Grastim 30 IV/SC Injection

• Chemotherapy-induced Neutropenia: Reduces incidence of infection in non-myeloid malignancies receiving myelosuppressive chemotherapy.
• Acute Myeloid Leukemia: Reduces time to neutrophil recovery and duration of fever in AML patients.
• Bone Marrow Transplantation: Reduces duration of neutropenia and neutropenia-related clinical sequelae.
• Severe Chronic Neutropenia: Reduces incidence and duration of sequelae in congenital, cyclic or idiopathic neutropenia.
• HIV Infection: Prevention and treatment of persistent neutropenia in advanced HIV infection.

Filgrastim is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation and differentiation. It also causes the enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst, antibody-dependent killing and the increased expression of some cell surface antigens.

Adult Dose (Parenteral):

• Chemotherapy-induced neutropenia: 5 mcg/kg/day SC or IV (start not <24 hr after last antineoplastic); continue until neutrophil count normal (up to 14 days or more).
• Bone Marrow Transplantation: 10 mcg/kg/day IV infusion over 30 min or 4 hr or continuous IV or SC infusion over 24 hr.
• PBPC Mobilization: 10 mcg/kg/day SC for 4-7 days.
• Congenital Neutropenia: 12 mcg/kg/day (single or divided doses).
• HIV and Persistent Neutropenia: Initially 1 mcg/kg/day; may increase to 4 mcg/kg/day; maintenance: 300 mcg daily.

Common Side Effects:

• Bone pain
• Weakness
• Headache
• Rash
• Nausea
• Increased lactate dehydrogenase
• Vomiting
• Increased uric acid
• Oropharyngeal pain
• Hair loss
• Fatigue
• Diarrhea
• Constipation
• Decreased appetite
• Cough
• Breathing problems

Use in Pregnancy: Category C; animal studies have shown harmful effects; should be used only if clearly needed.

Precautions:

• Filgrastim may cause fatigue which may affect driving ability.
• Do not administer within 24 hours before and after chemotherapy.
• Possibility of Filgrastim acting as a growth factor for any tumor type cannot be excluded.
• Complete blood count recommended twice per week during treatment.
• Stop and inform doctor if fever, shortness of breath, fast breathing, or trouble breathing occurs.
• Pain or redness in injection area is common; inform doctor if lump, swelling, or bruising doesn't go away.

Overdose: Patients in BMT studies received up to 138 mcg/kg/day without toxic effects; maximum tolerated dose not determined.

Storage: Refrigerate at 2-8 degree C. Protect from light. Do not freeze and avoid shaking.