FDA.reportPublic FDA data

Sublocade - INDIVIOR Inc.

Manufacturer
INDIVIOR Inc.
Effective date
2025-04-11
Label type
Risk Evaluation & Mitigation Strategies
Version
9
Source
full-release
Hydrated at
2026-06-04 22:50:39

Label at a glance#

ProductSublocade
Label structure6 sections

Label contents#

Full prescribing information#

I. Admistrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Serious harm or death that could result from intravenous self-administration
Application Number: NDA 209819
Application Holder: INDIVIOR Inc.
Initial REMS Approval: 11/2017
Most Recent REMS Update: 04/2025

II. REMS GOAL

REMS Goals

The goal of the SUBLOCADE REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:

  • Ensuring healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider

III. REMS Requirements

REMS REQUIREMENTS

REMS PARTICIPANT REQUIREMENTS

Indivior Inc. must ensure that healthcare settings, pharmacies, and wholesalers/distributors comply with the following requirements:

1. Healthcare settings and pharmacies that dispense SUBLOCADE must:
To become certified to dispense1. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the healthcare setting or pharmacy.
2. Have the authorized representative enroll in the REMS by completing the Healthcare Setting and Pharmacy Enrollment Form and submitting it to the REMS.
3. Train all relevant staff involved in dispensing that the drug must be dispensed directly to a healthcare provider for administration by a healthcare provider, and the drug must not be dispensed to the patient.
4. Establish processes and procedures to verify SUBLOCADE is dispensed directly to a healthcare provider and the drug is not dispensed to the patient.
5. Establish processes and procedures to notify the healthcare provider not to dispense the drug directly to patients.
Before dispensing6. Verify that SUBLOCADE is dispensed directly to a healthcare provider and the drug is not dispensed to the patient.
7. Notify the healthcare provider not to dispense the drug directly to patients.
To maintain certification to dispense8. Have a new authorized representative enroll in the REMS by completing the Healthcare Setting and Pharmacy Enrollment Form if the authorized representative changes.
At all times9. Not distribute, transfer, loan or sell SUBLOCADE.
10. Maintain records of all processes and procedures including compliance with those processes and procedures.
11. Comply with audits by Indivior Inc. or a third party acting on behalf of Indivior Inc. to ensure that all processes and procedures are in place and are being followed.

REMS PARTICIPANT REQUIREMENTS

2. Wholesalers/Distributors that distribute SUBLOCADE must:
To be able to distribute1. Establish processes and procedures to ensure that the drug is distributed only to certified healthcare settings and pharmacies.
2. Train all relevant staff involved in distributing SUBLOCADE on the process and procedures to verify the healthcare settings and pharmacies are certified.
At all times3. Distribute only to certified healthcare settings and pharmacies.
4. Maintain and submit records of all shipments of SUBLOCADE to Indivior Inc.
5. Comply with audits carried out by Indivior Inc. or a third party acting on behalf of Indivior Inc. to ensure that all processes and procedures are in place and are being followed.

REMS APPLICANT REQUIREMENTS

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

Target AudienceCommunication Materials & Dissemination Plans
All healthcare providers who prescribe buprenorphine for the treatment of opioid use disorder; all pharmacies DEA-registered to dispense schedule III controlled substances; all Opioid Treatment Programs certified under 42 CFR 8

REMS Letter: Healthcare Provider REMS Letter with attachment: Fact Sheet: How to Obtain SUBLOCADE

  1. Mail within 60 calendar days of the date SUBLOCADE is first commercially distributed and again 6 months later, or
  2. eMail within 60 calendar days of the date SUBLOCADE is first commercially distributed and again 6 months later.
  3. Make available via a link from the SUBLOCADE REMS Website.
  4. Disseminate through professional societies and request the content be provided to their members.
  5. Disseminate at Professional Meetings for 1 year from the date SUBLOCADE is first commercially distributed.
All new healthcare providers who prescribe buprenorphine for the treatment of opioid use disorder since the last dissemination; all pharmacies DEA-registered to dispense schedule III controlled substances since the last dissemination; all Opioid Treatment Programs certified under 42 CFR 8 since the last dissemination

REMS Letter: Healthcare Provider REMS Letter with attachment: Fact Sheet: How to Obtain SUBLOCADE

  1. Mail annually from the date SUBLOCADE is first commercially distributed, or
  2. eMail annually from the date SUBLOCADE is first commercially distributed.

To support REMS operations, Indivior Inc. must:

  1. Establish and maintain a REMS website, www.SUBLOCADEREMS.com. The SUBLOCADE REMS website must include the capability to complete healthcare setting and pharmacy certification online, the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the SUBLOCADE REMS website. The REMS website must not link back to the promotional product website.
  2. Make the SUBLOCADE REMS website fully operational and all REMS materials available through the website and call center by the date SUBLOCADE is first commercially distributed.
  3. Establish and maintain a SUBLOCADE REMS call center for REMS participants at 1-866-258-3905.
  4. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the SUBLOCADE REMS.
  5. Ensure healthcare settings and pharmacies are able to enroll by fax, mail, email, and online.
  6. Provide the Healthcare Provider REMS Letter, Fact Sheet: How to Obtain SUBLOCADE, Healthcare Setting and Pharmacy Enrollment Form and the Prescribing Information to REMS participants who
    (1) attempt to dispense SUBLOCADE and are not yet certified or (2) inquire about how to become certified.
  7. Notify healthcare settings and pharmacies, confirming certification, within 7 calendar days after they become certified in the REMS.
  8. Provide wholesalers/distributors access to the database of certified healthcare settings and pharmacies.

To ensure REMS participants’ compliance with the REMS, Indivior Inc. must:

  1. Verify annually that the authorized representative’s name and contact information correspond to those of the current designated authorized representative for the certified healthcare setting or pharmacy. If different, the healthcare setting and pharmacy must be required to re-certify with a new authorized representative.
  2. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: SUBLOCADE distribution and dispensing; certification of pharmacies and healthcare settings; and audits of REMS participants.
  3. Establish and maintain a plan for addressing non-compliance with REMS requirements.
  4. Monitor healthcare settings, pharmacies, and wholesalers/distributors on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, including de-certification.
  5. Audit 10% of healthcare settings no later than 90 calendar days after the healthcare setting becomes certified and receives its first shipment of SUBLOCADE, and 10% annually thereafter, to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements. Annual audits must include healthcare settings that have received at least one shipment of SUBLOCADE in the past 12 months and not have been audited in the past 3 years.
  6. Audit pharmacies no later than 90 calendar days after the pharmacy receives its first shipment, and 10% annually thereafter, to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements. Annual audits must include pharmacies that have received at least one shipment of SUBLOCADE in the past 12 months and not have been audited in the past 3 years.
  7. Audit wholesalers/distributors no later than 90 calendar days after they become authorized or from the date SUBLOCADE is first commercially distributed (whichever is later), and annually thereafter, to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.
  8. Take reasonable steps to improve operations of and compliance with the requirements in the SUBLOCADE REMS based on monitoring and evaluation of the SUBLOCADE REMS.

IV. REMS Assessment Timetable

REMS Timetable For Submission Assessments

Indivior Inc. must submit REMS Assessments at 6 months, 12 months, and annually thereafter from the date of the initial approval of the REMS (11/30/2017). 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. Indivior 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 SUBLOCADE REMS:

Enrollment Forms

Healthcare Setting and Pharmacy:

  1. Healthcare Setting and Pharmacy Enrollment Form

Communication Materials

  1. Healthcare Provider REMS Letter
  2. Fact Sheet: How to Obtain SUBLOCADE

Other Materials

  1. 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. Elements to Assure Safe Use (ETASU):
    • Pharmacies and health care settings that dispense SUBLOCADE are specially certified under 505-1(f)(3)(B)
  2. Implementation System
  3. Timetable for Submission of Assessments

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712

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 SUBLOCADE ® safely and effectively. See full prescribing information for SUBLOCADE. SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use, CIII Initial U.S. Approval: 2002SPL related document2026-07-27Indivior Inc. | SGS North America Inc. | Eurofins Lancaster Laboratories, LLC | Curia New Mexico, LLC | Curia New Mexico, LLC. | Curia Global, Inc. | Sharp Packaging Services, LLC | Nelson Laboratories, LLC | Indivior UK Limited | Wickham Micro Limited | QUOTIENT SCIENCES (ALNWICK) LIMITED | Sterling Pharma Solutions Limited20250613_2d4e93f5-3395-4111-beeb-f9c3c2ef8dc2.zip!2f520829-db88-4b19-8cdc-92abd45885d4.xml

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUBLOCADEBUPRENORPHINEIndivior Inc.6189fb21-9432-45f8-8481-0bfaf3ccde952026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SUBLOCADE

Reported adverse events (FAERS/openFDA)#

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