Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Vivitrol (naltrexone)

NDA #021897

REMS last update: 06/07/2019

Goals
Summary
REMS Materials
Update history

What is the purpose of the REMS?

The goals of this REMS are:

To inform patients and healthcare providers about severe injection site reactions associated with the use of VIVITROL.
To inform healthcare providers about the importance of counseling their patients about severe injection site reactions associated with the use of VIVITROL.

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).

View application holder(s) REMS Website

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 Vivitrol REMS, see the DailyMed link(s).

Material Name	Material Name Link
Dear Healthcare Provider (DHCP) Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 Dear Healthcare Provider DHCP Letter.pdf
Key Techniques to Reduce Severe Injection Site Reactions Poster (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 Key Techniques to Reduce Severe Injection Site Reactions Poster.pdf
Patient Counseling Tool (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 Patient Counseling Tool.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 REMS Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 REMS Full.pdf
REMS Website Screenshot (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol 2019 06 07 REMS Website Screenshot.pdf

What updates have been made to the REMS?

Date	Summary of change
06/07/2019	Modified to update the language in the Dear Healthcare Provider letter to remove the terms “new,” “recent,” and “now,” when discussing safety information that was added in 2015, and to change the signatory on the letter.
05/17/2016	Modified to clarify the implementation date of the communication plan and the timetable for submission of assessments of the REMS.
12/08/2015	Modified to change the REMS appended materials including the "Key Techniques to Reduce Injection Site Reactions" Poster, and the Dear Healthcare Provider Letter.
07/29/2013	Modified to revise the Medication Guide, add a communication plan to include information about the serious risks associated with Vivitrol (naltrexone for extended-release injectable suspension), and a revise the timetable for submission of REMS assessments.
10/12/2010	Modified to add information about the risks associated with the use of Vivitrol for the treatment of opioid dependence in the Medication Guide.
03/22/2010	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.