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Simeprevir Pregnancy and Breastfeeding Warnings

Simeprevir is also known as: Olysio

Simeprevir Pregnancy Warnings

Use of a ribavirin-containing regimen is contraindicated in pregnant women and in the male partners of women who are pregnant. This drug should be used in women who are or may become pregnant only if the benefit outweighs the risk. For regimens containing ribavirin and peginterferon alfa: -AU TGA pregnancy category: X -US FDA pregnancy category: X For simeprevir: -AU TGA pregnancy category: B3 -US FDA pregnancy category: C Comments: -Effective contraception (at least 2 reliable forms) is required during ribavirin therapy and for at least 6 months after the last dose; local protocol should be consulted regarding contraception timing. -Effective contraception is required for women of childbearing potential using this drug. -The manufacturer product information for coadministered hepatitis C virus (HCV) antiviral drugs should be consulted.

Animal studies with this drug have revealed evidence of fetal harm; embryofetal developmental toxicity was seen at drug exposures higher than human exposure at the recommended clinical dose. 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 the AUC in humans 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 the AUC in humans at the recommended daily dose, 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 this drug in utero; maternal exposure was similar to the AUC in humans at the recommended daily dose. There are no controlled data in human pregnancy. This drug must be used with other HCV antiviral drugs. Pregnancy must be avoided in female patients and female partners of male patients using a ribavirin-containing regimen. 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 therapy and for at least 6 months after therapy. A negative pregnancy test should be obtained immediately before the start of therapy and monthly pregnancy testing is recommended during and for 6 months after ribavirin therapy. To monitor maternal-fetal outcomes of pregnant patients or pregnant partners of male patients exposed to ribavirin, a Ribavirin Pregnancy Registry has been established. Healthcare providers and patients are encouraged to report exposures occurring during or up to 6 months before pregnancy. For additional information: AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy. US 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. US 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.

Simeprevir Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the infant; a different drug may be preferred. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -The effects in the nursing infant are unknown. -The manufacturer product information for coadministered hepatitis C virus antiviral drugs (especially ribavirin and peginterferon alfa) should be consulted.

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