Finished product reference

Filgrastim

Injection · Parenteral · 600 µg/1mL · 0.2 mL

List code
50330
Pharmacologic class
Leukocyte Growth Factor

What it is and how it works

Mechanism of Action Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation, differentiation commitment, and some end-cell functional activation. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes, fibroblasts, and endothelial cells.

Indications

is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoieti…

Dosage and administration (summary)

Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML Recommended starting dose is 5 mcg/kg/day subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion. See Full Prescribing Information for recommended dosage adjustments and timing of administration Patients with cancer undergoing bone marrow transplantation 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours.

Contraindications

is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim . Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim.

Warnings and precautions

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue NEUPOGEN in patients with ARDS. Serious allergic reactions, including anaphylaxis: Permanently discontinue NEUPOGEN in patients with serious allergic reactions. Fatal sickle cell crises: Discontinue NEUPOGEN if sickle cell crisis occurs.

Pregnancy

Pregnancy Risk Summary Available data from published studies, including several observational studies of pregnancy outcomes in women exposed to filgrastim products and those who were unexposed, have not established an association with NEUPOGEN use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes .

Storage and supply

Store NEUPOGEN vial refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light and physical damage. Do not leave NEUPOGEN vial in direct sunlight. Avoid freezing NEUPOGEN vial; if frozen, thaw in the refrigerator before administration. Discard NEUPOGEN vial if frozen more than once. Do not shake.

Source: Filgrastim (Neupogen) — US FDA prescribing information, 2026-07-23, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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