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Cegfila (Previously Pegfilgrastim Mundipharma) is a brand name for Pegfilgrastim. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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).
Verbatim from this product's EMA label. Tap a section to expand.
Cegfila 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 Cegfila is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
3 Special populations Paediatric population The safety and efficacy of pegfilgrastim in children has not yet been established. 2 but no recommendation on a posology can be made. Patients with renal impairment No dose change is recommended in patients with renal impairment, including those with end stage renal disease.
Method of administration Cegfila is injected subcutaneously. The injections should be given into the thigh, abdomen or upper arm. 6.
Summary of the safety profile The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common). Bone pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics.
Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥ 1/1 000 to < 1/100]). 4). 4 and section “Description of selected adverse reactions” below.
Splenomegaly, generally asymptomatic, is uncommon. 4). Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported. 4). 4). Tabulated list of adverse reactions The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 7 MedDRA system organ class Adverse reactions Very common Common Uncommon Rare Very rare (≥ 1/10) (≥ 1/100 to < 1/10) (≥ 1/1 000 to < 1/100) (≥ 1/10 000 to < 1/1 000) (< 1/10 000) Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome1 Acute myeloid leukaemia1 Blood and lymphatic system disorders Thrombocytope nia1 Leukocytosis1 Sickle cell anemia with crisis2; Splenomegaly2; Splenic rupture2 Immune system disorders Hypersensitivity reactions; Anaphylaxis Metabolism and nutrition disorders Elevations in uric acid Nervous system disorders Headache1 Vascular disorders Capillary leak syndrome1 Aortitis Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis Pulmonary hemorrhage Gastrointestina l disorders Nausea1 Skin and subcutaneous tissue disorders Sweet’s syndrome (acute febrile neutrophilic dermatosis)1,2; Cutaneous vasculitis1,2 Stevens- Johnson syndrome 8 MedDRA system organ class Adverse reactions Very common Common Uncommon Rare Very rare (≥ 1/10) (≥ 1/100 to < 1/10) (≥ 1/1 000 to < 1/100) (≥ 1/10 000 to < 1/1 000) (< 1/10 000) Musculoskeleta l and connective tissue disorders Bone pain Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain) Renal and urinary disorders Glomerulo- nephritis2 General disorders and administration site conditions Injection site pain, Non-cardiac chest pain 1 Injection site reactions2 Investigations Elevations in lactate dehydrogenase and alkaline phosphatase1; Transient elevations in LFT's for ALT or AST1 1 See section “Description of selected adverse reactions” below.
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. 1). However, the long-term effects of Cegfila have not been established in AML; therefore, it should be used with caution in this patient population.
Granulocyte-colony stimulating factor 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 Cegfila 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 Cegfila administration in de novo AML patients aged < 55 years with cytogenetics t (15;17) have not been established.
The safety and efficacy of Cegfila 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.
8). The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
8). Glomerulonephritis 4 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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pegfilgrastim in European Union.
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2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical trials in adults that supported the marketing authorisation. The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials.
Description of selected adverse reactions Uncommon cases of Sweet’s syndrome have been reported, although in some cases underlying haematological malignancies may play a role. Uncommon events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim.
The mechanism of vasculitis in patients receiving pegfilgrastim is unknown. Injection site reactions, including injection site erythaema (uncommon) as well as injection site pain (common) have occurred on initial or subsequent treatment with pegfilgrastim.
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 ALT (alanine aminotransferase) or AST 9 (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
These elevations are transient and return to baseline. 4). Common cases of thrombocytopenia have been reported. Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use.
4). Paediatric population The experience in children is limited. A higher frequency of serious adverse reactions in younger children aged 0-5 years […]
Capillary leak síndrome Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. 8). 8). 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. 8). Monitor breast and lung cancer patients for signs and symptoms of MDS/AML.
8). Therefore, physicians should use caution when prescribing Cegfila 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 100 × 109/L or greater have been observed in less than 1 % of patients receiving pegfilgrastim therapy. 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 50 × 109/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 Cegfila in patients with clinically significant hypersensitivity. Do not administer Cegfila to patients with a history of hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Stevens-Johnson syndrome Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.
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