Label Changes for:
Plegridy (peginterferon beta-1a)
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
USE IN SPECIFIC POPULATIONS
Pregnancy Exposure Registry
- There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to PLEGRIDY during pregnancy. Encourage patients to enroll by calling 1-866-810-1462 or visiting https://www.plegridypregnancyregistry.com/.
PATIENT COUNSELING INFORMATION
Pregnancy and Pregnancy Registry
- Encourage patients to enroll in the PLEGRIDY Pregnancy Registry if they become pregnant while taking PLEGRIDY.
Before using PLEGRIDY, tell your healthcare provider if you:
- are pregnant or plan to become pregnant
- If you become pregnant while taking PLEGRIDY, talk to your doctor about enrolling in the PLEGRIDY Pregnancy Registry. You can enroll in this registry by calling 1-866-810-1462 or visiting https://www.plegridypregnancyregistry.com/. The purpose of this registry is to collect information about the safety of PLEGRIDY during pregnancy.