GNH USA

Europe — EMA

Lenalidomide Stada

GNH USA supplies Lenalidomide Stada (Lenalidomide), an antineoplastic for multiple myeloma, MDS with del(5q) and mantle cell lymphoma.

Lenalidomide

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What is Lenalidomide?

Lenalidomide, the active ingredient in Lenalidomide Stada, is an immunomodulatory antineoplastic presented as an oral tablet for oral use. It is indicated for the treatment of multiple myeloma, myelodysplastic syndromes with del(5q), and mantle cell lymphoma in adult patients.

GNH USA supplies Lenalidomide Stada as a licensed, GDP‑compliant international pharmaceutical product to hospitals, oncology centres, pharmacies and clinics worldwide, ensuring reliable quality and regulatory conformity across global markets. The company manages end‑to‑end logistics, documentation and post‑market support for each shipment.

What is Lenalidomide used for?

Lenalidomide is used in hematologic malignancies that respond to immunomodulatory therapy.

Multiple Myeloma: prolongs progression‑free survival and overall survival, and may deepen response when combined with dexamethasone in eligible patients. Myelodysplastic Syndromes with del(5q): reduces transfusion dependence, improves hemoglobin levels and platelet counts, and can lead to cytogenetic remission in appropriate patients. Mantle Cell Lymphoma: induces partial and complete responses, extends duration of remission, and is used after failure of prior chemo‑immunotherapy regimens. Maintenance Therapy in Multiple Myeloma: helps sustain remission after initial response and may delay disease progression when administered continuously.

What are the side effects of Lenalidomide?

Lenalidomide may cause a range of adverse reactions, classified by frequency and severity.

Common Side Effects: - Neutropenia: decreased neutrophil count that can increase susceptibility to bacterial infections. - Thrombocytopenia: reduced platelet levels that may cause easy bruising, petechiae or bleeding. - Fatigue: persistent tiredness that can limit physical activity and affect quality of life. - Gastrointestinal disturbances: nausea, diarrhea, constipation or abdominal discomfort that may require supportive care.

Serious or Rare Side Effects: - Venous thromboembolism: formation of deep‑vein thrombosis or pulmonary embolism, potentially life‑threatening. - Severe skin reactions: rare events such as Stevens‑Johnson syndrome or toxic epidermal necrolysis requiring immediate discontinuation. - Secondary malignancies: possible development of new cancers, including acute myeloid leukemia, during or after therapy.

What precautions apply to Lenalidomide?

Before initiating Lenalidomide therapy, several precautions should be observed to ensure patient safety. - Pregnancy avoidance: contraindicated in pregnancy (Category X); effective contraception must be used for women of childbearing potential. - Renal impairment: dose adjustment and close monitoring of renal function are required in patients with reduced kidney function. - Hematologic monitoring: regular complete blood counts are essential to detect neutropenia or thrombocytopenia early. - Thromboembolic risk: assess need for prophylactic anticoagulation, especially when combined with dexamethasone or other agents. - Drug interactions: review concomitant medications for agents that may increase toxicity or reduce efficacy. - Store at ambient temperature: keep tablets in the original container, protect from moisture and direct sunlight.

What does Lenalidomide interact with?

Lenalidomide interacts with several medicines; understanding the interaction level helps guide clinical decisions.

Major Interactions (Avoid): - Anticoagulants (e.g., warfarin): increased bleeding risk; concurrent use should be avoided or closely monitored. - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce lenalidomide exposure and efficacy. - Live vaccines: heightened risk of infection; vaccination should be avoided during treatment. - Thalidomide: combined use increases risk of severe peripheral neuropathy and hematologic toxicity.

Moderate Interactions (Monitor Closely): - CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase lenalidomide plasma levels, requiring dose adjustment. - NSAIDs or other myelosuppressive agents: additive bone‑marrow suppression may occur, necessitating frequent blood count monitoring. - Antibiotics such as fluoroquinolones: potential QT prolongation when combined with other QT‑prolonging drugs.

Frequently asked questions

What is Lenalidomide Stada used for?+
Lenalidomide Stada is prescribed for adult patients with multiple myeloma, myelodysplastic syndromes that carry the del(5q) chromosomal abnormality, and mantle cell lymphoma. In each condition it aims to control disease progression, improve blood counts, and extend survival when used according to approved clinical guidelines.
How does Lenalidomide work?+
Lenalidomide binds to the cereblon protein within the CRL4‑CRBN E3 ubiquitin ligase complex, changing the complex’s target profile. This triggers ubiquitination and degradation of transcription factors Ikaros and Aiolos, which suppresses malignant cell growth, reduces angiogenesis, and enhances immune‑mediated tumor cell killing.
What is the usual dose of Lenalidomide Stada?+
The dose of Lenalidomide Stada is individualized by the treating physician based on the specific indication, patient characteristics, renal function, and prior therapies. Only a qualified prescriber can determine the appropriate regimen, and patients should follow the prescribed schedule exactly as written.
Is Lenalidomide safe in pregnancy or breastfeeding?+
Lenalidomide is classified as Pregnancy Category X, meaning it is contraindicated during pregnancy because of a high risk of fetal harm. Women of childbearing potential must use effective contraception. The drug is also not recommended while breastfeeding, as it may be excreted in milk and affect the infant.
How do I order Lenalidomide Stada from GNH USA?+
To request Lenalidomide Stada, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.
How does Lenalidomide compare with other IMiDs such as thalidomide or pomalidomide?+
Lenalidomide shares the same cereblon‑binding mechanism as thalidomide and pomalidomide but generally offers a more favorable safety profile, especially regarding peripheral neuropathy. Compared with thalidomide, it provides stronger anti‑angiogenic and immunomodulatory effects. Pomalidomide is often reserved for patients who have progressed after lenalidomide, offering activity in more refractory disease.
How should Lenalidomide Stada be stored and handled?+
Lenalidomide tablets should be stored at ambient temperature, below 25 °C, in the original blister or bottle. Keep the container tightly closed, protect from moisture and direct sunlight, and keep out of reach of children. No refrigeration is required for this oral formulation.
How is Lenalidomide administered?+
Lenalidomide Stada is taken orally, usually with a glass of water. The tablets are swallowed whole and should be taken on an empty stomach unless the prescriber advises otherwise. Dosing frequency and duration are determined by the treating physician based on the specific disease and patient response.
What are the most serious risks to watch for while taking Lenalidomide?+
The most serious risks include severe neutropenia or thrombocytopenia that can lead to infections or bleeding, venous thromboembolism such as deep‑vein thrombosis or pulmonary embolism, and rare but life‑threatening skin reactions like Stevens‑Johnson syndrome. Patients should be monitored regularly for blood counts and signs of clotting or skin changes.
Who should not use Lenalidomide?+
Lenalidomide should not be used by pregnant women, individuals with known hypersensitivity to the drug, or patients with severe renal impairment without appropriate dose adjustment. It is also contraindicated in patients receiving live vaccines and in those with uncontrolled active infections. The prescriber must evaluate each patient’s medical history before initiating therapy.
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
Lenalidomide
Route
Oral Use
Manufacturer
Stada Arzneimittel Ag
Origin
EU

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