Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Sanofi Belgium, Leonardo Da Vincilaan 19, B-1831, Diegem, Belgium
LEMTRADA is indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups:
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 (see also package leaflet).
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:
Up to two additional treatment courses, as needed, may be considered (see section 5.1):
Missed doses should not be given on the same day as a scheduled dose.
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 4.4).
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 4.4). In clinical trials, patients were administered aciclovir 200 mg twice a day or equivalent.
Clinical studies did not include any patients aged over 61 years old. It has not been determined whether they respond differently than younger patients.
LEMTRADA has not been studied in patients with renal or hepatic impairment.
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.
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.
In controlled clinical trials two MS patients accidentally received up to 60 mg LEMTRADA (i.e. total dose for initial treatment course) in a single infusion and experienced serious reactions (headache, rash, and either hypotension or sinus tachycardia). Doses of LEMTRADA greater than those tested in clinical studies may increase the intensity and/or duration of infusion-associated adverse reactions or its immune effects.
There is no known antidote for alemtuzumab over dosage. Treatment consists of discontinuation of the medicinal product and supportive therapy.
Concentrate: 3 years.
Diluted solution: Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C-8°C. From a microbiological point of view, it is recommended that the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 8 hours at 2°C-8°C, under protection from light.
Concentrate:
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
LEMTRADA is supplied in a clear, 2 ml glass vial, with a butyl rubber stopper and aluminium seal with a plastic flip-off cap.
Pack size: carton with 1 vial
The vial contents should be inspected for particulate matter and discoloration prior to administration. Do not use if particulate matter is present or the concentrate is discoloured. Do not shake the vials prior to use.
For intravenous administration, withdraw 1.2 ml of LEMTRADA from the vial into a syringe using aseptic technique. Inject into 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion. This medicinal product must not be diluted with other solvents. The bag should be inverted gently to mix the solution.
Care should be taken to ensure the sterility of the prepared solution. It is recommended that the diluted product be administered immediately. Each vial is intended for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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