Sofosbuvir Pregnancy and Breastfeeding Warnings

Sofosbuvir is also known as: Sovaldi

Sofosbuvir Pregnancy Warnings

Animal studies with sofosbuvir have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Monotherapy of sofosbuvir is not recommended. Pregnancy must be avoided in female patients and female partners of male patients during sofosbuvir 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. Since there are no data regarding efficacy of systemic hormonal contraceptives with sofosbuvir, 2 effective non-hormonal methods of contraception should be used during sofosbuvir/ribavirin 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 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; such exposures should be reported by calling 1-800-593-2214 (USA). For HCV/HIV-1 coinfected patients taking concomitant antiretrovirals, an Antiretroviral Pregnancy Registry is available at 1-800-258-4263 (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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

FDA pregnancy category: X (sofosbuvir combination therapy [use with ribavirin or peginterferon alfa/ribavirin]) FDA pregnancy category: B (sofosbuvir monotherapy) Use of sofosbuvir combination therapy is contraindicated in women who are or may become pregnant and in 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. -The manufacturer's product information for ribavirin should be consulted.

Sofosbuvir Breastfeeding Warnings

Due to the potential for side effects in nursing infants, a decision should be made to discontinue nursing or discontinue the ribavirin-containing regimen, taking into account the importance of the therapy to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes (the main circulating metabolite [GS-331007]) Comments: -The effects in the nursing infant are unknown. -The manufacturer's product information for ribavirin should be consulted.

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