Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older 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.
In adults, the recommended dose of teriflunomide is 14 mg once daily.
In paediatric patients (10 years of age and above), the recommended dose is dependent on body weight:
Paediatric patients who reach a stable body weight above 40 kg should be switched to 14 mg once daily.
Film-coated tablets can be taken with or without food.
AUBAGIO should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy.
No dose 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 dose 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 below 10 years have not been established. No data are available.
The film-coated tablets are for oral use. The tablets should be swallowed whole with some water.
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).
3 years.
This medicinal product does not require any special storage conditions.
AUBAGIO 7 mg film-coated tablets:
Polyamide/aluminium/poly(vinyl chloride)-aluminium blisters inserted in a wallet (28 film-coated tablets) and packed in a carton containing 28 film-coated tablets.
AUBAGIO 14 mg film-coated tablets:
Polyamide/aluminium/poly(vinyl chloride)-aluminium blisters inserted in wallets (14 and 28 filmcoated tablets) and packed in cartons containing 14, 28, 84 (3 wallets of 28), and 98 (7 wallets of 14) film-coated tablets.
Polyamide/aluminium/poly(vinyl chloride)-aluminium perforated unit-dose blisters 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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