About SUBLOCADE

How SUBLOCADE works

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

Knowing how SUBLOCADE works and why the medicine used in it, buprenorphine, is different from other opioids is important.

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.

Sustained levels throughout the month

Buprenorphine is delivered at sustained levels. This means that the levels of buprenorphine in the blood stay consistent throughout the month. The chart below shows what the levels look like during treatment with once-monthly SUBLOCADE.

In a study of buprenorphine plasma levels

How the study was conducted

Throughout the study, levels of buprenorphine were measured in patients’ blood. Patients started with a required preliminary period on daily oral buprenorphine (under the tongue or inside the cheek) to control withdrawal symptoms. After patients were stabilized, they were transitioned to treatment with once-monthly SUBLOCADE. The buprenorphine levels peaked within 24 hours, then decreased to a level that was maintained throughout the month.

This data was gathered during a 12-week study designed to measure if SUBLOCADE 300 mg blocked the subjective effects of opioids (hydromorphone 6 mg or 18 mg) in 39 patients. The graph represents modeled measurements and not actual treatment. SUBLOCADE data was not collected daily. Individual results may vary. Before starting treatment with SUBLOCADE, patients must be stabilized for at least 7 days on transmucosal buprenorphine.

How SUBLOCADE blocks the rewarding
effects of opioids*

When the medicine in SUBLOCADE, buprenorphine, attaches to 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 opioids.

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For most people with insurance SUBLOCADE is covered.
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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.

In an emergency, you or your family should tell the emergency medical staff that you are physically dependent on an opioid and are being treated with SUBLOCADE.

Buprenorphine, the medicine in SUBLOCADE, can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you:

  • feel faint or dizzy
  • have mental changes such as confusion
  • have slower breathing than you normally have
  • have severe sleepiness
  • have blurred vision
  • have problems with coordination
  • have slurred speech
  • cannot think well or clearly
  • have a high body temperature
  • have slowed reflexes
  • feel agitated
  • have stiff muscles
  • have trouble walking

These can be signs of an overdose or other serious problems.

Death or serious harm, including life-threatening breathing problems, can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, muscle relaxants, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with SUBLOCADE. Tell your healthcare provider if you are taking any of these medicines and if you drink alcohol.

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 AND INDICATION

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.

In an emergency, you or your family should tell the emergency medical staff that you are physically dependent on an opioid and are being treated with SUBLOCADE.

Buprenorphine, the medicine in SUBLOCADE, can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you:

These can be signs of an overdose or other serious problems.

Death or serious harm, including life-threatening breathing problems, can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, muscle relaxants, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with SUBLOCADE. Tell your healthcare provider if you are taking any of these medicines and if you drink alcohol.

SUBLOCADE is a controlled substance (CIII) because it contains buprenorphine that can be a target for people who abuse prescription medicines or street drugs.

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

Do not use SUBLOCADE if you are allergic to buprenorphine or any ingredient in the prefilled syringe (ATRIGEL® Delivery System, a biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, N-methyl-2-pyrrolidone (NMP)).

SUBLOCADE may not be right for you. Before starting SUBLOCADE, tell your healthcare provider about all of your medical conditions, including:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. SUBLOCADE may affect the way other medicines work and other medicines may affect how SUBLOCADE works. Some medicines may cause serious or life-threatening medical problems when taken with SUBLOCADE. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

The doses of certain medicines may need to be changed if used during treatment with SUBLOCADE. Do not take any medicine during treatment with SUBLOCADE until you have talked with your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines during treatment with SUBLOCADE.

You should not take anxiety medicines or benzodiazepines (such as Valium® or Xanax®), sleeping pills, tranquilizers, muscle relaxants, or sedatives (such as Ambien®), antidepressants, or antihistamines that are not prescribed to you during treatment with SUBLOCADE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death. If a healthcare provider is considering prescribing such a medicine for you, remind the healthcare provider that you are being treated with SUBLOCADE.

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

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 symptoms may start weeks to months after your last dose of SUBLOCADE.

Your healthcare provider may do tests before and during treatment with SUBLOCADE to check your liver.

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

To report pregnancy or side effects associated with taking SUBLOCADE, please call 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.

Indication

SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use (CIII) is a prescription medicine used to treat adults with moderate to severe addiction (dependence) to opioid drugs (prescription or illegal) who have received an oral transmucosal (used under the tongue or inside the cheek) buprenorphine-containing medicine at a dose that controls withdrawal symptoms for at least 7 days. SUBLOCADE is part of a complete treatment plan that should include counseling.

For more information about SUBLOCADE, see the full Prescribing Information including BOXED WARNING, and Medication Guide or talk to your healthcare provider. For REMS information visit www.sublocadeREMS.com.