alemtuzumab: clinical use

Prescribing considerations

• Initiate and supervise through an MS-experienced neurologist in a hospital with immediate access to intensive care and relevant specialists.
• Confirm restricted licensed-indication eligibility and ability to commit to prolonged safety monitoring.
• Assess infection risks, vaccination status, possible PML and, where relevant, tuberculosis, hepatitis B or C, HPV and varicella status.
• Consider malignancy, previous immunosuppression and lack of established safety and efficacy data in children or renal or hepatic impairment.

Contraindications and cautions

• Hypersensitivity to alemtuzumab or an excipient
• HIV infection
• Severe active infection until resolved
• Uncontrolled hypertension
• Previous cervicocephalic arterial dissection, stroke, angina or myocardial infarction
• Known coagulopathy or current antiplatelet or anticoagulant treatment
• A concomitant autoimmune disease other than multiple sclerosis

Monitoring

• Before treatment: clinical assessment, ECG, blood pressure and heart rate; full blood count with differential, liver tests, creatinine, thyroid function and urinalysis with microscopy.
• During infusion: frequent clinical, blood-pressure and heart-rate monitoring; stop the infusion if a serious reaction is suspected.
• After treatment: ongoing blood, liver, kidney, urine and thyroid monitoring; remain alert to later autoimmune disease.

Clinical pharmacology

Alemtuzumab is a recombinant humanised IgG1 monoclonal antibody targeting CD52. Antibody-dependent cellular cytolysis and complement-mediated lysis deplete circulating T and B lymphocytes, followed by differential immune-cell repopulation.

Formulation and product differences

• The selected MS product is a sterile intravenous concentrate requiring dilution; it is not a ready-to-use injection.
• Non-licensed transplant protocols may use a different route and must not be inferred from the selected MS product information.

Solution for infusion

Route: Intravenous

Strengths: 12 mg