Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Sanofi-aventis groupe, 54, rue La Boétie, F-75008, Paris, France
AUBAGIO is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (MS).
(please refer to section 5.1 for important information on the population for which efficacy has been established).
The treatment should be initiated and supervised by a physician experienced in the management of multiple sclerosis.
The recommended dose of teriflunomide is 14 mg once daily. Special populations
AUBAGIO should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy.
No dosage adjustment is necessary for patients with mild, moderate or severe renal impairment not undergoing dialysis.
Patients with severe renal impairment undergoing dialysis were not evaluated. Teriflunomide is contraindicated in this population (see section 4.3).
No dosage adjustment is necessary for patients with mild and moderate hepatic impairment. Teriflunomide is contraindicated in patients with severe hepatic impairment (see section 4.3).
The safety and efficacy of teriflunomide in children aged from 10 to less than 18 years has not yet been established. There is no relevant use of teriflunomide in children aged from birth to less than 10 years for the treatment of multiple sclerosis. No data are available.
The film-coated tablets are for oral use. The tablets should be swallowed whole with some water. AUBAGIO can be taken with or without food.
There is no experience regarding teriflunomide overdose or intoxication in humans. Teriflunomide 70 mg daily was administered up to 14 days in healthy subjects. The adverse reactions were consistent with the safety profile for teriflunomide in MS patients.
In the event of relevant overdose or toxicity, cholestyramine or activated charcoal is recommended to accelerate elimination. The recommended elimination procedure is cholestyramine 8 g three times a day for 11 days. If this is not well tolerated, cholestyramine 4 g three times a day for 11 days can be used. Alternatively, when cholestyramine is not available, activated charcoal 50 g twice a day for 11 days may also be used. In addition, if required for tolerability reasons, administration of cholestyramine or activated charcoal does not need to occur on consecutive days (see section 5.2).
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
Polyamide/aluminium/poly(vinyl chloride) - aluminium blisters inserted in wallets (14 and 28 film-coated tablets) and packed in cartons containing 14, 28, 84 (3 wallets of 28), and 98 (7 wallets of 14) film-coated tablets.
Each wallet is placed in a protective sleeve.
Polyamide/aluminium/poly(vinyl chloride) - aluminium perforated unit-dose blister packs in cartons containing 10x1 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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