from your skin before your full dose delivery, 
do not reapply it. Call your healthcare provider immediately as you may need a replacement 
dose. 

 Keep the on-body injector dry for the last 3 hours prior to the start of dose delivery. Avoid 
getting lotions, creams, oils or cleaning agents near the on-body injector, as these products may 
loosen the adhesive. 

 Do not sleep on the on-body injector or apply pressure during wear, especially during dose 
delivery. This may affect the on-body injector’s performance. 

 
Important: If at any time you hear beeping, check the status light. 
If it is flashing red, contact your healthcare provider immediately as you may need a replacement dose.

 

OK LIGHT



 

56 

 

B After about 27 hours, your on-body injector will produce a series of beeps to let you know 
your dose delivery is about to begin. Do not remove the on-body injector at this time. 

 
Do not remove the on-body injector at this time. 

 
 Dose delivery will start and take about 45 minutes to complete. The on-body injector will 

flash a fast green light. 
 Do not remove the on-body injector before the dose delivery is complete. This may result 

in a missed or incomplete dose of Neulasta. 
 

Important: If at any time you hear beeping, check the status light. If it is flashing red, contact 
your healthcare provider immediately as you may need a replacement dose. 

 
Do not remove the on-body injector before the dose delivery is complete. 

 

Step 2: Monitor Dose Delivery 

 

For the next 45 minutes, monitor your on-body injector frequently for leaks 
during dose delivery. 
If it was placed on the back of your arm, a caregiver must be available to monitor 
your on-body injector. 

Not working correctly Not working correctly 

 

Noticeably wet (saturated) adhesive Dripping fluid from your on-body injector 

If the adhesive becomes noticeably wet (saturated) with fluid, or you see dripping, contact your 
healthcare provider immediately as you may need a replacement dose. 

 

OK LIGHT

“BEEPS”

STOP 



 

57 

A Your dose delivery will take around 45 minutes to complete. 

 During this time, the on-body injector will flash a fast green light. 
 You may hear a series of clicks. This is ok. 
 When dose delivery is complete, a long beep will sound and the status light will be solid 

green. 

 

45 minutes

 
Important: If at any time you hear beeping, check the status light.  
If it is flashing red, contact your healthcare provider immediately. 

 

Step 3: Remove your on-body injector  
when dose delivery is complete 

A After the beep, check the colour of the status light. 

Correct 
 

Not working correctly 
 

 
 

  
 

Check to see if the status light is SOLID 
GREEN or has switched off. This means the 
dose is complete. If the dose is complete, go to 
the next step. 

If you see the status light is flashing red, your 
on-body injector is not functioning properly. 
Remember, any time you see a status light 
flashing red, call your healthcare provider 
immediately, as you may need a replacement 
dose. 

 

OK LIGHT

 

ERROR LIGHT “BEEPS” 
FINISH LIGHT 



 

58 

B Grab the edge of the adhesive pad. Slowly peel off the on-body injector. 

 

 If medicine has leaked or the adhesive is noticeably wet (saturated), contact your 
healthcare provider immediately as you may not have received your full dose and you may 
need a replacement dose. 

 Remove any extra adhesive using soap and water. 

Important: Do not grasp the on-body injector itself to try to pull it off of your body. 

 

Step 4: Finish 

 Check to see if your on-body injector is empty. 

 You should see a black line next to the 0% (empty) indicator to confirm you have received a full 
dose. If the on-body injector is not empty, contact your healthcare provider immediately as you 
may need a replacement dose. 

 

 Check your status light again. Watch for at least 10 seconds. If the status light is solid green or it 
has switched off, it is ok. 

 If you hear beeping, or when you check the status light and it is flashing red, contact your 
healthcare provider immediately. 

 If there is blood, press a clean cotton ball or gauze pad on the application site. Apply a plaster if 
needed. 

 Contact your healthcare provider immediately if you experience persistent or worsening redness 
or tenderness at the application site, as this can be a sign of infection. 

 After your on-body injector removal, place the on-body injector in a sharps disposal container 
whether the needle is exposed or not. If the needle is exposed, contact your healthcare provider 
immediately. 

 

STOP 



 

59 

A Record the end status of your on-body injector. 

 Mark the box of the description that represents your on-body injector after it has been used.

 Status light is solid green or the status light has switched off. This means that the 
delivery is complete. 

 The on-body injector leaked, contact your healthcare provider immediately as you 
may need a replacement dose. 

 Status light is red, contact your healthcare provider immediately as you may need a 
replacement dose.  

B Properly dispose of the on-body injector. 

 The on-body injector contains batteries, electronics, and a needle. Dispose of it in a 
sharps disposal container as instructed by your healthcare provider or in accordance with 
local requirements. 

 Keep children away from the used on-body injector. 

 

Attention! 
What to do if you hear beeping or when you look at the status light and it is flashing red. 
 
 If the status light is flashing red, you may not have received your full dose and you may need a 

replacement dose. Contact your healthcare provider immediately. 

Not working correctly 

 

 
 

 
 

 
  

 

ERROR LIGHT

“BEEPS” 



 

60 

What to do if the on-body injector adhesive becomes noticeably wet (saturated) with fluid, or 
you see dripping. 

Not working correctly Not working correctly 

Noticeably wet (saturated) adhesive Dripping fluid from on-body injector 

 If the adhesive becomes saturated with fluid, or you see dripping, your medicine may have 
leaked out. 

 Even with a leak, the status light may remain green and the fill indicator may be at 0% (empty).

 Contact your healthcare provider immediately as you may not have received your full dose and 
may need a replacement dose. 

Note: It is normal to see a few drops of fluid at the application site, but not normal to see a noticeably 
wet (saturated) adhesive. 

 

What do I do if the on-body injector comes off before the full dose is delivered? 

Contact your healthcare provider immediately if the on-body injector comes away from your skin at 
any time before your full dose has been delivered. There is a small cannula which sits just under your 
skin. If the on-body injector has been knocked or moved, this may become dislodged. If this happens, 
you may not receive your dose of Neulasta. Do not reapply it.
What if there is blood at my application site after the on-body injector has been removed?

If there is blood, press a clean cotton ball or gauze pad on the application site. Apply a plaster if 
needed. 
What if my application site is red or tender after on-body injector removal? 
Contact your healthcare provider immediately if you experience persistent or worsening redness or 
tenderness at the application site, as this can be a sign of infection.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURER(S) 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