• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Zenpep (Pancrelipase) Delayed-release Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • Postmarketing data for Zenpep have been available since 2009. The following adverse reactions have been identified during post-approval use of Zenpep…
 

PATIENT COUNSELING INFORMATION

Dosing and Administration
  • Instruct patients and caregivers to notify the healthcare professional if the patient has a history of abnormal glucose levels before initiating treatment with Zenpep.
  • Pregnancy and Breast Feeding - Instruct patients to notify their healthcare professional if they are pregnant or thinking of becoming pregnant during treatment with Zenpep…