With Sanofi-Aventis biotech subsidiary Genzyme continues pursuing U.S. Food and Drug approval for rebranding leukemia medication Campath (alemtuzumab) as multiple sclerosis treatment Lemtrada, Genzyme has received FDA's blessing to enter the MS drug market with Aubagio (teriflunomide).

The newly approved medication adds an oral tablet option for patients with relapsing-remitting MS who do not want injections. But its active pharmaceutical ingredient could make Aubagio a poor choice for younger women and individuals with impaired liver function.

The prescribing information for Aubagio includes black box warnings about possible liver damage from the drug and about the importance of not becoming pregnant while taking the medication. Everyone prescribed Aubagio should have liver function tests before starting the drug and regularly while on the treatment.

Women who can get pregnant need a negative pregnancy test before their first dose. They also need to commit to consistently using reliable contraception. Teriflunomide caused fetal damage during animal testing and has been assigned to pregnancy category X by FDA.

Drug labeling warns that hormonal contraceptives need to be chosen carefully. Aubagio can increase women's exposure to ethinylestradiol and levonorgestrel, which are in dozens of brand name and generic birth control pills.

A Medication Guide and patient education and support program called MS One to One accompany Aubagio.

The MedGuide, which Genzyme calls "Patient Counseling Information,"  informs patients that they should take one Aubagio tablet each day with or without food. It also explains that the most common side effects reported by people treated with the drug have been diarrhea, hair loss (i.e., alopecia), flu, nausea and numbness/tingling (i.e., parethesia).

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