Copiktra REMS

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® 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.

Indication

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

  • Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior systemic therapies.

Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality.

Counsel patients using the COPIKTRA Patient Safety Wallet Card. Provide the COPIKTRA Patient Safety Wallet Card to your patients.