Mozobil

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 



 

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1. NAME OF THE MEDICINAL PRODUCT 

 

Mozobil 20 mg/ml solution for injection 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

One ml of solution contains 20 mg plerixafor. 

Each vial contains 24 mg plerixafor in 1.2 ml solution. 

 

Excipients with known effect: 

Each ml contains approximately 5 mg (0.2 mmol) of sodium. 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Solution for injection. 

 

Clear, colourless to pale yellow solution, with a pH of 6.0-7.5 and an osmolality of 

260 - 320 mOsm/kg. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Adult patients 

Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance 

mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent 

autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise 

poorly (see section 4.2). 

 

Paediatric patients (1 to less than 18 years)  

Mozobil is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells 

to the peripheral blood for collection and subsequent autologous transplantation in children with 

lymphoma or solid malignant tumours, either: 

- pre-emptively, when circulating stem cell count on the predicted day of collection after 
adequate mobilization with G-CSF (with or without chemotherapy) is expected to be 

insufficient with regards to desired hematopoietic stem cells yield, or 

- who previously failed to collect sufficient haematopoietic stem cells (see section 4.2). 
 

 

 

4.2 Posology and method of administration 

 

Mozobil therapy should be initiated and supervised by a physician experienced in oncology and/or 

haematology. The mobilisation and apheresis procedures should be performed in collaboration with an 

oncology-haematology centre with acceptable experience in this field and where the monitoring of 

haematopoietic progenitor cells can be correctly performed. 

 

Age over 60 and/ or prior myelosuppressive chemotherapy and/or extensive prior chemotherapy 

and/or a peak circulating stem cell count of less than 20 stem cells/microliter, have been identified as 

predictors of poor mobilisation. 

 



 

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Posology  

Adult 

The recommended daily dose of plerixafor by subcutaneous injection (SC) is:  

• 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing ≤ 83 kg (see section 
5.2).  

• 0.24 mg/kg of body weight for patients weighing > 83 kg. 
 

Paediatric (1 to less than 18 years) 

The recommended daily dose of plerixafor by subcutaneous injection (SC) is: 

• 0.24 mg/kg of body weight (see section 5.1). 
 

Each vial of plerixafor is filled to deliver 1.2 ml of 20 mg/ml plerixafor aqueous solution for injection 

containing 24 mg of plerixafor. 

Plerixafor has to be drawn up into a syringe size type which should be selected according to the weight 

of the patient. 

For low weight patients, up to 45 kg of body weight, 1 ml syringes for use in infant patients can be 

used. This type of syringe has major graduations for 0.1 ml and minor graduations for 0.01 ml and 

therefore is suitable to administer plerixafor, at a dose of 240 µg/kg, to paediatric patients of at least 

9 kg body weight. 

For patients of more than 45 kg, a1 ml or 2 ml syringe with graduations that allow a volume to 0.1 ml 

to be measured can be used. 

 

It should be administered by subcutaneous injection 6 to 11 hours prior to initiation of each apheresis 

following 4 day pre-treatment with G-CSF. In clinical trials, Mozobil has been commonly used for 2 

to 4 (and up to 7) consecutive days. 

 

The weight used to calculate the dose of plerixafor should be obtained within 1 week before the first 

dose of plerixafor. In clinical studies, the dose of plerixafor has been calculated based on body weight 

in patients up to 175% of ideal body weight. Plerixafor dose and treatment of patients weighing more 

than 175% of ideal body weight have not been investigated. Ideal body weight can be determined 

using the following equations:  

 

male (kg):  50 + 2.3  x  ((Height (cm)  x  0.394) – 60); 

female (kg):  45.5 + 2.3  x  ((Height (cm)  x  0.394) – 60).  

 

Based on increasing exposure with increasing body weight, the plerixafor dose should not exceed 

40 mg/day. 

 

Recommended concomitant medicinal products 

In pivotal clinical studies supporting the use of Mozobil, all patients received daily morning doses of 

10 g/kg G-CSF for 4 consecutive days prior to the first dose of plerixafor and on each morning prior 

to apheresis.  

 

Special populations 

Renal impairment 

Patients with creatinine clearance 20-50 ml/min should have their dose of plerixafor reduced by 

one-third to 0.16 mg/kg/day (see section 5.2). Clinical data with this dose adjustment are limited. 

There is insufficient clinical experience to make alternative posology recommendations for patients 

with a creatinine clearance <20 ml/min, as well as to make posology recommendations for patients on 

haemodialysis. 

 

Based on increasing exposure with increasing body weight the dose should not exceed 27 mg/day if 

the creatinine clearance is lower than 50 ml/min. 

 



 

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Paediatric population 

The safety and efficacy of Mozobil in children (1 to less than 18 years) were studied in an open label, 

multicenter, controlled study (see sections 4.8, 5.1, and 5.2). 

 

Elderly patients (> 65 years old) 

No dose modifications are necessary in elderly patients with normal renal function. Dose adjustment 

in elderly patients with creatinine clearance ≤ 50 ml/min is recommended (see Renal impairment 

above). In general, care should be taken in dose selection for elderly patients due to the greater 

frequency of decreased renal function with advanced age.   

 

Method of administration 

Mozobil is for subcutaneous injection. Each vial is intended for single use only. 

 

Vials should be inspected visually prior to administration and not used if there is particulate matter or 

discolouration. Since Mozobil is supplied as a sterile, preservative-free formulation, aseptic technique 

should be followed when transferring the contents of the vial to a suitable syringe for subcutaneous 

administration (see section 6.3). 

 

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 

 

Tumour cell mobilisation in patients with lymphoma and multiple myeloma 

When Mozobil is used in conjunction with G-CSF for haematopoietic stem cell mobilisation in 

patients with lymphoma or multiple myeloma‚ tumour cells may be released from the marrow and 

subsequently collected in the leukapheresis product. Results showed that, in case tumour cells are 

mobilised, the number of tumour cells mobilised is not increased upon Mozobil plus G-CSF compared 

to G-CSF alone.  

 

Tumour cell mobilisation in leukaemia patients 

In a compassionate use programme, Mozobil and G-CSF have been administered to patients with 

acute myelogenous leukaemia and plasma cell leukaemia. In some instances, these patients 

experienced an increase in the number of circulating leukaemia cells. For the purpose of 

haematopoietic stem cell mobilisation, plerixafor may cause mobilisation of leukaemic cells and 

subsequent contamination of the apheresis product. Therefore, plerixafor is not recommended for 

haematopoietic stem cell mobilisation and harvest in patients with leukaemia. 

 

Haematological effects 

Hyperleukocytosis 

Administration of Mozobil in conjunction with G-CSF increases circulating leukocytes as well as 

haematopoietic stem cell populations. White blood cell counts should be monitored during Mozobil 

therapy. Clinical judgment should be exercised when administering Mozobil to patients with 

peripheral blood neutrophil counts above 50 x 109/L.  

 

Thrombocytopenia 

Thrombocytopenia is a known complication of apheresis and has been observed in patients receiving 

Mozobil.  Platelet counts should be monitored in all patients receiving Mozobil and undergoing 

apheresis. 

 

Allergic reactions 

Mozobil has been uncommonly associated with potential systemic reactions related to subcutaneous 

injection such as urticaria, periorbital swelling, dyspnoea, or hypoxia (see section 4.8). Symptoms 

responded to treatments (e.g., antihistamines, corticosteroids, hydration or supplemental oxygen) or 

resolved spontaneously. Cases of anaphylactic reactions, including anaphylactic shock, have been 



 

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reported from world-wide post-marketing experience. Appropriate precautions should be taken 

because of the potential for these reactions. 

 

Vasovagal reactions 

Vasovagal reactions, orthostatic hypotension, and/or syncope can occur following subcutaneous 

injections (see section 4.8). Appropriate precautions should be taken because of the potential for these 

reactions. 

 

Effect on the spleen 

In preclinical studies, higher absolute and relative spleen weights associated with extramedullary 

haematopoiesis were observed following prolonged (2 to 4 weeks) daily plerixafor subcutaneous 

administration in rats at doses approximately 4 fold higher than the recommended human dose. 

 

The effect of plerixafor on spleen size in patients has not been specifically evaluated in clinical 

studies. Cases of splenic enlargement and/or rupture have been reported following the administration 

of Mozobil in conjunction with growth factor G-CSF. Individuals receiving Mozobil in conjunction 

with G-CSF who report left upper abdominal pain and/or scapular or shoulder pain should be 

evaluated for splenic integrity.  

 

Sodium 

Mozobil contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

No interaction studies have been performed. In vitro tests showed that plerixafor was not metabolised 

by P450 CYP enzymes, did not inhibit or induce P450 CYP enzymes. Plerixafor did not act as a 

substrate or inhibitor of P-glycoprotein in an in vitro study.  

 

In clinical studies of patients with Non-Hodgkin’s lymphoma, the addition of rituximab to a 

mobilisation regimen of plerixafor and G-CSF did not impact patient safety or CD34+ cell yield. 

 

4.6 Fertility, pregnancy and lactation 

 

Women of childbearing potential 

Women of childbearing potential have to use effective contraception during treatment. 

 

Pregnancy 

There are no adequate data on the use of plerixafor in pregnant women. 

Based on the pharmacodynamic mechanism of action, plerixafor is suggested to cause congenital 

malformations when administered during pregnancy. Studies in animals have shown teratogenicity 

(see section 5.3). Mozobil should not be used during pregnancy unless the clinical condition of the 

woman requires treatment with plerixafor.  

 

Breast-feeding 

It is unknown whether plerixafor is excreted in human milk. A risk to the suckling child cannot be 

excluded. Breast-feeding should be discontinued during treatment with Mozobil. 

 

Fertility 

The effects of plerixafor on male and female fertility are not known (see section 5.3). 

 

4.7 Effects on ability to drive and use machines 

 

Mozobil may influence the ability to drive and use machines. Some patients have experienced 

dizziness, fatigue or vasovagal reactions; therefore caution is advised when driving or operating 

machines. 

 



 

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4.8 Undesirable effects 
 

Summary of the safety profile 

Safety data for Mozobil in conjunction with G-CSF in oncology patients with lymphoma and multiple 

myeloma were obtained from 2 placebo-controlled Phase III studies (301 patients) and 10 uncontrolled 

Phase II studies (242 patients). Patients were primarily treated with daily doses of 0.24 mg/kg 

plerixafor by subcutaneous injection. The exposure to plerixafor in these studies ranged from 1 to 

7 consecutive days (median = 2 days). 

 

In the two Phase III studies in non-Hodgkin’s lymphoma and multiple myeloma patients 

(AMD3100-3101 and AMD3100-3102, respectively), a total of 301 patients were treated in the 

Mozobil and G-CSF group and 292 patients were treated in the placebo and G-CSF group. Patients 

received daily morning doses of G-CSF 10 g/kg for 4 days prior to the first dose of plerixafor or 

placebo and on each morning prior to apheresis. Adverse reactions that occurred more frequently with 

Mozobil and G-CSF than placebo and G-CSF and were reported as related in ≥1% of the patients who 

received Mozobil, during haematopoietic stem cell mobilisation and apheresis and prior to 

chemotherapy/ablative treatment in preparation for transplantation are shown in Table 1.  

 

From chemotherapy/ablative treatment in preparation of transplantation through 12 months 

post-transplantation, no significant differences in the incidence of adverse reactions were observed 

across treatment groups.  

 

Tabulated list of adverse reactions 

Adverse reactions are listed by System Organ Class and frequency. Frequencies are defined according 

to the following convention: 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); very rare (< 1/10,000); not known (cannot be 

estimated from the available data).  

 

Table 1. Adverse reactions occurring more frequently with Mozobil than placebo and 

considered related to Mozobil during mobilisation and apheresis in phase III studies 

 

Blood and lymphatic system disorders 

 

Not known  Splenomegaly, splenic rupture (see section 

4.4)** 

Immune system disorders 

Uncommon Allergic reaction* 

Anaphylactic reactions, including anaphylactic 

shock (see section 4.4) ** 

Psychiatric disorders 

Common Insomnia 

Uncommon Abnormal dreams, nightmares 

Nervous system disorders 

Common Dizziness, headache 

Gastrointestinal disorders 

Very common Diarrhoea, nausea 

Common Vomiting, abdominal pain, stomach 

discomfort, dyspepsia, abdominal distention, 

constipation, flatulence, hypoaesthesia oral, 

dry mouth 

Skin and subcutaneous tissue disorders 



 

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Common Hyperhidrosis, erythema 

Musculoskeletal and connective tissue disorders 

Common Arthralgia, musculoskeletal pain 

General disorders and administration site conditions 

Very common Injection and infusion site reactions 

Common Fatigue, malaise 

* The frequency of allergic reactions presented is based on adverse reactions that occurred in the oncology studies 

(679 patients). Events included one or more of the following: urticaria (n = 2), periorbital swelling (n = 2), dyspnoea 

(n = 1) or hypoxia (n = 1). These events were generally mild or moderate and occurred within approximately 30 min 

after Mozobil administration. 

** From post-marketing experience 
 

The adverse reactions reported in patients with lymphoma and multiple myeloma who received 

Mozobil in the controlled Phase III studies and uncontrolled studies, including a Phase II study of 

Mozobil as monotherapy for haematopoietic stem cell mobilisation, are similar. No significant 

differences in the incidence of adverse reactions were observed for oncology patients by disease, age, 

or gender. 

 

Description of selected adverse reactions 

Myocardial infarction 

In clinical studies, 7 of 679 oncology patients experienced myocardial infarctions after haematopoietic 

stem cell mobilisation with plerixafor and G-CSF. All events occurred at least 14 days after last 

Mozobil administration. Additionally, two female oncology patients in the compassionate use 

programme experienced myocardial infarction following haematopoietic stem cell mobilisation with 

plerixafor and G-CSF. One of these events occurred 4 days after last Mozobil administration. Lack of 

temporal relationship in 8 of 9 patients coupled with the risk profile of patients with myocardial 

infarction does not suggest Mozobil confers an independent risk for myocardial infarction in patients 

who also receive G-CSF. 

 

Hyperleukocytosis 

White blood cell counts of 100 x 109/L or greater were observed, on the day prior to or any day of 

apheresis, in 7% patients receiving Mozobil and in 1% patients receiving placebo in the Phase III 

studies. No complications or clinical symptoms of leukostasis were observed. 

 

Vasovagal reactions 

In Mozobil oncology and healthy volunteer clinical studies, less than 1% of subjects experienced 

vasovagal reactions (orthostatic hypotension and/or syncope) following subcutaneous administration 

of plerixafor doses ≤0.24 mg/kg. The majority of these events occurred within 1 hour of Mozobil 

administration. 

 

Gastrointestinal disorders 

In Mozobil clinical studies of oncology patients, there have been rare reports of severe gastrointestinal 

events, including diarrhoea, nausea, vomiting, and abdominal pain. 

 

Paraesthesia 

Paraesthesia is commonly observed in oncology patients undergoing autologous transplantation 

following multiple disease interventions. In the placebo-controlled Phase III studies, the incidence of 

paraesthesia was 20.6% and 21.2% in the plerixafor and placebo groups, respectively. 

 

Elderly patients 

In the two placebo-controlled clinical studies of plerixafor, 24% of patients were ≥ 65 years old. No 

notable differences in the incidence of adverse reactions were observed in these elderly patients when 

compared with younger ones. 

 



 

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Paediatric population  

Thirty patients were treated with 0.24 mg/kg of Mozobil in an open label, multicenter, controlled study 

(DFI 12860) (see section 5.1). 

The safety profile in this paediatric study was consistent with what has been observed in adults. 

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 

 

No case of overdose has been reported. Based on limited data at doses above the recommended dose 

and up to 0.48 mg/kg the frequency of gastrointestinal disorders, vasovagal reactions, orthostatic 

hypotension, and/or syncope may be higher. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: Other immunostimulants; ATC code: L03AX16 

 

Mechanism of action 

Plerixafor is a bicyclam derivative, a selective reversible antagonist of the CXCR4 chemokine receptor 

and blocks binding of its cognate ligand, stromal cell-derived factor-1 (SDF-1), also known as 

CXCL12. Plerixafor-induced leukocytosis and elevations in circulating haematopoietic progenitor cell 

levels are thought to result from a disruption of CXCR4 binding to its cognate ligand, resulting in the 

appearance of both mature and pluripotent cells in the systemic circulation. CD34+ cells mobilised by 

plerixafor are functional and capable of engraftment with long-term repopulating capacity. 

 

Pharmacodynamic effects 

In pharmacodynamic studies in healthy volunteers of plerixafor alone, peak mobilisation of CD34+ 

cells was observed from 6 to 9 hours after administration. In pharmacodynamic studies in healthy 

volunteers of plerixafor in conjunction with G-CSF administered at identical dose regimen to that in 

studies in patients, a sustained elevation in the peripheral blood CD34+ count was observed from 4 to 

18 hours after plerixafor administration with peak response between 10 and 14 hours. 

 

In order to compare the pharmacokinetics and pharmacodynamics of plerixafor following 0.24 mg/kg 

based and fixed (20 mg) doses, a trial was conducted in adult patients with NHL (N=61) who were 

treated with 0.24 mg/kg or 20 mg of plerixafor. The trial was conducted in patients weighing 70 kg or 

less (median: 63.7 kg , min: 34.2 kg, max: 70 kg). The fixed 20 mg dose showed 1.43-fold higher 

exposure (AUC0-10h) than the 0.24 mg/kg dose (Table 2). The fixed 20 mg dose also showed 

numerically higher response rate (5.2% [60.0% vs 54.8%] based on the local lab data and 11.7% 

[63.3% vs 51.6%] based on the central lab data) in attaining the target of ≥ 5 × 106 CD34+ cells/kg 

than the mg/kg-based dose. The median time to reach ≥ 5 × 106 CD34+ cells/kg was 3 days for both 

treatment groups, and the safety profile between the groups was similar. Body weight of 83 kg was 

selected as the cut-off point to transition patients from fixed to weight based dosing (83 kg x 0.24 mg 

= 19.92 mg/kg). 

 

Table 2. Systemic Exposure (AUC0-10h) comparisons of fixed and weight based regimens 

 

Regimen Geometric Mean AUC 

Fixed 20 mg (n=30) 3991.2 

0.24 mg/kg (n=31) 2792.7 

Ratio (90% CI) 1.43 (1.32,1.54) 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

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Clinical efficacy and safety 

In two Phase III randomised-controlled studies patients with non-Hodgkin’s lymphoma or multiple 

myeloma received Mozobil 0.24 mg/kg or placebo on each evening prior to apheresis. Patients 

received daily morning doses of G-CSF 10 μg/kg for 4 days prior to the first dose of plerixafor or 

placebo and on each morning prior to apheresis. Optimal (5 or 6 x 106 cells/kg) and minimal 

(2 x 106 cells/kg) numbers of CD34+ cells/kg within a given number of days, as well as the primary 

composite endpoints which incorporated successful engraftment are presented in Tables 3 and 5; the 

proportion of patients reaching optimal numbers of CD34+ cells/kg by apheresis day are presented in 

Tables 4 and 6. 

 

Table 3. Study AMD3100-3101 efficacy results - CD34+ cell mobilisation in non-Hodgkin’s 

lymphoma patients 

 

Efficacy endpointb 

Mozobil and 

G-CSF 

(n = 150) 

Placebo and 

G-CSF 

(n = 148) 

p-value a 

Patients achieving ≥ 5 x 106 cells/kg in ≤ 4 

apheresis days and successful engraftment 
86 (57.3%) 28 (18.9%) <0.001 

Patients achieving ≥ 2 x 106 cells/kg in ≤ 4 

apheresis days and successful engraftment 
126 (84.0%) 64 (43.2%) < 0.001 

a p-value calculated using Pearson’s Chi-Squared test 
bStatistically significantly more patients achieved  ≥ 5 x 106 cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=89; 

59.3%) than with placebo and G-CSF (n=29; 19.6%), p<0.001; statistically significantly more patients achieved  

≥ 2 x 106 cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=130; 86.7%) than with placebo and G-CSF (n=70; 

47.3%), p<0.001. 

 

Table 4.  Study AMD3100-3101 – Proportion of patients who achieved ≥ 5 x 106 CD34+ 

cells/kg by apheresis day in non-Hodgkin’s lymphoma patients 
 

Days 

Proportiona 

in Mozobil and G-CSF 

(n=147b) 

Proportiona 

in Placebo and G-CSF 

(n=142b) 

1 27.9% 4.2% 

2 49.1% 14.2% 

3 57.7% 21.6% 

4 65.6% 24.2% 
aPercents determined by Kaplan Meier method 
b n includes all patients who received at least one day of apheresis 

 

Table 5. Study AMD3100-3102 efficacy results – CD34+ cell mobilisation in multiple 

myeloma patients 

 

Efficacy endpointb 

Mozobil and 

G-CSF 

(n = 148) 

Placebo and 

G-CSF 

(n = 154) 

p-value a 

Patients achieving ≥ 6 x 106 cells/kg in ≤ 2 

apheresis days and successful engraftment 

104 (70.3%) 53 (34.4%) <0.001 

ap-value calculated using Cochran-Mantel-Haenszel statistic blocked by baseline platelet count 
bStatistically significantly more patients achieved  ≥ 6 x 106 cells/kg in ≤ 2 apheresis days with Mozobil and G-CSF 

(n=106; 71.6%) than with placebo and G-CSF (n=53; 34.4%), p<0.001; statistically significantly more patients achieved 

≥ 6 x 106 cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=112; 75.7%) than with placebo and G-CSF (n=79; 

51.3%), p<0.001; statistically significantly more patients achieved  ≥ 2 x 106 cells/kg in ≤ 4 apheresis days with Mozobil 

and G-CSF (n=141; 95.3%) than with placebo and G-CSF (n=136; 88.3%), p=0.031. 

 



 

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Table 6.  Study AMD3100-3102 – Proportion of patients who achieved ≥ 6 x 106 CD34+ 

cells/kg by apheresis day in multiple myeloma patients 

 

Days Proportiona 

in Mozobil and G-CSF 

(n=144b) 

Proportiona 

in Placebo and G-CSF 

(n=150b) 

1 54.2% 17.3% 

2 77.9% 35.3% 

3 86.8% 48.9% 

4 86.8% 55.9% 
aPercents determined by Kaplan Meier method 
b n includes all patients who received at least one day of apheresis 

 

Rescue patients 

In study AMD3100-3101, 62 patients (10 in the Mozobil + G-CSF group and 52 in the placebo + G-

CSF group), who could not mobilise sufficient numbers of CD34+ cells and thus could not proceed to 

transplantation, entered into an open-label Rescue procedure with Mozobil and G-CSF. Of these 

patients, 55 % (34 out of 62) mobilised ≥ 2 x106/kg CD34+ cells and had successful engraftment. In 

study AMD3100-3102, 7 patients (all from the placebo + G-CSF group) entered the Rescue procedure. 

Of these patients, 100% (7 out of 7) mobilised ≥ 2 x106/kg CD34+ cells and had successful 

engraftment. 

 

The dose of haematopoietic stem cells used for each transplant was determined by the investigator and 

all haematopoietic stem cells that were collected were not necessarily transplanted. For transplanted 

patients in the Phase III studies, median time to neutrophil engraftment (10-11 days), median time to 

platelet engraftment (18-20 days) and graft durability up to 12 months post-transplantation were 

similar across the Mozobil and placebo groups. 

 

Mobilisation and engraftment data from supportive Phase II studies (plerixafor 0.24 mg/kg dosed on 

the evening or morning prior to apheresis) in patients with non-Hodgkin’s lymphoma, Hodgkin’s 

disease, or multiple myeloma were similar to those data for the Phase III studies. 

 

In the placebo-controlled studies, fold increase in peripheral blood CD34+ cell count (cells/l) over 

the 24-hour period from the day prior to the first apheresis to just before the first apheresis was 

evaluated (Table 7). During that 24-hour period, the first dose of plerixafor 0.24 mg/kg or placebo was 

administered 10-11 hours prior to apheresis. 

 

Table 7.  Fold increase in peripheral blood CD34+ cell count following Mozobil 

administration 

 

Study 

Mozobil and G-CSF Placebo and G-CSF 

Median 
Mean 

(SD) 
Median 

Mean 

(SD) 

AMD3100-3101 5.0 6.1 (5.4) 1.4 1.9 (1.5) 

AMD3100-3102 4.8 6.4 (6.8) 1.7 2.4 (7.3) 

 

 

Paediatric population 

The European Medicines Agency has waived the obligation to submit the results of studies with 

Mozobil in children aged 0 to 1 year in myelosuppression caused by chemotherapy to treat malignant 

disorders, which requires an autologous haematopoietic stem cell transplant (see section 4.2 for 

information on paediatric use). 

 



 

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The efficacy and safety of Mozobil were evaluated in an open label, multi-center, controlled study in 

paediatric patients with solid tumors (including neuroblastoma, sarcoma, Ewing sarcoma) or 

lymphoma who were eligible for autologous hematopoietic stem cell transplantation (DFI12860). 

Patients with leukemia, persistent high percentage marrow involvement prior to mobilization, or 

previous stem cell transplantation were excluded. 

 

Forty-five paediatric patients (1 to less than 18 years) were randomised, 2:1, using 0.24 mg/kg of 

Mozobil plus standard mobilisation (G-CSF plus or minus chemotherapy) versus control (standard 

mobilisation alone). Median age was 5.3 years (min: max 1:18) in the Mozobil arm versus 4.7 years 

(min:max 1:17) in the control arm. 

Only one patient aged less than 2 years old was randomized to the plerixafor treatment arm. There was 

an imbalance between treatment arms in peripheral blood CD34+ counts on the day prior to first 

apheresis (i.e. prior to administration of plerixafor), with less circulating PB CD34+ in the plerixafor 

arm. The median PB CD34+ cell counts at baseline were 15 cells/µl in the Mozobil arm versus 

35 cells/µl in control arm. The primary analysis showed that 80% of patients in the Mozobil arm 

experienced at least a doubling of the PB CD34+ count, observed from the morning of the day 

preceding the first planned apheresis to the morning prior to apheresis, versus, 28.6 % of patients in 

the control arm (p=0.0019). The median increase in PB CD34+ cell counts from baseline to the day of 

apheresis was by 3.2 fold in the Mozobil arm versus by 1.4 fold in the control arm. 

 

 

5.2 Pharmacokinetic properties 

 

The pharmacokinetics of plerixafor have been evaluated in lymphoma and multiple myeloma patients 

at the clinical dose level of 0.24 mg/kg following pre-treatment with G-CSF (10 g/kg once daily for 

4 consecutive days). 

 

Absorption 

Plerixafor is rapidly absorbed following subcutaneous injection, reaching peak concentrations in 

approximately 30-60 minutes (tmax). Following subcutaneous administration of a 0.24 mg/kg dose to 

patients after receiving 4-days of G-CSF pre-treatment, the maximal plasma concentration (Cmax) and 

systemic exposure (AUC0-24) of plerixafor were 887 ± 217 ng/ml and 4337 ± 922 ng·hr/ml, 

respectively. 

 

Distribution 

Plerixafor is moderately bound to human plasma proteins up to 58%. The apparent volume of 

distribution of plerixafor in humans is 0.3 l/kg demonstrating that plerixafor is largely confined to, but 

not limited to, the extravascular fluid space.  

 

Biotransformation 

Plerixafor is not metabolised in vitro using human liver microsomes or human primary hepatocytes 

and does not exhibit inhibitory activity in vitro towards the major drug-metabolising CYP450 enzymes 

(1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5). In in vitro studies with human hepatocytes, 

plerixafor does not induce CYP1A2, CYP2B6, and CYP3A4 enzymes. These findings suggest that 

plerixafor has a low potential for involvement in P450-dependent drug-drug interactions. 

 

Elimination 

The major route of elimination of plerixafor is urinary. Following a 0.24 mg/kg dose in healthy 

volunteers with normal renal function, approximately 70% of the dose was excreted unchanged in 

urine during the first 24 hours following administration. The elimination half-life (t1/2) in plasma is 

3-5 hours. Plerixafor did not act as a substrate or inhibitor of P-glycoprotein in an in vitro study with 

MDCKII and MDCKII-MDR1 cell models. 

 



 

12 

Special populations 

Renal impairment 

Following a single dose of 0.24 mg/kg plerixafor, clearance was reduced in subjects with varying 

degrees of renal impairment and was positively correlated with creatinine clearance (CrCl). Mean 

values of AUC0-24 of plerixafor in subjects with mild (CrCl 51-80 ml/min), moderate 

(CrCl 31-50 ml/min) and severe (CrCl ≤ 30 ml/min) renal impairment were 5410, 6780, and 

6990 ng.hr/ml, respectively, which were higher than the exposure observed in healthy subjects with 

normal renal function (5070 ng·hr/ml). Renal impairment had no effect on Cmax.. 

 

Gender 

A population pharmacokinetic analysis showed no effect of gender on pharmacokinetics of plerixafor. 

 

Elderly 

A population pharmacokinetic analysis showed no effect of age on pharmacokinetics of plerixafor. 

 

Paediatric population 

 

The pharmacokinetics of plerixafor were evaluated in 48 paediatric patients (1 to less than 18 years) 

with solid tumours at subcutaneous doses of 0.16, 0.24 and 0.32 mg/kg with standard mobilisation (G-

CSF plus or minus chemotherapy). Based on population pharmacokinetic modeling and similar to 

adults, µg/kg-based dosage results in increase in plerixafor exposure with increasing body weight in 

paediatric patients. At the same weight-based dosing regimen of 240 µg/kg, the plerixafor mean 

exposure (AUC0-24h) is lower in paediatric patients aged 2 to <6 years (1410 ng.h/mL), 6 to <12 years 

(2318 ng.h/mL), and 12 to <18 years (2981 ng.h/mL) than in adults (4337 ng.h/mL). Based on 

population pharmacokinetic modeling, the plerixafor mean exposures (AUC0-24h) in paediatric patients 

aged 2 to <6 years (1905 ng.h/mL), 6 to <12 years (3063 ng.h/mL), and 12 to <18 years (4015  

ng.h/mL), at the dose of 320 µg/kg are closer to the exposure in adults receiving 240 µg/kg.  

However, mobilization of PB CD34+ count was observed in stage 2 of the trial. 

 

5.3 Preclinical safety data 

 

The results from single dose subcutaneous studies in rats and mice showed plerixafor can induce 

transient but severe neuromuscular effects (uncoordinated movement), sedative-like effects 

(hypoactivity), dyspnoea, ventral or lateral recumbency, and/or muscle spasms. Additional effects of 

plerixafor consistently noted in repeated dose animal studies included increased levels of circulating 

white blood cells and increased urinary excretion of calcium and magnesium in rats and dogs, slightly 

higher spleen weights in rats, and diarrhoea and tachycardia in dogs. Histopathology findings of 

extramedullary haematopoiesis were observed in the liver and spleen of rats and/or dogs. One or more 

of these findings were usually observed at systemic exposures in the same order of magnitude or 

slightly higher than the human clinical exposure.  

 

The results of the dose range-finding study in juvenile miniature pigs and the range-finding and 

definitive studies in juvenile rats were similar to those observed in adult mice, rats, and dogs. 

Exposure margins in the juvenile rat study at the maximum tolerated dose (MTD) were ≥18 fold when 

compared with the highest clinical paediatric dose in children up to 18 years of age. 

 

An in vitro general receptor activity screen showed that plerixafor, at a concentration (5 µg/ml) several 

fold higher than the maximum human systemic level, has moderate or strong binding affinity for a 

number of different receptors predominantly located on pre-synaptic nerve endings in the central 

nervous system (CNS) and/or the peripheral nervous system (PNS) (N-type calcium channel, 

potassium channel SKCA, histamine H3, acetylcholine muscarinic M1 and M2, adrenergic α1B and α2C, 

neuropeptide Y/Y1 and glutamate NMDA polyamine receptors). The clinical relevance of these 

findings is not known. 

Safety pharmacology studies with intravenously administered plerixafor in rats showed respiratory and 

cardiac depressant effects at systemic exposure slightly above the human clinical exposure, whilst 

subcutaneous administration elicited respiratory and cardiovascular effects only at higher systemic 

levels. 



 

13 

 

SDF-1α and CXCR4 play major roles in embryo-foetal development. Plerixafor has been shown to 

cause increased resorptions, decreased foetal weights, retarded skeletal development and increased 

foetal abnormalities in rats and rabbits. Data from animal models also suggest modulation of foetal 

haematopoiesis, vascularisation, and cerebellar development by SDF-1α and CXCR4. Systemic 

exposure at No Observed Adverse Effect Level for teratogenic effects in rats and rabbits was of the 

same magnitude or lower as found at therapeutic doses in patients. This teratogenic potential is likely 

due to its pharmacodynamic mechanism of action. 

In rat distribution studies concentrations of radiolabelled plerixafor was detected in reproductive 

organs (testes, ovaria, uterus) two weeks after single or 7 daily repeated doses in males and after 

7 daily repeated doses in females. The elimination rate from tissues was slow. 

The potential effects of plerixafor on male fertility and postnatal development have not been evaluated 

in non-clinical studies. 

 

Carcinogenicity studies with plerixafor have not been conducted. Plerixafor was not genotoxic in an 

adequate battery of genotoxicity tests. 

 

Plerixafor inhibited tumour growth in in vivo models of non-Hodgkin’s lymphoma, glioblastoma, 

medulloblastoma, and acute lymphoblastic leukaemia when dosed intermittently. An increase of non-

Hodgkin’s lymphoma growth was noted after a continuous administration of plerixafor for 28 days. 

The potential risk associated with this effect is expected to be low for the intended short term duration 

of dosing plerixafor in humans. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Sodium chloride 

Hydrochloric acid, concentrated (pH adjustment) 

Sodium hydroxide (pH adjustment) 

Water for injections 

 

6.2 Incompatibilities 

 

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 

products.  

 

6.3 Shelf life 

 

Unopened vial 

3 years. 

 

After opening 

From a microbiological point of view the product should be used immediately. If not used 

immediately, in-use storage times and conditions prior to use are the responsibility of the user. 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions.  

 

6.5 Nature and contents of container 
 

Clear type I glass 2 ml vial with a chlorobutyl/butyl rubber stopper and aluminium seal with a plastic 

flip-off cap. Each vial contains 1.2 ml solution. 

 

Pack size of 1 vial. 



 

14 

 

6.6 Special precautions for disposal 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Genzyme Europe B.V. 

Paasheuvelweg 25 

1105 BP Amsterdam 

The Netherlands. 

 

 

8. MARKETING AUTHORISATION NUMBER  

 

EU/1/09/537/001 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 31 July 2009 

Date of latest renewal: 11 April 2014 

 

 

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. 

 

http://www.ema.europa.eu/
http://www.ema.europa.eu/


 

15 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER 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 RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer responsible for batch release 

 

Genzyme Ltd. 

37 Hollands Road 

Haverhill, Suffolk 

CB9 8PU 

United Kingdom 

 

Or 

 

Genzyme Ireland Ltd. 

IDA Industrial Park 

Old Kilmeaden Road 

Waterford, Ireland 

 

 

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 
 

The marketing authorisation holder shall submit periodic safety update reports for this product in 

accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 

under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   

 

• Risk Management Plan (RMP) 
 

The MAH shall perform the 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. 

 

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 

same time. 

 

 

 

 

 

 



 

17 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



 

18 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



 

19 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

OUTER CARTON 

 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Mozobil 20 mg/ml solution for injection 

Plerixafor 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each ml contains 20 mg plerixafor. 

Each vial contains 24 mg plerixafor in 1.2 ml solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Excipients: sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH 

adjustment and water for injections. See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

1 vial 

24 mg/1.2 ml 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use. 

For single use only. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 



 

20 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Any unused solution should be discarded. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Genzyme Europe B.V. 

Paasheuvelweg 25 

1105 BP Amsterdam 

The Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER 

 

EU/1/09/537/001 

 

 

13. BATCH NUMBER 

 

Batch 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Justification for not including Braille accepted. 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC:  

SN:  

NN:  



 

21 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

VIAL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 

 

Mozobil 20 mg/ml solution for injection 

Plerixafor 

Subcutaneous use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Batch 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

24 mg/1.2 ml 

 

 

6. OTHER 

 



 

22 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

 



 

23 

Package leaflet: Information for the user 

 

Mozobil 20 mg/ml solution for injection 

Plerixafor 

 

 

 

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. 
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

  

1. What Mozobil is and what it is used for 

2. What you need to know before you use Mozobil 

3. How to use Mozobil 

4. Possible side effects 

5.  How to store Mozobil 
6. Contents of the pack and other information 

 

 

1. What Mozobil is and what it is used for 
 

Mozobil contains the active substance plerixafor which blocks a protein on the surface of blood stem 

cells. This protein “ties” blood stem cells to the bone marrow. Plerixafor improves the release of stem 

cells into the blood stream (mobilisation). The stem cells can then be collected by a machine that 

separates blood constituents (apheresis machine), and subsequently frozen and stored until your 

transplant. 

 

If mobilisation is poor, Mozobil is used to help collect blood stem cells from the patient, for collection, 

storage and reintroduction (transplantation), 

• In adults who have lymphoma (a cancer of the white blood cells) or multiple myeloma (a cancer 
that affects plasma cells in the bone marrow). 

• In children age 1 to less than 18 years of age with lymphoma or solid tumours.  
 

 

2. What you need to know before you use Mozobil 
 

Do not use Mozobil 

• if you are allergic to plerixafor or any of the other ingredients of this medicine (listed in 

section 6). 

 

Warnings and precautions 

Talk to your doctor before using Mozobil. 

 

Tell your doctor:  

• if you have or have had any heart problems. 

• if you have kidney problems. Your doctor may adjust the dose. 

• if you have high white blood cell counts.  

• if you have low platelet counts. 

• if you have a history of feeling faint or lightheaded on standing or sitting or have fainted before 

upon injections. 

 



 

24 

Your doctor may perform regular blood tests to monitor your blood cell count. 

 

It is not recommended to use Mozobil for stem cell mobilisation if you have leukaemia (a cancer of 

the blood or bone marrow). 

 

Other medicines and Mozobil 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

Pregnancy and breast-feeding  

You should not use Mozobil if you are pregnant, since there is no experience with Mozobil in pregnant 

women. It is important to tell your doctor if you are, think you may be or are planning to become 

pregnant. It is recommended to use contraception if you are of child-bearing age. 

 

You should not breast-feed if you are using Mozobil, since it is not known if Mozobil is excreted in 

human milk.  

 

Driving and using machines 

Mozobil may cause dizziness and fatigue. Therefore, you should avoid driving if you feel dizzy, tired 

or unwell. 

 

Mozobil contains sodium  

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’. 

 

 

3. How to use Mozobil 
 

Your medicine will be injected by a doctor or a nurse.  

 

You will first receive G-CSF, then you will be given Mozobil 

Mobilisation will be started by first giving you another medicine called G-CSF (granulocyte-colony 

stimulating factor). G-CSF will help Mozobil to work properly in your body. If you want to know 

more about G-CSF ask your doctor and read the corresponding package leaflet. 

 

How much Mozobil is given? 

The recommended adult dose is either a 20 mg (fixed dose) or 0.24 mg/kg body weight/day.  

The recommended dose for children, 1 to less than 18 years of age is 0.24 mg/kg of body weight/day.  

 

Your dose will depend on your body weight, which should be measured the week before you receive 

your first dose. If you have moderate or severe kidney problems, your doctor will reduce the dose.  

 

How is Mozobil given? 

Mozobil is given by subcutaneous injection (under your skin). 

 

When is Mozobil given for the first time? 

You will receive your first dose 6 to 11 hours before apheresis (collection of your blood stem cells). 

 

How long will Mozobil be given? 

Treatment lasts 2 to 4 consecutive days (in some cases up to 7 days), until enough stem cells have 

been collected for your transplant. In a few cases, enough stem cells may not be collected, and the 

collection attempt will be stopped. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 



 

25 

Please tell your doctor immediately if 

• shortly after receiving Mozobil, you experience rash, swelling around the eyes, shortness of 

breath or lack of oxygen, feeling lightheaded on standing or sitting, feeling faint or fainting 

• you have pain in the upper left abdomen (belly) or your left shoulder 

 

Very common side effects (may affect more than 1 in 10 people) 

• diarrhoea, nausea (feeling sick), injection site redness or irritation 

• low red blood cell count by laboratory test (anaemia in children) 
 

Common side effects (may affect up to 1 in 10 people) 

• headache  

• dizziness, feeling tired or unwell  

• difficulty in sleeping 

• flatulence, constipation, indigestion, vomiting  

• stomach symptoms such as pain, swelling or discomfort  

• dry mouth, numbness around the mouth  

• sweating, generalised redness of the skin, joint pains, pains in muscles and bones 
 

Uncommon side effects (may affect up to 1 in 100 people) 

• allergic reactions such as skin rash, swelling around the eyes, shortness of breath 

• anaphylactic reactions, including anaphylactic shock 

• abnormal dreams, nightmares 
 

Rarely, gastrointestinal side effects may be severe (diarrhoea, vomiting, stomach pain and nausea). 

 

Heart attacks 

In clinical trials, patients with risk factors for a heart attack uncommonly suffered heart attacks after 

being given Mozobil and G-CSF. Please inform your doctor immediately if you experience chest 

discomfort. 

 

Pins and needles and numbness 

Pins and needles and numbness are common in patients being treated for cancers. About one in five 

patients suffered from these feelings. However, these effects do not seem to occur more frequently 

when you use Mozobil. 

You may also have an increase in white blood cells count (leucocytosis), in your blood tests. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor 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 Mozobil 

 

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 vial. 

 

This medicine does not require any special storage conditions. 

 

After opening the vial, Mozobil should be used immediately. 

 

Do not throw away any medicines via wastewater or household waste. The pharmacist will throw 

away medicines you no longer use. These measures will help protect the environment. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

26 

 

6. Contents of the pack and other information 

 

What Mozobil contains 

- The active substance is plerixafor. Each ml solution for injection contains 20 mg plerixafor. Each 
vial contains 24 mg plerixafor in 1.2 ml solution. 

- The other ingredients are sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide 
for pH adjustment and water for injections. 

 

What Mozobil looks like and contents of the pack 

Mozobil is supplied as a clear colourless or pale yellow solution for injection in a glass vial with a 

non-latex rubber stopper. Each vial contains 1.2 ml solution. 

 

Each pack contains 1 vial. 

 

Marketing Authorisation Holder 

Genzyme Europe B.V. 

Paasheuvelweg 25 

1105 BP Amsterdam 

The Netherlands. 

 

Manufacturer 

Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom. 

 

Or Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland 

 



 

27 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien/ 

Luxembourg/Luxemburg 

Sanofi Belgium 

Tél/Tel: + 32 2 710 54 00 

 

Lietuva 

UAB SANOFI-AVENTIS LIETUVA“ 

Tel. +370 5 275 5224 

 

България 

SANOFI BULGARIA EOOD 

Tел: +359 2 9705300  

 

Magyarország 

SANOFI-AVENTIS Zrt. 

Tel: +36 1 505 0050 

Česká republika 

sanofi-aventis, s.r.o. 

Tel: +420 233 086 111 

 

Malta 

Sanofi S.p.A 

Tel: +39 02 39394275 

 

Danmark 

sanofi A/S  

Tlf: +45 45 16 70 00 

 

Nederland 

Genzyme Europe B.V. 

Tel: +31 20 245 4000 

Deutschland 

Sanofi-Aventis Deutschland GmbH 

Tel: +49 (0)180 2 222010 

 

Norge 

sanofi-aventis Norge AS 

Tlf: + 47 67 10 71 00 

 

Eesti 

sanofi-aventis Estonia OÜ 

Tel. +372 6 273 488 

 

Österreich 

sanofi-aventis GmbH 

Tel: + 43 1 80 185 - 0 

Ελλάδα 

sanofi-aventis AEBE  

Τηλ: +30 210 900 1600 

Polska 

sanofi-aventis Sp. z o.o. 

Tel.: +48 22 280 00 00 

 

España 

sanofi-aventis, S.A. 

Tel: +34 93 485 94 00 

  

Portugal 

Sanofi – Produtos Farmacêuticos, Lda. 

Tel: +351 21 35 89 400 

 

France 

sanofi-aventis France 

Tél : 0 800 222 555 

Appel depuis l’étranger : +33 1 57 63 23 23 
 

România 

Sanofi Romania SRL 

Tel: +40 (0) 21 317 31 36  

Hrvatska 

sanofi-aventis Croatia d.o.o. 

Tel: +385 1 600 34 00 

 

Slovenija 

sanofi-aventis d.o.o. 

Tel: +386 1 560 4800 

 

Ireland 

sanofi-aventis Ireland Ltd T/A SANOFI 

Tel:  +353 (0) 1 4035 600  

 

Slovenská republika 

sanofi-aventis Pharma Slovakia s.r.o. 

Tel.:  +421 2 33 100 100 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Suomi/Finland 

Sanofi Oy 

Puh/Tel: + 358 201 200 300 

 

Italia 

Sanofi S.p.A. 

Tel: +800536389 

 

Sverige 

Sanofi AB 

Tel: +46 (0)8 634 50 00 

 



 

28 

 

Latvija 

sanofi-aventis Latvia SIA 

Tel: +371 67 33 24 51 

 

Κύπρος 

sanofi-aventis Cyprus Ltd. 

Τηλ: +357 22 871600 

 

United Kingdom 

Sanofi 

Tel: +44 (0) 845 372 7101 

 

This leaflet was last approved in. 

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 

http://www.ema.europa.eu/
http://www.ema.europa.eu/

	ANNEX ISUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER 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
	A. LABELLING
	B. PACKAGE LEAFLET