INDICATION: SUBLOCADE^® (buprenorphine extended-release) injection, for subcutaneous use (CIII) is for adults with moderate to severe opioid addiction whose withdrawal symptoms are controlled by oral buprenorphine for at least 7 days. READ MORE FOR FULL INDICATION

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

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:

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.

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:

trouble breathing or lung problems
a curve in your spine that affects your breathing
Addison’s disease
an enlarged prostate (men)
problems urinating
liver, kidney, or gallbladder problems
alcoholism
a head injury or brain problem
mental health problems
adrenal gland or thyroid gland problems

Tell your healthcare provider if you are:

pregnant or plan to become pregnant. If you receive SUBLOCADE while pregnant, your baby may have symptoms of opioid withdrawal at birth that could be life‐threatening if not recognized and treated. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
breastfeeding or plan to breastfeed. SUBLOCADE can pass into your breast milk and harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with SUBLOCADE. Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with SUBLOCADE.

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?

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBLOCADE affects you. SUBLOCADE can make you sleepy, dizzy, or lightheaded. This may happen more often in the first few days after your injection and when your dose is changed.

Do not drink alcohol or take prescription or over‐the‐counter medicines that contain alcohol during treatment with SUBLOCADE, because this can lead to loss of consciousness or even death.

What are the possible side effects of SUBLOCADE?

SUBLOCADE can cause serious side effects, including:

Trouble breathing. Taking other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants during treatment with SUBLOCADE can cause breathing problems that can lead to coma and death.

Sleepiness, dizziness, and problems with coordination.

Physical dependence.

Liver problems. Call your healthcare provider right away if you notice any of these symptoms: your skin or the white part of your eyes turns yellow (jaundice), dark or “tea‐colored” urine, light colored stools (bowel movements), loss of appetite, pain, aching, or tenderness on the right side of your stomach area, or nausea.

Your healthcare provider should do blood tests to check your liver before you start and during treatment with SUBLOCADE.

Allergic reaction. You may have rash, hives, itching, swelling of your face, wheezing, low blood pressure, or loss of consciousness. Call your healthcare provider or get emergency help right away.

Opioid withdrawal. Call your healthcare provider right away if you get any of these symptoms: shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting, or muscle aches.

Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down.

The most common side effects of SUBLOCADE include: constipation, headache, nausea, injection site itching, vomiting, increase in liver enzymes, tiredness, or injection site pain.

SUBLOCADE may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

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.

Important Safety Information

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

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

Before you continue, please review the following information.

This free tool provides a list of physicians, nurse practitioners, and physician assistants (hereafter collectively and individually referred to as HCP(s) or Healthcare Providers) who have the required legal permissions to treat opioid dependence with FDA-approved medications, have prescribed SUBLOCADE^® (buprenorphine extended-release) at least once in the previous two years, and have agreed to be included in the Indivior Find a SUBLOCADE Treatment Provider Tool.

Participating HCPs do not pay a fee to be listed in the tool, and their participation does not impose any requirements on the manner in which they treat or provide services to patients.
Participating HCPs are chosen for your search based on the geographical search information entered.
Some of the participating HCPs may be consultants to Indivior and receive payment for services. Some may have other financial relationships with Indivior as recipients of research grants, or other similar payments, or they may have an ownership interest in Indivior.
HCPs may request to be removed from the tool at any time, and Indivior retains the right to remove HCPs from the tool for the following reasons, including but not limited to:
- The HCP's contact information is no longer valid;
- The HCP's medical license, healthcare provider license, or state prescribing license is suspended, revoked, or restricted;
- The company has information or determines after investigation that the HCP may be engaging in the unsafe prescription of our products; or
- The HCP has not prescribed SUBLOCADE in the previous two years.

Limitation of Indivior Liabilities

Indivior does not warrant, whether expressed or implied, that the tool is accurate or complete. Indivior does not recommend or endorse any HCP included in the tool for any purpose, nor is the tool intended to verify a specific HCP's credentials or qualifications. It is your responsibility to select an HCP appropriate for your needs and you assume full responsibility for your interactions with any HCP you contact through the tool. Indivior is not responsible for the medical care or advice given by any participating HCP you choose to contact.

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