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.
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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)?+
In which clinical situations is Grastofil typically prescribed?+
Can Grastofil be administered intravenously and subcutaneously?+
What are the most frequently reported side effects of Grastofil?+
What serious adverse events should patients be monitored for while receiving Grastofil?+
Should patients receive live vaccines while being treated with Grastofil?+
How should Grastofil be used in patients with a history of splenomegaly?+
Is dose adjustment of Grastofil required for patients with renal or hepatic impairment?+
Can Grastofil be combined with other growth factors?+
What monitoring is recommended during Grastofil therapy?+
Is Grastofil available over the counter in the European Union?+
What is the ATC classification code for Grastofil?+
Product details
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