Europe — EMA
Grasustek
Grasustek pegfilgrastim is a subcutaneous colony‑stimulating factor used in the EU to prevent chemotherapy‑induced neutropenia and mobilize stem cells.
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What is Pegfilgrastim?
Grasustek is a prescription medication that contains the active ingredient pegfilgrastim, a long‑acting granulocyte colony‑stimulating factor. It is supplied for subcutaneous injection and is marketed in the European Union. Pegfilgrastim belongs to the hematopoietic growth factor class and works by stimulating the production and activation of neutrophil precursors. Grasustek is used under medical supervision to manage chemotherapy‑related neutropenia and to aid stem‑cell mobilization in clinical practice.
What is Pegfilgrastim used for?
Grasustek is indicated for specific hematologic support in patients receiving myelosuppressive therapy.
- Prevention of chemotherapy‑induced neutropenia in adult patients. - Reduction of the duration of severe neutropenia following cytotoxic chemotherapy. - Mobilization of peripheral blood stem cells for autologous transplantation. - Support of patients with high‑risk regimens where neutrophil recovery is critical. - Use in clinical protocols that require rapid neutrophil count recovery.
What are the side effects of Pegfilgrastim?
The safety profile of pegfilgrastim includes a range of observed adverse events, which are categorized by frequency and severity.
Common: - Bone pain, often in the back, hips, or legs. - Injection‑site reactions such as redness, swelling, or itching. - Mild fever or flu‑like symptoms. - Fatigue or weakness. - Nausea or vomiting. - Headache.
Serious: - Splenic rupture, a rare but potentially life‑threatening event. - Acute respiratory distress syndrome (ARDS) or severe pulmonary toxicity. - Severe allergic reactions, including anaphylaxis and angioedema.
What precautions apply to Pegfilgrastim?
Clinicians should evaluate patient history and monitor for specific conditions before initiating Grasustek therapy.
- Assess for prior splenic injury or known splenomegaly. - Use caution in patients with a history of severe allergic reactions to biologics. - Evaluate renal or hepatic impairment, as dose adjustments may be required. - Monitor complete blood counts regularly to detect unexpected leukocytosis or thrombocytopenia. - Avoid concurrent use with other colony‑stimulating factors unless medically justified. - Consider postponing treatment in patients with active infections. - Discuss potential bone pain management strategies with patients.
What does Pegfilgrastim interact with?
Pegfilgrastim may interact with other medications or biologic agents, influencing efficacy or safety.
Avoid: - Concurrent administration of other granulocyte colony‑stimulating factors (e.g., filgrastim) without clear clinical indication. - Use with live vaccines during the period of neutrophil recovery, as immune response may be altered.
Use with caution: - Chemotherapeutic agents that cause profound myelosuppression, requiring close monitoring of neutrophil counts. - Corticosteroids, which may mask signs of infection. - Antimicrobial prophylaxis agents, to ensure appropriate timing relative to pegfilgrastim dosing. - Immunosuppressive therapies, as combined effects on the immune system may increase infection risk.
Frequently asked questions
What is the mechanism of action of Grasustek pegfilgrastim?+
For which patients is Grasustek typically prescribed?+
How is Grasustek administered?+
Can Grasustek be used with other colony‑stimulating factors?+
What are the most common side effects of pegfilgrastim?+
Is splenic rupture a possible risk with Grasustek?+
Should live vaccines be given after receiving Grasustek?+
How often should blood counts be monitored while on Grasustek?+
Can Grasustek be used in patients with renal or hepatic impairment?+
Is Grasustek available over the counter?+
What should a patient do if they experience severe bone pain after injection?+
Does Grasustek interact with corticosteroids?+
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