Peginterferon alfa-2b Pregnancy and Breastfeeding Warnings
Peginterferon alfa-2b Pregnancy Warnings
FDA pregnancy category: X (combination therapy with ribavirin) FDA pregnancy category: C (monotherapy) Peginterferon alfa-2b/ribavirin combination therapy is contraindicated in pregnant women and in the male partners of women who are pregnant. Peginterferon alfa-2b should be used during pregnancy only if the benefit outweighs the risk to the fetus. Comments: -Combination therapy: Effective contraception (at least 2 reliable forms) is required during ribavirin therapy and for at least 6 months after therapy. -Monotherapy: Recommended for use in fertile women only when effective contraception is used during therapy
Animal studies with nonpegylated interferon alfa-2b have revealed evidence of abortifacient effects. There are no controlled data in human pregnancy. 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. 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 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.
Peginterferon alfa-2b 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. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.
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