Leucogen Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Filgrastim

Indications/Uses

Treatment or prevention of neutropenia in patients receiving myelosuppressive cancer chemotherapy & to reduce the period of neutropenia in patients undergoing bone marrow transplantation; to mobilize peripheral blood progenitor cells for collection & subsequent use in autologous or allogenic peripheral blood stem cell transplantation; management of chronic neutropenia (congenital, cyclic or idiopathic), & for persistent neutropenia in patients w/ advanced HIV infection.

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Dosage/Direction for Use

Myelosuppressive chemotherapy 5 mcg/kg/day as single daily inj by SC bolus inj. May increase in increments of 5 mcg/kg for each chemotherapy cycle. Cancer patient receiving bone marrow transplant 10 mcg/kg/day as IV infusion of 4 or 24 hr. Mobilization of peripheral blood progenitor cell 10 mcg/kg/day as SC. To be given for at least 4 days before the 1st leukapheresis & continued until the last leukapheresis. Patient w/ severe chronic neutropenia Median daily doses: 6 mcg/kg (congenital neutropenia), 2.1 mcg/kg (cyclic neutropenia), 1.2 mcg/kg (idiopathic neutropenia). Patient w/ acute myeloid leukemia receiving induction or consolidation chemotherapy 5 mcg/kg/day as SC bolus. The 1st dose should be administered at least 24 hr after cytotoxic chemotherapy.

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Overdosage

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Contraindications

Hypersensitivity to E. coli-derived protein. Severe hepatic or renal dysfunction. Pregnancy & lactation.

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Warnings

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Special Precautions

Avoid simultaneous use w/ chemotherapy & radiation therapy. Chronic myeloid leukemia, myelodysplasia; leukocytosis. Premature discontinuation of therapy. Hematocrit & platelet count should be monitored regularly. Discontinue therapy if ANC surpasses 10,000/mm³ after expected chemotherapy-induced neutrophil nadir. Monitor bone density in patients w/ osteoporosis. Possible adult resp distress syndrome in septic patients. Do not use filgrastim in the period 24 hr before & after the administration of cytotoxic chemotherapy.

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Adverse Reactions

Mild to moderate medullary bone pain, dysuria & transient decreased in BP; elevations in serum uric acid, lactase dehydrogenase & alkaline phosphatase.

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Drug Interactions

Potentiate the release of neutrophils w/ lithium.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Haematopoietic Agents / Supportive Care Therapy

ATC Classification

L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.

Regulatory Classification

Presentation/Packing

Form

Leucogen soln for inj 300 mcg/mL

Packing/Price

1 mL x 10 × 1's

Leucogen

filgrastim

Manufacturer:

Innokeys

Distributor:

Globo Asiatico