Filastin(Filgrastim)

Therapeutic Group: Bio Tech

Presentation

Filastin 30 pre-filled syringe injection: Each pre-filled syringe contains 0.5 ml sterile solution which contains Filgrastim (G-CSF) 300 microgram (30 MU) as Filgrastim concentrated solution EP.

Description

Filgrastim is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation, differentiation and enhances phagocytic activity.

Indications

Cancer patients receiving myelosuppressive chemotherapy

Patients with Acute Myeloid Leukemia receiving induction or consolidation chemotherapy

Cancer patients receiving bone marrow transplant

Patients with severe neutropenia

Peripheral blood progenitor cell collection and therapy

Dosage & Administration

Cancer patients receiving myelosuppressive chemotherapy: The recommended starting dose of Filgrastim is 5 mcg/kg/day. Doses may be increased in increments of 5 mcg/kg for each chemotherapy cycle

Cancer patients receiving bone marrow transplant: The recommended dose of Filgrastim following bone marrow transplantation is 10 mcg/kg/day. During the period of neutrophil recovery, the daily dose should be titrated against the neutrophil response as follows:


Absolute Neutrophil Count (ANC) Dose adjustment
ANC>1000/mm3 for consecutive 3 days Reduces to 5 mcg/kg/day
Then, If ANC remains >1000/mm3 for consecutive 3 days Discontinue drug

Then, If ANC remains <1000/mm3 for consecutive 3 days Resume at 5 mcg/kg/day


Patients with chronic neutropenia: The recommended daily starting dose is 5 mcg/kg/day in idiopathic neutropenia

Peripheral blood progenitor cell collection and therapy: The recommended starting dose is 10 mcg/kg/day. Dose may be adjusted as required

Side Effects


• Splenic rupture
• Acute Respiratory Distress Syndrome
• Alveolar hemorrhage and haemoptysis
• Sickle cell crisis

Precautions

• Filgrastim should not be administered within 24 hours before and after chemotherapy
• The possibility of Filgrastim acting as a growth factor for any tumor type cannot be excluded
• To avoid adverse effects of excessive neutrophils complete blood count is recommended twice per week during treatment
• Filgrastim is given by subcutaneous or intravenous infusion as required
• Dilution of Filgrastim conc less than 5 mcg/ml is not recommended at any time
• Filgrastim may be diluted in 5% dextrose as required

Use in Pregnancy & Lactation

There are no adequate and well controlled trial on pregnant women, the effect of Filgrastim on the developing fetus and mother is unknown.

Drug Interaction

Drug interactions between Filgrastim and other drugs have not been fully evaluated. Drugs which may potentiate the release of neutrophils, such as lithium should be used with caution.

Over Dose

The possibility of Filgrastim acting as a growth factor for any tumor type and adverse effects of excessive neutrophils may occur in overdose of Filgrastim.

Storage

Filgrastim should be stored at 2°C to 8°C in a refrigerator and shaking should be avoided.

Commercial Pack

Filastin 30 pre-filled syringe injection: Each pre-filled syringe contains 0.5 ml sterile solution which contains Filgrastim (G-CSF) 300 microgram (30 MU) as Filgrastim concentrated solution EP.