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 monoclonal antibody presented as a 12 mg/mL intravenous solution for intravenous use. It is indicated for the treatment of relapsing‑remitting multiple sclerosis in adult patients, helping to reduce relapse frequency and slow disability progression.

GNH India supplies Lemtrada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, ensuring consistent quality, regulatory compliance and reliable cold‑chain logistics for biologic medicines through its global network of certified partners.

Manufacturer / TM Owner

Sanofi Belgium

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Indications & Clinical Uses

Lemtrada (alemtuzumab) is a disease‑modifying therapy that targets immune activity in multiple sclerosis.

  • Relapsing‑remitting multiple sclerosis: reduces the annualized relapse rate, delays accumulation of disability, and lowers the risk of sustained disease progression.
  • Active disease in adult RRMS patients: decreases the number of new or enlarging MRI lesions, improves radiological disease activity, and contributes to longer periods of relapse‑free status.
  • High‑activity RRMS: provides sustained disease control and may be considered when previous disease‑modifying therapies have not achieved adequate response.

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 subsequent immune reconstitution alters the autoreactive immune repertoire, thereby reducing the inflammatory attacks that drive multiple sclerosis pathology. The lymphocyte nadir typically occurs within days after infusion, and gradual repopulation occurs over several months.

Side Effects

Alemtuzumab is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Infusion‑related reactions (fever, chills, rash, hypotension)
  • Headache
  • Nausea
  • Fatigue
  • Lymphopenia
  • Upper respiratory tract infections

Serious or Rare Side Effects

  • Autoimmune thyroid disease (hyper‑ or hypothyroidism)
  • Immune thrombocytopenic purpura
  • Nephropathies (e.g., membranous nephropathy)
  • Serious infections (herpesvirus, opportunistic)
  • Malignancies (e.g., thyroid cancer)
  • Severe infusion reactions (anaphylaxis)

Precautions & Warnings

Prior to initiating alemtuzumab therapy, clinicians should observe several precautionary measures to minimise risks.

  • Baseline blood counts: obtain complete blood count and lymphocyte subsets before first infusion.
  • Thyroid function testing: screen TSH and free T4 prior to treatment and monitor periodically.
  • Infection risk assessment: evaluate for active infections and vaccinate according to guidelines, avoiding live vaccines.
  • Contraception: advise both male and female patients to use effective contraception during treatment and for several months after.
  • Monitoring for autoimmunity: conduct regular clinical and laboratory surveillance for autoimmune disorders throughout the first 48 months.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Alemtuzumab may interact with other medicines, affecting efficacy or safety.

Major Interactions (Avoid)

  • Live attenuated vaccines: may cause severe infection; avoid administration during and after treatment.
  • Concurrent use of other potent immunosuppressants (e.g., high‑dose steroids, cyclophosphamide): increases risk of serious infections.
  • Antithymocyte globulin: additive lymphocyte depletion leading to profound immunosuppression.

Moderate Interactions (Monitor Closely)

  • Vaccines containing inactivated antigens: efficacy may be reduced; assess antibody response.
  • Antiviral prophylaxis (e.g., acyclovir): may be required to prevent herpes reactivation.
  • Hormonal contraceptives: monitor for reduced effectiveness due to immune changes.

Frequently Asked Questions

Lemtrada is the brand name for alemtuzumab, a disease‑modifying therapy indicated for the treatment of relapsing‑remitting multiple sclerosis in adult patients. It helps to lower the frequency of clinical relapses and to slow the accumulation of disability associated with the disease.

Alemtuzumab binds to the CD52 antigen on mature T and B lymphocytes, triggering antibody‑dependent cellular cytotoxicity and complement‑mediated lysis. This results in rapid depletion of circulating lymphocytes, followed by immune reconstitution that reduces the autoreactive immune response responsible for multiple sclerosis attacks.

The dosing regimen for Lemtrada is determined by the prescribing physician based on the patient’s clinical condition, body weight and regulatory guidelines. Specific dose amounts, infusion rates and treatment intervals are individualized and should be obtained from the treating neurologist or specialist.

Lemtrada is classified as Pregnancy Category C, indicating that risk to the fetus cannot be ruled out. It is generally recommended to avoid use during pregnancy and to discontinue treatment before conception if possible. Breastfeeding is not advised while receiving alemtuzumab because the drug may be excreted in milk.

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. After confirmation, the team provides pricing, availability, cold‑chain shipping details and any necessary import documentation.

The principal alternatives for relapsing‑remitting multiple sclerosis include other monoclonal antibodies such as ocrelizumab and natalizumab. Compared with ocrelizumab, alemtuzumab induces a deeper, though transient, lymphocyte depletion and may offer longer intervals between dosing. Natalizumab works by blocking cell adhesion rather than depleting lymphocytes, and carries a different risk profile, notably a higher association with progressive multifocal leukoencephalopathy.

Lemtrada must be stored refrigerated at 2 °C to 8 °C. The product should be kept in its original packaging, protected from light, and must never be frozen or shaken. Prior to infusion, the solution is inspected for particulate matter and may be gently mixed if required, following the manufacturer’s instructions.

Lemtrada is administered as an intravenous infusion in a clinical setting. The initial course typically consists of two treatment cycles given on separate days, followed by additional courses at defined intervals, each lasting several hours. Infusion rates are gradually increased under medical supervision, and patients are monitored for infusion‑related reactions throughout the procedure.

Serious risks include the development of autoimmune disorders such as thyroid disease, immune thrombocytopenic purpura, and nephropathies; severe infections including opportunistic pathogens; and an increased incidence of certain malignancies, notably thyroid cancer. Patients should undergo regular laboratory monitoring and clinical assessment to detect these conditions early.

Lemtrada is contraindicated in individuals with known hypersensitivity to alemtuzumab or any of its excipients, in patients with active infections, and in those who are pregnant or planning pregnancy without appropriate contraception. Caution is also advised for patients with a history of autoimmune disease, severe cardiac or pulmonary conditions, or those receiving other potent immunosuppressive agents.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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