INCIVEK and Pregnancy
What Is Pregnancy Category X?Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
Ribavirin has not been studied in pregnant women. However, the drug has caused birth defects in hamsters, rats, and rabbits, including defects of the skull, eye, jaw, limbs, and skeleton. The use of a pregnancy Category X medicine during pregnancy is not recommended.
Ribavirin should not be used in women who are pregnant or may become pregnant. Therefore, the combination of INCIVEK, ribavirin, and peginterferon alfa should also not be used in women who are pregnant or may become pregnant.
Pregnancy must be ruled out before treatment begins, and pregnancy testing should occur every month during treatment. In addition, women must use two forms of birth control while receiving INCIVEK, and for at least six months after stopping ribavirin.
Can INCIVEK Be Used by My Partner While I Am Pregnant?At this time, it is unclear if INCIVEK (with ribavirin) use by a male partner will harm a developing fetus. However, it is recommended that the medicine not be used in males whose partner is pregnant.
Final ThoughtsBecause INCIVEK is only approved for use in combination with peginterferon alfa and ribavirin, the medicine should not be used during pregnancy. Using these medications during pregnancy could cause birth defects. Therefore, if you are pregnant or thinking about becoming pregnant, let your healthcare provider know immediately.