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U.S. Department of Health and Human Services

Safety

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Cimzia (Certolizumab Pegol) Lyophilized Powder or Solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View

 

USE IN SPECIFIC POPULATIONS

Pregnancy
  • Pregnancy Category B
  • Risk Summary: Adequate and well-controlled studies with Cimzia have not been conducted in pregnant women…
 
Pediatric Use
  • Safety and effectiveness in pediatric patients have not been established. Due to its inhibition of TNFα, Cimzia administered during pregnancy could affect immune responses in the in uteroexposed newborn and infant…