Europe — EMA
Granocyte
Granocyte lenograstim is a prescription G‑CSF used to treat chemotherapy‑induced neutropenia and other low‑neutrophil conditions in the EU.
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What is Lenograstim?
Granocyte is a prescription medication that contains the recombinant protein lenograstim as its active ingredient. It is supplied for intravenous or subcutaneous administration and is classified as a granulocyte colony‑stimulating factor (G‑CSF) used to support hematopoietic function. Granocyte is indicated for patients who develop low neutrophil counts after chemotherapy, bone‑marrow transplantation, or chronic neutropenia, and it is currently marketed within the European Union, specifically widely.
What is Lenograstim used for?
Granocyte is prescribed to help patients whose neutrophil counts are reduced due to specific medical conditions or treatments.
- Chemotherapy‑induced neutropenia in adult cancer patients. - Neutropenia following allogeneic bone‑marrow or stem‑cell transplantation. - Severe chronic neutropenia of congenital or acquired origin. - Supportive care to reduce infection risk during intensive myelosuppressive therapy. - Off‑label use may be considered in clinical trials under physician supervision.
What are the side effects of Lenograstim?
Granocyte can cause a range of adverse reactions, most of which are mild to moderate, while rare events may be serious.
Common: - Bone pain, especially in the lower back or limbs. - Injection‑site reactions such as redness, swelling, or tenderness. - Fever, chills, or flu‑like symptoms shortly after dosing. - Nausea, vomiting, or mild gastrointestinal discomfort.
Serious: - Splenic rupture or enlargement leading to abdominal pain. - Acute respiratory distress or severe allergic reactions (anaphylaxis). - Development of leukocytosis with excessively high white‑blood‑cell counts. - Capillary leak syndrome presenting with hypotension and edema.
What precautions apply to Lenograstim?
Before initiating Granocyte, clinicians should evaluate patient history and monitor specific parameters to minimize risks.
- Assess baseline neutrophil count and overall bone‑marrow function. - Screen for hypersensitivity to recombinant proteins or excipients. - Use caution in patients with a history of splenic disorders or trauma. - Monitor for signs of leukocytosis or abnormal white‑blood‑cell proliferation. - Adjust dosing in renal or hepatic impairment as per clinical judgment. - Avoid use in patients with active uncontrolled infections.
What does Lenograstim interact with?
Granocyte may interact with other agents that affect the immune system or hematologic parameters.
Avoid: - Concurrent use of other granulocyte colony‑stimulating factors (e.g., filgrastim, pegfilgrastim) due to overlapping mechanisms. - High‑dose corticosteroids that may blunt neutrophil response. - Chemotherapeutic agents that cause profound myelosuppression when administered simultaneously without appropriate timing.
Use with caution: - Anticoagulants, as rapid neutrophil recovery can influence coagulation status. - Immunosuppressive biologics (e.g., rituximab) that may alter infection risk. - Vaccines, particularly live attenuated vaccines, due to potential altered immune response.
Frequently asked questions
What is the active ingredient in Granocyte?+
How does Granocyte work to increase neutrophil counts?+
For which conditions is Granocyte typically prescribed?+
Can Granocyte be given both intravenously and subcutaneously?+
What are the most common side effects reported with Granocyte?+
Are there any serious adverse reactions associated with Granocyte?+
What laboratory tests should be performed before starting Granocyte therapy?+
How should Granocyte be stored before use?+
Can Granocyte be used together with other G‑CSF products?+
What precautions should be taken for patients with a history of splenic injury?+
Does Granocyte interact with chemotherapy agents?+
Is Granocyte available over the counter in the European Union?+
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