About SUBLOCADE

How SUBLOCADE works

SUBLOCADE is delivered continuously at a sustained level throughout the month.

It is important to know how SUBLOCADE works and why the medicine in SUBLOCADE, buprenorphine, is different from other opioids.

Extended release

SUBLOCADE is injected by a treatment provider as a liquid and, once inside the body, turns to a solid gel called a depot (dee-poh).

The depot gradually releases buprenorphine at a controlled rate all month.

For illustrative purposes only. May not accurately show subject matter.

SUBLOCADE continuously releases medicine all month at sustained levels with no real daily ups and downs

How SUBLOCADE was studied*

  • In a clinical study, levels of buprenorphine in participants' blood were measured. Participants were first given daily oral transmucosal buprenorphine to control withdrawal symptoms and once stabilized, switched to treatment with once‑monthly SUBLOCADE
  • After SUBLOCADE administration, buprenorphine levels peaked at 24 hours, then decreased to approximate target levels that were maintained throughout the month
  • The graph represents average buprenorphine blood levels observed, and individual results may vary
*Data were gathered during a 12‑week study of 39 participants designed to measure if SUBLOCADE 300 mg blocked the rewarding effects of an opioid (hydromorphone 6 mg or 18 mg). Blood samples were not collected daily, and the graph above represents average buprenorphine blood levels observed. Before starting treatment with SUBLOCADE, patients must be stabilized for at least 7 days on oral transmucosal buprenorphine (8–24 mg/day).

How SUBLOCADE blocks the rewarding
effects of opioids*

When the medicine in SUBLOCADE, buprenorphine, attaches to opioid receptors in the brain, other opioids are less likely to attach.

While on SUBLOCADE, a person will receive a continuous delivery of buprenorphine all month.

*In a 12-week study of 39 non-treatment-seeking adults, SUBLOCADE blocked the rewarding effects of an opioid.

Find a SUBLOCADE treatment provider

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For more information on how to find a facility, call INSUPPORT® at 1-844-467-7778.

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For most people with insurance, SUBLOCADE is covered.
Check with your insurance provider for more details.

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What’s the most important information to know about SUBLOCADE?

Because of the serious risk of potential harm or death from self-injecting SUBLOCADE into a vein (intravenously), it is only available through a restricted program called the SUBLOCADE REMS Program.

  • SUBLOCADE is not available in retail pharmacies.
  • Your SUBLOCADE injection will only be given to you by a certified healthcare provider.

SUBLOCADE contains an opioid medicine called buprenorphine that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs.

Talk to your healthcare provider about naloxone, a medicine available to patients for emergency treatment of an opioid overdose. If naloxone is given, you must call 911 or get emergency medical help right away to treat overdose or accidental use of an opioid.

SUBLOCADE may cause serious and life‐threatening breathing problems. Get emergency help right away if you:

  • feel faint
  • feel dizzy
  • are confused
  • feel sleepy or uncoordinated
  • have blurred vision
  • have slurred speech
  • are breathing slower than normal
  • cannot think well or clearly

Do not take certain medicines during treatment with SUBLOCADE. Taking other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) while on SUBLOCADE can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with SUBLOCADE.

You may have detectable levels of SUBLOCADE in your body for a long period after stopping treatment with SUBLOCADE.

Death has been reported in those who are not opioid dependent who received buprenorphine sublingually.

Call your healthcare provider for medical advice about side effects. You may also report side effects to the FDA at 1-800-FDA-1088.

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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SUBLOCADE?

Because of the serious risk of potential harm or death from self-injecting SUBLOCADE into a vein (intravenously), it is only available through a restricted program called the SUBLOCADE REMS Program.

SUBLOCADE contains a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life‑threatening breathing problems, especially if you take or use certain other medicines or drugs.

Talk to your healthcare provider about naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose. If naloxone is given, you must call 911 or get emergency medical help right away to treat overdose or accidental use of an opioid.

SUBLOCADE may cause serious and life‑threatening breathing problems. Get emergency help right away if you:

Do not take certain medicines during treatment with SUBLOCADE. Taking other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) while on SUBLOCADE can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with SUBLOCADE.

You may have detectable levels of SUBLOCADE in your body for a long period after stopping treatment with SUBLOCADE.

Death has been reported in those who are not opioid dependent who received buprenorphine sublingually.

Who should not take SUBLOCADE?

Do not use SUBLOCADE if you are allergic to buprenorphine or any ingredient in the prefilled syringe (Indivior’s proprietary buprenorphine gel depot delivery system, a biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, N-methyl-2-pyrrolidone (NMP)).

Before starting SUBLOCADE, tell your healthcare provider about all of your medical conditions, including if you have:

Tell your healthcare provider if you are:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

What should I avoid while being treated with SUBLOCADE?

What are the possible side effects of SUBLOCADE?

SUBLOCADE can cause serious side effects, including:

These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

To report a pregnancy or side effects associated with taking SUBLOCADE or any safety related information, product complaint, request for medical information, or product query, please contact PatientSafetyNA@indivior.com or 1-877-782-6966. You are encouraged to report negative side effects of drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

See full Prescribing Information, including BOXED WARNING, and Medication Guide. For REMS information visit www.sublocadeREMS.com.