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Filgrastim information from DrugsUpdate  

See Available Brands of Filgrastim in India

P - Caution when used during pregnancy
L - Caution when used during lactation
LI - Lab *

Filgrastim is a granulocyte colony-stimulating factor (G-CSF) analog used to stimulate the proliferation and differentiation of granulocytes. It is produced by recombinant DNA technology. The gene for human granulocyte colony-stimulating factor is inserted into the genetic material of Escherichia coli. The G-CSF then produced by E. coli is only slightly different from G-CSF naturally made in humans.

It is marketed by Amgen with the brand name Neupogen, Reliance Biopharmaceuticals with the brand name Religrast and also by Zenotech Laboratories Limited with the brand name Nugraf.

Pharmacodynamics

Pharmacokinetics

Filgrastim is a granulocyte-colony stimulating factor which binds to cell surface receptors on haemetopoietic cells thus stimulating the development of granulocytes to increase their migration and cytotoxicity.

Onset

Approximately 24 hours

Absorption
Serum concentrations peak about 8 hours after SC admin.

Excretion
Elimination half-life: About 3.5 hours. Mainly eliminated by neutrophil-mediated clearance.

Filgrastim Indications / Filgrastim Uses

Information Not Available

Filgrastim Adverse Reactions / Filgrastim Side Effects

Musculoskeletal pain, bone pain, hypersensitivity reactions, splenic enlargement, hepatomegaly, thrombocytopaenia, anaemia, epistaxis, headache, nausea, vomiting, diarrhoea, urinary abnormalities (dysuria, proteinuria, haematuria), osteoporosis, exacerbation of rheumatoid arthritis, transient decrease in blood glucose, raised uric acid, cutaneous vasculitis, transient hypotension.

Potentially Fatal: Pulmonary infiltrates leading to resp failure or acute resp distress syndrome.

Precautions

Monitor
Bone marrow transplant
Obtain CBC and platelet count at least 3 times/wk following marrow transplantation.

Myelosuppressive chemotherapy

Obtain CBC, WBC, and platelet count prior to chemotherapy and 2 times/wk during filgrastim therapy.

Severe chronic neutropenia

Obtain CBC with differential and platelet count 2 times/wk during first 4 wk of filgrastim therapy, and during the 2 wk following any dose adjustment; once stable, obtain once monthly for first year then at least quarterly thereafter. Perform bone marrow and cytogenetic evaluations annually in patients with congenital neutropenia.

PBPC collection/therapy
Obtain neutrophil count after 4 days of filgrastim. Consider dose modification if WBC count greater than 100,000/mm 3 .

Special Precautions

Premalignant or malignant myeloid condition; sickle-cell disease; osteoporotic bone disease; withdraw treatment if there are signs of pulmonary infiltrates. Fluid retention or heart failure. Monitor CBC and platelet count during therapy. Monitor bone density in patients with osteoporosis (long-term treatment). Regular morphological and cytogenic bone-marrow examinations in severe congenital neutropenia. Pregnancy and lactation.

Other Drug Interactions

Myelosuppressive antineoplastic agents. Drugs which may potentiate the release of neutrophils e.g. lithium.

Other Interactions

Information Not Available

Dosage

Subcutaneous
Mobilisation of peripheral blood progenitor cells for autologous peripheral blood stem cell transplantation
Adult: 10 mcg/kg daily, as a single inj or by continuous infusion, for 4-7 days until the last leucapheresis procedure. If it is given after myelosuppressive chemotherapy: 5 mcg/kg daily by inj; given from the 1st day after chemotherapy completion until expected neutrophil nadir is passed and neutrophil count has returned to normal range, so that leucapheresis can be performed.

Subcutaneous
Congenital neutropenia
Adult: 12 mcg/kg daily in single or divided doses. Adjust according to response. In patients with cyclic or idiopathic neutropenia: 5 mcg/kg daily in single or divided doses. Adjust according to response.

Subcutaneous
HIV infection and persistent neutropenia
Adult: Initially, 1 mcg/kg daily. Dose may be increased to 4 mcg/kg daily until normal neutrophil count is achieved. Maintenance: 300 mcg daily. Max: 4 mcg/kg daily.

Parenteral

Adjunct to antineoplastic therapy
Adult: 5 mcg/kg daily as a single daily SC inj, as a continuous IV or SC infusion, or as a daily IV infusion over 15-30 minutes, starting not <24 hr after the last dose of antineoplastic. Continue treatment until neutrophil count has stabilised within the normal range which may take up to 14 days or more.

Parenteral
Bone marrow transplantation
Adult: 10 mcg/kg daily by IV infusion over 30 min or 4 hr or continuous IV or SC infusion over 24 hr. Adjust according to response.

Food(before/after)

Information Not Available

List of Contraindications

Filgrastim and Pregnancy

Caution when used during pregnancy.

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Filgrastim and Lactation

Caution when used during lactation

Filgrastim and Children

Safety and efficacy in neonates and patients with autoimmune neutropenia of infancy not established.

Filgrastim and Geriatic

Following myelosuppressive chemotherapy, no overall differences in safety and efficacy have been observed between subjects 65 yr of age and older compared with younger subjects. For other approved indications, data are insufficient to make a comparison.

Filgrastim and Other Contraindications

Myeloid malignancies. Not to be used within 24 hr of cytotoxic chemotherapy admin due to the sensitivity of rapidly dividing myeloid cells. Severe congenital neutropaenia (Kostman's syndrome) with abnormal cytogenetics.

Storage

Parenteral
Refrigerate at 2-8°C. Do not freeze.

Subcutaneous

Refrigerate at 2-8°C. Do not freeze.

Lab interference

Parenteral
Refrigerate at 2-8°C. Do not freeze.

Subcutaneous

Refrigerate at 2-8°C. Do not freeze.

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