Peginterferon alfa-2a Pregnancy and Breastfeeding Warnings
Peginterferon alfa-2a is also known as: Pegasys
Peginterferon alfa-2a Pregnancy Warnings
Animal studies with nonpegylated interferon alfa-2a have revealed a statistically significant increase in abortions, but no teratogenic effects were reported in offspring delivered at term. There are no controlled data in human pregnancy. 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. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
FDA pregnancy category: X (combination therapy with ribavirin) FDA pregnancy category: C (monotherapy) Peginterferon alfa-2a/ribavirin combination therapy is contraindicated in pregnant women and in the male partners of women who are pregnant. Peginterferon alfa-2a should be used during pregnancy only if the benefit outweighs the risk to the fetus. Comments: -Combination therapy: Effective contraception (at least 2 reliable forms) is required during ribavirin therapy and for at least 6 months after therapy. -Monotherapy: Recommended for use in women of childbearing potential only when effective contraception is used during therapy
Peginterferon alfa-2a Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available The effects in the nursing infant are unknown.
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.