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Multiple Sclerosis — Disease-Modifying Therapy Pregnancy: Contraindicated — foetal harm; effective contraception required during and for 4 months after each course; thyroid autoimmunity may develop in pregnancy even after stopping

Alemtuzumab

Brand names: Lemtrada

Adult dose

Dose: 12 mg/day IV for 5 days (Course 1, year 1); 12 mg/day IV for 3 days (Course 2, year 2); further courses of 3 days if needed at year 3 and 4
Route: IV infusion over 4 hours
Frequency: Annual pulsed courses (not continuous)
Max: 12 mg/day per course
Pre-medicate: methylprednisolone 1 g IV on first 3 days of each course. Antiviral prophylaxis with aciclovir 200 mg twice daily from day 1 until 1 month after last infusion. Monitor vitals and infusion reactions during each infusion.

Paediatric dose

Dose: Seek specialist opinion N/A/kg
Route: IV
Frequency: N/A
Max: N/A
Not licensed in paediatrics under 18; seek specialist paediatric neurology opinion

Dose adjustments

Renal

No dose adjustment required

Hepatic

No dose adjustment required

Paediatric weight-based calculator

Not licensed in paediatrics under 18; seek specialist paediatric neurology opinion

Clinical pearls

  • Mechanism: anti-CD52 monoclonal antibody — CD52 expressed on T and B lymphocytes, monocytes, NK cells, and dendritic cells; profound lymphocyte depletion; immune reconstitution over 12–24 months with altered T and B cell populations; unique immune reconstitution mechanism
  • CARE-MS I and II trials (Lancet 2012): alemtuzumab vs interferon beta-1a in RRMS — 49–55% relative reduction in annualised relapse rate; 42% relative reduction in sustained disability progression in CARE-MS II (active/highly active RRMS)
  • MAJOR ADVANTAGE: pulsed dosing — given only twice (or rarely 3 times); no daily/weekly treatment burden; long-term treatment-free remission possible after 2 courses (no evidence of disease activity for years in many patients)
  • SECONDARY AUTOIMMUNITY MONITORING IS LIFELONG: thyroid function (every 3 months for 4 years after last course); FBC monthly for 4 years; serum creatinine and urinalysis monthly for 4 years; urinalysis for blood (Goodpasture — anti-GBM antibodies)
  • MHRA RESTRICTIONS 2019: MHRA restricted alemtuzumab to highly active RRMS only (1 failed DMT or rapidly evolving severe MS) due to serious cardiovascular, autoimmune, and haematological risks; must be prescribed by experienced specialists
  • UK Epilepsy-free — Lemtrada Programme: patient monitoring card and monitoring programme mandatory; prescribers must register patients; patient self-monitoring for bruising (ITP), proteinuria (nephritis), neck pain/stroke symptoms

Contraindications

  • HIV infection
  • Active infections
  • Autoimmune conditions beyond MS (relative — high risk of secondary autoimmunity)
  • Pregnancy and breastfeeding
  • Live vaccines (during treatment and until lymphocyte recovery)

Side effects

  • Secondary autoimmunity (most serious): immune thrombocytopenia ITP (2%), thyroid disorders (36%), Goodpasture syndrome (anti-GBM nephritis — rare but potentially fatal without monitoring)
  • Infusion reactions (common — manage with premedication and slow infusion)
  • Serious infections (including listeriosis, PML — JC virus, herpes viruses)
  • Malignancies (thyroid carcinoma, melanoma — rare)
  • Stroke and arterial dissection (rare — temporal relationship with infusion)

Interactions

  • Immunosuppressants (avoid — profound immunosuppression)
  • Live vaccines (contraindicated during treatment and for 6 months after)
  • Antihypertensives (hypotension risk during infusion)

Monitoring

  • FBC with differential (monthly for 4 years after last infusion — ITP monitoring)
  • Thyroid function (every 3 months for 4 years — thyroid autoimmunity)
  • Serum creatinine and urinalysis (monthly for 4 years — nephritis/Goodpasture)
  • Anti-GBM antibodies if urinalysis shows haematuria or proteinuria
  • MRI brain (annual — MS disease activity)
  • Infusion reactions during each course

Reference: BNFc; BNF 90; CARE-MS I Lancet 2012;380(9839):308-317; CARE-MS II Lancet 2012;380(9839):318-327; NICE TA312; MHRA 2019 Restrictions. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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