Get ready for treatment

What to expect

There are 2 parts to starting SUBLOCADE.

Once you and your treatment provider have decided that SUBLOCADE is right for you, treatment can begin.

Induction

Before receiving SUBLOCADE, you’ll need to take a daily transmucosal form of buprenorphine (under the tongue or inside the cheek) for at least 7 days to help control withdrawal symptoms. Make sure your follow-up appointment is scheduled.

Administration

SUBLOCADE will be administered in office by your treatment provider after you complete induction.

What to expect during the appointment

Your treatment provider will administer SUBLOCADE

The injection is given just under the skin (subcutaneous) in your abdomen.

You may feel or see a small bump

A small bump under your skin at the injection site for several weeks is normal. The bump is called a depot, which releases medicine throughout the month. Over time, as medication is released into your body, the bump will get smaller. See how the depot works.

Talk to your treatment provider if you have questions about the size of the bump.

Do not try to remove the depot, and do not rub or massage the injection site. Likewise, try not to let belts or waistbands rub against the injection site.

Find a buprenorphine treatment provider

What to know about dosing

SUBLOCADE comes in 2 doses: 300 mg and 100 mg. You’ll receive a dose once a month (with at least 26 days between doses).

Your treatment provider will start with 300 mg to help the medication reach an effective level in your body. After 2 months, they may decide to lower the dose to 100 mg or stay at 300 mg. Learn more about how SUBLOCADE sustains medication levels in your body.

If you miss a dose, see your treatment provider as soon as possible.

The level of medicine in your blood is important. Ask your treatment provider about how the delivery system used in SUBLOCADE maintains medicine levels even when the dose is lowered.

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Stay committed

It may take time for your brain to reset and for you to make healthy changes. Be patient and stay with your treatment plan. Don’t give up.

If you experience a slip-up and use illicit opioids while on SUBLOCADE, talk to your treatment provider. Because buprenorphine blocks the rewarding effects of opioids,* continued opioid use can become less appealing.

The journey towards recovery is different for everyone. Some people may experience relapse. If this happens to you, treatment can be restarted. You can keep moving towards recovery.

Tell your treatment provider about your goals, so you can work together to decide the length of treatment.

*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. Check with your insurance provider for more details.

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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.