Nyvepria

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 

 

This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

 

 
1. NAME OF THE MEDICINAL PRODUCT  

 

Nyvepria 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 medicinal 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).  

 

Clear, colourless, free from visible particles, 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  

 

Nyvepria 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 Nyvepria is recommended for each chemotherapy cycle, 

given at least 24 hours after cytotoxic chemotherapy. 

 



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Special populations 

 

Renal impairment 

No dose change is recommended in patients with renal impairment, including those with end-stage 

renal disease.  

 
Paediatric population 

The safety and efficacy of pegfilgrastim in children and adolescents have 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.  

 

Method of administration 

 

Nyvepria is injected subcutaneously.  

 

The injections should be given into the thigh, abdomen or upper arm.  

 

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 biological medicinal products, the name and the batch number 

of the administered product should be clearly recorded.  

 

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.  

 

Granulocyte-colony stimulating factor (G-CSF) can promote growth of myeloid cells in vitro and 

similar effects may be seen on some non-myeloid cells in vitro.  

 

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 dose 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).  

 



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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.  

 

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 medicinal product 

with splenic enlargement and vaso-occlusive crisis.  

 

Leukocytosis 

 

White blood cell (WBC) counts of 100x109/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 medicinal product. 

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 50x109/L after the expected 

nadir, this medicinal product 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 



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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 (see also 

section 4.8). 

 

Immunogenicity 

 

As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of 

antibodies against pegfilgrastim are generally low. Binding antibodies do occur as expected with all 

biologics; however, they have not been associated with neutralising activity at present.  

 

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 WBC count). In most cases aortitis was diagnosed 

by computed tomography (CT) scan and generally resolved after withdrawal of G-CSF (see also 

section 4.8). 

 
Other warnings 

 

The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or 

healthy donors have not been adequately evaluated.  

 

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.  

 

Nyvepria contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 50 mg/mL. The 

additive effect of concomitantly administered medicinal products containing sorbitol (or fructose) and 

dietary intake of sorbitol (or fructose) should be taken into account.  

 

This medicinal product 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 studies, pegfilgrastim has been safely administered 14 days before chemotherapy. 

Concomitant use of pegfilgrastim with any chemotherapy agent has not been evaluated in patients. In 

animal models concomitant administration of pegfilgrastim 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 studies.  

 

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 pegfilgrastim have not been evaluated in patients receiving chemotherapy 

associated with delayed myelosuppression e.g. nitrosoureas.  



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Specific interaction or metabolism studies have not been performed, however, clinical studies have not 

indicated an interaction of pegfilgrastim with any other medicinal products.  

 

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  

 

Nyvepria 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, erythema, 

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 studies 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) 

Blood and 

lymphatic 

system 

disorders 

 Thrombocytopenia1; 

Leukocytosis1 

Sickle cell 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 

  Sweet’s syndrome 

(acute febrile 

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; 

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 studies in adults. The frequency category was estimated from a 

statistical calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical 

studies.  

 

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 erythema (uncommon) as well as injection site pain 

(common) have occurred on initial or subsequent treatment with pegfilgrastim.  

 

Common cases of leukocytosis (WBC >100x109/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 pegfilgrastim 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.  

 

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).  

 

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 



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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 factors; ATC Code: L03AA13. 

 

Nyvepria is a biosimilar medicinal product. Detailed information is available on the website of the 

European Medicines Agency http://www.ema.europa.eu. 

 

Human 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 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%).  

 

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 

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


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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 <0.5x109) 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).  

 

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). 

 

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.  

 



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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 was 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 mcg·hr/mL) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg·hr/mL and 

29.3 ± 23.2 mcg·hr/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 

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 trihydrate  

Glacial acetic acid 

Sorbitol (E420)  

Polysorbate 20  

Water for injections  

 

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).  

 

Nyvepria may be exposed to room temperature (not above 25°C) for a maximum single period of up to 

15 days. Nyvepria left at room temperature for more than 15 days should be discarded.  

 



12 

 

Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours 

does not adversely affect the stability of Nyvepria.  

 

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 cover with an 

automatic needle guard. The Nyvepria syringe plunger stopper and needle cover are not made with 

natural rubber latex. 

 

Each pre-filled syringe contains 0.6 mL of solution for injection.  

 

Pack size of one pre-filled syringe, in a carton.  

 

6.6 Special precautions for disposal and other handling  

 

Before use, Nyvepria solution should be inspected visually for particulate matter. Only a solution that 

is clear and colourless should be injected.  

 

Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.  

 

Allow the pre-filled syringe to reach room temperature (not above 25°C) before injecting.  

 

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

requirements.  

 

 

7. MARKETING AUTHORISATION HOLDER  

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/20/1486/001 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  

 

Date of first authorisation:  

 

 

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. 

 

  



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ANNEX II 

 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR 

BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 

 



14 

 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE  

 

Name and address of the manufacturers of the biological active substance  

 

Hospira Adelaide Pty Ltd 

8 Dalgleish Street 

Thebarton 

Adelaide 5031 

South Australia 

Australia  

 

Hospira Zagreb d.o.o. 

Prudnička cesta 60 

10291 Prigorje Brdovečko 

Croatia 

 

Name and address of the manufacturer responsible for batch release  

 

Hospira Zagreb d.o.o. 

Prudnička cesta 60 

10291 Prigorje Brdovečko 

Croatia 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  

 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 

Characteristics, section 4.2).  

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  

 

• Periodic safety update reports (PSURs) 
 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 

reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 

subsequent updates published on the European medicines web-portal.  

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT  

 

• Risk management plan (RMP)  
 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 

and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 

and any agreed subsequent updates of the RMP.  

 

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.  

 



15 

 

 

 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

 

 

  



16 

 

 

 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

 

 
 

 

 

 



17 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

OUTER CARTON  

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

Nyvepria 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 trihydrate, glacial acetic acid, sorbitol (E420), polysorbate 20, water for 

injections. See the package leaflet for further information.  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS  

 

Solution for injection 

1 single use pre-filled syringe with automatic needle guard. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION  

 

Read the package leaflet before use.  

Important: read the package leaflet before handling pre-filled syringe.  

For subcutaneous use.  

 

 

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

OF THE SIGHT AND REACH OF CHILDREN  

 

Keep out of the sight and reach of children.  

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY  

 

Avoid vigorous shaking.  

 

 

8. EXPIRY DATE  

 

EXP  

 

 

9. SPECIAL STORAGE CONDITIONS  

 

Store in a refrigerator.  



18 

 

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  

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/20/1486/001 

 

 

13. BATCH NUMBER  

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY  

 

 

15. INSTRUCTIONS ON USE  

 

Lift here to open. 

 

 

16. INFORMATION IN BRAILLE  

 

Nyvepria  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC  

SN  

NN  

 



19 

 

PARTICULARS TO APPEAR ON UNIT SYRINGE CARTON  

 

UNIT SYRINGE CARTON WITH SYRINGE WITH AUTOMATIC NEEDLE GUARD 

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

Nyvepria 6 mg solution for injection  

pegfilgrastim  

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER  

 

Pfizer Europe MA EEIG 

 

 

3. EXPIRY DATE  

 

EXP  

 

 

4. BATCH NUMBER  

 

Lot  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION  

 

Read the package leaflet before use.  

Important: read the package leaflet before handling pre-filled syringe.  

For subcutaneous use.  

 

 

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

OF THE SIGHT AND REACH OF CHILDREN  

 

Keep out of the sight and reach of children.  

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY  

 

Avoid vigorous shaking.  

 

 

8. INSTRUCTIONS ON USE 

 

Lift here to open. 

 

 

9. SPECIAL STORAGE CONDITIONS  

 

Store in a refrigerator.  

Do not freeze.  

Keep the container in the outer carton in order to protect from light.  



20 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS  

 

SYRINGE LABEL  

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION  

 

Nyvepria 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  

 

Pfizer Europe MA EEIG 

 

 

  



21 

 

 

 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

 

 

 



22 

 

Package leaflet: Information for the user 

 

Nyvepria 6 mg solution for injection  

pegfilgrastim 

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

 
Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you.  

− Keep this leaflet. You may need to read it again.  

− If you have any further questions, ask your doctor, pharmacist or nurse.  

− This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 
even if their signs of illness are the same as yours.  

− If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4.  

 

 

What is in this leaflet  

1. What Nyvepria is and what it is used for  

2. What you need to know before you use Nyvepria  

3. How to use Nyvepria  

4. Possible side effects  

5. How to store Nyvepria  

6. Contents of the pack and other information  

 

 

1. What Nyvepria is and what it is used for  

 

Nyvepria contains the active substance pegfilgrastim. It is used in patients treated with cytotoxic 

chemotherapy (medicines that destroy rapidly growing cells) to reduce the duration of neutropenia 

(low neutrophil count, a type of white blood cell) and to help prevent febrile neutropenia (low white 

blood cell count with a fever). Nyvepria is for use in adults aged 18 years and over. 

 

White blood cells are important for fighting off infection. If the white blood cell count to fall too low, 

due to your cytotoxic chemotherapy, your body may not be able to fight off microorganisms and this 

will increase the chances of an infection. Pegfilgrastim, is very similar to a natural protein in the body 

called granulocyte colony stimulating factor and it works by encouraging your bone marrow to 

produce more white blood cells that help your body fight off infections.  

 

2. What you need to know before you use Nyvepria  

 

Do not use Nyvepria  

• if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine 
(listed in section 6).  

 

Warnings and precautions  

 

Talk to your doctor, pharmacist or nurse before using Nyvepria: 

• 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 (thrombocytopenia), which reduces the ability of your blood 

to clot. Your doctor may want to monitor you more closely.  



23 

 

• If you have sickle cell anaemia. Your doctor may monitor your condition more closely.  
 

Talk to your doctor, pharmacist or nurse while using Nyvepria:  

• If you get an allergic reaction including weakness, drop in blood pressure, difficulty breathing, 
swelling of the face, lips, tongue or other parts of the body (anaphylaxis), redness and flushing, 

skin rash or hives on the skin and areas of the skin that itch.  

• If you get a cough or fever, and have difficulty breathing. This can be a sign of acute respiratory 
distress syndrome (ARDS).  

• If you have any of the following side effects:  

− swelling or puffiness, passing urine less frequently, difficulty breathing, abdominal (belly) 
swelling and feeling of fullness, and a general feeling of tiredness.  

These could be symptoms of 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 get fever, abdominal pain, malaise, and back pain as these may be symptoms of 
inflammation of the aorta (the large blood vessel which transports blood from the heart to the 

body). This disorder can occur rarely in cancer patients and healthy donors. 

 

Your doctor will check your blood and urine regularly as Nyvepria can damage your kidneys 

(glomerulonephritis).  

 

Severe skin reactions (Stevens-Johnson syndrome; a skin condition that causes painful blisters and 

sores of the skin and mucous membranes, especially in the mouth) have been reported with the use of 

pegfilgrastim. Stop using Nyvepria and get medical attention immediately if you notice any of these 

symptoms: reddish target like or circular patches often with central blisters on the trunk, skin peeling, 

ulcers of mouth, throat, nose, genitals and eyes possibly with fever and flu-like symptoms beforehand. 

See section 4. 

 

You should talk to your doctor about your risks of developing cancers of the blood. If you have a 

cancer of the blood or have been told by your doctor that you are at risk of one, you should not use 

Nyvepria, unless instructed by your doctor.  

 

Loss of response to pegfilgrastim  

If pegfilgrastim treatment does not work or stops working, your doctor will investigate why this has 

happened including whether you have developed antibodies which neutralise pegfilgrastim’s activity.  

 

Children and adolescents 

Nyvepria is not recommended for use in children and adolescents because there is insufficient 

information on its safety and effectiveness. 

 

Other medicines and Nyvepria  

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

medicines.  

 

Pregnancy and breast-feeding  

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor or pharmacist for advice before taking this medicine.  

 

Nyvepria has not been studied in pregnant women. Therefore, your doctor may decide that you should 

not use this medicine. 

 

If you become pregnant during Nyvepria treatment, speak with your doctor. 

 

Unless your doctor tells you otherwise, you must stop breast-feeding if you use Nyvepria.  

 



24 

 

Driving and using machines  

Nyvepria has no or negligible effect on the ability to drive or use machines.  

 
Nyvepria contains sorbitol (E420) and sodium acetate  

This medicine contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 50 mg/mL. The 

additive effect of concomitantly administered medicines containing sorbitol (or fructose) and dietary 

intake of sorbitol (or fructose) should be taken into account. 

 

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 Nyvepria  

 

Nyvepria is for use in adults aged 18 years and over.  

 

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 

you are not sure.  

 

The recommended dose is one 6 mg subcutaneous injection (injection under your skin) using a 

pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the 

end of each chemotherapy cycle.  

 

Injecting Nyvepria yourself  

Your doctor may decide that you can inject Nyvepria yourself. Your doctor or nurse will show you 

how to inject it yourself. Do not try to inject it yourself if you have not been trained.  

 

For instructions on how to inject Nyvepria, read the section at the end of this leaflet.  

 

Do not shake Nyvepria vigorously as this may affect its activity. 

 
If you use more Nyvepria than you should  

If you use more Nyvepria than you should contact your doctor, pharmacist or nurse for advice.  

 
If you forget to inject Nyvepria  

If you have forgotten a dose of Nyvepria, 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.  

 
4. Possible side effects  

 

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

 

Tell your doctor immediately if you have any of the following side effects:  

• swelling or puffiness, passing urine less frequently, difficulty breathing, abdominal (belly) 
swelling and feeling of fullness, and a general feeling of tiredness. These symptoms generally 

develop quickly.  

 

They 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 treatment.  

 
Very common: 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.  
 



25 

 

Common: may affect up to 1 in 10 people 

• pain at the site of injection.  

• 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. Your platelet count may become low 

which might result in bruising.  

• chest pain not related to heart disorders. 
 

Uncommon: 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 (the spleen is an organ located in the belly to the left of the stomach 
involved in the production and removal of blood cells and forming part of the immune system). 

Tell your doctor if you have an increase of volume in the upper left side of your abdomen. 

• spleen rupture, which can be fatal. It is important that you contact your doctor immediately if 
you get 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 tell your doctor.  

• Sweet’s syndrome (plum-coloured, raised, painful damage on the limbs and sometimes the face 
and neck with fever).  

• cutaneous vasculitis (inflammation of the blood vessels in the skin).  

• damage to your kidneys (called glomerulonephritis).  

• redness at the site of injection.  

• coughing up blood (haemoptysis). 
 

Rare: may affect up to 1 in 1000 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 

possibly with fever and flu-like symptoms beforehand. Stop using Nyvepria if you develop these 

symptoms and contact your doctor or get medical attention immediately. See also section 2. 

 

Reporting of side effects  

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

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine.  

 

 
5. How to store Nyvepria  

 

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 Nyvepria out of the refrigerator and keep it at room temperature (not above 25°C) for no 

longer than 15 days. Once a syringe has been removed from the refrigerator and has reached room 

temperature (not above 25°C) it must either be used within 15 days or disposed of.  

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


26 

 

 

Do not freeze. Nyvepria 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 Nyvepria 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 trihydrate, glacial acetic acid, sorbitol (E420), 
polysorbate 20 and water for injections (see section 2 “Nyvepria contains sorbitol (E420) and 

sodium acetate”). 

 

What Nyvepria looks like and contents of the pack  

Nyvepria is a clear, colourless, free from visible particles, 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, needle cover and 

an automatic needle guard.  

 

Marketing Authorisation Holder  

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

Manufacturer 

Hospira Zagreb d.o.o. 

Prudnička cesta 60 

10291 Prigorje Brdovečko 

Croatia  

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

Authorisation Holder.  

 
België/Belgique/Belgien 

Luxembourg/Luxemburg 

Pfizer NV/SA 

Tél/Tel: +32 (0)2 554 62 11 

 

Kύπρος 

PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) 

T: +357 22 817690 

 

Česká Republika 

Pfizer spol. s r.o. 

Tel: +420-283-004-111 

 

Magyarország 

Pfizer Kft. 

Tel: +36 1 488 3700 

 

Danmark 

Pfizer ApS 

Tlf: +45 44 20 11 00 

 

Malta 

Drugsales Ltd 

Tel: +356 21 419 070/1/2 

 



27 

 

Deutschland 

Pfizer Pharma PFE GmbH 

Tel: +49 (0)800 8535555 

 

Nederland 

Pfizer bv 

Tel: +31 (0)10 406 43 01 

 

България 

Пфайзер Люксембург САРЛ, 

Клон България 

Teл: +359 2 970 4333 

 

Norge 

Pfizer AS 

Tlf: +47 67 52 61 00 

 

Eesti 

Pfizer Luxembourg SARL Eesti filiaal 

Tel: +372 666 7500 

 

Österreich 

Pfizer Corporation Austria Ges.m.b.H. 

Tel: +43 (0)1 521 15-0 

 

Ελλάδα 

PFIZER EΛΛAΣ A.E. 

Τηλ.: +30 210 67 85 800 

 

Polska 

Pfizer Polska Sp. z o.o. 

Tel.: +48 22 335 61 00 

 

España 

Pfizer, S.L. 

Tel: +34 91 490 99 00 

 

Portugal 

Pfizer Laboratórios, Lda. 

Tel: +351 21 423 5500 

 

France 

Pfizer 

Tél: +33 (0)1 58 07 34 40 

 

România 

Pfizer Romania S.R.L 

Tel: +40 (0) 21 207 28 00 

 

Hrvatska 

Pfizer Croatia d.o.o. 

Tel: +385 1 3908 777 

 

Slovenija 

Pfizer Luxembourg SARL 

Pfizer, podružnica za svetovanje s področja 

farmacevtske dejavnosti, Ljubljana 

Tel: +386 (0) 1 52 11 400 

 

Ireland 

Pfizer Healthcare Ireland 

Tel: +1800 633 363 (toll free) 

Tel: +44 (0)1304 616161 

 

Slovenská Republika 

Pfizer Luxembourg SARL, organizačná zložka 

Tel: +421 2 3355 5500 

 

Ísland 

Icepharma hf. 

Tel: +354 540 8000 

 

Suomi/Finland 

Pfizer Oy 

Puh/Tel: +358 (0)9 430 040 

 

Italia 

Pfizer S.r.l. 

Tel: +39 06 33 18 21 

 

Sverige 

Pfizer Innovations AB 

Tel: +46 (0)8 550 520 00 

 

Latvija 

Pfizer Luxembourg SARL filiāle Latvijā 

Tel. +371 67035775 

 

United Kingdom 

Pfizer Limited 

Tel: +44 (0)1304 616161 

 

Lietuva 

Pfizer Luxembourg SARL filialas Lietuvoje 

Tel. +3705 2514000 

 

 



28 

 

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. 

 
  



29 

 

Instructions for using Nyvepria: 

Guide to parts: 

Before use After use 

 

 

 

 

 

Important 

Before you use a Nyvepria pre-filled syringe with automatic needle guard, read this important 

information: 

• It is important that you do not give yourself the injection unless you have received training 
from your doctor or healthcare provider. If you have questions about how to inject, please ask 

your doctor or healthcare provider for help. 

• Make sure the name Nyvepria appears on the carton and pre-filled syringe label. 

• Check the carton and pre-filled syringe label to make sure the dose strength is 6 mg 
(6 mg/0.6 mL). 

• Nyvepria is given as an injection into the tissue just under the skin (subcutaneous injection). 

 Do not use the pre-filled syringe if the date has passed the last day of the month shown. 

 Do not remove the needle cover 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 activate the pre-filled syringe before injection. 

 Do not remove the clear automatic needle guard from the pre-filled syringe. 



30 

 

 Do not remove the peelable label on the pre-filled syringe barrel before injecting the 
medicine. 

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

 

Step 1: Prepare 

A Remove the pre-filled syringe carton from the refrigerator. Remove the pre-filled syringe inner 

carton from the outer carton by peeling away the cover 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 (not above 25°C) 

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 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 inner syringe carton by peeling away the cover. Grab the pre-filled syringe automatic 

needle guard to remove the pre-filled syringe from the carton. 

 
For safety reasons: 

 Do not grasp the plunger rod. 
 Do not grasp the needle cover. 
 

C Inspect the medicine and pre-filled syringe. 

 

 
 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 needle cover 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. 



31 

 

Step 2: Get ready 

A Wash your hands thoroughly. Prepare and clean your injection site. 

 

 
You can use: 

• 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. 

 



32 

 

B Hold the pre-filled syringe by the automatic needle guard. Carefully pull the needle cover straight 

out and away from your body. Throw away the needle cover into the sharps disposal container. Do 

not recap. 

 

            
 

C Pinch your injection site to create a firm surface. 

 

 
 

 

It is important to keep the skin pinched when injecting. 



33 

 

Step 3: Inject 

A Hold the pinch. INSERT the needle into skin at 45 to 90 degrees. 

 

 

 
 

 Do not touch the cleaned area of the skin.  
 

B PUSH the plunger rod with slow and constant pressure until it reaches the bottom. 

 



34 

 

C When the syringe is empty, LIFT the syringe off skin. 

 

 
 

After releasing the plunger rod, the pre-filled syringe automatic needle guard will safely cover the 

injection needle.  

 
 

 Do not put the needle cover back on used pre-filled syringes.  
 

When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this 

means you have not received a full dose. Call your doctor or healthcare provider right away.  



35 

 

Healthcare providers only 

The trade name and the batch number of the administered product should be clearly recorded in the 

patient file. 

Remove and save the pre-filled syringe label. 

 

 
Turn the plunger rod 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 Check 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. 

 

 

 
 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 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