Sofosbuvir Pregnancy and Breastfeeding Warnings
Sofosbuvir is also known as: Sovaldi
Sofosbuvir Pregnancy Warnings
Animal studies with this drug have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Monotherapy is not recommended. Pregnancy must be avoided in female patients and female partners of male patients during 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 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 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: ribavirinpregnancyregistry.com AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage. 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 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. 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.
Use should be avoided; use of a ribavirin-containing regimen is contraindicated in pregnant women and in the male partners of women who are pregnant. Combination therapy (with ribavirin or peginterferon alfa/ribavirin): AU TGA pregnancy category: X US FDA pregnancy category: X Sofosbuvir: AU TGA pregnancy category: B1 US FDA pregnancy category: B 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. -The manufacturer product information for ribavirin and peginterferon alfa should be consulted.
Sofosbuvir Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug; a decision should be made to discontinue breastfeeding 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 product information for ribavirin and peginterferon alfa should be consulted.
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