Europe — EMA
Granocyte
Granocyte (lenograstim) is a prescription G‑CSF injection used to treat chemotherapy‑induced neutropenia and other severe neutropenia conditions.
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What is Lenograstim?
Granocyte is a prescription medication that contains the active ingredient lenograstim, supplied as a solution for injection. It is classified as a granulocyte colony‑stimulating factor (G‑CSF) and is marketed in the European Union. Lenograstim works by stimulating the proliferation and differentiation of neutrophil precursors, thereby supporting neutrophil production in patients with certain hematologic conditions. The product is administered intravenously or subcutaneously and is indicated for specific types of neutropenia.
What is Lenograstim used for?
Granocyte (lenograstim) is used in clinical practice to reduce the risk of infection associated with low neutrophil counts.
- Management of chemotherapy‑induced neutropenia in adult patients receiving myelosuppressive regimens. - Prevention and treatment of neutropenia that occurs after autologous or allogeneic bone‑marrow transplantation. - Therapeutic option for severe chronic neutropenia of either congenital or acquired origin. - Supportive therapy to accelerate hematopoietic recovery following high‑dose chemotherapy or radiation. - Facilitates mobilization of peripheral blood stem cells for collection in stem‑cell transplantation protocols. - May be considered off‑label in selected immunodeficiency disorders when judged appropriate by a specialist.
What are the side effects of Lenograstim?
Lenograstim can cause a range of adverse reactions, most of which are mild and transient, while rare events may be serious.
Common: - Bone pain, often localized to the lower back, hips, or sternum, occurring shortly after injection. - Mild fever or flu‑like symptoms such as chills, muscle aches, and fatigue that usually resolve within 24–48 hours. - Injection‑site reactions including redness, swelling, tenderness, or itching that are typically transient. - Nausea, occasional vomiting, or mild gastrointestinal discomfort that does not require medical intervention.
Serious: - Splenic enlargement or rupture, presenting as left‑upper‑quadrant abdominal pain and requiring immediate evaluation. - Acute respiratory distress syndrome (ARDS) or severe pulmonary toxicity, characterized by shortness of breath, hypoxia, and diffuse lung infiltrates. - Anaphylactic or severe allergic reactions, including hives, facial swelling, bronchospasm, or hypotension, that demand emergency treatment.
What precautions apply to Lenograstim?
When prescribing or administering Granocyte, clinicians should consider several precautionary measures to ensure patient safety.
- Evaluate baseline neutrophil count and overall bone‑marrow function before initiating therapy. - Monitor for signs of splenomegaly or abdominal pain during treatment. - Use caution in patients with a history of hypersensitivity to recombinant proteins. - Adjust dosing or discontinue if rapid leukocytosis or leukemoid reaction occurs. - Avoid use in patients with active uncontrolled infection unless benefits outweigh risks. - Consider pregnancy and lactation status; data are limited, so use only if clearly needed.
What does Lenograstim interact with?
Lenograstim may interact with other agents; some combinations should be avoided while others require careful monitoring.
Avoid: - Concurrent use with cytotoxic chemotherapy agents that cause profound marrow suppression, as this may blunt the intended effect. - Co‑administration with other colony‑stimulating factors (e.g., filgrastim) without clear clinical justification.
Use with caution: - Anticoagulants or antiplatelet drugs, because rapid neutrophil recovery can affect bleeding risk. - Corticosteroids, which may alter the pharmacodynamic response. - Immunosuppressive biologics, where overlapping effects on immune cells may require dose adjustments.
Frequently asked questions
What is the mechanism of action of lenograstim in Granocyte?+
Which patients are most likely to receive Granocyte therapy?+
Can Granocyte be given subcutaneously as well as intravenously?+
How soon after injection might bone pain appear?+
Is it necessary to monitor blood counts during Granocyte treatment?+
What should be done if a patient develops a severe allergic reaction to Granocyte?+
Are there any known contraindications for using Granocyte?+
Can Granocyte be used in pregnant or breastfeeding women?+
Does Granocyte interact with anticoagulant therapy?+
What is the recommended storage condition for Granocyte solution for injection?+
Is Granocyte approved for use in children?+
How does Granocyte differ from other G‑CSF products like filgrastim?+
Product details
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