Product image of Lenalidomide Stada (Lenalidomide) supplied by GNH India

Lenalidomide Stada

Active Ingredient:
Lenalidomide
Origin:
EU

Lenalidomide Stada (Lenalidomide)

Lenalidomide, the active ingredient in Lenalidomide Stada, is an immunomodulatory drug (IMiD) presented as an oral formulation for oral use. It is employed in the treatment of certain blood cancers, specifically multiple myeloma and myelodysplastic syndromes with deletion 5q, and is prescribed for adult patients under specialist supervision.

GNH India supplies Lenalidomide Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches to hospitals, pharmacies and clinical trial sites.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Lenalidomide is an immunomodulatory agent used in hematologic malignancies and related disorders.

  • Multiple Myeloma: improves disease control and prolongs survival in patients with relapsed or refractory disease.
  • Myelodysplastic Syndromes with del(5q): reduces transfusion dependence and can lead to cytogenetic remission.
  • Mantle Cell Lymphoma: used in relapsed or refractory cases to achieve tumor reduction.

How It Works

  • Lenalidomide binds to the cereblon component of the CRL4‑E3 ubiquitin ligase complex, altering its substrate specificity. This interaction promotes ubiquitination and proteasomal degradation of transcription factors Ikaros (IKZF1) and Aiolos (IKZF3), leading to reduced proliferation of malignant plasma cells, inhibition of angiogenesis, and modulation of cytokine production that enhances immune‑mediated tumor clearance.

Side Effects

Lenalidomide may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Neutropenia: decreased neutrophil count.
  • Thrombocytopenia: reduced platelet levels.
  • Fatigue: persistent tiredness.
  • Diarrhea: loose stools.
  • Rash: skin irritation.
  • Constipation: difficulty passing stool.

Serious or Rare Side Effects

  • Venous thromboembolism: blood clots in veins.
  • Severe cutaneous reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Secondary primary malignancies: emergence of new cancers.
  • Hepatic failure: serious liver injury.
  • Tumor lysis syndrome: rapid tumor cell breakdown.
  • Anaphylaxis: life‑threatening allergic reaction.

Precautions & Warnings

When prescribing Lenalidomide, clinicians should observe several safety measures to minimize risk.

  • Pregnancy: contraindicated; teratogenic, use effective contraception.
  • Thromboembolism risk: assess and consider prophylactic anticoagulation.
  • Hematologic monitoring: regular CBC to detect neutropenia or thrombocytopenia.
  • Infection risk: monitor for signs of infection and manage promptly.
  • Renal impairment: adjust dose in patients with reduced kidney function.
  • Store at ambient temperature: keep below 25 °C, in original container, protect from moisture.

Avoid Interactions

Lenalidomide interacts with several drug classes; awareness of these interactions helps avoid adverse outcomes.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase lenalidomide exposure.
  • Strong CYP3A4 inducers (e.g., rifampin): may reduce efficacy.
  • Anticoagulants (e.g., warfarin): heightened bleeding risk.

Moderate Interactions (Monitor Closely)

  • NSAIDs: additive risk of gastrointestinal bleeding.
  • Antiplatelet agents (e.g., aspirin): monitor for bleeding.
  • Hormonal contraceptives: reduced effectiveness, consider alternative methods.
  • Live vaccines: increased infection risk, avoid during therapy.

Frequently Asked Questions

Lenalidomide Stada is indicated for the treatment of multiple myeloma, myelodysplastic syndromes that carry a deletion of chromosome 5q, and mantle cell lymphoma that has relapsed or is refractory to prior therapy. These are hematologic malignancies where the drug’s immunomodulatory and anti‑angiogenic actions provide clinical benefit.

Lenalidomide binds to the cereblon subunit of the CRL4‑E3 ubiquitin ligase complex, changing its target profile. This leads to the ubiquitination and proteasomal degradation of transcription factors Ikaros and Aiolos, which suppresses malignant plasma‑cell growth, inhibits new blood‑vessel formation, and enhances immune‑mediated tumor killing.

The specific dose of Lenalidomide Stada is determined by the prescribing physician based on the patient’s diagnosis, disease stage, renal function, and other clinical factors. Dosing regimens may differ between multiple myeloma, MDS with del(5q), and mantle‑cell lymphoma, and should follow the latest approved labeling and clinical guidelines.

Lenalidomide is classified as Pregnancy Category X because it is known to cause fetal harm. It is contraindicated in pregnancy, and effective contraception must be used by both male and female patients of reproductive potential. The drug is also not recommended while breastfeeding, as it may be excreted in milk and affect the infant.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India 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.

Lenalidomide belongs to the immunomodulatory drug class, offering a distinct mechanism from proteasome inhibitors or monoclonal antibodies. It is often used in combination regimens and provides benefits such as oral administration and anti‑angiogenic effects. Compared with older agents like thalidomide, Lenalidomide generally has a more favorable side‑effect profile, especially regarding neuropathy.

Lenalidomide Stada should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid storing it in bathrooms or other humid environments.

Lenalidomide Stada is taken orally, usually once daily, with or without food, as directed by the treating physician. The tablets should be swallowed whole with a glass of water and not crushed or chewed unless specifically instructed.

The most serious risks include severe neutropenia or thrombocytopenia that can lead to infection or bleeding, venous thromboembolism, life‑threatening skin reactions such as Stevens‑Johnson syndrome, secondary primary malignancies, and hepatic failure. Patients should be monitored closely for these events throughout treatment.

Lenalidomide Stada is contraindicated in pregnant women, patients with known hypersensitivity to lenalidomide or any component of the formulation, and individuals who cannot comply with required contraception measures. Caution is also advised for patients with severe renal impairment, uncontrolled infections, or a history of thromboembolic events.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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