VIDEO TRANSCRIPT

[DESCRIPTION]

There is a towering stone wall with the words "OPIOID ADDICTION" carved into it. Down at the bottom of the wall, there is a group of people who are living with opioid addiction.

[SPEECH]

Living with opioid addiction can be a struggle.

[DESCRIPTION]

Zoom in closer to the people and then pan up the wall. On top of the wall, a man is leaving his house to walk his dog on sidewalk.

On-screen text:

For adults who have started treatment with a dose of oral buprenorphine or are being treated with buprenorphine.

[SPEECH]

SUBLOCADE, with counseling, is for adults with moderate to severe opioid addiction who have started treatment with a dose of oral buprenorphine or are being treated with buprenorphine.

[DESCRIPTION]

On top of the wall, a man walks his dog on sidewalk.

On-screen text:

SUBLOCADE (buprenorphine extended-release) injection for subcutaneous use CIII 100mg-300mg

ONCE-MONTHLY
Plus counseling

SUBLOCADE should be used with counseling.

[SPEECH]
SUBLOCADE may help you keep moving towards recovery.

On-screen text:
CONTINUOUSLY

SUBLOCADE is available by prescription only.

[DESCRIPTION]

Man walking on sidewalk.

[SPEECH]

SUBLOCADE continuously releases the medicine buprenorphine all month

On-screen text:

SUBLOCADE is available by prescription only.

[DESCRIPTION]

Man walking on sidewalk

[Speech]

with no real daily ups and downs.

On-screen text:

Results may vary.

[DESCRIPTION]

The scene transitions to man with basketball walking along basketball court.

[SPEECH]

Buprenorphine is known to reduce cravings and block the rewarding effects of opioids.

On-screen text:

REDUCE CRAVINGS

BLOCK REWARDING EFFECTS

Results may vary.

[DESCRIPTION]

Man walking along basketball court with his friend.

On-screen text:

SUBLOCADE may cause harm or death if injected in a vein.

[SPEECH]

SUBLOCADE may cause harm or death if injected in a vein.

[DESCRIPTION]

The scene transitions to the man attending a group counseling meeting.

On-screen text:

As an opioid, it may cause serious life-threatening breathing problems.

[SPEECH]

As an opioid, it may cause serious life-threatening breathing problems.

[DESCRIPTION]

Man walks into a group meeting, picks up a cup of coffee and hands the cup to a woman.

On-screen text:

Ask about naloxone for opioid overdose.

[SPEECH]

Ask about naloxone for opioid overdose.

[DESCRIPTION]

The man continues to walk through the group meeting, picks up a jacket off a chair, shakes the group leader’s hand, and continues walking. The scene transitions to an office setting.

On-screen text:

Get emergency help right away if you’re faint, dizzy, sleepy, confused, have problems breathing, seeing, or talking, or if naloxone is given.

[SPEECH]

Get emergency help right away if you’re faint, dizzy, sleepy, confused, have problems breathing, seeing, or talking, or if naloxone is given.

[DESCRIPTION]

The scene transitions to the man walking through an airport, rolling a suitcase.

On-screen text:

Don't take with other opioids, benzos, alcohol, or other drugs including street drugs.

[SPEECH]

Don't take with other opioids, benzos, alcohol, or other drugs including street drugs.

[DESCRIPTION]

Man continues to walk through an airport, rolling a suitcase. He walks past a banner that reads, “SUBLOCADE.”

On-screen text:

This can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

[SPEECH]

This can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

[DESCRIPTION]

The man continues down the airport to embrace family. The airport is on the side of the addiction wall.

On-screen text:

In emergencies, tell medical staff you’re on SUBLOCADE for opioid dependence.

[SPEECH]

In emergencies, tell medical staff you’re on SUBLOCADE for opioid dependence.

[DESCRIPTION]

The man leaves the airport and joins a group of people walking on top of the wall of Opioid Addiction. The scene pans out to show people above and below the wall. Everyone disappears, leaving only the wall of Opioid Addiction.

On-screen text:
This isn't a full list of risks and side effects. Talk to your doctor and read patient label for more information.

[SPEECH]
This isn't a full list of risks and side effects. Talk to your doctor and read patient label for more information.

[DESCRIPTION]
The scene transitions to a screen showing the once-monthly SUBLOCADE logo.

On-screen text:
Once-monthly SUBLOCADE^®logo

For product information and pricing, call 1-877-782-6966 or visit SUBLOCADE.com.

Indivior^®logo

[SPEECH]

Don't give up. Ask a doctor if SUBLOCADE can help you keep moving towards recovery.

[END OF TRANSCRIPT]

INDICATION

Prescription SUBLOCADE, with counseling and psychosocial support, is for adults with moderate to severe opioid addiction who have started treatment with a dose of oral buprenorphine or are being treated with buprenorphine.

IMPORTANT SAFETY INFORMATION

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

· Because of 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 which 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, which is a medicine that is available to patients for emergency treatment of an opioid overdose. If naloxone is given, 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, dizzy, confused, sleepy or uncoordinated, have blurred vision or slurred speech, are breathing slower than normal or cannot think well or clearly.

· Do not take SUBLOCADE with certain medicines. Taking SUBLOCADE with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) 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 several months after stopping treatment with SUBLOCADE.

Who should not receive SUBLOCADE?

Do not receive SUBLOCADE if you are allergic to buprenorphine or any ingredient in the prefilled syringe (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, problems urinating, liver, kidney, gallbladder or mental health problems, alcoholism, head injury or brain problem, adrenal or thyroid gland problems.

Tell your healthcare provider if you are pregnant or breastfeeding or plan to become pregnant or breastfeed:

· 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.

· 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 before starting any new medicines and during or after stopping treatment with SUBLOCADE.

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

· Sleepiness, dizziness, and problems with coordination.

· Physical dependence or abuse.

· 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, light-headedness, feeling faint 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 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.

P-BAG-US-01744