Europe — EMA
Granocyte
Granocyte (lenograstim) is an EU‑approved injectable G‑CSF used to prevent chemotherapy‑induced neutropenia and support bone‑marrow transplant patients.
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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, though strength and dosage form details are not disclosed. Marketed within the European Union, Granocyte belongs to the hematopoietic growth factor class and works by stimulating neutrophil production for patients undergoing chemotherapy or bone‑marrow transplantation.
What is Lenograstim used for?
Granocyte is indicated for the prevention and treatment of neutropenia in specific clinical situations.
- Chemotherapy‑induced neutropenia in adult patients. - Neutropenia associated with high‑dose chemotherapy for stem cell mobilization. - Neutropenia following autologous or allogeneic bone‑marrow transplantation. - Situations where rapid neutrophil recovery is clinically desired.
What are the side effects of Lenograstim?
The safety profile of lenograstim includes a range of observed adverse events, which are generally categorized by frequency.
Common: - Bone pain, especially in the lower back or limbs. - Injection site reactions such as erythema, swelling, or tenderness. - Mild fever or flu‑like symptoms. - Headache or fatigue.
Serious: - Splenic rupture or enlargement. - Severe allergic reactions including anaphylaxis. - Acute respiratory distress or pulmonary edema. - Rapid increase in white blood cell count (leukocytosis) with potential complications.
What precautions apply to Lenograstim?
Before initiating Granocyte, clinicians should evaluate several precautionary factors to minimize risk.
- Known hypersensitivity to lenograstim or any excipients. - History of splenic disorders or prior splenic injury. - Active uncontrolled infections, especially bacterial. - Concurrent use of other hematopoietic growth factors. - Pregnancy or breastfeeding status, as safety data are limited. - Renal or hepatic impairment may require monitoring.
What does Lenograstim interact with?
Lenograstim may interact with other agents; awareness of potential interactions helps guide safe co‑administration.
Avoid: - Concurrent administration of other G‑CSF products (e.g., filgrastim, pegfilgrastim). - Live vaccines during active treatment, due to altered immune response.
Use with caution: - Chemotherapeutic agents that cause profound myelosuppression. - Corticosteroids, which may potentiate neutrophil effects. - Anticoagulants, as neutrophil activation can influence coagulation.
Frequently asked questions
What is the mechanism of action of Granocyte (lenograstim)?+
In which clinical situations is Granocyte typically prescribed?+
How is Granocyte administered to patients?+
What are the most common side effects associated with Granocyte?+
Can Granocyte cause serious complications such as splenic rupture?+
Are there any contraindications for using Granocyte?+
How should Granocyte be used in patients undergoing bone‑marrow transplantation?+
What monitoring is recommended during Granocyte therapy?+
Does Granocyte interact with chemotherapy drugs?+
Is Granocyte safe to use during pregnancy or breastfeeding?+
How does Granocyte differ from other G‑CSF products like filgrastim?+
What is the ATC classification for Granocyte?+
Product details
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