Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**Posology and method of administration** The treatment should be initiated and supervised by a physician experienced in the management of multiple sclerosis. Posology The recommended dose of AUBAGIO is 14 mg once daily. Special populations _Elderly population_ AUBAGIO should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy. _Renal impairment_ 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 _Contraindications_). _Hepatic impairment_ No dosage adjustment is necessary for patients with mild and moderate hepatic impairment. Teriflunomide is contraindicated in patients with severe hepatic impairment (see section _Contraindications_). _Paediatric population_ The safety and efficacy of AUBAGIO 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. Method of administration 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.
ORAL
Medical Information
**Therapeutic indications** AUBAGIO is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (MS). (please refer to section _Pharmacodynamic properties_ for important information on the population for which efficacy has been established – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.)
**Contraindications** Hypersensitivity to the active substance or to any of the excipients. Patients with severe hepatic impairment (Child-Pugh class C). Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l (see section _Fertility, pregnancy and lactation_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Pregnancy must be excluded before start of treatment (see section _Fertility, pregnancy and lactation_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Breast-feeding women (see section _Fertility, pregnancy and lactation_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients with severe immunodeficiency states, e.g. AIDS. Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia. Patients with severe active infection until resolution (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_). Patients with severe renal impairment undergoing dialysis, because insufficient clinical experience is available in this patient group. Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.
L04AA31
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Manufacturer Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Opella Healthcare International SAS
Active Ingredients
Documents
Package Inserts
Aubagio_ PI.pdf
Approved: April 13, 2023