Aubagio Use In Pregnancy & Lactation

Use in males: The risk of male-mediated embryo-foetal toxicity through teriflunomide treatment is considered low (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Pregnancy: There are limited amount of data from the use of teriflunomide in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Teriflunomide may cause serious birth defects when administered during pregnancy. Teriflunomide is contraindicated in pregnancy (see Contraindications).
Women of childbearing potential have to use effective contraception during treatment and after treatment as long as teriflunomide plasma concentration is above 0.02 mg/l. During this period women should discuss any plans to stop or change contraception with the treating physician.
The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy. It is possible that rapidly lowering the blood level of teriflunomide, by instituting the accelerated elimination procedure described as follows, at the first delay of menses, may decrease the risk to the foetus.
For women receiving teriflunomide treatment, who wish to become pregnant, the medicine should be stopped and an accelerated elimination procedure is recommended in order to more rapidly achieve concentration below 0.02 mg/l (see as follows).
If an accelerated elimination procedure is not used, teriflunomide plasma levels can be expected to be above 0.02 mg/l for an average of 8 months, however, in some patients it may take up to 2 years to reach plasma concentration below 0.02 mg/l. Therefore, teriflunomide plasma concentrations should be measured before a woman begins to attempt to become pregnant. Once the teriflunomide plasma concentration is determined to be below 0.02 mg/l, the plasma concentration must be determined again after an interval of at least 14 days.
If both plasma concentrations are below 0.02 mg/l, no risk to the foetus is to be expected.
For further information on the sample testing contact the Marketing Authorisation Holder or its local representative.
Accelerated elimination procedure: After stopping treatment with teriflunomide: cholestyramine 8 g is administered 3 times daily for a period of 11 days, or cholestyramine 4 g three times a day can be used, if cholestyramine 8 g three times a day is not well tolerated, alternatively, 50 g of activated powdered charcoal is administered every 12 hours for a period of 11 days.
However, also following either of the accelerated elimination procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/l and fertilisation is required.
Both cholestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the accelerated elimination procedure with cholestyramine or activated powdered charcoal. Use of alternative contraceptive methods is recommended.
Breast-feeding: Animal studies have shown excretion of teriflunomide in breast milk. Breast-feeding women must, therefore, not receive teriflunomide.
Fertility: Results of studies in animals have not shown an effect on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions). Although human data are lacking, no effect on male and female fertility is anticipated.