Simeprevir Pregnancy and Breastfeeding Warnings

Simeprevir is also known as: Olysio

Simeprevir Pregnancy Warnings

FDA pregnancy category: X (simeprevir, ribavirin, peginterferon alfa combination therapy) FDA pregnancy category: C (simeprevir monotherapy) Use of simeprevir combination therapy is contraindicated in pregnant women and in the male partners of women who are pregnant. Comments: Effective contraception (at least 2 reliable forms) is required during ribavirin therapy and for at least 6 months after therapy.

Animal studies with simeprevir have revealed evidence of fetal harm. In mice, significantly reduced fetal weights, increased fetal skeletal variations, early and late in utero fetal losses, and early maternal deaths were seen with exposures about 4 or 6 times higher than human AUC at the recommended daily dose. In pregnant rats, early deaths and significantly reduced body weight gain were seen at exposures similar to and 0.7 times clinical AUC, respectively. Significantly reduced body weight and negative effects on physical growth (delay and small size) and development (decreased motor activity) were seen in developing rat offspring exposed to simeprevir in utero; maternal exposure was similar to clinical AUC at the recommended daily dose. There are no controlled data in human pregnancy. Simeprevir must not be used as monotherapy. Pregnancy must be avoided in female patients and female partners of male patients during simeprevir combination therapy. Females of reproductive potential and their male partners should not receive ribavirin unless they are using at least 2 reliable forms of effective contraception during ribavirin therapy and for at least 6 months after therapy. A negative pregnancy test should be obtained immediately before the start of combination therapy and monthly pregnancy testing is recommended during and for 6 months after treatment. To monitor maternal-fetal outcomes of pregnant patients or pregnant partners of male patients exposed to ribavirin, a Ribavirin Pregnancy Registry has been established. Such exposures should be reported by calling 1-800-593-2214 (USA). FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Simeprevir Breastfeeding Warnings

Due to the potential for side effects in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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