Boceprevir Pregnancy and Breastfeeding Warnings

Boceprevir is also known as: Victrelis

Boceprevir Pregnancy Warnings

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 and peginterferon alfa): AU TGA pregnancy category: X US FDA pregnancy category: X Monotherapy: AU TGA pregnancy category: B2 US FDA pregnancy category: B Comments: -Effective contraception (at least 2 reliable forms) is required during ribavirin therapy and for at least 4 to 7 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.

Animal studies with this drug have failed to reveal evidence of fetotoxicity. There are no controlled data in human pregnancy. This drug must not be used as monotherapy. 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 4 to 7 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 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: ribavirinpregnancyregistry.com 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. AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. 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. 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.

Boceprevir 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.

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