LEMTRADA CONCENTRATE FOR SOLUTION FOR INFUSION 12 MG/ 1.2 ML

Therapeutic indications

LEMTRADA is indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups:

• Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or
• Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Contraindications

Hypersensitivity to the active substance, or to any of the excipients listed in section List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Human Immunodeficiency Virus (HIV) infection.

Patients with severe active infection until complete resolution.

Patients with uncontrolled hypertension.

Patients with a history of arterial dissection of the cervicocephalic arteries.

Patients with a history of stroke.

Patients with a history of angina pectoris or myocardial infarction.

Patients with known coagulopathy, on anti-platelet or anti-coagulant therapy.

Patients with other concomitant autoimmune diseases (besides MS).

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.