Generic Name

ALemtuzumab

Brand Names
Lemtrada, Campath
FDA approval date: November 30, 2009
Classification: CD52-directed Cytolytic Antibody
Form: Injection

What is Lemtrada (ALemtuzumab)?

Living with multiple sclerosis (MS) can feel like your body is working against you fatigue, numbness, and loss of coordination can make everyday activities unpredictable. For many, finding a treatment that slows the disease’s progression and restores stability is life-changing. Lemtrada (alemtuzumab) is one such medication that offers hope to people with relapsing forms of MS who have not responded well to other treatments. 

Lemtrada is a monoclonal antibody, a laboratory-made protein that targets specific cells in the immune system. It belongs to a class of drugs designed to modify the immune response, helping reduce the attacks on the nervous system that cause MS symptoms. While it’s not a first-line treatment, Lemtrada is an important option for patients with active, relapsing multiple sclerosis who have had inadequate results with at least two other disease-modifying therapies. 

Approved by the U.S. Food and Drug Administration (FDA) in 2014, Lemtrada is a specialized therapy administered under close medical supervision. Its unique dosing schedule and long-lasting effects distinguish it from many other MS treatments, offering a chance for extended periods of disease control after just a few annual treatment cycles. 

What does Lemtrada do? 

Lemtrada is used to treat relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS), the most common type of the disease. MS occurs when the immune system mistakenly attacks the protective myelin sheath surrounding nerve fibers in the brain and spinal cord, leading to inflammation and nerve damage. This can cause a wide range of symptoms, from vision problems and fatigue to muscle weakness and cognitive difficulties. 

Lemtrada helps by reducing the number of relapses (flare-ups) and slowing the progression of physical disability. In clinical studies, patients taking Lemtrada experienced significantly fewer relapses and improved or stabilized neurological function compared with those taking other MS therapies (NIH, 2024). 

For many patients, the benefits extend beyond fewer relapses; they often report greater day-to-day stability, reduced fatigue, and better control of symptoms. Because Lemtrada’s effects can last for years after treatment, it offers the possibility of long-term disease management with fewer ongoing doses. 

How does Lemtrada work? 

Lemtrada’s active ingredient, alemtuzumab, works by targeting a specific protein on immune cells called CD52. This protein is found on the surface of certain white blood cells particularly T and B lymphocytes, which are involved in the abnormal immune attack that damages the nervous system in MS. 

When alemtuzumab binds to CD52, it destroys these overactive immune cells, temporarily reducing their numbers in the bloodstream. Over time, the immune system rebuilds itself, but in a more balanced way, with fewer cells that trigger MS attacks. This process, sometimes called immune system “resetting” , is what allows Lemtrada to deliver long-lasting benefits after a short course of treatment. 

Clinically, this mechanism matters because it helps prevent further damage to the brain and spinal cord, protecting nerve function and slowing disability progression. While the immune system is temporarily weakened, careful monitoring ensures patients remain safe throughout recovery. 

Lemtrada side effects 

Because Lemtrada significantly alters the immune system, side effects are possible and can range from mild to serious. Understanding these effects helps patients stay alert and safe during treatment. 

Common side effects may include: 

  • Headache 
     
  • Rash or itching 
     
  • Nausea 
     
  • Fatigue or fever after infusion 
     
  • Infections such as urinary tract or respiratory infections 

Serious side effects (less common): 

  • Infusion reactions, including difficulty breathing, chest pain, or dizziness during or shortly after the infusion 
     
  • Autoimmune conditions, such as thyroid disorders or low platelet counts (which may cause easy bruising or bleeding) 
     
  • Kidney problems 
     
  • Increased risk of certain infections, including viral or bacterial infections 

Lemtrada patients need close monitoring during and after infusions due to increased risk of autoimmune reactions and infections, even years later. Doctors perform regular blood and urine tests for at least four years post-treatment (FDA, 2024). 

Lemtrada is contraindicated for those with active infections, HIV, or severe immune suppression. Pregnant women or those planning pregnancy should discuss risks, as Lemtrada can harm an unborn baby. 

Seek immediate medical help for shortness of breath, facial swelling, severe rash, unexplained bleeding, or signs of infection (fever, persistent sore throat). 

Lemtrada dosage 

Lemtrada is administered via IV infusion in a hospital or clinic under professional supervision. Treatment involves two main courses: an initial series over consecutive days, followed by a shorter round a year later. Additional courses may be given if symptoms or disease activity persist. Patients are pretreated with corticosteroids to minimize infusion reactions, and doctors monitor for infections, potentially prescribing antivirals. 

Regular lab tests (complete blood counts, thyroid, and kidney function) detect early complications. Patients should attend follow-up appointments and report unusual symptoms. Older adults or those with significant heart or kidney disease may need extra monitoring, but dosage adjustments are typically not required due to fixed Lemtrada infusion protocols. 

Does Lemtrada have a generic version? 

As of 2025, Lemtrada (alemtuzumab) does not have an FDA-approved generic version in the United States. It is only available under the brand name Lemtrada, manufactured by Sanofi Genzyme. However, international versions may exist in other markets. 

Alemtuzumab (Campath) treats certain leukemias, but its oncology use differs significantly from its role in Lemtrada for other conditions. Dosing and monitoring vary, so never substitute without medical guidance. Future generic/biosimilar Lemtrada versions must meet FDA safety and effectiveness standards. 

Conclusion 

Lemtrada is a powerful disease-modifying therapy for people with relapsing forms of multiple sclerosis who have not found success with other treatments. By resetting the immune system, it helps reduce relapses, limit nerve damage, and slow the progression of disability often with long-lasting effects after only a few treatment cycles. 

Despite significant risks, strict monitoring allows Lemtrada to offer strong protective effects for MS patients. Open communication with healthcare providers is essential, and when used responsibly, Lemtrada can greatly improve independence, energy, and quality of life for those with multiple sclerosis. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Lemtrada (alemtuzumab) prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Alemtuzumab (intravenous route) drug information. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Alemtuzumab injection: Uses, side effects, and precautions. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). Disease-modifying therapies for multiple sclerosis. Retrieved from https://www.nih.gov 
     

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Brand Information

    LEMTRADA (ALEMTUZUMAB)
    WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES
    • LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after the last dose of LEMTRADA
    • LEMTRADA causes serious and life-threatening infusion reactions. LEMTRADA must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Monitor patients for two hours after each infusion. Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period
    • Serious and life-threatening stroke (including ischemic and hemorrhagic stroke) has been reported within 3 days of LEMTRADA administration. Instruct patients to seek immediate medical attention if symptoms of stroke occur
    • LEMTRADA may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams
    • Because of the risk of autoimmunity, infusion reactions, and malignancies, LEMTRADA is available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) Program. Call 1-855-676-6326 to enroll in the LEMTRADA REMS program
    1INDICATIONS AND USAGE
    LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS
    2DOSAGE FORMS AND STRENGTHS
    Injection: 12 mg/1.2 mL (10 mg/mL) in a single-dose vial. LEMTRADA is a clear and colorless to slightly yellow solution that requires dilution prior to intravenous infusion.
    3CONTRAINDICATIONS
    LEMTRADA is contraindicated in patients:
    • with known hypersensitivity or anaphylactic reactions to alemtuzumab or any of the excipients in LEMTRADA
    • who are infected with human immunodeficiency virus (HIV) because LEMTRADA causes prolonged reductions of CD4+ lymphocyte counts
    • with active infection
    4ADVERSE REACTIONS
    The following serious adverse reactions are described below and elsewhere in the labeling:
    • Autoimmunity
    • Infusion Reactions
    • Stroke and Cervicocephalic Arterial Dissection
    • Malignancies
    • Immune Thrombocytopenia
    • Glomerular Nephropathies Including Anti-glomerular Basement Membrane Disease
    • Thyroid Disorders
    • Other Autoimmune Cytopenias
    • Autoimmune Hepatitis
    • Hemophagocytic Lymphohistiocytosis
    • Adult Onset Still's Disease
    • Thrombotic Thrombocytopenic Purpura (TTP)
    • Autoimmune Encephalitis (AIE)
    • Acquired Hemophilia A
    • Immune-Mediated Colitis
    • Infections
    • Progressive Multifocal Leukoencephalopathy (PML)
    • Acute Acalculous Cholecystitis
    • Pneumonitis
    4.1Clinical Trials Experience
    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
    In controlled clinical trials (Study 1 and Study 2), a total of 811 patients with relapsing forms of MS received LEMTRADA. The population was 18 to 55 years of age, 65% were female, and 92% were Caucasian. A total of 811 patients received 1 course of therapy, and 789 patients received a second course of therapy at 12 months. The overall follow-up in the controlled trials was equivalent to 1622 patient years.
    In MS clinical studies (controlled and open-label extension), overall, a total of 1217 patients received LEMTRADA. Approximately 60% of patients received a total of 2 treatment courses and approximately 24% of patients received a total of 3 treatment courses; others received a total of 4 or more treatment courses, although data beyond 3 treatment courses are limited. The overall follow-up was 6858 person-years. Patients had a median of 6 years of follow-up from the first LEMTRADA dose, with approximately 14% having at least 7 years of follow-up.
    4.2Lymphopenia
    Nearly all (99.9%) patients treated with LEMTRADA in MS clinical trials experienced lymphopenia. The lowest lymphocyte counts occurred approximately by 1 month after each course of treatment. The mean lymphocyte count at 1 month after LEMTRADA treatment was 0.25 × 10
    4.3Suicidal Behavior or Ideation
    In clinical studies, 0.6% of patients in both the LEMTRADA and interferon beta-1a groups had events of attempted suicide or suicidal ideation. There were no completed suicides in either clinical study treatment group. Suicidal behavior or ideation occurred in patients with or without a history of a psychiatric or thyroid disorder. Advise patients to report immediately any symptoms of depression or suicidal ideation to the prescribing physician.
    4.4Immunogenicity
    As with all therapeutic proteins, there is potential for immunogenicity. The incidence of antibodies is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including inhibitory antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to LEMTRADA with the incidence of antibodies to other products may be misleading.
    Using an enzyme-linked immunosorbent assay (ELISA) and a competitive binding assay, anti-alemtuzumab binding antibodies were detected in 62%, 67%, and 29% of LEMTRADA-treated patients, at months 1, 3, and 12 (Course 1) as well as 83%, 83%, and 75% of LEMTRADA-treated patients at months 13, 15, and 24 (Course 2). Samples that tested positive for binding antibodies were further evaluated for evidence of
    4.5Postmarketing Experience
    The following adverse reactions have been identified during post approval use of alemtuzumab. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
    5OVERDOSAGE
    Two MS patients experienced serious reactions (headache, rash, and either hypotension or sinus tachycardia) after a single accidental infusion up to 60 mg of LEMTRADA. Doses of LEMTRADA greater than those recommended may increase the intensity and/or duration of infusion reactions or its immune effects. There is no known antidote for alemtuzumab overdosage.
    6DESCRIPTION
    Alemtuzumab is a recombinant humanized IgG1 kappa monoclonal antibody directed against the cell surface glycoprotein, CD52. Alemtuzumab has an approximate molecular weight of 150 kD. Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a nutrient medium containing neomycin. Neomycin is not detectable in the final product.
    LEMTRADA (alemtuzumab) injection is a sterile, clear and colorless to slightly yellow, solution (pH 7.2 ± 0.2) for intravenous infusion.
    Each 1 mL of solution contains 10 mg alemtuzumab, dibasic sodium phosphate (1.15 mg), disodium edetate dihydrate (0.0187 mg), polysorbate 80 (0.1 mg), potassium chloride (0.2 mg), potassium dihydrogen phosphate (0.2 mg), sodium chloride (8 mg), and Water for Injection, USP.
    7CLINICAL STUDIES
    The efficacy of LEMTRADA was demonstrated in two studies (Study 1 and 2) that evaluated LEMTRADA 12 mg in patients with relapsing-remitting multiple sclerosis (RRMS). LEMTRADA was administered by intravenous infusion once daily over a 5-day course, followed one year later by intravenous infusion once daily over a 3-day course. Both studies included patients who had experienced at least 2 relapses during the 2 years prior to trial entry and at least 1 relapse during the year prior to trial entry. Neurological examinations were performed every 12 weeks and at the time of suspected relapse. Magnetic resonance imaging (MRI) evaluations were performed annually.
    8PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide).
    9PRINCIPAL DISPLAY PANEL - 12 mg/1.2 mL Vial Carton
    NDC 58468-0200-1
    LEMTRADA
    12 mg/1.2 mL
    For Intravenous Infusion Only
    Dilute before
    Single-Dose Vial,
    Rx only
    Dispense the enclosed
    PRINCIPAL DISPLAY PANEL - 12 mg/1.2 mL Vial Carton
    Lemtrada has been selected.