Europe — EMA
Granocyte
Granocyte (lenograstim) is an injectable granulocyte colony‑stimulating factor used in the EU to support neutrophil recovery after chemotherapy.
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What is Lenograstim?
Granocyte is a prescription injectable medication whose active ingredient is lenograstim, a recombinant granulocyte colony‑stimulating factor. It is supplied as a sterile solution for intravenous or subcutaneous administration. Lenograstim belongs to the hematopoietic growth‑factor class and is used in the European market to support neutrophil recovery in patients undergoing myelosuppressive therapy. Granocyte is indicated for patients with chemotherapy‑induced neutropenia and for stem‑cell donors to enhance mobilization of white blood cells.
What is Lenograstim used for?
Granocyte (lenograstim) is employed in clinical practice to reduce the duration of neutropenia and to support hematopoietic recovery in several settings.
- Patients receiving myelosuppressive chemotherapy who are at risk of febrile neutropenia. - Individuals undergoing high‑dose chemotherapy prior to autologous stem‑cell transplantation. - Healthy donors of peripheral blood stem cells to improve CD34+ cell yield. - Patients with severe congenital neutropenia when other treatments are insufficient. - Off‑label use in radiation‑induced bone‑marrow suppression where supported by clinical judgment.
What are the side effects of Lenograstim?
The safety profile of lenograstim reflects its pharmacologic stimulation of neutrophil production; most adverse events are mild to moderate, while rare serious reactions have been reported.
Common: - Bone pain, typically localized to the lower back, hips, or sternum, occurring within days of dosing. - Transient fever or flu‑like symptoms such as chills, muscle aches, and malaise. - Mild injection‑site reactions including redness, swelling, or tenderness that resolve spontaneously. - Headache or generalized fatigue reported by some patients during treatment.
Serious: - Splenic enlargement that can progress to rupture, presenting as acute abdominal pain and hypotension. - Acute respiratory distress syndrome (ARDS) characterized by sudden shortness of breath and hypoxemia. - Severe hypersensitivity reactions, including anaphylaxis or serum sickness, with rash, bronchospasm, or angioedema.
What precautions apply to Lenograstim?
When prescribing Granocyte, clinicians should evaluate patient history and monitor for conditions that could increase the risk of adverse events or reduce therapeutic benefit.
- Confirm neutrophil deficiency before initiation; avoid treatment in patients with normal or elevated counts. - Exercise caution in patients with prior splenic enlargement, rupture, or recent abdominal injury. - Monitor for infections during therapy, recognizing that neutrophil recovery does not eliminate all infection risk. - Assess renal and hepatic function; severe impairment may necessitate dose modification or increased monitoring. - Pregnancy and breastfeeding are contraindicated or discouraged due to insufficient safety data.
What does Lenograstim interact with?
Lenograstim may interact with other agents that affect bone‑marrow function or immune response; awareness of these interactions helps optimize safety.
Avoid: - Concurrent use with cytotoxic chemotherapy agents that cause profound myelosuppression, as this may blunt the intended neutrophil response. - Co‑administration with other colony‑stimulating factors (e.g., filgrastim, sargramostim) without clear clinical justification, due to overlapping mechanisms.
Use with caution: - Antimicrobial agents such as antibiotics that may mask signs of infection; monitor clinical status closely. - Immunosuppressive drugs (e.g., corticosteroids, calcineurin inhibitors) that could alter neutrophil function. - Radiopharmaceuticals or radiation therapy, which can synergistically affect bone‑marrow recovery.
Frequently asked questions
What is the mechanism of action of Granocyte (lenograstim)?+
How is Granocyte administered to patients?+
In which clinical situations is lenograstim typically prescribed?+
What are the most common side effects associated with lenograstim injections?+
Can lenograstim cause splenic enlargement or rupture?+
Is it safe to use Granocyte during pregnancy or while breastfeeding?+
How does lenograstim interact with chemotherapy agents?+
What monitoring is recommended while a patient receives lenograstim?+
Are there any contraindications for using Granocyte in stem‑cell donors?+
How does lenograstim differ from other G‑CSF products like filgrastim?+
What should a patient do if they experience an allergic reaction to lenograstim?+
Can lenograstim be used in patients with renal or hepatic impairment?+
Product details
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