Telaprevir Pregnancy and Breastfeeding Warnings
Telaprevir is also known as: Incivek
Telaprevir Pregnancy Warnings
Telaprevir has been assigned to pregnancy category B by the FDA; however, telaprevir must be used in combination with ribavirin and peginterferon alfa. The combination of telaprevir, ribavirin, and peginterferon alfa has been assigned to pregnancy category X by the FDA. 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 combination therapy is contraindicated in women who are or may become pregnant and in the male partners of women who are pregnant.
Pregnancy must be avoided in female patients and female partners of male patients during telaprevir combination therapy. The manufacturer recommends the use of at least two reliable forms of effective contraception during treatment with ribavirin and during the 6 months after completion of treatment; otherwise, women of childbearing potential and their male partners should not receive ribavirin. Since systemic hormonal contraceptives may not be as effective in women taking telaprevir, two alternative effective methods of contraception (including intrauterine devices and barrier methods) should be used during combination therapy. 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).
Telaprevir Breastfeeding Warnings
There are no data on the excretion of telaprevir into 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.
- telaprevir Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
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