Europe — EMA
Granocyte
Granocyte (lenograstim) is an EU‑approved injectable G‑CSF analog used to support neutrophil recovery after chemotherapy or stem cell transplantation. Learn indications, safety, and dosing considerations.
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What is Lenograstim?
Granocyte is a prescription medication that contains the active ingredient lenograstim, a granulocyte colony‑stimulating factor (G‑CSF) analog. It is supplied in an injectable form for intravenous or subcutaneous administration. Granocyte is marketed in the European Union and is used as a hematopoietic growth factor to support neutrophil production in patients undergoing myelosuppressive therapy. The product is prescribed by oncologists or hematologists and is stored under temperature conditions to maintain stability.
What is Lenograstim used for?
Granocyte is indicated for clinical situations where neutrophil recovery is needed after myelosuppressive treatments.
- To reduce the duration of neutropenia following chemotherapy in cancer patients. - To support neutrophil counts after autologous or allogeneic stem cell transplantation. - To mobilize peripheral blood progenitor cells for collection prior to transplantation. - To treat severe chronic neutropenia in patients with congenital or acquired disorders. - To facilitate faster hematologic recovery in patients receiving high‑dose radiation therapy.
What are the side effects of Lenograstim?
The safety profile of lenograstim includes a range of observed adverse events that vary in frequency and severity.
Common: - Bone pain, especially in the lower back or hips. - Mild fever or chills. - Injection site reactions such as redness, swelling, or itching. - Fatigue or general weakness. - Elevated liver enzymes.
Serious: - Splenic rupture, a rare but potentially life‑threatening condition. - Acute respiratory distress syndrome (ARDS) or severe pulmonary edema. - Allergic reactions including anaphylaxis, characterized by rash, swelling, and difficulty breathing. - Thrombotic events such as deep‑vein thrombosis. - Severe hypotension or shock related to hypersensitivity.
What precautions apply to Lenograstim?
When prescribing Granocyte, clinicians should evaluate patient history and monitor specific parameters to minimize risk.
- Assess baseline neutrophil counts and overall bone marrow function before initiating therapy. - Use caution in patients with a history of splenic enlargement or trauma. - Monitor for signs of hypersensitivity during and after each injection. - Adjust dose or discontinue if persistent fever or unexplained infections develop. - Avoid use in patients with active malignant disease that may be stimulated by growth factors. - Consider renal or hepatic impairment when determining dosing intervals.
What does Lenograstim interact with?
Lenograstim may interact with other medications or clinical conditions, influencing its efficacy or safety.
Avoid: - Concurrent use of chemotherapy agents that cause profound myelosuppression without appropriate timing adjustments. - Co‑administration with other hematopoietic growth factors unless clinically justified. - Use with investigational agents that lack safety data in combination with G‑CSF.
Use with caution: - Anticoagulants, as rapid neutrophil recovery can affect bleeding risk. - Corticosteroids, which may mask fever or infection signs. - Immunosuppressive biologics that could alter immune response to G‑CSF.
Frequently asked questions
What is the mechanism of action of Granocyte (lenograstim)?+
Which routes of administration are approved for Granocyte?+
Can Granocyte be used to mobilize stem cells for transplantation?+
Is Granocyte prescribed for patients undergoing chemotherapy?+
What are common side effects associated with lenograstim?+
What serious adverse reactions should be monitored while on Granocyte?+
Should Granocyte be avoided in patients with active malignancy?+
How should renal or hepatic impairment affect Granocyte use?+
Are there any drug interactions that require dose modification of Granocyte?+
Is Granocyte available over the counter?+
What monitoring is recommended during Granocyte therapy?+
Can pregnant or breastfeeding women receive Granocyte?+
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