GNH USA

Europe — EMA

Granocyte

Granocyte (lenograstim) is an EU‑approved injectable G‑CSF used for chemotherapy‑induced neutropenia, bone‑marrow transplant recovery, and stem‑cell mobilization.

Lenograstim

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What is Lenograstim?

Granocyte is an injectable solution containing the recombinant granulocyte colony‑stimulating factor lenograstim. It is supplied in a standard concentration for intravenous or subcutaneous administration and is marketed in the European Union as a prescription‑only hematopoietic growth factor. The product is used to support neutrophil recovery in patients undergoing chemotherapy, bone‑marrow transplantation, or stem‑cell mobilization, and it is classified under ATC code L03AA02 as part of standard supportive care protocols.

What is Lenograstim used for?

Granocyte is indicated for several hematologic conditions where neutrophil counts are compromised.

- Management of chemotherapy‑induced neutropenia to reduce infection risk. - Treatment of neutropenia following allogeneic or autologous bone‑marrow transplantation. - Mobilization of peripheral blood stem cells for collection prior to transplantation. - Support of neutrophil recovery in patients receiving high‑dose radiation therapy.

What are the side effects of Lenograstim?

Adverse reactions to lenograstim are generally mild to moderate, but serious events can occur.

Common: - Bone pain, especially in the lower back or hips. - Mild fever or flu‑like symptoms. - Injection site erythema or discomfort. - Nausea or mild gastrointestinal upset.

Serious: - Splenic rupture or enlargement. - Acute respiratory distress syndrome (ARDS). - Severe allergic reactions such as anaphylaxis. - Capillary leak syndrome.

What precautions apply to Lenograstim?

When prescribing Granocyte, clinicians should evaluate patient history and monitor for specific safety concerns.

- Assess baseline neutrophil counts and overall bone‑marrow function before initiation. - Use caution in patients with a history of splenic disorders or abdominal trauma. - Avoid in individuals with known hypersensitivity to lenograstim or any excipients. - Monitor for signs of infection, fever, or unexpected inflammation during therapy. - Consider dose adjustment or discontinuation if severe bone pain or systemic reactions develop. - Pregnancy and lactation status should be reviewed, as safety data are limited.

What does Lenograstim interact with?

Lenograstim may interact with other medications or clinical conditions that affect immune function or hematopoiesis.

Avoid: - Concurrent use of other granulocyte colony‑stimulating factors or high‑dose corticosteroids without specialist guidance. - Live vaccines administered during treatment, due to altered immune response.

Use with caution: - Chemotherapeutic agents that cause profound myelosuppression, requiring close monitoring of blood counts. - Anticoagulants, as changes in platelet function may occur. - Immunosuppressive biologics, which could modify the efficacy of neutrophil recovery.

Frequently asked questions

What type of medication is Granocyte and what is its active ingredient?+
Granocyte is a prescription‑only injectable solution whose active ingredient is the recombinant protein lenograstim, a granulocyte colony‑stimulating factor.
For which patients is Granocyte typically prescribed in the European Union?+
It is commonly prescribed for patients who develop neutropenia after chemotherapy, those undergoing bone‑marrow transplantation, and individuals requiring peripheral blood stem‑cell mobilization.
How does lenograstim work to increase neutrophil counts?+
Lenograstim binds to the G‑CSF receptor on hematopoietic progenitor cells, stimulating their proliferation, differentiation, and activation into mature neutrophils.
Can Granocyte be given both intravenously and subcutaneously?+
Yes, the injectable solution is approved for administration by either intravenous infusion or subcutaneous injection, depending on clinical need.
What are the most frequently reported side effects of Granocyte?+
Common adverse effects include bone pain, mild fever or flu‑like symptoms, injection‑site redness or discomfort, and occasional nausea or mild gastrointestinal upset.
What serious adverse events should clinicians monitor for during Granocyte therapy?+
Serious events, although rare, can include splenic rupture or enlargement, acute respiratory distress syndrome, severe allergic reactions such as anaphylaxis, and capillary leak syndrome.
Are there any specific patient conditions that require extra caution before starting Granocyte?+
Patients with a history of splenic disorders, recent abdominal trauma, or known hypersensitivity to lenograstim or its excipients should be evaluated carefully before treatment.
Is Granocyte compatible with live vaccines?+
Live vaccines are generally avoided during Granocyte therapy because the altered immune response may affect vaccine efficacy and safety.
Should Granocyte be used together with other growth factors or high‑dose steroids?+
Concurrent use of additional granulocyte colony‑stimulating factors or high‑dose corticosteroids is discouraged unless directed by a specialist, due to potential overlapping effects.
What monitoring is recommended while a patient receives Granocyte?+
Regular blood counts to assess neutrophil recovery, evaluation for signs of infection or fever, and observation for bone pain or unexpected systemic reactions are recommended.
Is there any information on the safety of Granocyte during pregnancy or breastfeeding?+
Safety data for lenograstim in pregnancy and lactation are limited; the pregnancy category is listed as unknown, so risk‑benefit assessment is required.
What ATC classification does Granocyte belong to?+
Granocyte is classified under the Anatomical Therapeutic Chemical (ATC) code L03AA02, which denotes granulocyte colony‑stimulating factors.
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
Sanofi-Aventis Monoprosopi A.E.B.E
Origin
EU

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