Grafil

Filgrastim BP

COMPOSITION : Grafil pre-filled syringe injection: Each pre-filled syringe contains 0.5 ml sterile solution of Filgrastim BP 300 mcg (30 MU).

INDICATIONS:Filgrastim is Indicatod forCancer patients receiving myelosuppressive chemotherapy : The decrease of the incidence of infection, as manifested by febrile neutropenia, in patients with non myeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever

Cancer patients undergoing Acute Myeloid Leukemia: The reduction of the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).


Cancer Patients Receiving Bone Marrow Transplantation (BMT): The reduction of the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablatlve chemotherapy followed by bone marrow transplantation.


Patients with severe chronic neutropenia : The reduction of the incidence and duration of sequelae of neutropenia (e.g., fever, infection or opharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia or idiopathic neutropenia. Patients acutely exposed to myelosuppressive doses of radiation: The increase of the survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic syndrome of acute radiation syndrome).

Patients with HIV infection: The prevention and treatment of persistent neutropenia (ANC <_ 1.0 x 109/I) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections, when other options to manage neutropenia are inappropriate.


Dosage & Administration: Cancer patients receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML: The recommended dose of Filgrastim is 0.5 MU (5 mcg)/kg/day, administered as a single daily subcutaneous injection or by intravenous infusion (over 30 minutes). The first dose shouldn't be administered in less than 24 hours following cytotoxic Chemotherapy. Continue until neutrophil count in normal range, usually for 14 days (up to 38 days in AML.) Cancer patients undergoing bone marrow transplantation: The recommended dosage of Filgrastim following bone marrow transplantation (BMT) is 1.0 MU (10 mcg)/kg/day given as an intravenous infusion no longer than 24 hours. Administer the first dose of Filgrastim at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow transplantation. Dose adjustment should be accordingly to absolute neutrophil count (ANC). During the period of neutrophil recovery‚ the daily dose of Filgrastim should be titrated against the neutrophil response as follows:

Absolute Neutrophil Count

Filgrastim Dose Adjustment

When ANC greater than 1000/mm³ for consecutive 3 days

Reduce to 5 mcg/kg/day

If ANC remains greater than 1000/mm³ for 3 more consecutive days

Discontinue drug

If ANC decreases to less than 1000/mm³

Resume at 5 mcg/kg/day

Patients undergoing autologous peripheral blood progenitor cell (PBPC) collection and therapy: The recommended dosage of Filgrastim for the mobilization of autologous PBPC is 1.0 MU (10 mcg)/kg/day given by subcutaneous injection for 5-7 days. Administer Filgrastim for at least 4 days before the first leukapheresis procedure and continue until the last leukapheresis. Discontinue Filgrastim if the white blood cell (WBC) count rises to greater than 100,000/mm³.

Patients with severe chronic neutropenia: The recommended starting dosage in patients with congenital neutropenia is 0.6 MU (6 mcg)/kg as a twice daily subcutaneous injection and with idiopathic or cyclic neutropenia is 0.5 MU (5 mcg)/kg as a single daily subcutaneous injection. Dose adjustment should be accordingly to ANC and complete blood count (CBC). Patients acutely exposed to myelosuppressive doses of radiation hematopoietic syndrome of acute radiation syndrome : The recommended dose of Filgrastim is 1.0 MU (10 mcg)/kg as a single daily subcutaneous injection for patients exposed to myelosuppressive doses of radiation. Patients with HIV infection: The recommended starting dose of Filgrastim is 0.1 MU (1.0 mcg)/kg/day is given daily by subcutaneous injection with titration up to a maximum of 0.4 MU (4 mcg) /kg/day until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 109 /I), Or, as directed by the registered physicians.


Use in pregnancy and lactation: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Nursing Mother- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if it is administered to women who are breastfeeding.


Packing: Grafil pre-filled syringe injection: Each per-filled syringe contains 0.5 ml sterile solution which contains Filgrastim BP 300 mcg (30 MU).

Prescribing Description

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