Grastim 300 mcg/0.5 ml IV/SC Injection

Overview

Grastim IV/SC Injection contains Filgrastim 300 mcg/0.5 ml, a 175-amino acid recombinant human Granulocyte Colony-Stimulating Factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim regulates neutrophil production within the bone marrow, stimulating progenitor proliferation and differentiation and enhancing phagocytic ability, respiratory burst, antibody-dependent killing, and surface antigen expression. Grastim is indicated for: reducing febrile neutropenia in non-myeloid malignancy patients on myelosuppressive chemotherapy; reducing neutropenia duration in Acute Myeloid Leukemia; supporting bone marrow transplantation; treating severe chronic neutropenia; increasing survival in patients acutely exposed to myelosuppressive radiation; and preventing persistent neutropenia in advanced HIV infection.

Dosage and Administration

Myelosuppressive chemotherapy / AML: 5 mcg/kg/day subcutaneously or IV (over 30 minutes). Start no sooner than 24 hours after chemotherapy; continue until neutrophil count normalises (up to 14 days; up to 38 days in AML).

Bone marrow transplantation: 10 mcg/kg/day by IV infusion over no longer than 24 hours. Administer at least 24 hours after cytotoxic chemotherapy and at least 24 hours after transplantation. Adjust dose according to ANC.

Peripheral blood progenitor cell mobilisation: 10 mcg/kg/day subcutaneously for 5–7 days, beginning at least 4 days before the first leukapheresis. Discontinue if WBC exceeds 100,000/mm³.

Severe chronic neutropenia: Congenital — 6 mcg/kg twice daily subcutaneously; Idiopathic or cyclic — 5 mcg/kg once daily subcutaneously. Adjust per ANC and CBC.

Acute radiation syndrome: 10 mcg/kg once daily subcutaneously.

HIV infection: Starting dose 1 mcg/kg/day subcutaneously, titrated up to 4 mcg/kg/day until ANC normalises (>2.0 × 10⁹/l).

Grastim should not be administered within 24 hours before or after chemotherapy. Do not dilute to concentrations below 5 mcg/ml; may be diluted in 5% dextrose if required.

Interaction

Drug interactions between Grastim and other medications have not been fully evaluated. Drugs that may potentiate neutrophil release, such as Lithium, should be used with caution. Grastim should not be administered within 24 hours before or after cytotoxic chemotherapy.

Contraindications

Grastim is contraindicated in patients with a history of serious allergic reactions to human G-CSF agents such as Filgrastim or Peg-Filgrastim, and in patients with severe congenital neutropenia (Kostmann's syndrome).

Side Effects

In non-myeloid malignancy patients receiving chemotherapy: pyrexia, pain, rash, cough, and dyspnoea. In AML patients: pain, epistaxis, and rash. After BMT: rash. During PBPC mobilisation: bone pain, pyrexia, and headache. In severe chronic neutropenia: pain, anaemia, epistaxis, diarrhoea, hypoaesthesia, and alopecia. Complete blood counts are recommended twice weekly during treatment to monitor for excessive neutrophilia.

Pregnancy and Lactation

Pregnancy Category C. There are no adequate well-controlled studies in pregnant women. It is not known whether Filgrastim is excreted in human milk; caution should be exercised when administering to breastfeeding women. Use only if the potential benefit justifies the potential risk.

Precautions and Warnings

Do not administer Grastim within 24 hours before or after chemotherapy. The possibility of Grastim acting as a growth factor for any tumour type cannot be excluded. Monitor CBC twice weekly during treatment to avoid adverse effects of excessive neutrophilia. Grastim should not be diluted to less than 5 mcg/ml at any time. Refrigerate at 2–8°C; do not freeze or shake. The maximum tolerated dose has not been determined; doses up to 138 mcg/kg/day have been administered without toxic effects in BMT patients.

Storage Conditions

Refrigerate at 2–8°C. Protect from light. Do not freeze and avoid shaking. Keep out of the reach of children.

Frequently Asked Questions

Q: What is Grastim Injection used for?
Grastim Injection (Filgrastim) is used to stimulate the production of white blood cells (neutrophils) in patients whose white cell counts are dangerously low due to cancer chemotherapy, bone marrow transplantation, severe chronic neutropenia, acute radiation exposure, or advanced HIV infection. It reduces the risk of life-threatening infections associated with neutropenia.

Q: How is Grastim Injection administered?
Grastim is administered either as a subcutaneous (SC) injection or as an intravenous (IV) infusion, depending on the clinical indication. The dose and duration vary by indication and must be determined by the treating physician. It should not be given within 24 hours before or after chemotherapy.