Approved Risk Evaluation and Mitigation Strategies (REMS)
Vivitrol (naltrexone)
NDA #021897
REMS last update: 06/07/2019
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).
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.
| 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.
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