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Boceprevir Pregnancy and Breastfeeding Warnings

Boceprevir is also known as: Victrelis

Boceprevir Pregnancy Warnings

FDA pregnancy category: X (boceprevir, ribavirin, peginterferon alfa combination therapy) FDA pregnancy category: B (boceprevir monotherapy) Use of boceprevir 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 boceprevir have failed to reveal evidence of fetotoxicity. There are no controlled data in human pregnancy. Boceprevir must not be used as monotherapy. Pregnancy must be avoided in female patients and female partners of male patients during boceprevir 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 combined oral contraceptive product containing at least 1 mg of norethindrone can be 1 reliable form of contraception. Oral contraceptives containing lower doses of norethindrone and other forms of hormonal contraception have not been studied or are contraindicated. 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 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.

Boceprevir Breastfeeding Warnings

There are no data on the excretion of boceprevir in human milk. The effects in the nursing infant are unknown. The manufacturer recommends that due to the potential for serious adverse reactions 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.

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