Incivek Pregnancy Warnings
FDA pregnancy category: X (telaprevir, ribavirin, peginterferon alfa combination therapy)
FDA pregnancy category: B (telaprevir monotherapy)
Use of telaprevir combination therapy is contraindicated in women who are or may become pregnant 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 telaprevir have failed to reveal evidence of fetal harm; however, effects on fertility parameters have been observed in rats. The no observed adverse effect level for testicular toxicity was established at exposures 0.17-fold the human exposures at the recommended clinical dose. Potential effects on sperm (such as decreased percent motile sperm and increased nonmotile sperm count) occurred in rats at exposures 0.3-fold the human exposures at the recommended clinical dose. Additional fertility effects (including minor increases in preimplantation loss, nonviable embryos, and nonviable conceptuses per litter) are probably associated with testicular toxicity, but female contributions cannot be excluded. There are no controlled data in human pregnancy. Telaprevir must not be used as monotherapy.
Pregnancy must be avoided in female patients and female partners of male patients during telaprevir 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 systemic hormonal contraceptives may not be as effective during telaprevir therapy and for up to 2 weeks after telaprevir is stopped, 2 effective non-hormonal methods of contraception (including intrauterine devices and barrier methods) should be used during this time. 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.
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