What to Expect Video Transcript

 

[ON-SCREEN TEXT]

STARTING SUBLOCADE®

 

ONCE-MONTHLY

SUBLOCADE® (buprenorphine extended-release)

injection for subcutaneous use CIII

100mg-300mg

 

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.

 

Remember to watch the complete video to see additional Important Safety Information.

 

[DESCRIPTION AND ON-SCREEN TEXT]

Important Safety Information remains on screen while VO is read. Timer to start the video

gradually counts down.

 

[SPEECH]

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.

 

Because of 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 Important Safety Information.

 

[DESCRIPTION AND ON-SCREEN TEXT]

“STARTING SUBLOCADE” moves off screen as an animated person begins walking to the right. It shrugs shoulders. Zoom into its thought bubble, which contains a question mark.

 

[SPEECH]

If you're considering starting SUBLOCADE for opioid addiction, or have already made the decision to start, you may be wondering what's next.

 

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

 

[DESCRIPTION AND ON-SCREEN TEXT]

The person is shown in a box that pushes out to show a full calendar with the first day of the month highlighted. On the left, “ONCE-MONTHLY” appears.

 

[SPEECH]

Once injected, it continuously releases medication all month so you keep receiving treatment without the burden of daily dosing.

 

[DESCRIPTION AND ON-SCREEN TEXT]

The calendar shifts to the left. The person vanishes, and checkmarks begin to fill each box in the calendar, one by one. On the right, “CONTINUOUS DELIVERY ALL MONTH” appears. Zoom in on one day’s checkmark on the calendar; the rest of the calendar fades away and just the checkmark remains. To the right, “NO DAILY REMINDERS” appears.

 

[SPEECH]

If you are currently being treated with oral transmucosal buprenorphine, used under the tongue or inside the cheek, you can transition directly to SUBLOCADE and receive your first dose in your treatment provider's office.

 

[DESCRIPTION AND ON-SCREEN TEXT]

Zoom into checkmark. “ARE YOU CURRENTLY BEING TREATED WITH BUPRENORPHINE?” and the following super appears: “Buprenorphine is a controlled substance that can be abused. When taken by those not addicted to opioids, death has been reported.” 

 

[SPEECH]

If you are not already being treated with buprenorphine, you'll need to take a small oral dose under your tongue or in your cheek to ensure tolerability and be monitored by your doctor for 1 hour.

 

[DESCRIPTION AND ON-SCREEN TEXT]

The person walks across the screen and stops. Zoom into person’s face. A small strip enters its opened mouth; the mouth closes once the strip is in. The line of the mouth spins as the face transforms into a clock with hands that move and demonstrate an hour passing. The super reads, "Buprenorphine is a controlled substance that can be abused. When taken by those not addicted to opioids, death has been reported.”

 

[SPEECH]

If you respond well, you can receive your first injection of SUBLOCADE the same day.

 

[DESCRIPTION AND ON-SCREEN TEXT]

Clock vanishes; replaced by “SAME DAY”.

 

[SPEECH]

SUBLOCADE can be injected into 1 of 4 locations on your body: your abdomen, thigh, buttock, or back of the upper arm. So you don’t have to stick with just one spot month after month.

 

[DESCRIPTION AND ON-SCREEN TEXT]

The "E" in "SAME DAY" turns into a line that extends horizontally to the right. Copy shifts off-screen to the left as a figure appears from the right. The line, and another beneath it, point to highlighted parts of the figure’s body. The figure rotates and 2 other horizontal lines come in from the right and point to parts of the figure.

 

[SPEECH]

SUBLOCADE is injected just under the skin. After your provider gives you the injection, you may feel or see a small bump at the injection site. This is normal.

 

[DESCRIPTION]

Figure moves to the left; a horizontal line is still visible. A syringe drops from the top and injects into the horizontal line. A droplet grows below the line and creates an oval depot. The oval shape distorts the horizontal line.

 

[SPEECH]

This bump slowly releases medicine into your bloodstream all month long with no real daily ups and downs.

 

[DESCRIPTION AND ON-SCREEN TEXT]

As color spreads from inside the oval depot to the entire part of the screen below horizontal line, “GRADUAL RELEASE OF MEDICINE” appears below the oval depot. All image and copy shifts up; “NO REAL DAILY UPS AND DOWNS” appears with "Results may vary." super underneath.

 

[SPEECH]

You can get a second injection as early as 1 week and up to 1 month after the first injection. This second injection is designed to help you achieve targeted levels of buprenorphine.

 

[DESCRIPTION AND ON-SCREEN TEXT]

Screen rotates to show “1 WEEK” and a calendar icon with a check mark at the end of the first week. On the right, screen rotates to show “1 MONTH” and a calendar icon with a checkmark at the end of the month.

 

[SPEECH]

After your first two injections, you'll receive ongoing injections of SUBLOCADE once a month throughout your recovery journey.

 

[DESCRIPTION]

Multiple calendars fill the screen and slide from right to left. The animated person appears.

 

[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]

Zoom in on animated person’s head and shoulders. A thought bubble that contains the words "CRAVINGS" appears along with the super "Results may vary." The bubble gradually fades and shrinks without fully disappearing. Footnote fades away. Animated person appears next to red and blue spinning wheel that reads "CYCLE OF ADDICTION.” He nudges the cycle, which then slows down and turns blue.

 

[SPEECH]

In a 24-week clinical study, SUBLOCADE patients were 14 times more likely to achieve treatment success.

 

Medication should be used with counseling as part of a complete treatment plan.

 

[DESCRIPTION AND ON-SCREEN TEXT]

Zooms in on animated person’s head and text appears; at first it displays “1x” but quickly counts up to “14x”. The final text on screen reads: “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 super below that reads: “The body can develop a dependence on SUBLOCADE and can experience opioid withdrawal symptoms weeks or months after last dose.”

 

[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.

 

When you're ready to start once-monthly SUBLOCADE, find a SUBLOCADE treatment provider to get started today.

 

Please stay tuned for additional Important Safety Information about SUBLOCADE.

 

[DESCRIPTION AND ON-SCREEN TEXT]

Animated person appears in a thunderstorm, pulls out an umbrella, then the scene changes to a sunny day. Sun grows bigger; animated person moves off-screen. A "$0" appears in the middle of a sun along with this super: "$0 for the first two doses of each calendar year, if eligible. Subsequent copays may be reduced."

 

Animated person then reappears, smiling, and sun and super disappear. Animated person in doctor's coat walks alongside them.

 

Zoom into the person with a thought bubble stating, "PLEASE STAY TUNED FOR ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT SUBLOCADE".

 

[SPEECH AND ON-SCREEN TEXT]

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.

 

To learn more about SUBLOCADE, go to SUBLOCADE.com.

 

[ON-SCREEN TEXT]

 

©2025 Indivior UK Limited | SUBLOCADE® and INDIVIOR® are registered trademarks of Indivior UK Limited or its affiliate companies. | All rights reserved.

 

Intended Only for US Audiences.

 

P-BAG-US-01657 Apr 2025

 

[SPEECH AND ON-SCREEN TEXT]

 

SEE FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING AND MEDICATION GUIDE AT SUBLOCADE.COM.

 

[END OF TRANSCRIPT]

 

P-BAG-US-01658 Apr 2025