Product image of Grastofil (Filgrastim) supplied by GNH India

Grastofil

Active Ingredient:
Filgrastim
Origin:
EU

Grastofil (Filgrastim)

Grastofil is a medicinal product that contains the active ingredient filgrastim, supplied as an injectable solution for intravenous or subcutaneous administration. It is marketed in the European Union and classified as a granulocyte colony‑stimulating factor (G‑CSF) hematopoietic growth factor. Grastofil works by binding to the G‑CSF receptor to promote the production of neutrophils, supporting patients with compromised immune cell counts during chemotherapy or bone‑marrow transplantation.

Manufacturer / TM Owner

Accord Healthcare S.L.U.

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Indications & Clinical Uses

Grastofil is prescribed to stimulate neutrophil recovery in clinical situations where white‑blood‑cell counts are low.

  • Reducing the duration of neutropenia after intensive chemotherapy.
  • Supporting hematopoietic recovery following autologous or allogeneic stem‑cell transplantation.
  • Managing neutropenia associated with severe chronic neutropenia syndromes.
  • Facilitating peripheral blood stem‑cell mobilization for collection prior to transplantation.
  • Assisting patients with congenital or acquired neutrophil production defects when other therapies are insufficient.

Side Effects

The safety profile of Grastofil reflects the pharmacologic activity of filgrastim and includes both frequent mild reactions and less common serious events.

Common

  • Bone pain, especially in the long bones.
  • Mild fever or chills.
  • Injection‑site erythema or discomfort.
  • Fatigue or headache.

Serious

  • Splenic rupture or enlargement.
  • Acute respiratory distress syndrome (ARDS).
  • Severe allergic reactions such as anaphylaxis.

Precautions & Warnings

Healthcare providers should evaluate patient history and clinical status before initiating Grastofil therapy.

  • Assess for active infections, as rapid neutrophil changes may mask symptoms.
  • Use caution in patients with a history of splenomegaly or splenic injury.
  • Monitor complete blood counts regularly to avoid excessive leukocytosis.
  • Consider dose adjustment in individuals with renal or hepatic impairment.
  • Review prior hypersensitivity reactions to filgrastim or any G‑CSF products.
  • Avoid use in patients with known hypersensitivity to the formulation excipients.

Avoid Interactions

Grastofil may interact with other medications that affect blood cell production or immune response.

Avoid

  • Concurrent use of other granulocyte colony‑stimulating factors.
  • Live vaccines administered during treatment, due to altered immune response.

Use with caution

  • Chemotherapeutic agents that cause profound myelosuppression; timing should be coordinated.
  • Corticosteroids, which may modify the neutrophil response.
  • Anticoagulants, as splenic enlargement could increase bleeding risk.

Frequently Asked Questions

Grastofil contains filgrastim, a granulocyte colony‑stimulating factor that binds to the G‑CSF receptor on hematopoietic cells, stimulating proliferation and differentiation of neutrophil precursors and thereby increasing neutrophil production.

Grastofil is commonly used to reduce the duration of neutropenia after intensive chemotherapy, to support recovery after stem‑cell transplantation, to manage chronic neutropenia syndromes, and to mobilize peripheral blood stem cells for collection.

Yes, Grastofil is formulated for both intravenous and subcutaneous injection, allowing flexibility based on the treatment protocol and patient needs.

The most common adverse reactions include bone pain, mild fever or chills, injection‑site erythema or discomfort, and general fatigue or headache.

Serious events, although rare, can include splenic rupture or enlargement, acute respiratory distress syndrome (ARDS), and severe allergic reactions such as anaphylaxis.

Live vaccines are generally avoided during Grastofil therapy because the altered immune response may affect vaccine efficacy and safety.

Patients with known splenomegaly should be monitored closely for splenic enlargement, and the decision to use Grastofil should weigh the benefits against the risk of splenic complications.

Dose adjustments may be considered for patients with significant renal or hepatic dysfunction, and clinicians should monitor blood counts closely to avoid excessive leukocytosis.

Concurrent use of other granulocyte colony‑stimulating factors is generally avoided to prevent overlapping pharmacologic effects and potential toxicity.

Regular complete blood counts are recommended to assess neutrophil response and to detect any signs of leukocytosis or other hematologic changes.

No, Grastofil is a prescription‑only medication (Rx‑only) in the EU and must be prescribed by a qualified healthcare professional.

Grastofil is classified under the ATC code L03AA02, which corresponds to granulocyte colony‑stimulating factors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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