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Label Changes for:

Plegridy (peginterferon beta-1a)

July 2016

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)

July 2016

USE IN SPECIFIC POPULATIONS

Pregnancy
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.

MEDICATION GUIDE

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.
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