GNH USA

Europe — EMA

Granocyte

Granocyte (lenograstim) is an injectable granulocyte colony‑stimulating factor used in the EU to support neutrophil recovery after chemotherapy.

Lenograstim

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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)?+
Lenograstim binds to the granulocyte colony‑stimulating factor receptor on hematopoietic progenitor cells, stimulating proliferation, differentiation, and activation of neutrophil precursors.
How is Granocyte administered to patients?+
Granocyte is supplied as a sterile solution for intravenous or subcutaneous injection, given according to the prescribing clinician’s dosing schedule.
In which clinical situations is lenograstim typically prescribed?+
It is used to reduce the duration of chemotherapy‑induced neutropenia, to support recovery after high‑dose chemotherapy for stem‑cell transplantation, and to mobilize white‑blood cells in healthy stem‑cell donors.
What are the most common side effects associated with lenograstim injections?+
Common adverse events include bone pain, mild fever or flu‑like symptoms, injection‑site redness or tenderness, and occasional headache or fatigue.
Can lenograstim cause splenic enlargement or rupture?+
Rarely, lenograstim may lead to splenic enlargement, which in extreme cases can progress to rupture; patients should be monitored for abdominal pain.
Is it safe to use Granocyte during pregnancy or while breastfeeding?+
Safety data are limited; the product is generally avoided during pregnancy and lactation unless the potential benefit outweighs the unknown risk.
How does lenograstim interact with chemotherapy agents?+
Concurrent use with highly myelosuppressive chemotherapy may diminish the intended neutrophil‑stimulating effect, so timing and dosing should be coordinated by the treating physician.
What monitoring is recommended while a patient receives lenograstim?+
Regular complete blood counts to assess neutrophil recovery, clinical evaluation for signs of infection, and observation for any adverse reactions such as splenic symptoms are advised.
Are there any contraindications for using Granocyte in stem‑cell donors?+
Donors with active infections, uncontrolled splenic disease, or known hypersensitivity to lenograstim should not receive the product.
How does lenograstim differ from other G‑CSF products like filgrastim?+
Lenograstim is a glycosylated recombinant form of G‑CSF, whereas filgrastim is non‑glycosylated; both stimulate neutrophil production but may have different pharmacokinetic profiles.
What should a patient do if they experience an allergic reaction to lenograstim?+
The patient should stop the injection immediately, seek emergency medical care, and inform the healthcare provider for appropriate management and alternative therapy.
Can lenograstim be used in patients with renal or hepatic impairment?+
Dose adjustment is not routinely required, but severe renal or hepatic dysfunction warrants close monitoring and possible modification of the treatment regimen.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Lenograstim
Route
Intravenous Use , Subcutaneous Use
Manufacturer
Chugai Pharma France, Fr, Puteaux
Origin
EU

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