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Label Changes for:

Emend (aprepitant) capsules

August 2014

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

August 2014

ADVERSE REACTIONS

Postmarketing Experience
  • Nervous system disorders: Events of ifosfamide-induced neurotoxicity have been reported after aprepitant and ifosfamide coadministration.

 

ADVERSE REACTIONS

Clinical Trials Experience
  • section (including Table 2) was updated to include the adverse experience data from the sponsor's completed postmarketing study.

CLINICAL STUDIES

Post-Marketing Trial
  • Entire Section Updated
  • In a postmarketing, multicenter, randomized, double-blind, parallel-group, clinical study in 848 cancer patients, the aprepitant regimen (N=430) was compared with a standard of care therapy (N=418) in patients receiving a moderately emetogenic chemotherapy regimen that included...

 

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