Section 04 · Monograph
Alemtuzumab
Reviewed Nov 2026FDA label
LemtradaAnti-CD52 mAb
- Forms
- IV: 12mg/1.2mL
- Dose
- 12mg/day x5 days, then 12mg/day x3 days 1yr later
- MOA
- Depletes CD52+ lymphocytes
Black Box Warning
- Serious, sometimes fatal autoimmune conditions including immune thrombocytopenia and anti-glomerular basement membrane disease (nephropathy)
- Serious and life-threatening infusion reactions
- Increased malignancy risk, including thyroid cancer, melanoma, and lymphoproliferative disorders
- Available only through the restricted Lemtrada REMS Program
Indications
- Relapsing forms of multiple sclerosis, generally reserved for patients with inadequate response to two or more other MS therapies given its safety profileFDA-labeled
Mechanism of Action
- Humanized monoclonal antibody targeting CD52, a surface antigen on T and B lymphocytes
- Causes antibody-dependent cellular cytolysis and complement-mediated lysis of CD52-expressing cells, followed by lymphocyte repopulation with altered composition
Full Dosing
Adult / usual
- Course 1: 12 mg/day IV infusion on 5 consecutive days
- Course 2 (12 months later): 12 mg/day IV infusion on 3 consecutive days
- Premedicate with corticosteroids, antihistamines, and antipyretics before each infusion
Contraindications
- HIV infection
Drug Interactions
- Avoid concurrent use with other immunosuppressive/antineoplastic agents
- Live vaccines should be avoided during and shortly after treatment
Adverse Effects
- Rash
- Headache
- Pyrexia
- Nasopharyngitis
- Nausea
- Urinary tract infection
- Fatigue
- Infusion-associated reactions
- Thyroid disorders (hypo/hyperthyroidism, autoimmune thyroiditis)
- Immune thrombocytopenia
- Nephropathies
- Increased malignancy risk
Monitoring Parameters
- CBC with differential monthly for 48 months after last infusion
- Serum creatinine monthly for 48 months
- Urinalysis with cell counts monthly for 48 months
- Thyroid function tests every 3 months for 48 months
- Baseline and periodic skin exams for melanoma
Pregnancy & Lactation
- May cross the placenta; monitor for autoimmune conditions in neonates including thyroid disorders
- Thyroid autoantibodies may transfer to fetus
- Unknown if present in human milk