Product image of Lemtrada (Alemtuzumab) supplied by GNH India

Lemtrada

Active Ingredient:
Alemtuzumab
Origin:
EU

Lemtrada (Alemtuzumab)

Alemtuzumab, the active ingredient in Lemtrada, is a humanized monoclonal antibody presented as an intravenous solution for infusion. It is used as a disease-modifying therapy for relapsing forms of multiple sclerosis in adult patients.

GNH India supplies Lemtrada as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable access to this specialty biologic for qualified healthcare providers. The company adheres to stringent quality standards and offers temperature-controlled logistics to maintain product integrity during global distribution.

Manufacturer / TM Owner

Sanofi Belgium

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Indications & Clinical Uses

Lemtrada (alemtuzumab) is a humanized monoclonal antibody approved as a disease-modifying therapy for multiple sclerosis. It is administered intravenously and is indicated for patients with relapsing disease activity, offering a targeted approach to reduce relapses and disability progression.

  • Relapsing‑remitting multiple sclerosis: in adult patients it significantly lowers the annualized relapse rate, reduces the number of new MRI lesions, and delays the accumulation of disability over time.
  • Active secondary progressive multiple sclerosis with relapses: provides disease-modifying benefit by decreasing relapse frequency and may modestly slow the progression of disability in patients who have experienced recent disease activity.

How It Works

  • Alemtuzumab binds with high affinity to the CD52 antigen expressed on the surface of mature T and B lymphocytes. This binding triggers antibody‑dependent cellular cytotoxicity and complement‑mediated lysis, leading to rapid and profound depletion of circulating lymphocytes. The depletion is followed by a gradual repopulation of lymphocyte subsets, which is thought to reset the immune system toward a less autoreactive profile.

Side Effects

Lemtrada may be associated with a range of adverse reactions, varying in frequency and severity.

Common Side Effects

  • Infusion‑related reactions: fever, chills, flushing, hypotension, or dyspnea occurring during or shortly after the IV infusion.
  • Skin reactions: rash, pruritus, or mild erythema that may appear within days of treatment.
  • Gastrointestinal symptoms: nausea, vomiting, or abdominal discomfort.

Serious or Rare Side Effects

  • Autoimmune thyroid disease: hyperthyroidism, hypothyroidism, or thyroiditis requiring endocrine monitoring.
  • Immune‑mediated cytopenias: thrombocytopenia, neutropenia, or hemolytic anemia that can be severe.
  • Serious infections: reactivation of herpes viruses, opportunistic bacterial or fungal infections, and sepsis.

Precautions & Warnings

When using Lemtrada, clinicians should observe several precautionary measures to minimize risks and ensure optimal patient outcomes.

  • Baseline screening: perform complete blood count, renal function, and thyroid function tests before initiating therapy.
  • Infection monitoring: assess for active infections and vaccinate appropriately prior to infusion.
  • Autoimmune surveillance: regularly monitor thyroid antibodies and complete blood counts during and after treatment.
  • Pregnancy and lactation: avoid use in pregnant or breastfeeding women unless benefits outweigh risks; discuss with specialist.
  • Concomitant immunosuppression: limit use of other immunosuppressive agents to reduce infection risk.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the infusion solution.

Avoid Interactions

Lemtrada can interact with other medicines that affect the immune system or increase infection risk.

Major Interactions (Avoid)

  • Live vaccines: administration during or up to 6 months after treatment can cause severe infection.
  • Other potent immunosuppressants (e.g., cyclophosphamide, azathioprine): may exacerbate lymphocyte depletion and infection risk.

Moderate Interactions (Monitor Closely)

  • Antiviral prophylaxis agents (e.g., acyclovir): may be required to prevent herpes reactivation.
  • Hormonal contraceptives: immune modulation may alter efficacy; consider alternative methods.
  • Thyroid hormone replacement: dose adjustments may be needed due to autoimmune thyroid changes.
  • Inactivated vaccines: may have reduced immunogenicity; assess antibody titers where appropriate.

Frequently Asked Questions

Lemtrada (alemtuzumab) is indicated as a disease-modifying therapy for the treatment of relapsing forms of multiple sclerosis in adult patients. It helps reduce the frequency of clinical relapses and can slow the progression of disability associated with the disease.

Alemtuzumab targets the CD52 antigen on mature T and B lymphocytes. By binding to CD52, it triggers antibody‑dependent cellular cytotoxicity and complement‑mediated lysis, leading to rapid depletion of these immune cells. The subsequent immune reconstitution is thought to reduce the autoimmune activity that drives multiple sclerosis.

The dosing regimen for Lemtrada is determined by the prescribing physician based on the approved label, patient characteristics, and clinical judgment. Specific dosing information, including infusion volume and schedule, should be obtained from the healthcare professional overseeing the patient’s treatment.

The safety of Lemtrada in pregnancy or while breastfeeding has not been established. It is generally avoided in these situations unless the potential benefits outweigh the risks, and the decision should be made in consultation with a specialist familiar with the patient’s condition.

To order Lemtrada, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details (including cold‑chain handling if needed) and import documentation.

Lemtrada is a monoclonal antibody that depletes lymphocytes, offering a distinct mechanism compared with interferon‑beta or oral agents that modulate immune signaling. It is typically reserved for patients with high disease activity or those who have not responded adequately to first‑line therapies, providing an alternative option with a different risk‑benefit profile.

Lemtrada should be stored at 2‑8 °C (refrigerated). Keep the infusion solution in its original packaging, protect it from light, and do not freeze or shake the vial. Follow any additional handling instructions provided by the manufacturer to maintain product stability.

Lemtrada is given as an intravenous infusion in a clinical setting. The infusion is typically performed over several hours on the first day, followed by a second infusion a few days later, with subsequent courses administered annually according to the prescribing information.

The most serious risks include autoimmune disorders such as thyroid disease, immune‑mediated cytopenias, and severe infections. Renal complications like anti‑glomerular basement membrane disease have also been reported. Patients should be monitored closely for these events throughout treatment and during the post‑treatment follow‑up period.

Lemtrada is contraindicated in patients with active infections, known hypersensitivity to alemtuzumab or any component of the formulation, and in individuals who have received live vaccines within four weeks prior to treatment. Caution is also advised for patients with a history of autoimmune disease or severe organ dysfunction.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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