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

Lenalidomid Stada

Active Ingredient:
Lenalidomide
Origin:
EU

Lenalidomid Stada (Lenalidomide)

Lenalidomide, the active ingredient in Lenalidomid Stada, is an immunomodulatory drug (IMiD) presented as an oral formulation for systemic use. Approved in the European Union, it is used to treat multiple myeloma, mantle cell lymphoma, and myelodysplastic syndromes with del(5q) in adult patients.

GNH India supplies Lenalidomid Stada as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, oncology centres, pharmacies and clinics worldwide. Our distribution network ensures reliable delivery and regulatory compliance across multiple regions, including adherence to local import requirements and quality standards.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

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

  • Multiple myeloma: improves progression‑free survival and overall response rates in patients with relapsed or refractory disease.
  • Mantle cell lymphoma: induces tumor regression and prolongs remission when combined with standard chemotherapy.
  • Myelodysplastic syndromes with del(5q): corrects ineffective hematopoiesis and reduces transfusion dependence.

How It Works

  • Lenalidomide binds to the cereblon subunit of the CRL4^CRBN E3 ubiquitin ligase complex, altering its substrate specificity. This leads to ubiquitination and proteasomal degradation of transcription factors Ikaros (IKZF1) and Aiolos (IKZF3), resulting in anti‑angiogenic, anti‑proliferative and immunomodulatory actions that suppress malignant plasma cells and modulate the tumor microenvironment.

Side Effects

Lenalidomide may cause a range of adverse reactions, varying in frequency and severity.

Common Side Effects

  • Neutropenia: reduced neutrophil count increasing infection risk.
  • Thrombocytopenia: low platelet levels leading to bleeding tendencies.
  • Fatigue: persistent tiredness affecting daily activities.
  • Diarrhea: loose stools that may require supportive care.
  • Rash: mild skin eruptions or itching.

Serious or Rare Side Effects

  • Venous thromboembolism: deep vein thrombosis or pulmonary embolism.
  • Severe neutropenia: markedly low neutrophils with fever.
  • Secondary primary malignancies: emergence of new cancers.
  • Hepatotoxicity: elevated liver enzymes or liver injury.
  • Embryo‑fetal toxicity: high risk of birth defects if exposure occurs during pregnancy.

Precautions & Warnings

When prescribing Lenalidomide, clinicians should observe several safety precautions to minimize risks.

  • Pregnancy contraindication: drug is category X; avoid use in pregnant women and ensure effective contraception.
  • Thromboembolic risk: assess need for prophylactic anticoagulation in patients with additional risk factors.
  • Renal impairment: adjust monitoring and consider dose modification in patients with reduced kidney function.
  • Hematologic monitoring: perform regular complete blood counts to detect neutropenia or thrombocytopenia.
  • Drug interactions: review concomitant medications for potential major interactions.
  • Store at ambient temperature: keep below 25 °C in the original packaging, protect from moisture and light.

Avoid Interactions

Lenalidomide can interact with other medicines, influencing its efficacy or safety profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce Lenalidomide exposure.
  • Anticoagulants (warfarin, direct oral anticoagulants): increased risk of bleeding when combined with thrombocytopenia.

Moderate Interactions (Monitor Closely)

  • P‑glycoprotein inhibitors (e.g., verapamil): may raise plasma levels modestly.
  • Immunosuppressants (e.g., cyclosporine): potential additive hematologic toxicity.
  • Hormonal contraceptives: reduced effectiveness; advise additional non‑hormonal methods.

Frequently Asked Questions

Lenalidomid Stada is indicated for adult patients with multiple myeloma, mantle cell lymphoma, and myelodysplastic syndromes that carry the del(5q) chromosomal abnormality. In each of these hematologic cancers, the drug helps control disease progression and can improve survival outcomes when used as part of an approved therapeutic regimen.

Lenalidomide binds to cereblon, a component of the CRL4^CRBN E3 ubiquitin ligase complex. This binding changes the complex’s substrate preference, leading to the ubiquitination and subsequent proteasomal degradation of transcription factors Ikaros and Aiolos. The loss of these proteins produces anti‑angiogenic, anti‑proliferative, and immunomodulatory effects that suppress malignant plasma cells and modify the tumor microenvironment.

The dose of Lenalidomid Stada is individualized and set by the prescribing physician based on the specific indication, disease stage, patient’s renal function, prior therapies, and overall health status. Clinicians follow approved labeling and clinical guidelines to select the appropriate starting dose and any necessary adjustments.

Lenalidomid Stada is classified as pregnancy category X, meaning it is contraindicated in pregnancy because it can cause severe fetal harm, including birth defects. Women of child‑bearing potential must use effective contraception during treatment and for a defined period after the last dose. Breastfeeding is not recommended, as the drug may be excreted in milk.

To request Lenalidomid Stada, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, and will ask for trade or institutional credentials. After verification, the sales team provides pricing, availability, shipping details (including any cold‑chain requirements), and assists with import documentation.

Lenalidomid Stada belongs to the same class of immunomodulatory drugs (IMiDs) as thalidomide and pomalidomide. Compared with thalidomide, lenalidomide generally offers greater potency with a more favorable peripheral neuropathy profile, while still sharing risks such as thrombosis and embryofetal toxicity. Pomalidomide is often reserved for patients who have progressed after lenalidomide therapy, reflecting a stepwise treatment approach within the class.

Lenalidomid 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 exposure to extreme heat. Do not refrigerate or freeze the tablets, as this could affect their stability.

Lenalidomid Stada is taken orally, usually as whole tablets swallowed with water. It can be taken with or without food, but patients should follow the prescribing physician’s instructions regarding timing relative to meals. The medication should not be crushed, chewed, or split unless specifically directed by a healthcare professional.

The most serious risks include venous thromboembolism (blood clots), severe neutropenia that can lead to life‑threatening infections, and embryo‑fetal toxicity that can cause major birth defects. Patients should be monitored closely for signs of clotting, infection, and any unexpected bleeding, and strict contraception must be used throughout treatment.

Lenalidomid Stada should not be used by pregnant women or women who could become pregnant without effective contraception. It is also contraindicated in patients with known hypersensitivity to lenalidomide or any component of the formulation. Caution is advised for individuals with severe renal impairment, uncontrolled infections, or a history of thromboembolic events, and the prescriber should evaluate suitability before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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