Interferon alfa-2b / ribavirin Pregnancy and Breastfeeding Warnings

Brand names: Rebetron

Interferon alfa-2b / ribavirin Pregnancy Warnings

Interferon alfa-2b-ribavirin has been assigned to a pregnancy category X by the FDA. Animal studies have revealed evidence of abortifacient effects with interferon alfa-2b. There are no controlled data in human pregnancy with interferon alfa-2b. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species studied. Malformations of the skull, palate, eye, jaw, limbs, skeleton, and gastrointestinal tract were noted with ribavirin. Interferon alfa-2b-ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant.

Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in female patients, and in female partners of male patients who are taking combination interferon alfa-2b-ribavirin therapy. Women of childbearing potential and men must use two reliable forms of effective contraception during treatment and during the 6-month posttreatment follow-up period.

If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment cessation, physicians are encouraged to report such cases by calling 1-800-727-7064 (USA).

To monitor maternal-fetal outcomes of pregnant women or female partners of male patients exposed to ribavirin, a Ribavirin Pregnancy Registry has been established. Healthcare providers are encouraged to register patients by calling 1-800-593-2214 (USA).

See references

Interferon alfa-2b / ribavirin Breastfeeding Warnings

There are no data on the excretion of ribavirin and interferon alfa-2b into human milk. 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 combination interferon alfa-2b-ribavirin therapy, taking into account the importance of the drug to the mother.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer