Product image of Grastofil (Filgrastim) supplied by GNH India

Grastofil

Active Ingredient:
Filgrastim
Origin:
EU

Grastofil (Filgrastim)

Grastofil is a prescription medication that contains the active ingredient filgrastim, a recombinant granulocyte colony‑stimulating factor (G‑CSF). It is supplied in a sterile solution for intravenous or subcutaneous administration. As a hematopoietic growth factor, Grastofil stimulates the production and activation of neutrophil precursors, helping to raise neutrophil counts in patients with certain types of neutropenia. The product is marketed in the European Union region and is intended for clinical use.

Manufacturer / TM Owner

Accord Healthcare S.L.U.

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Indications & Clinical Uses

Grastofil is indicated for several clinical situations in which neutrophil production is compromised.

  • Management of chemotherapy‑induced neutropenia
  • Prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy
  • Treatment of neutropenia associated with bone marrow transplantation
  • Supportive therapy for patients with severe chronic neutropenia
  • Use in aplastic anemia when neutrophil recovery is needed

Side Effects

The safety profile of filgrastim includes both frequently observed and less common adverse reactions.

Common

  • Bone pain at injection site or systemic
  • Redness, swelling, or itching at injection site
  • Headache
  • Fatigue or malaise
  • Low‑grade fever
  • Nausea or mild gastrointestinal upset

Serious

  • Splenic rupture or enlargement
  • Acute respiratory distress syndrome (ARDS)
  • Severe allergic reactions including anaphylaxis
  • Capillary leak syndrome
  • Severe hypotension or shock

Precautions & Warnings

Healthcare providers should consider the following precautions when prescribing Grastofil.

  • Assess baseline neutrophil count before initiation
  • Monitor for signs of splenic enlargement during therapy
  • Use caution in patients with known hypersensitivity to filgrastim or any excipient
  • Evaluate renal and hepatic function in patients with organ impairment
  • Avoid use in patients with active uncontrolled infection unless benefits outweigh risks
  • Consider dose adjustment in pediatric patients when appropriate
  • Counsel patients on proper injection technique to reduce local reactions

Avoid Interactions

Grastofil may interact with other medications; awareness of potential interactions helps optimize safety.

Avoid

  • Concurrent use with chemotherapy agents that cause severe myelosuppression may diminish efficacy
  • Concomitant administration with other colony‑stimulating factors may increase risk of bone pain

Use with caution

  • Antimicrobial agents that can cause neutropenia (e.g., linezolid) may require monitoring
  • Corticosteroids may augment neutrophil response
  • Drugs affecting the immune system (e.g., immunosuppressants) may alter expected outcomes
  • Vaccines, especially live attenuated, should be administered with caution
  • Agents that affect platelet function may require additional observation

Frequently Asked Questions

Filgrastim binds to the granulocyte‑colony stimulating factor receptor on hematopoietic cells, stimulating proliferation, differentiation and activation of neutrophil precursors, which increases circulating neutrophil counts.

Grastofil is supplied as a sterile solution for injection and can be given either intravenously or subcutaneously according to the prescribing information.

Grastofil is used for chemotherapy‑induced neutropenia, neutropenia after bone marrow transplantation, severe chronic neutropenia, and neutropenia associated with aplastic anemia.

Filgrastim may be used in children under medical supervision; dosing and monitoring should be individualized based on age, weight and clinical condition.

The most frequently reported adverse reactions include bone pain, injection‑site redness or swelling, headache, fatigue, low‑grade fever and mild nausea.

Blood counts are typically monitored before the first dose and then periodically (often every 2–3 days) to assess neutrophil response and adjust therapy as needed.

The safety of filgrastim in pregnancy has not been fully established; it should be used only if the potential benefit justifies the potential risk to the fetus.

Grastofil is often given after chemotherapy to reduce the duration of neutropenia; however, concurrent use with agents that cause severe myelosuppression may lessen its effectiveness.

Patients with an enlarged spleen should be monitored closely for signs of splenic rupture, and therapy may be discontinued if splenic complications develop.

Concurrent use with other colony‑stimulating factors is generally avoided because it can increase the risk of bone pain and other adverse effects.

Patients should inform their healthcare provider promptly; analgesics may be prescribed and the dosing schedule may be reassessed.

The product should be stored in a refrigerator (2–8 °C) and protected from light; it should not be frozen. Once prepared for injection, it may be used according to the stability guidelines in the label.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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