GETFIL
FILGRASTIM · by GETZ
Composition
Inj 75 mcg: Filgrastim 75 mcg/7.5 MIU; (0.5 ml); pre-filled syringes. Inj 150 mcg: Filgrastim 150 mcg/15 MIU; (0.5 ml), pre-filled syringes. Inj300 mcg: Filgrastim 300 mcg/30 MIU; (1 mU0.5 ml
Indications & Dosage
Reduction in duration of neutropenia and incidence of febrile neutropenia in cytotoxic chemotherapy for malignancy: BY SC INJ OR IV INF: Adult & Children 1 mth-18 yr:5 mcg/kg daily started not less than 24 hr after cytotoxic chemotherapy, continued until neutrophil count in normal range, usually for up to 14 days (up to 38 days in acute myeloid leukaemia). Reduction in duration of neutropenia (and associated sequelae) in Myeloablative therapy followed by bone-marrow transplantation: BY IV INF OR SC INF: Adult & Children 1 month-18 yrs:10 mcg/kg daily, started not less than 24 hr following cytotoxic chemotherapy (and within 24 hr of bone-marrow INF), then adjusted according to absolute neutrophil count. BMT Cancer: BY SC OR IV INF: Adults: Initial: 10 mcg/kg/day. Peripheral Blood Progenitor Cell Collection: BY SC INJ: Adults: Initially 10 mcg/kg/day four day before & for 6-7 day with leukapheresis on day 5th, day 6th & day 7th. Mobilisation of peripheral blood progenitor cells for autologous INF, used alone: BY SC INJ OR SC INF: Adult & Children 1 month-18 yrs:10 mcg/kg daily for 5-7 days. Mobilization of peripheral blood progenitor cells for autologous INF following adjunctive myelosuppressive chemotherapy (to improve yield): BY SC INJ: Adult & Children 1 month-18 yrs: 5 mcg/kg daily, started the day after completion of chemotherapy and continued until neutrophil count in normal range; for timing of leucopheresis consult product literature. Mobilisation of peripheral blood progenitor cells in normal donors for allogeneic INF: BY SC INJ: Adult & Children Above 16 yr: 10 mcg/kg daily for 4-5 days; for timing of leucopheresis consult product literature. Severe congenital neutropenia and history of severe or recurrent infections: BY IV INF: Adult: Initially 12 mcg/kg daily, adjusted according to response, can be given in single or divided doses, consult product literature. Severe cyclic neutropenia, or idiopathic neutropenia and history of severe or recurrent infections: BY IV INF: Adult: Initially 5 mcg/kg daily, adjusted according to response, can be given in single or divided doses, consult product literature and local protocol. Severe chronic neutropenia: BY SC INJ: Adult & Children 1 month-18 yrs: Initially 12 mcg/kg daily in single or divided doses (initially 5 mcg/kg daily in idiopathic or cyclic neutropenia), adjusted according to response (consult product literature). Persistent neutropenia in HIV infection: BY SC INJ: Adult & Children 1 mth18 yr: Initially 1 mcg/kg daily, increased as necessary until absolute neutrophil count in normal range (usual max 4 mcg/kg daily), then adjusted to maintain absolute neutrophil count in normal range (consult product literature).
Administration
For IV infusion give continuously over 30 min or intermittently in Glucose 5%; for a filgrastim concentration of less than 1 500 000 units/ml(15 mcg/ml) albumin solution is added to produce a final albumin concentration of 2 mg/ml; should not be diluted to a filgrastim concentration of less than 200 000 units/ml (2 mcg/ml) and should not be diluted with sodium chloride solution. For SC dose larger than 1 ml, divide and give in more than one site.
Compatibility
Standard diluent: >375 mcg/25 ml D5W. Stable in D5W; incompatible with NS
Stability
Store at 2C-8T (36T-46F). Avoid shaking prior to injection, filgrastim may be allowed to reach room temperature for a maximum of 24 hours, however, if left at room temperature for more than 24 hours should be discarded.
Contraindications
Severe congenital neutropenia (Kostmanns syndrome) with abnormal cytogenetics.
Precautions
Patients with pre-malignant or malignant myeloid conditions. Withdraw in patients who develop pulmonary infiltration, Sickle-cell disease, distinguish carefully from other haematological disorders. Full blood counts including differential white cell and platelet counts should be monitored. Spleen size should be monitored during treatment risk of splenomegaly and rupture.
Interactions
Fluorouracil.
Pregnancy
Risk cannot be ruled out, should not be used during pregnancy unless the potential benefit outweighs the risk.
Lactation
Caution advised or effect undetermined.
Side Effects
Anorexia, anaemia, dysuria, epistaxis, exacerbation of rheumatoid arthritis, haematuria, hepatomegaly, mucositis, osteoporosis, proteinuria, pseudogout, raised uric acid, splenic enlargement (rarely; spleen rupture), transient decrease in blood glucose, transient hypotension, urinary abnormalities, Capillary leak syndrome.