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alemtuzumab

Lemtrada · ATC code L04AA34

Key facts
Active substance
alemtuzumab
Drug class
Immunosuppressive drug
ATC code
L04AA34
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
LEMTRADA 12 mg concentrate for solution for infusion
Marketing authorisation holder
Sanofi Belgium
Information as of
2026-10-28

Key facts

Alemtuzumab (Lemtrada) is a monoclonal antibody used as a disease-modifying therapy for highly active relapsing remitting multiple sclerosis (RRMS) in adults.

What it is used for

  • Single disease-modifying therapy in adults with highly active RRMS despite a full and adequate course of at least one disease-modifying therapy.
  • Or rapidly evolving severe RRMS (2 or more disabling relapses in one year, with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load).

Dosing

  • Recommended dose: 12 mg/day by intravenous infusion.
  • First course: on 5 consecutive days (60 mg total dose); second course: on 3 consecutive days (36 mg total dose), 12 months after the first course.
  • Up to two additional courses (3 days each) may be considered, at least 12 months after the prior course.
  • Corticosteroid pre-treatment immediately before infusion on each of the first 3 days of any course (1,000 mg methylprednisolone in trials); oral herpes prophylaxis from the first day of each course for at least 1 month.
  • Only initiated and supervised by an experienced neurologist in a hospital with access to intensive care; not studied in renal or hepatic impairment.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • HIV infection; severe active infection until complete resolution.
  • Uncontrolled hypertension; history of cervicocephalic arterial dissection, stroke, angina pectoris or myocardial infarction.
  • Known coagulopathy, or anti-platelet or anti-coagulant therapy.
  • Other concomitant autoimmune diseases (besides MS).

Important warnings

  • Autoimmunity: thyroid disorders, immune thrombocytopenic purpura (ITP), nephropathies (e.g. anti-GBM disease), autoimmune hepatitis, acquired haemophilia A, TTP and autoimmune encephalitis, possibly with late onset.
  • Monthly complete blood counts, serum creatinine and urinalysis until at least 48 months after the last infusion; regular thyroid function tests.
  • Infusion-associated reactions during or within 24 hours of infusion; serious cardiovascular events and stroke mostly within 1-3 days of infusion.
  • Infections, including herpes infections; prophylaxis and monitoring are required.
  • Patients must receive the Patient Alert Card and Patient Guide and commit to follow-up.

Side effects

  • Most common (in ≥20% of patients): rash, headache, pyrexia and respiratory tract infections.
  • Most important: autoimmunity (ITP, thyroid disorders, nephropathies, cytopenias), infusion-associated reactions and infections.
  • Thyroid disorders were observed in 36.8% of patients treated with 12 mg in clinical trials.

Interactions

  • No formal interaction studies in MS; in one trial beta interferon and glatiramer acetate were discontinued 28 days before starting treatment.

Pregnancy and breastfeeding

  • Women of childbearing potential must use effective contraception during a treatment course and up to 4 months after each course.
  • Use in pregnancy only if the potential benefit justifies the potential risk to the foetus.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • LemtradaSanofi Belgium · EMEA/H/C/003718

Source: European Medicines Agency (EMA), product information

Turkey

  • LemtradaSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 1 register entry
  • Mabcampath Inf Sol IcinGENZYME SAĞLIK HİZMETLERİ VE TEDAVİ ÜRÜNLERİ TİC. LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Lemtrada
Liechtenstein
Lemtrada
Norway
Lemtrada

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Lemtrada – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/lemtrada-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L04AA.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.