LEMTRADA CONCENTRATE FOR SOLUTION FOR INFUSION 12 MG/ 1.2 ML

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

INFUSION, SOLUTION CONCENTRATE

**Posology and method of administration** LEMTRADA treatment should only be initiated and supervised by a neurologist experienced in the treatment of patients with multiple sclerosis (MS) in a hospital with ready access to intensive care. Specialists and equipment required for the timely diagnosis and management of adverse reactions, especially myocardial ischaemia and myocardial infarction, cerebrovascular adverse reactions, autoimmune conditions, and infections, should be available. Resources for the management of cytokine release syndrome, 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. Posology The recommended dose of alemtuzumab is 12 mg/day administered by intravenous infusion for 2 initial treatment courses, with up to 2 additional treatment courses if needed. _Initial treatment of 2 courses:_ - First 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 first treatment course. _Up to two additional treatment courses, as needed, may be considered (see section Pharmacodynamic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _):_ - Third or fourth course: 12 mg/day on 3 consecutive days (36 mg total dose) administered at least 12 months after the prior treatment course (see section _Therapeutic indications, Pharmacodynamic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Missed doses should not be given on the same day as a scheduled dose. _Follow-up of patients_ The therapy is recommended as an initial treatment of 2 courses with up to 2 additional treatment courses if needed (see posology) with safety follow-up of patients from initiation of the first treatment course and for at least 48 months after the last infusion of the second treatment course. If an additional third or fourth course is administered, continue safety follow-up for at least 48 months after the last infusion (see section _Special warnings and precautions for use_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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. 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 _Special warnings and precautions for use_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In clinical trials, patients were administered aciclovir 200 mg twice a day or equivalent. Special populations _Elderly_ Clinical studies did not include any patients aged over 61 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 _Special precautions for disposal and other handling_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.