Product image of Lenalidomide Fresenius Kabi (Lenalidomide) supplied by GNH India

Lenalidomide Fresenius Kabi

Active Ingredient:
Lenalidomide
Origin:
EU

Lenalidomide Fresenius Kabi (Lenalidomide)

Lenalidomide, the active ingredient in Lenalidomide Fresenius Kabi, is an immunomodulatory drug presented as an oral formulation 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 India supplies Lenalidomide Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies, clinics and procurement teams worldwide, with reliable logistics and regulatory support.

Manufacturer / TM Owner

Fresenius Kabi Nederland B.V.

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Indications & Clinical Uses

Lenalidomide is an immunomodulatory agent used in hematologic malignancies.

  • Multiple Myeloma: improves progression‑free survival and overall response rates in relapsed or refractory disease.
  • Myelodysplastic Syndromes with del(5q): reduces transfusion dependence and can induce cytogenetic remission.
  • Mantle Cell Lymphoma: contributes to disease control when used in combination therapy.

How It Works

  • Lenalidomide binds to cereblon, a component of the CRL4‑E3 ubiquitin ligase complex, altering its substrate specificity. This promotes ubiquitination and proteasomal degradation of transcription factors Ikaros (IKZF1) and Aiolos (IKZF3), leading to inhibition of angiogenesis, modulation of cytokine production, and activation of T‑ and NK‑cell mediated anti‑tumor immunity, resulting in anti‑proliferative and pro‑apoptotic effects in malignant hematologic cells.

Side Effects

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

Common Side Effects

  • Fatigue: persistent tiredness affecting daily activities.
  • Diarrhea: loose stools that may be mild to moderate.
  • Nausea: feeling of sickness often accompanied by vomiting.
  • Rash: skin redness or mild eruption.
  • Constipation: difficulty passing stools.
  • Peripheral neuropathy: tingling or numbness in extremities.

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 primary malignancies: emergence of new cancers.
  • Severe cutaneous reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

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

  • Pregnancy risk: contraindicated in pregnancy (Category X); ensure effective contraception for both male and female patients.
  • Thrombosis prophylaxis: assess need for anticoagulation in patients with additional risk factors.
  • Renal impairment: adjust monitoring and dosing in patients with reduced kidney function.
  • Hepatic impairment: monitor liver function tests regularly.
  • Infections: monitor for signs of infection and manage promptly.
  • Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and light.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inducers: may reduce lenalidomide exposure (e.g., rifampin, carbamazepine).
  • Anticoagulants: increased risk of bleeding when combined with warfarin or direct oral anticoagulants.
  • Immunosuppressants: heightened risk of infection when used with high‑dose steroids or cyclosporine.

Moderate Interactions (Monitor Closely)

  • P‑glycoprotein substrates: may alter plasma levels (e.g., digoxin).
  • Vaccines: live attenuated vaccines may be less effective; avoid during therapy.
  • Hormonal contraceptives: reduced efficacy; consider additional barrier methods.

Frequently Asked Questions

Lenalidomide Fresenius Kabi 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 response rates, and reduce the need for blood transfusions where applicable.

Lenalidomide binds to the cereblon component of the CRL4‑E3 ubiquitin ligase complex, changing the complex’s substrate specificity. This leads to the degradation of transcription factors Ikaros and Aiolos, which suppresses angiogenesis, modulates cytokine release, and enhances T‑ and NK‑cell anti‑tumor activity, producing anti‑proliferative and pro‑apoptotic effects in malignant cells.

The dose of Lenalidomide is individualized by the prescribing physician based on the specific indication, disease stage, renal function, and patient tolerance. Healthcare providers determine the appropriate strength, schedule, and any necessary dose adjustments, and patients should follow the prescriber’s written instructions exactly.

Lenalidomide is classified as Pregnancy Category X, meaning it is contraindicated in pregnancy because of a high risk of fetal harm. Women of childbearing potential must use effective contraception. Breastfeeding is not recommended while taking Lenalidomide, as the drug may be excreted in milk and could 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 assistance with import documentation.

The primary alternative within the same class is thalidomide, while pomalidomide is a newer analogue. Compared with thalidomide, Lenalidomide generally offers a more favorable safety profile, especially regarding peripheral neuropathy, and provides stronger anti‑angiogenic and immunomodulatory effects. Pomalidomide may be used after Lenalidomide failure, but it can have a higher risk of hematologic toxicity.

Lenalidomide 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 ensure the container is tightly closed. Do not store in a refrigerator or freezer unless the manufacturer’s labeling specifically indicates otherwise.

Lenalidomide is taken orally, usually as a tablet, with or without food according to the prescriber’s instructions. The medication should be swallowed whole with a full glass of water, and patients should follow any specific timing recommendations provided by their healthcare professional.

The most serious risks include thromboembolic events such as deep‑vein thrombosis or pulmonary embolism, severe neutropenia leading to infection, hepatotoxicity indicated by elevated liver enzymes, and the potential development of secondary primary malignancies. Patients should be monitored regularly for signs of these conditions and report any concerning symptoms promptly.

Lenalidomide is contraindicated in pregnant women and in individuals who are unable to use effective contraception. It should also be avoided in patients with known hypersensitivity to Lenalidomide or any component of the formulation, and caution is advised in those with severe renal or hepatic impairment where the risk‑benefit ratio must be carefully evaluated.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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