Interferon alfa-2b / ribavirin Pregnancy and Breastfeeding Warnings
Interferon alfa-2b / ribavirin is also known as: Rebetron
Interferon alfa-2b / ribavirin Pregnancy Warnings
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).
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.
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.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.