"The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
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There is no experience regarding teriflunomide overdose or intoxication in humans. Teriflunomide 70 mg daily up to 14 days was well tolerated by healthy subjects.
Severe Hepatic Impairment
Patients with severe hepatic impairment [see WARNINGS AND PRECAUTIONS].
Patients Who are Pregnant or Women of Childbearing Potential Not Using Reliable Contraception
AUBAGIO may cause fetal harm when administered to a pregnant woman.
In animal studies, teriflunomide has been shown to be selectively teratogenic and embryolethal in multiple species when administered during pregnancy at doses less than those used clinically. Nonclinical studies indicate further that the intended pharmacologic action of the drug is involved in the mechanism of developmental toxicity [see Use In Specific Populations].
AUBAGIO is contraindicated in women who are pregnant or women of child bearing potential not using reliable contraception. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. If pregnancy does occur during treatment, the drug should be immediately discontinued and an accelerated elimination procedure should be initiated [see WARNINGS AND PRECAUTIONS]. Under these conditions, the patient should be referred to an obstetrician/gynecologist, preferably experienced in reproductive toxicity, for further evaluation and counseling. [See WARNINGS AND PRECAUTIONS and Use In Specific Populations]
Current treatment with leflunomide
Co-administration of teriflunomide with leflunomide is contraindicated.
Last reviewed on RxList: 9/21/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Aubagio Information
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