FDA.reportPublic FDA data

COPIKTRA - Secura Bio, Inc.

Manufacturer
Secura Bio, Inc.
Effective date
2025-10-24
Label type
Risk Evaluation & Mitigation Strategies
Version
5
Source
full-release
Hydrated at
2026-06-04 22:50:45

Label at a glance#

ProductCOPIKTRA
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risks: Treatment-related mortality, infections, diarrhea or colitis, cutaneous reactions, and pneumonitis

Application Number: NDA 211155

Application Holder: Secura Bio, Inc.

Initial REMS Approval: 09/2018

Most Recent REMS Update: 10/2025

II. REMS Goal

REMS Goals

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

III. REMS Requirements

REMS REQUIREMENTS

To inform healthcare providers about the REMS and the risks and safe use of COPIKTRA, Secura Bio, Inc. must disseminate REMS communication materials according to the table below:

REMS APPLICANT REQUIREMENTS

Target AudienceCommunication Materials & Dissemination Plans
Healthcare providers who are likely to prescribe COPIKTRAREMS Letters: Healthcare Provider REMS Letter, Professional Society REMS Letter with hyperlink to the Fact Sheet.
  1. E-mail within 60 calendar days of the date of approval of this REMS modification. If a health care provider’s email address is not available, send by mail.
    1. For emails that are undeliverable: send by mail within 30 calendar days of the date of approval of this REMS modification.
    2. For first emails marked unopened: send a second email within 30 calendar days of the date the first email was sent.
    3. For second emails marked unopened: send by mail within 30 calendar days of the date the second email was sent.
  2. Make available via a link from the COPIKTRA REMS Website.
  3. Disseminate through field-based sales and medical representatives for 1 year from the date of approval of this REMS modification.
  4. Disseminate within 60 calendar days of the date of approval of this REMS modification through the following professional societies, and request the letter or its content be provided to their members.
    1. American Society of Clinical Oncology (ASCO); American Society of Hematology (ASH); Oncology Nursing Society (ONS); National Comprehensive Cancer Network (NCCN); Hematology Oncology Pharmacy Association (HOPA); American Pharmacists Association (APhA); American Society of Health-System Pharmacists (ASHP)
  5. Disseminate at Professional Meetings where Secura Bio has a COPIKTRA commercial presence for 1 year from the date of approval of this REMS modification.

Fact Sheet

  1. Disseminate and prominently display at Professional Meetings where Secura Bio, Inc. has a COPIKTRA commercial presence for 1 year from the date of approval of this REMS modification.
  2. Disseminate through field-based sales and medical representatives during initial and/or follow-up discussions with healthcare providers for 1 year after approval of this REMS modification. Field-based sales and medical representatives to verbally review the risk messages contained in the Fact Sheet during visits with the healthcare providers.

Patient Safety Wallet Card

  1. Disseminate through field-based sales and medical representatives to healthcare providers for 1 year from the date of approval of this REMS modification.

Website

  1. Make the REMS Program website fully operational and all REMS materials available and updated through the website within 60 days of approval of this REMS modification.
  2. Maintain the REMS Website from the date of approval of this REMS modification.
  3. Include a prominent REMS-specific link to the COPIKTRA REMS website on all product websites for consumers and healthcare providers. The COPIKTRA REMS website must not link back to the promotional product website(s).

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Secura Bio, Inc. must submit REMS Assessments to FDA on 9/24/2025 and 1 year from the date of the REMS modification approval (07/28/2025). To facilitate inclusion of as much information as possible, while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Secura Bio, Inc. must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS MATERIAL

The following materials are part of the COPIKTRA REMS:

Communication Materials

  • Healthcare Provider REMS letter
  • Professional Society REMS letter
  • Fact Sheet
  • Patient Safety Wallet Card

Other Materials

  • COPIKTRA REMS website

VI. Statutory Elements

REMS ELEMENTS

This REMS is required under section 505-1 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C 355-1) and consists of the following elements:

  1. Communication Plan
  2. Timetable for Submission of Assessments

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6d81ea0-c2f8-4387-a55d-e6815cb97837Product name120181231

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use COPIKTRA safely and effectively. See full prescribing information for COPIKTRA. COPIKTRA ® (duvelisib), capsules for oral use Initial U.S. Approval: 2018SPL related document2025-12-18Secura Bio, Inc | Curia Global, Inc. | Catalent CTS, LLC | Packaging Coordinators, Inc.20260410_75570cb5-a82d-4382-87a2-baae66a94da4.zip!f4ff1650-2689-4564-b089-31e832eb2fba.xml

Products#

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Source XML

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COPIKTRADUVELISIBSecura Bio, Ince3c5ac56-e1f6-473a-bc73-6878365347802025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: COPIKTRA

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.