سعر نيفيستيم 480مكجم/0.5مل 5 سرنجات معبأة 2022

Nivestim (filgrastim biosimilar, Hospira/Pfizer) 480 micrograms/0.5 ml, 5 pre-filled syringes, sold in Egypt; G-CSF for neutropenia and stem-cell mobilisation.

• Reduction in the duration of neutropenia and incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (except CML and MDS)Population: Adults and childrenEuropean Medicines Agency (EMA)
• Reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantationPopulation: Adults and childrenEuropean Medicines Agency (EMA)
• Mobilisation of peripheral blood progenitor cells (PBPC)Population: Patients and healthy donorsEuropean Medicines Agency (EMA)

• Most common: pyrexia, musculoskeletal pain (bone pain, back pain, arthralgia, myalgia), anaemia, vomiting, nausea. Very common: thrombocytopenia. Common: splenomegaly, sepsis, bronchitis, upper respiratory and urinary tract infections. Serious: anaphylaxis, interstitial pneumonia/ARDS, capillary leak syndrome, splenic rupture, sickle cell crisis.International label, same product · European Medicines Agency (EMA)

• Hypersensitivity to filgrastim or to any of the excipients.International label, same product · European Medicines Agency (EMA)

• Hypersensitivity including anaphylaxis (permanently discontinue); pulmonary adverse effects including interstitial lung disease and ARDS; glomerulonephritis; capillary leak syndrome; splenomegaly and splenic rupture (some fatal); thrombocytopenia; leucocytosis; aortitis; sickle cell crises in sickle cell disease/trait; not for MDS or CML; caution in secondary AML; MDS/AML association in breast and lung cancer patients.International label, same product · European Medicines Agency (EMA)

• Myelosuppressive cytotoxic chemotherapyUse not recommended from 24 hours before to 24 hours after chemotherapy; with 5-fluorouracil neutropenia may be exacerbated.European Medicines Agency (EMA)
• LithiumLithium promotes neutrophil release and is likely to potentiate filgrastim (not formally studied).European Medicines Agency (EMA)

• Limited data in pregnant women; reproductive toxicity in animals (embryo loss in rabbits); transplacental passage reported. Filgrastim is not recommended during pregnancy.International label, same product · European Medicines Agency (EMA)
• Unknown whether excreted in human milk; a risk to the infant cannot be excluded; decide whether to discontinue breastfeeding or therapy.International label, same product · European Medicines Agency (EMA)

• Filgrastim: Recombinant methionyl human G-CSF (r-metHuG-CSF); regulates production and release of functional neutrophils from the bone marrow, causing marked increases in peripheral neutrophil counts within 24 hours (EU Nivestim SmPC 5.1).