What to Expect Video Transcript

[ON-SCREEN TEXT]
OPIOID ADDICTION AND YOU

INDICATION:
SUBLOCADE^® (buprenorphine extended-release) 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.

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.

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

Remember to watch the complete video to see additional safety information.

[DESCRIPTION]
Important Safety Information remains on screen while VO is read. Timer to start the video gradually counts down.

[SPEECH]
SUBLOCADE injection is a prescription medicine used to treat adults with moderate to severe addiction to opioid drugs who have received an oral transmucosal 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.

Because of the serious risk of potential harm or death from self-injecting SUBLOCADE into a vein, 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.

Remember to watch the complete video to see additional safety information.

[DESCRIPTION AND ON-SCREEN TEXT]
“OPIOID ADDICTION AND YOU” moves off screen and is replaced by animated person next to a cycle graphic.

Cycle graphic moves off screen and graphic depicting one hand pulling up another hand comes on screen. Animated person smiles slightly. Zoom out to animated person with thought bubble reading “NOW WHAT?” SUBLOCADE logo enters.

[SPEECH]
Now that you’ve made the decision to get treatment for opioid addiction, you may be wondering what’s next.

Learn more about once-monthly SUBLOCADE that can keep you moving towards recovery.

[DESCRIPTION AND ON-SCREEN TEXT]
SUBLOCADE logo shrinks. Animated person walks a line behind “KEEP MOVING TOWARDS RECOVERY.” Animated person walks through the letter “O” in recovery and over a horizontal line, under which reads “OPIOID ADDICTION.” After he walks off screen, “OPIOIDS CHANGE YOUR BRAIN” appear on screen.

[SPEECH]
Before you understand how SUBLOCADE works, you first need to know how opioids change your brain.

[DESCRIPTION AND ON-SCREEN TEXT]
Zoom into the animated person’s brain. As “RELEASES DOPAMINE” comes on screen, the center of the brain fills with blue. Gradually a portion of the brain that is blue turns red, while "RELEASES DOPAMINE" turns red and goes off screen. It is replaced by “OPIOIDS HIJACK YOUR BRAIN.”

[SPEECH]
When you experience pleasure or a sense of reward, your brain releases a chemical called dopamine.

The increased use of opioids begin to hijack your brain and cause it to release an abnormal amount of dopamine.

[DESCRIPTION]
Animated person approaches a thermometer-like scale with red on top, medium blue in the center, and light blue on the bottom. An arrow on the scale moves from the bottom to the top and back down again.

[SPEECH]
This leads to extreme highs and lows that can feel out of your control.

[DESCRIPTION AND ON-SCREEN TEXT]
The animated person enters the CYCLE OF ADDICTION, which is half blue and half red. The person pushes against the arrows and the cycle slows and turns blue. The person is then shown in a window box that pushes out to show a full calendar with the first day of the month highlighted.

[SPEECH]
You become trapped in the cycle of addiction, which can seem impossible to escape.

The good news is, SUBLOCADE plus counseling can help you break out of this cycle and help move towards recovery.

[DESCRIPTION AND ON-SCREEN TEXT]
Checkmarks fill in the squares of the calendar. Zoom out to reveal the text "ONCE MONTHLY" and then "CONTINUOUS DELIVERY ALL MONTH."

[SPEECH]
SUBLOCADE is an injection of a medicine called buprenorphine that you’re given once a month.

Once injected, it continuously releases medication all month.

[DESCRIPTION AND ON-SCREEN TEXT]
Zoom in on checkmarks. “FIRSTEPS” appears, then changes to “FIRST.” “FIRST” becomes a rectangle, which shrinks and goes into the mouth of the animated person. A blue line oscillates up and down behind animated person’s head. The blue line flattens out, and a needle appears on screen. The screen reads, “Buprenorphine is a controlled substance that can be abused. When taken by those not addicted to opioids, death has been reported,”

[SPEECH]
There are 2 phases to get started on SUBLOCADE.

First, you’ll need to take a daily oral form of buprenorphine for at least 7 days to help control withdrawal.

Next you receive your first injection of SUBLOCADE.

[DESCRIPTION AND ON-SCREEN TEXT]
Needle injects into line, which creates a bubble beneath the “skin,” which grows. The word “DEPOT” appears within the bubble. The bubble slowly shrinks, and its border disappears. “GRADUAL RELEASE OF MEDICINE” appears on screen. Animated person reappears walking down the path, and “NO REAL DAILY UPS AND DOWNS” appears on screen, then disappears.

[SPEECH]
Once your provider injects SUBLOCADE just under the skin, SUBLOCADE turns into a gel called a depot that slowly releases medicine into your bloodstream all month long with no real daily ups and downs.

[DESCRIPTION AND ON-SCREEN TEXT]
Zoom in on animated person’s head and shoulders. A thought bubble appears reading “CRAVINGS,” with the footnote “Results may vary.” The bubble gradually fades and shrinks without fully disappearing. Animated person appears next to cycle of addiction, which reads “CYCLE OF ADDICTION,” which is red and blue and spinning. He nudges the cycle, which then turns blue and disappears.

[SPEECH]
Buprenorphine is known to reduce cravings and block the rewarding effects of opioids, which can make taking them less appealing. SUBLOCADE helps you break the cycle of addiction.

[DESCRIPTION AND ON-SCREEN TEXT]
Text appears on screen: 14x MORE LIKELY TO ACHIEVE TREATMENT SUCCESS ON SUBLOCADE*
*Treatment success was defined as at least 80% of weeks (not always consecutive) free of illicit opioids.

Horizontal line appears and new line appears below “14X MORE LIKELY”: 28% SUBLOCADE + COUNSELING vs 2% PLACEBO + COUNSELING

Animated person appears on screen next to SUBLOCADE + COUNSELING with text below that reads: The body can develop a dependence on SUBLOCADE and can experience opioid withdrawal symptoms weeks or months after last dose,

[SPEECH]
In a 24-week clinical study, SUBLOCADE patients were 14x more likely to achieve treatment success.

Medication, combined with counseling as part of a complete treatment plan, can help you keep moving towards recovery.

[DESCRIPTION]
Animated person appears in a thunderstorm, pulls out an umbrella, then the scene changes to a sunny day. $0 appears on screen. The dollar symbol drops into animated person’s hands as animated person smiles. Animated person walks through 0 onto his path, next to a direction sign pointing in the direction he’s walking. Zoom into the person with a thought bubble stating "Please stay tuned for the Important Safety Information.”

[ON-SCREEN]
$0 for the first two doses of each calendar year, if eligible. Subsequent copays may be reduced.

[SPEECH]
SUBLOCADE is covered for most people with health insurance, and some patients may pay as little as $0 per monthly dose.

Everyone’s journey is different. Your doctor can help you outline a treatment plan so you can keep moving towards recovery with once-monthly SUBLOCADE.

Please stay tuned for Important Safety Information about SUBLOCADE that is important to know before treatment.

[SPEECH + ON-SCREEN TEXT]
SUMMARY OF 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 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, goosebumps, 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.

This is only a summary of important information about SUBLOCADE and does not replace talking to your healthcare provider about your condition and your treatment. Talk to your healthcare provider if you have questions about SUBLOCADE. Share this important information with members of your household.

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.

To learn more about SUBLOCADE, go to SUBLOCADE.com. For REMS information visit www.sublocadeREMS.com.

Please see the SUBLOCADE medication guide at sublocade.com

SUBLOCADE is manufactured by Curia Global Inc., Albany, NY 12203
© 2023 Indivior UK Limited | INDIVIOR® and SUBLOCADE® are registered trademarks of Indivior UK Limited | All Rights Reserved.

P-BAG-US-01381 Expiry September 2025 Intended for US audiences.