[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. Trapped in a cycle of opioid use, withdrawal, and cravings.
[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 whose withdrawal symptoms are controlled by oral buprenorphine for at least 7 days.
[SPEECH]
SUBLOCADE is for adults with moderate to severe opioid addiction whose withdrawal symptoms are controlled by oral buprenorphine for at least 7 days,
[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]
and should be used with counseling.
[DESCRIPTION]
The scene transitions to the man walking on a sidewalk.
[SPEECH]
SUBLOCADE may help them 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, then the scene transitions to the man attending a group counseling meeting.
On-screen text:
SUBLOCADE can cause serious, life-threatening reactions and death if injected in a vein or if taken with certain other medicines or illicit drugs.
[SPEECH]
SUBLOCADE can cause serious life-threatening reactions and death if injected in a vein or if taken with certain other medicines or illicit drugs.
[DESCRIPTION]
Man walks into a group meeting, picks up a jacket off a chair, shakes the group leader’s hand, and continues walking.
On-screen text:
Do not take SUBLOCADE with other opioid medicines, benzodiazepines, alcohol, or other depressants without your doctor's approval.
[SPEECH]
Do not take SUBLOCADE with other opioid medicines, benzodiazepines, alcohol, or other depressants without your doctor's approval.
[DESCRIPTION]
The scene transitions to the man walking through a barbeque outside.
On-screen text:
Ask your doctor about naloxone for emergency treatment of opioid overdose.
[SPEECH]
Ask your doctor about naloxone for emergency treatment of opioid overdose.
[DESCRIPTION]
Man continues walking through the barbeque. Then the scene transitions to the man walking through an office setting.
On-screen text:
Get emergency help if naloxone is given, or if you feel faint, dizzy, confused, sleepy, uncoordinated, have blurred vision, slurred speech, or are breathing slower than normal. These can be signs of an overdose or other serious problems.
[SPEECH]
Get emergency help if naloxone is given, or if you feel faint, dizzy, confused, sleepy, uncoordinated, have blurred vision, slurred speech, or are breathing slower than normal. These can be signs of an overdose or other serious problems.
[DESCRIPTION]
Man continues to walk through the office setting as the scene begins to transition into an airport setting.
On-screen text:
Buprenorphine is a controlled substance that can be abused. When taken by those not addicted to opioids, death has been reported.
[SPEECH]
Buprenorphine is a controlled substance that can be abused. When taken by those not addicted to opioids, death has been reported.
[DESCRIPTION]
The scene transitions to the man walking through an airport, rolling a
suitcase.
On-screen text:
SUBLOCADE logo
In an emergency, have family and friends tell medical staff you are physically
dependent on opioids and are being treated with SUBLOCADE.
[SPEECH]
In an emergency, have family and friends tell medical staff you are physically
dependent on opioids and are being treated with SUBLOCADE.
[DESCRIPTION]
The man continues down the airport to embrace family. The airport is on the
side of the addiction wall.
On-screen text:
The body can develop a dependence on SUBLOCADE, and can experience opioid
withdrawal symptoms weeks or months after last dose.
[SPEECH]
The body can develop a dependence on SUBLOCADE, and can experience opioid
withdrawal symptoms weeks or months after last dose.
[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
the patient labeling for more information.
[SPEECH]
This isn't a full list of risks and side effects. Talk to your doctor and read
the patient labeling 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
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.
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.
SUBLOCADE® is manufactured for
Indivior Inc., North Chesterfield VA, 23235.
© 2024 Indivior UK Limited | SUBLOCADE® and INDIVIOR®
are registered trademarks of Indivior UK Limited or its affiliate companies. |
All Rights Reserved.
P-BAG-US-01570