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

Lenalidomida Stada

Active Ingredient:
Lenalidomide
Origin:
EU

Lenalidomida Stada (Lenalidomide)

Lenalidomide, the active ingredient in Lenalidomida Stada, is an immunomodulatory agent (IMiD) presented as an oral formulation for oral use. It is employed in the treatment of certain hematologic malignancies, including multiple myeloma, myelodysplastic syndromes with del(5q), and mantle cell lymphoma, in adult patients.

GNH India supplies Lenalidomida Stada as a licensed, GDP‑compliant international pharmaceutical product serving hospitals, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution, ensuring product integrity throughout the supply chain.

Manufacturer / TM Owner

Stada Lda.

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Indications & Clinical Uses

  • Lenalidomide is used in hematologic oncology to target malignant plasma cells and related disorders.
  • Multiple Myeloma: improves progression‑free survival and overall response rates in adult patients.
  • Myelodysplastic Syndromes with del(5q): reduces transfusion dependence and may improve cytopenias.
  • Mantle Cell Lymphoma: used in combination regimens to achieve disease control in relapsed or refractory cases.

How It Works

  • Lenalidomide binds to the cereblon component of the CRL4‑CRBN E3 ubiquitin ligase complex, modifying its substrate specificity. This leads to ubiquitination and proteasomal degradation of transcription factors Ikaros (IKZF1) and Aiolos (IKZF3), resulting in anti‑angiogenic activity, modulation of cytokine production, enhanced immune‑mediated tumor cell killing, and direct antiproliferative effects on malignant cells. It also influences the tumor microenvironment by decreasing pro‑survival signaling pathways.

Side Effects

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

Common Side Effects

  • Fatigue: persistent tiredness or lack of energy.
  • Diarrhea: loose stools that may be mild to moderate.
  • Rash: skin redness or itching.
  • Nausea: feeling of sickness or urge to vomit.

Serious or Rare Side Effects

  • Thromboembolic events: deep vein thrombosis or pulmonary embolism.
  • Severe neutropenia: marked reduction in neutrophil count increasing infection risk.
  • Hepatotoxicity: elevated liver enzymes or liver injury.
  • Secondary malignancies: emergence of new cancers during therapy.

Precautions & Warnings

When prescribing Lenalidomida Stada, clinicians should observe several safety considerations.

  • Pregnancy risk: contraindicated in pregnancy (Category X); ensure effective contraception.
  • Thrombosis monitoring: assess risk factors and consider prophylactic anticoagulation.
  • Hematologic monitoring: regular complete blood counts to detect neutropenia or anemia.
  • Renal function: adjust use in patients with impaired kidney function.
  • Hepatic function: monitor liver enzymes during treatment.
  • Store at ambient temperature: keep below 25 °C, in the original packaging, protected from moisture and light.

Avoid Interactions

Lenalidomide can interact with other medicines, affecting efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers: may reduce lenalidomide exposure.
  • Anticoagulants (e.g., warfarin): increased risk of bleeding.
  • Immunosuppressants: heightened risk of infection.

Moderate Interactions (Monitor Closely)

  • P-glycoprotein inhibitors: may increase plasma levels.
  • Vaccines: live attenuated vaccines should be avoided.
  • NSAIDs: may exacerbate renal toxicity.

Frequently Asked Questions

Lenalidomida Stada, containing lenalidomide, is indicated for adult patients with multiple myeloma, myelodysplastic syndromes that have a deletion of chromosome 5q, and mantle cell lymphoma. In each case the drug is used as part of a therapeutic regimen aimed at controlling disease progression and improving patient outcomes.

Lenalidomide binds to cereblon, a component of the CRL4‑CRBN E3 ubiquitin ligase complex, altering its activity. This triggers the degradation of transcription factors Ikaros and Aiolos, which leads to anti‑angiogenic effects, modulation of cytokine release, enhanced immune‑mediated tumor cell killing, and direct inhibition of malignant cell growth.

The prescribed dose of Lenalidomida Stada is individualized by the treating physician based on the specific indication, disease stage, patient’s renal and hepatic function, and any concomitant therapies. No universal dosing schedule is provided; the prescriber sets the appropriate regimen for each patient.

Lenalidomida Stada is classified as Pregnancy Category X, meaning it is contraindicated in pregnancy because of a high risk of fetal harm. It should not be used by breastfeeding mothers, and effective contraception is required for women of child‑bearing potential during treatment and for a defined period after the last dose.

To place an order, submit an enquiry on the Lenalidomida Stada 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.

The primary alternative to lenalidomide is thalidomide, another immunomodulatory agent. Lenalidomide generally offers a more favorable safety profile, with lower rates of peripheral neuropathy, and stronger anti‑angiogenic and immune‑modulating activity. Pomalidomide is a newer analogue that may be used after lenalidomide failure, but it can have higher hematologic toxicity.

Lenalidomida Stada should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and avoid storing it in areas with high humidity or temperature fluctuations to maintain potency.

Lenalidomida Stada is taken orally, usually with a glass of water. The tablet can be swallowed with or without food, unless the prescribing physician advises otherwise. Patients should follow the dosing schedule provided by their healthcare professional and not alter the regimen without medical guidance.

Serious risks include thromboembolic events such as deep‑vein thrombosis or pulmonary embolism, severe neutropenia that can predispose to infections, hepatotoxicity indicated by elevated liver enzymes, and the possible development of secondary malignancies. Prompt reporting of any unusual symptoms to a healthcare provider is essential.

Lenalidomida Stada should not be used by pregnant women or women who may become pregnant without effective contraception. Patients with known hypersensitivity to lenalidomide or any component of the formulation should avoid it. Caution is also advised for individuals with severe renal impairment, uncontrolled infections, or a history of thromboembolic disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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