INDICATIONS AND USAGE

SUBLOCADE™ (buprenorphine extended-release) is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.

SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.

MORE SAFETY INFORMATION

PATIENT SAVINGS & SUPPORT

A savings program may help reduce costs each month for eligible patients

The INSUPPORT™ Copay Assistance Program may help eligible patients pay as little as $5 per injection

INSUPPORT(TM) Copay Assistance Program

Are you ready to enroll your patient?

 

Get eligible patients started in the INSUPPORT™ Copay Assistance Program for SUBLOCADE in 3 steps

  • Complete the enrollment form with your patients
  • Ensure all necessary signatures are included
  • Fax the completed form to INSUPPORTTM at 844.814.0671, or submit via the INSUPPORTTM Provider Portal at www.providerportal.insupport.com

The INSUPPORT™ Copay Assistance Program for SUBLOCADE may help eligible patients with the cost of treatment

 

The INSUPPORT™ Copay Assistance Program helps patients seeking treatment with SUBLOCADE by reducing their out-of-pocket copay

Here's how the program works:

  • Eligible patients pay as little as $5 per injection for the first 2 injections in each calendar year*
  • After that, patients can receive a maximum of $800 per injection for the remainder of the calendar year
  • If the patient's financial responsibility is greater than the maximum benefit per injection, they will be responsible for any remaining costs not covered by the program
  • The expanded benefit ($5 copay) resets at the beginning of each calendar year

Who is eligible?

Does your patient meet these criteria?

  • Private insurance member not covered by a government-funded plan
  • Insurance plan that permits coupons or copay assistance for SUBLOCADE
  • Resident of a state where copay assistance is not prohibited
  • 18 years of age or older, but under age 65
  • Citizen of the United States or a US territory
  • SUBLOCADE is prescribed for an FDA-approved indication

If so, your patient may be eligible for the Copay Assistance Program.

*The INSUPPORTTM Copay Assistance Program is valid ONLY for patients with private insurance who are prescribed SUBLOCADE for on-label use. Patients with government insurance are not eligible for the Copay Assistance Program, including, but not limited to, Medicare, Medicaid, Medigap, VA, DoD, TRICARE, CHAMPVA, or any other federally or state-funded government-assisted program. Other restrictions apply.

FIND A TREATMENT PROVIDER

Find a Treatment Provider Locator

This free service provides a list of physicians, nurse practitioners, and physician assistants who are qualified per the Drug Addiction Treatment Act of 2000 (DATA 2000) and the Comprehensive Addiction and Recovery Act of 2016 (CARA) to treat opioid dependence with FDA-approved medications and who have agreed to be included in the Indivior Treatment Provider Locator.

Search by:

The Substance Abuse and Mental Health Services Administration also provides treatment information at samhsa.gov/treatment/.

LIST YOUR PRACTICE

Provided by Indivior Inc. (Indivior)

List your practice in the Indivior Treatment Provider Locator

Do you have questions about the form you've submitted or the process for submitting? Contact information is below:

Phone:
Fax:
Email
1-866-973-4373
1-855-874-2167
Forms@EnrollmentProfile.com

Would you like to be added to the Indivior Treatment Provider Locator?
If you are an HCP and have the appropriate qualifications, as noted in the Terms and Conditions, and DO NOT currently appear on the Indivior Treatment Provider Locator, then please fill out the Opt‑in form below:

Opt‑in Form

Already on the Indivior Treatment Provider Locator?
If you are an HCP and have the appropriate qualifications, as noted in the Terms and Conditions, and DO appear on the Indivior Treatment Provider Locator and would like to adjust your information or Opt‑out, then please fill out the Opt‑out/Change form below to amend a current listing:

Opt‑Out/Change Form

Physicians waivered under the Drug Addiction Treatment Act of 2000 (DATA 2000) and DATA 2000‑waivered Nurse Practitioners and Physician Assistants qualified under the Comprehensive Addiction and Recovery Act of 2016 may elect to list their practices in the Indivior Treatment Provider Locator to help opioid-dependent patients find waivered physicians, nurse practitioners, and physician assistants.


Physician qualifications

 

Only physicians qualified under DATA 2000 may participate in the Indivior Treatment Provider Locator. To participate in the Indivior Treatment Provider Locator, eligible physicians must:

  • Have a medical license, which is active and in good standing
  • Have a unique identifier (ie, X-DEA number), which is in good standing, from the Drug Enforcement Administration (DEA) that indicates he or she is DATA 2000-waivered
  • Be in compliance and continue to comply with DATA 2000 and its implementing regulations
  • Have reviewed the Indivior Treatment Provider Locator program Terms and Conditions and formally opted to participate in writing

Nurse Practitioner and Physician Assistant qualifications

 

Only Nurse Practitioners and Physician Assistants qualified under the Comprehensive Addiction and Recovery Act of 2016 (CARA 2016) may participate in the Indivior Treatment Provider Locator. To participate in the Indivior Treatment Provider Locator, eligible Nurse Practitioners and Physician Assistants must:

  • Be licensed under state law to prescribe Schedule III, IV, or V medications for the treatment of pain, and the license must be active and in good standing
  • If required by state law, must collaborate or be supervised by a qualified (waivered) physician to prescribe medications for the treatment of opioid use disorder
  • Have a unique identifier (ie, X-DEA number), which is in good standing, from the Drug Enforcement Administration (DEA) that indicates he or she is DATA 2000-waivered
  • Be in compliance and continue to comply with DATA 2000 and its implementing regulations
  • Have reviewed the Indivior Treatment Provider Locator program Terms and Conditions and formally opted to participate in writing

Display of your office contact information

 

Physicians, Nurse Practitioners, and Physician Assistants (hereafter collectively and individually referred to as HCP(s) or Healthcare Providers) will have their information displayed on the Indivior Treatment Provider Locator* as well as to be provided to callers that contact the Indivior Treatment Provider Locator Call Center.

*Search results are served up randomly per state or per ZIP code. All searches may be sorted by city, alphabetically, or by distance from ZIP code center (or "near me" if using mobile website).

The Indivior Call Center provides information as it appears on the online locator based on the caller's location. The caller chooses the HCP(s) they want to contact from among the search results presented by Call Center personnel.

At any time, you may opt‑out of providing your contact information by completing one of the forms linked below. Complete Terms and Conditions are provided on the forms.

Would you like to be added to the Indivior Treatment Provider Locator?
If you are an HCP and have the appropriate qualifications, as noted in the Terms and Conditions, and DO NOT currently appear on the Indivior Treatment Provider Locator, then please fill out the Opt‑in form below:

Opt‑in Form

Already on the Indivior Treatment Provider Locator?
If you are an HCP and have the appropriate qualifications, as noted in the Terms and Conditions, and DO appear on the Indivior Treatment Provider Locator and would like to adjust your information or Opt‑out, then please fill out the Opt‑out/Change form below to amend a current listing:

Opt‑Out/Change Form

Do you have questions about the form you've submitted or the process for submitting? Contact information is below:

Phone:
Fax:
Email
1-866-973-4373
1-855-874-2167
Forms@EnrollmentProfile.com

STAY INFORMED

Stay informed and receive updates

Register below to receive information related to SUBLOCADE

 

FAQs

Frequently asked questions about SUBLOCADE

What does drug liking refer to, and why is this term being used in this study?

Drug liking is defined as the subjective drug effects described during a full agonist-induced challenge with terms that reflect abuse potential.1

Drug liking is used in this study to define the primary endpoint of the blockade study.2

The primary objective of the study was to demonstrate that the “drug-liking” VAS measure after a challenge with 6-mg and 18-mg hydromorphone was non‐inferior (ie, similar) to the “drug-liking” VAS measured after a challenge with placebo at Weeks 1 to 4 post first injection of 300 mg SUBLOCADE.2,3

What was the Phase 2 Study Design?

See details of the Phase 2 Study Design.

What is the definition of mild in terms of inclusion/exclusion criteria?

Mild was defined by the DSM-5 as the presence of 2-3 symptoms of the diagnostic criteria for OUD.4

What is the Phase 3 Study Design?

See details of the Phase 3 Study Design.

What happens if SUBLOCADE is injected intravenously or intramuscularly?

SUBLOCADE is for abdominal subcutaneous injection only; do not administer SUBLOCADE intravenously or intramuscularly. Serious harm or death could result if administered intravenously.1

Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously.2

Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements.2

Additional information regarding the Sublocade REMS program is available at SublocadeREMS.com or by calling 866.258.3905.

What should a clinician do if someone is on SUBLOCADE, and they are involved in an emergency situation that requires analgesia?

While on SUBLOCADE, situations may arise where patients need acute pain management, or may require anesthesia. Treat patients receiving SUBLOCADE with a non-opioid analgesic whenever possible. Patients requiring opioid therapy for analgesia may be treated with a high-affinity full opioid analgesic under the supervision of a physician, with particular attention to respiratory function. Higher doses may be required for analgesic effect. Therefore, a higher potential for toxicity exists with opioid administration. If opioid therapy is required as part of anesthesia, patients should be continuously monitored in an anesthesia care setting by persons not involved in the conduct of the surgical or diagnostic procedure. The opioid therapy should be provided by individuals specifically trained in the use of anesthetic drugs and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation.

What is the half-life of this drug? What are the pathways of elimination?

Buprenorphine is metabolized and eliminated in urine and feces. The apparent terminal plasma half-life of buprenorphine following subcutaneous injection of SUBLOCADE ranged between 43 and 60 days as a result of the slow release of buprenorphine from the subcutaneous depot.2

A mass balance study of buprenorphine administered by IV infusion in humans showed complete recovery of radiolabel in urine (30%) and feces (69%) collected up to 11 days after dosing.2

How long does it take for the plasma levels to reach below 2 ng/mL once the patient discontinues treatment?

Model simulations indicate that steady-state buprenorphine plasma concentrations decreased slowly over time following the last injection and remained at therapeutic levels for 2 to 5 months on average, depending on the dosage administered (100 mg or 300 mg, respectively). Patients who elect to discontinue treatment with SUBLOCADE should be monitored for withdrawal signs and symptoms. Consider transmucosal buprenorphine if needed to treat withdrawal after discontinuing SUBLOCADE.2

How does a clinician decide between 100 mg and 300 mg?

The recommended dose of SUBLOCADE following induction and dose adjustment with transmucosal buprenorphine is 300 mg monthly for the first 2 months, followed by a maintenance dose of 100 mg monthly.2

The maintenance dose may be increased to 300 mg monthly for patients who tolerate the 100 mg dose, but do not demonstrate a satisfactory clinical response, as evidenced by self-reported illicit opioid use or urine drug screens positive for illicit opioid use.2

For patients who have been on transmucosal buprenorphine for an extended period of time, will they require a higher dose?

Increased tolerance to buprenorphine and the need for higher doses was not studied in the Phase 3 trial.

How long can a patient miss an appointment/follow-up?

A patient who misses a dose should receive the next dose as soon as possible, with the following dose given no less than 26 days later. Unavoidable occasional delays in dosing of up to 2 weeks are not expected to have a clinically significant impact on treatment effect.2

What is the volume of each administered dose?

The 100 mg dose is 0.5 mL; the 300 mg dose is 1.5 mL.2

How long can a clinician keep patients on SUBLOCADE?

Periodic assessment is necessary to determine effectiveness of the treatment plan and overall patient progress.2

Due to the chronic nature of opioid use disorder, the need for continuing medication-assisted treatment should be re-evaluated periodically. If considering stopping treatment, the clinical status of the patient should be considered. If SUBLOCADE is discontinued, its extended-release characteristics should be considered, and the patient should be monitored for several months for signs and symptoms of withdrawal and treated appropriately.2

After steady-state has been achieved (4-6 months), patients discontinuing SUBLOCADE may have detectable plasma levels of buprenorphine for 12 months or longer. The correlation between plasma concentrations of buprenorphine and those detectable in urine is not known.2

Model simulations indicate that steady-state buprenorphine plasma concentrations decreased slowly over time following the last injection and remained at therapeutic levels for 2 to 5 months on average, depending on the dosage administered (100 mg or 300 mg, respectively).2

How does the buprenorphine plasma concentration change when patients discontinue treatment?

If SUBLOCADE is discontinued, its extended-release characteristics should be considered and the patient should be monitored for several months for signs and symptoms of withdrawal and treated appropriately. After steady-state has been achieved (4-6 months), patients discontinuing SUBLOCADE may have detectable plasma levels of buprenorphine for 12 months or longer. The correlation between plasma concentrations of buprenorphine and those detectable in urine is not known.2

Model simulations indicate that steady-state buprenorphine plasma concentrations decreased slowly over time following the last injection and remained at therapeutic levels for 2 to 5 months on average, depending on the dosage administered (100 mg or 300 mg, respectively).2

How are patients tapered off SUBLOCADE?

Tapering was not part of the Phase 3 study.

Withdrawal signs and symptoms were not observed in the month following discontinuation of SUBLOCADE. Considering the long half-life, any withdrawal signs and symptoms that may occur would be expected to be delayed.2

Model simulations indicate that steady-state buprenorphine plasma concentrations decreased slowly over time following the last injection and remained at therapeutic levels for 2 to 5 months on average, depending on the dosage administered (100 mg or 300 mg, respectively).2

Patients who elect to discontinue treatment with SUBLOCADE should be monitored for withdrawal signs and symptoms. Consider transmucosal buprenorphine if needed to treat withdrawal after discontinuing SUBLOCADE.2

Does a clinician need anything special to preserve this medication (eg, a refrigerator)?

Store refrigerated at 2°C – 8°C (35.6°F – 46.4°F).2

Once outside the refrigerator, this product may be stored in its original packaging at room temperature, 15°C – 30°C (59°F – 86°F), for up to 7 days prior to administration. Discard SUBLOCADE if left at room temperature for longer than 7 days.2

Is the waivered prescriber required to administer this medication?

SUBLOCADE is available only through a restricted program called the SUBLOCADE REMS Program because of the risk of serious harm or death that could result from intravenous self-administration. The goal of the REMS is to mitigate serious harm or death that could result from intravenous self-administration by ensuring that healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider.3

Notable requirements of the SUBLOCADE REMS Program include the following:

Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in the SUBLOCADE REMS Program.3

Certified healthcare settings and pharmacies must establish processes and procedures to verify SUBLOCADE is provided directly to a healthcare provider for administration by a healthcare provider, and the drug is not dispensed to the patient.3

Certified healthcare settings and pharmacies must not distribute, transfer, loan, or sell SUBLOCADE.3

REFERENCES: 1. Greenwald MK, Comer SD, Fiellin DA. Buprenorphine maintenance and mu-opioid receptor availability in the treatment of opioid use disorder: implications for clinical use and policy. Drug Alcohol Depend. 2014;144:1-11. 2. SUBLOCADE [prescribing information]. North Chesterfield, VA: Indivior Inc.; 2018. 3. Data on file. Indivior Inc. North Chesterfield, VA. 2018. 4. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Association; 2013.
IMPORTANT SAFETY INFORMATION AND BOXED WARNING
INDICATIONS AND USAGE

WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION;
SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY

  • Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously
  • Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements

SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.

SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Prescription use of this product is limited under the Drug Addiction Treatment Act.

CONTRAINDICATIONS: SUBLOCADE should not be administered to patients who are hypersensitive to buprenorphine or any component of the ATRIGEL® delivery system.

WARNINGS AND PRECAUTIONS

Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Buprenorphine is sought by people with opioid use disorder and is subject to criminal diversion. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.

Risk of Respiratory Depression and Concomitant Use of Benzodiazepines or Other CNS Depressants with Buprenorphine: Buprenorphine has been associated with life‐threatening respiratory depression, overdose, and death, particularly when misused by self-injection or with concomitant use of benzodiazepines or other CNS depressants, including alcohol. Warn patients of the potential danger of self-administration of benzodiazepines, other CNS depressants, opioid analgesics, and alcohol while under treatment with SUBLOCADE. Counsel patients that such medications should not be used concomitantly unless supervised by a healthcare provider.

Use with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression).

Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. Newborns should be observed for signs of NOWS and managed accordingly. Advise pregnant women receiving opioid addiction treatment with SUBLOCADE of the risk of neonatal opioid withdrawal syndrome.

Adrenal Insufficiency: Adrenal insufficiency has been reported with opioid use. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off the opioid.

Discontinuation of SUBLOCADE Treatment: Due to the long-acting nature of SUBLOCADE, if treatment is discontinued, monitor patients for several months for withdrawal and treat appropriately.

Inform patients that they may have detectable levels of buprenorphine for a prolonged period of time after treatment with SUBLOCADE. Considerations of drug-drug interactions, buprenorphine effects, and analgesia may continue to be relevant for several months after the last injection.

Risk of Hepatitis, Hepatic Events: Because cases of cytolytic hepatitis and hepatitis with jaundice have been observed in individuals receiving buprenorphine, monitor liver function tests prior to treatment and monthly during treatment.

Hypersensitivity Reactions: Hypersensitivity to buprenorphine-containing products have been reported most commonly as rashes, hives, and pruritus. Some cases of bronchospasm, angioneurotic edema, and anaphylactic shock have also been reported.

Precipitation of Opioid Withdrawal in Patients Dependent on Full Agonist Opioids: Buprenorphine may precipitate opioid withdrawal signs and symptoms in persons who are currently physically dependent on full opioid agonists such as heroin, morphine, or methadone before the effects of the full opioid agonist have subsided. Verify that patients have tolerated and are dose adjusted on transmucosal buprenorphine before subcutaneously injecting SUBLOCADE.

Risks Associated With Treatment of Emergent Acute Pain: When patients need acute pain management, or may require anesthesia, treat patients receiving SUBLOCADE currently or within the last 6 months with a non-opioid analgesic whenever possible. If opioid therapy is required, patients may be treated with a high-affinity full opioid analgesic under the supervision of a physician, with particular attention to respiratory function, as higher doses may be required for analgesic effect and therefore, a higher potential for toxicity exists with opioid administration.

Advise patients of the importance of instructing their family members, in the event of emergency, to inform the treating healthcare provider or emergency room staff that the patient is physically dependent on an opioid and that the patient is being treated with SUBLOCADE.

Use in Opioid Naïve Patients: Because death has been reported for opioid naïve individuals who received buprenorphine sublingual tablet, SUBLOCADE is not appropriate for use in opioid naïve patients.

Use in Patients With Impaired Hepatic Function: Because buprenorphine levels cannot be rapidly decreased, SUBLOCADE is not recommended for patients with pre-existing moderate to severe hepatic impairment. Patients who develop moderate to severe hepatic impairment while being treated with SUBLOCADE should be monitored for several months for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine.

Use in Patients at Risk for Arrhythmia: Buprenorphine has been observed to prolong the QTc interval in some patients participating in clinical trials. Avoid use of buprenorphine in patients with a history of Long QT Syndrome or an immediate family member with this condition or those taking Class IA antiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, dofetilide), or other medications that prolong the QT interval.

Impairment of Ability to Drive or Operate Machinery: SUBLOCADE may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery. Caution patients about driving or operating hazardous machinery until they are reasonably certain that SUBLOCADE does not adversely affect their ability to engage in such activities.

Orthostatic Hypotension: Buprenorphine may produce orthostatic hypotension.

Elevation of Cerebrospinal Fluid Pressure: Buprenorphine may elevate cerebrospinal fluid pressure and should be used with caution in patients with head injury, intracranial lesions, and other circumstances when cerebrospinal pressure may be increased. Buprenorphine can produce miosis and changes in the level of consciousness that may interfere with patient evaluation.

Elevation of Intracholedochal Pressure: Buprenorphine has been shown to increase intracholedochal pressure, as do other opioids, and thus should be administered with caution to patients with dysfunction of the biliary tract.

Effects in Acute Abdominal Conditions: Buprenorphine may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Unintentional Pediatric Exposure: Buprenorphine can cause severe, possibly fatal, respiratory depression in children who are accidentally exposed to it.

ADVERSE REACTIONS: Adverse reactions commonly associated with SUBLOCADE (≥5% of subjects) during clinical trials were constipation, headache, nausea, vomiting, increased hepatic enzymes, fatigue, and injection site pain and pruritus. This is not a complete list of potential adverse events. Please see the full Prescribing Information for a complete list.

DRUG INTERACTIONS

CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over- or under-dosing.

Serotonergic Drugs: If concomitant use with serotonergic drugs is warranted, monitor for serotonin syndrome, particularly during treatment initiation, and during dose adjustment of the serotonergic drug.

Consult the full Prescribing Information for SUBLOCADE for more information on potentially significant drug interactions.

USE IN SPECIFIC POPULATIONS

Pregnancy: Opioid-dependent women on buprenorphine maintenance therapy may require additional analgesia during labor.

Lactation: Buprenorphine passes into the mother's milk. Advise breastfeeding women to monitor the infant for increased drowsiness and breathing difficulties.

Fertility: Chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.

Geriatric Patients: Monitor geriatric patients receiving SUBLOCADE for sedation or respiratory depression.

To report pregnancy or side effects associated with taking SUBLOCADE, please call 1-877-782-6966.

INDICATIONS AND USAGE

SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.

SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.

For more information about SUBLOCADE, see the full Prescribing Information including BOXED WARNING, and Medication Guide. For REMS information visit www.sublocadeREMS.com.