Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml).
Alemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant DNA technology.
For the full list of excipients, see section 6.1.
LEMTRADA treatment should be initiated and supervised by a neurologist experienced in the treatment of patients with MS. Specialists and equipment required for the timely diagnosis and management of the most frequent adverse reactions, especially autoimmune conditions and infections, should be available.
Resources for the management of hypersensitivity and/or anaphylactic reactions should be available.
Patients treated with LEMTRADA must be given the Patient Alert Card and Patient Guide and be informed about the risks of LEMTRADA (see also package leaflet).
Posology
The recommended dose of LEMTRADA is 12 mg/day administered by intravenous infusion for 2 treatment courses.
• Initial 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 initial treatment course.
Missed doses should not be given on the same day as a scheduled dose.
Follow-up of patients
The therapy is recommended as 2 treatment courses (see posology) with safety follow-up of patients from initiation of treatment and until 48 months after the last infusion (see section 4.4).
Pre-treatment
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.
Additionally, pretreatment with antihistamines and/or antipyretics prior to LEMTRADA administration may also be considered.
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 (see also under 'Infections' in section 4.4). In clinical trials, patients were administered aciclovir 200 mg twice a day or equivalent.
Elderly
Clinical studies did not include any patients aged over 55 years old. It has not been determined whether they respond differently than younger patients.
Renal or hepatic impairment
LEMTRADA has not been studied in patients with renal or hepatic impairment.
Paediatric population
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.
Method of administration
LEMTRADA must be diluted before infusion. The diluted solution should be administered by intravenous infusion over a period of approximately 4 hours.
For instructions on dilution of the medicinal product before administration, see section 6.6.
