AUBAGIO FILM-COATED TABLETS 14mg

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.

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.