Approved Risk Evaluation and Mitigation Strategies (REMS)

Copiktra (duvelisib)

NDA #211155

REMS last update: 02/02/2022

• View the Copiktra Prescribing Information and Medication Guide at DailyMed.
• View Copiktra's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goal of the COPIKTRA REMS is to mitigate the risks of fatal and/or serious toxicities associated with the use of COPIKTRA, including infections, diarrhea or colitis, cutaneous reactions, and pneumonitis, by informing healthcare providers of these risks.

What do participants need to know?

Healthcare providers should read the relevant Medication Guide or communication materials included in the product-specific approved REMS to learn about the risk(s).

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Copiktra REMS, see the DailyMed link(s).

Material Name	Material Name Link
Fact Sheet (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_Fact_Sheet.pdf
Healthcare Provider REMS Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_Healthcare_Provider_REMS_Letter.pdf
Patient Safety Wallet Card (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_Patient_Safety_Wallet_Card.pdf
Professional Society REMS Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_Professional_Society_REMS_Letter.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_REMS_Full.pdf
REMS Program Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Copiktra_2022_02_02_REMS_Program_Website_Screenshots.pdf

Assessment Plan

This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date	Summary of change
02/02/2022	Modified to remove references to the follicular lymphoma indication from the Healthcare Provider REMS letter, Professional Society REMS letter, Fact Sheet, and the Copiktra REMS Program website. Additionally, editorial revisions were made to the REMS Document, Healthcare Provider REMS letter, Professional Society REMS letter, Fact Sheet, Patient Safety Wallet Card, and the Copiktra REMS Program website.
08/10/2021	Revised to reflect changes to the name of applicant holder.
09/24/2018	Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.