GNH USA

Europe — EMA

Grastofil

Grastofil (filgrastim) is an EU‑approved injectable G‑CSF used to boost neutrophil production in chemotherapy‑induced neutropenia and stem‑cell transplantation.

Filgrastim

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What is 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.

What is Filgrastim used for?

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.

What are the side effects of Filgrastim?

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.

What precautions apply to Filgrastim?

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.

What does Filgrastim interact with?

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

What is the mechanism of action of Grastofil (filgrastim)?+
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.
In which clinical situations is Grastofil typically prescribed?+
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.
Can Grastofil be administered intravenously and subcutaneously?+
Yes, Grastofil is formulated for both intravenous and subcutaneous injection, allowing flexibility based on the treatment protocol and patient needs.
What are the most frequently reported side effects of Grastofil?+
The most common adverse reactions include bone pain, mild fever or chills, injection‑site erythema or discomfort, and general fatigue or headache.
What serious adverse events should patients be monitored for while receiving Grastofil?+
Serious events, although rare, can include splenic rupture or enlargement, acute respiratory distress syndrome (ARDS), and severe allergic reactions such as anaphylaxis.
Should patients receive live vaccines while being treated with Grastofil?+
Live vaccines are generally avoided during Grastofil therapy because the altered immune response may affect vaccine efficacy and safety.
How should Grastofil be used in patients with a history of splenomegaly?+
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.
Is dose adjustment of Grastofil required for patients with renal or hepatic impairment?+
Dose adjustments may be considered for patients with significant renal or hepatic dysfunction, and clinicians should monitor blood counts closely to avoid excessive leukocytosis.
Can Grastofil be combined with other growth factors?+
Concurrent use of other granulocyte colony‑stimulating factors is generally avoided to prevent overlapping pharmacologic effects and potential toxicity.
What monitoring is recommended during Grastofil therapy?+
Regular complete blood counts are recommended to assess neutrophil response and to detect any signs of leukocytosis or other hematologic changes.
Is Grastofil available over the counter in the European Union?+
No, Grastofil is a prescription‑only medication (Rx‑only) in the EU and must be prescribed by a qualified healthcare professional.
What is the ATC classification code for Grastofil?+
Grastofil is classified under the ATC code L03AA02, which corresponds to granulocyte colony‑stimulating factors.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Filgrastim
Route
Intravenous Use , Subcutaneous Use
Manufacturer
Accord Healthcare S.L.U.
Origin
EU

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