Purpose

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.

The purpose of the COPIKTRA^TM REMS is to mitigate the risk of fatal and serious toxicities including:

• Infections

  • Serious, including fatal (4%) infection occurred in 31% of patients receiving COPIKTRA 25 mg twice daily (N=442).

• Diarrhea or Colitis

  • Serious, including fatal (<1%), diarrhea or colitis occurred in 18% of patients receiving COPIKTRA 25 mg twice daily (N=442).

• Cutaneous Reactions

  • Serious, including fatal (<1%) cutaneous reactions occurred in 5% of patients receiving COPIKTRA 25 mg twice daily (N=442).

• Pneumonitis

  • Serious, including fatal (<1%) pneumonitis without an apparent infectious cause occurred in 5% of patients receiving COPIKTRA 25 mg twice daily (N=442).

For more detailed information on these risks, please see the Fact Sheet.