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Multiple Sclerosis — Disease-Modifying Therapy Pregnancy: There is a limited amount of data from the use of alemtuzumab in pregnant women. LEMTRADA should be administered during pregnancy only if the potential benefit justifies the potential risk to the foetus. Human IgG is known to cross the placental barrier and alemtuzumab may cross as well, potentially posing a risk to the foetus; animal studies have shown reproductive toxicity. Women of childbearing potential have to use effective contraception when receiving a course of treatment and for up to 4 months after each course (serum concentrations were low or undetectable within approximately 30 days following each treatment course). Thyroid disease poses special risks in pregnancy - untreated hypothyroidism increases the risk of miscarriage and foetal effects, and in mothers with Graves' disease maternal thyroid stimulating hormone receptor antibodies can be transferred to the foetus and cause transient neonatal Graves' disease. Breast-feeding should be discontinued during each course of treatment and for 4 months following the last infusion of each course, although the benefits of conferred immunity through breast milk may outweigh the risks of potential exposure.

Alemtuzumab

Brand names: Lemtrada

Alemtuzumab is a humanised anti-CD52 monoclonal antibody used, given as intravenous courses, as a disease-modifying therapy for highly active relapsing-remitting multiple sclerosis.

Adult dose

Dose: Multiple sclerosis (disease-modifying therapy): the recommended dose of alemtuzumab is 12 mg/day administered by intravenous infusion for 2 initial treatment courses, with up to 2 additional treatment courses if needed. First treatment course: 12 mg/day on 5 consecutive days (60 mg total dose). Second treatment course: 12 mg/day on 3 consecutive days (36 mg total dose), administered 12 months after the first treatment course. Third or fourth course, as needed: 12 mg/day on 3 consecutive days (36 mg total dose), administered at least 12 months after the prior treatment course.
Route: Intravenous infusion. LEMTRADA must be diluted before infusion, and the diluted solution should be administered by intravenous infusion over a period of approximately 4 hours.
Frequency: 12 mg once daily on 5 consecutive days for the first course, then 12 mg once daily on 3 consecutive days 12 months later; further 3-day courses at least 12 months apart if needed. Missed doses should not be given on the same day as a scheduled dose.
Max: 12 mg/day - the SPC's only recommended dose. Per course this equals 60 mg total for the 5-day first course and 36 mg total for each 3-day subsequent course. No higher daily dose is given anywhere in this SPC's posology.
INITIATION: treatment should only be initiated and supervised by a neurologist experienced in the treatment of patients with multiple sclerosis, in a hospital with ready access to intensive care, with specialists and equipment available for the timely diagnosis and management of adverse reactions - especially myocardial ischaemia and myocardial infarction, cerebrovascular adverse reactions, autoimmune conditions and infections - and with resources for the management of cytokine release syndrome, hypersensitivity and/or anaphylactic reactions. Patients must be given the Patient Alert Card and Patient Guide and be informed about the risks. PRE-TREATMENT (verbatim): 'Patients should be pre-treated with corticosteroids immediately prior to LEMTRADA administration on each of the first 3 days of any treatment course. In clinical trials, patients were pre-treated with 1,000 mg methylprednisolone for the first 3 days of each LEMTRADA treatment course.' Pretreatment with antihistamines and/or antipyretics may also be considered. ANTIVIRAL PROPHYLAXIS (verbatim): 'Oral prophylaxis for herpes infection should be administered to all patients starting on the first day of each treatment course and continuing for a minimum of 1 month following treatment with LEMTRADA. In clinical trials, patients were administered aciclovir 200 mg twice a day or equivalent.' FOLLOW-UP: safety follow-up from initiation of the first treatment course and for at least 48 months after the last infusion of the second treatment course; if a third or fourth course is administered, continue safety follow-up for at least 48 months after the last infusion. NOT RECOMMENDED in patients with inactive disease or those stable on current therapy. ELDERLY: clinical studies did not include any patients aged over 61 years; it has not been determined whether they respond differently. RENAL OR HEPATIC IMPAIRMENT: LEMTRADA has not been studied in these patients. Some sections of the product information we used were incomplete — check the full SPC.

Paediatric dose

Route: Not applicable - no paediatric dose is established in this SPC
Frequency: Not applicable
NO PAEDIATRIC DOSE EXISTS IN THIS SOURCE - dosePerKg is deliberately null and no figure may be derived or scaled from the adult 12 mg/day regimen. VERBATIM: 'The safety and efficacy of LEMTRADA in children with MS aged 0 to 18 years have not yet been established. There is no relevant use of alemtuzumab in children aged from birth to less than 10 years for the treatment of multiple sclerosis. No data are available.' Verify any under-18 use against a children's formulary and specialist advice.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, or to any of the excipients
  • Human Immunodeficiency Virus (HIV) infection
  • Patients with severe active infection until complete resolution
  • Patients with uncontrolled hypertension
  • Patients with a history of arterial dissection of the cervicocephalic arteries
  • Patients with a history of stroke
  • Patients with a history of angina pectoris or myocardial infarction
  • Patients with known coagulopathy, on anti-platelet or anti-coagulant therapy
  • Patients with other concomitant autoimmune diseases (besides MS)

Side effects

  • Most common adverse reactions (in 20% or more of patients): rash, headache, pyrexia and respiratory tract infections
  • The most important adverse reactions are autoimmunity (immune thrombocytopenic purpura, thyroid disorders, nephropathies, cytopenias), infusion-related reactions, and infections
  • Infections - very common: upper respiratory tract infection, urinary tract infection, herpes virus infection; common: herpes zoster infections, lower respiratory tract infections, gastroenteritis, oral candidiasis, vulvovaginal candidiasis, influenza, ear infection; uncommon: pneumonia, vaginal infection, tooth infection, onychomycosis, gingivitis, tonsillitis, cellulitis, tuberculosis, cytomegalovirus infection; rare: listeriosis/listeria meningitis, Epstein-Barr virus infection including reactivation
  • Blood and lymphatic - very common: lymphopenia, leukopenia including neutropenia; common: lymphadenopathy, immune thrombocytopenic purpura, thrombocytopenia, anaemia; uncommon: pancytopenia, haemolytic anaemia, acquired haemophilia A; not known: haemophagocytic lymphohistiocytosis (HLH), thrombotic thrombocytopenic purpura (TTP)
  • Immune system - cytokine release syndrome; hypersensitivity including anaphylaxis; sarcoidosis
  • Endocrine - Basedow's disease, hyperthyroidism, hypothyroidism, autoimmune thyroiditis including subacute thyroiditis, goitre, anti-thyroid antibody positive
  • Nervous system - very common: headache; common: MS relapse, dizziness, hypoaesthesia, paraesthesia, tremor, dysgeusia, migraine
  • Psychiatric - insomnia, anxiety, depression; metabolism - decreased appetite; neoplasms - skin papilloma
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • Commit the patient to safety follow-up from initiation of the first treatment course and for at least 48 months after the last infusion of the second treatment course (and for at least 48 months after the last infusion if a third or fourth course is given); patients and physicians should be made aware of the potential later onset of autoimmune disorders after the 48-month monitoring period
  • Autoimmunity - treatment may result in the formation of autoantibodies and increase the risk of autoimmune-mediated conditions which may be serious and life threatening, including thyroid disorders, immune thrombocytopenic purpura, nephropathies (e.g. anti-glomerular basement membrane disease), autoimmune hepatitis, acquired haemophilia A, thrombotic thrombocytopenic purpura, sarcoidosis and autoimmune encephalitis; patients who develop autoimmunity should be assessed for other autoimmune-mediated conditions
  • Acquired haemophilia A - obtain a coagulopathy panel including aPTT in any patient presenting with spontaneous subcutaneous haematomas, extensive bruising, haematuria, epistaxis or gastrointestinal bleeding; refer to a haematologist if the aPTT is prolonged, and educate patients to seek immediate medical attention for these symptoms
  • Thrombotic thrombocytopenic purpura - can develop several months after the last infusion and requires urgent evaluation and prompt treatment; may present with thrombocytopenia, microangiopathic haemolytic anaemia, neurological symptoms, fever and renal impairment
  • Autoimmune encephalitis - subacute onset with rapid progression over months of memory impairment, altered mental status or psychiatric symptoms
  • Record the name and batch number of the administered product to support traceability of biological medicinal products
  • Women of childbearing potential must use effective contraception while receiving a course of treatment and for up to 4 months after each course
  • This list may be incomplete — check the full SPC.

Clinical monograph

How it works

It binds CD52 on lymphocytes, causing depletion of circulating T and B cells followed by a distinctive pattern of immune reconstitution that reduces inflammatory relapse activity.

Prescribing in practice

  • It carries serious risks of secondary autoimmune disease (notably thyroid disorders, immune thrombocytopenia and anti-GBM nephropathy), serious infusion reactions, stroke and arterial dissection, so it is restricted to specialist use under a risk-management programme with prolonged monthly monitoring.
  • Premedication, anti-herpes prophylaxis and infection screening are required around each treatment course.
  • Monthly blood and urine monitoring must continue for several years after the last dose.

Monitoring

Monitor full blood count, renal function, urinalysis and thyroid function monthly for an extended period after each course.

Counselling the patient

  • Attend every monthly blood and urine test, even when you feel well, for several years after treatment.
  • Report bruising, bleeding, swelling, palpitations or symptoms suggesting infection promptly.
  • Seek urgent help for sudden severe headache, neck pain or weakness after an infusion.

Evidence & guidelines

Use is governed by MHRA safety restrictions and a controlled risk-minimisation programme following reports of serious cardiovascular and immune-mediated reactions.

Reference: CARE-MS I Lancet 2012; 380(9839):308-317; CARE-MS II Lancet 2012; 380(9839):318-327; NICE TA312; MHRA 2019 Restrictions; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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