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 an opioid medicine called buprenorphine 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, a medicine available to patients for 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.
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
- Your healthcare provider should do blood tests to check your liver before you start and during treatment with SUBLOCADE.
- Allergic reaction. You may have a rash, hives, 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:
- sweating more than normal
- feeling hot or cold more than normal
- runny nose
- watery eyes
- goose bumps
- 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:
- injection site itching
- increase in liver enzymes
- 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 pregnancy or side effects associated with taking SUBLOCADE, please call 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.
What is SUBLOCADE?
SUBLOCADE is a prescription medicine used to treat adults with moderate to severe addiction (dependence) to opioid drugs (prescription or illegal) who:
- have received treatment with an oral transmucosal (used under the tongue or inside the cheek) buprenorphine‑containing medicine for 7 days and
- are taking a dose that controls withdrawal symptoms for at least seven days.
- SUBLOCADE is part of a complete treatment plan that should include counseling.
It is not known if SUBLOCADE is safe or effective in children.
SUBLOCADE is a controlled substance (CIII) because it contains buprenorphine that can be a target for people who abuse prescription medicines or street drugs.
What should I tell my healthcare provider before starting SUBLOCADE?
SUBLOCADE may not be right for you. 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
- 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. Opioid-dependent women on buprenorphine maintenance therapy may require additional analgesia during labor. 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.
- breastfeeding or plan to breastfeed. SUBLOCADE can pass into your breast milk and harm your baby. Talk with your healthcare provider about the best way to feed your baby during treatment with SUBLOCADE. Monitor your baby for increased drowsiness and breathing problems.
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. Buprenorphine can cause drowsiness and slow reaction times. 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.
- You should 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.
How soon can someone start SUBLOCADE?
If a healthcare provider decides SUBLOCADE is an appropriate option, a patient must receive treatment with an oral transmucosal (used under the tongue or inside the cheek) a buprenorphine-containing medicine for 7 days and must be taking a dose that controls withdrawal symptoms for at least seven days. Following this period SUBLOCADE will be given by their healthcare provider as an injection just under the skin (subcutaneous) of their stomach (abdomen).
Can someone get SUBLOCADE at a pharmacy?
No, SUBLOCADE is not available in retail pharmacies. SUBLOCADE must be prescribed, obtained, and administered by a healthcare provider. If the healthcare provider practices in an office‑based setting, then he/she must be waivered to prescribe SUBLOCADE.
What if a dose of SUBLOCADE is missed?
If a dose is missed, the next dose should be received as soon as possible, with the following dose given at least 26 days later. See a healthcare provider to receive a SUBLOCADE injection as soon as possible.
How long will a person be on SUBLOCADE?
Everyone is different. A healthcare provider should monitor treatment and overall progress to help determine how long a patient will need treatment with SUBLOCADE.
Is SUBLOCADE addictive?
Yes, SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in the same way as other opioids. It could be a target for people who abuse prescription medicines or street drugs.
How is SUBLOCADE different from other opioids?
Buprenorphine helps the brain get used to functioning without illicit opioids. At prescribed doses, it's designed to have a weaker effect on the brain compared to illicit opioids and not cause a "high." These doses may help reduce cravings, while blocking other opioids from causing rewarding effects. This can make taking them less appealing.
What results have people experienced while on SUBLOCADE?
In a clinical study, SUBLOCADE patients were 14x* more likely to achieve treatment success.†
*28% of people with SUBLOCADE plus counseling compared to 2% of people with placebo plus counseling.
†In a 24‑week study, treatment success was defined as opioid‑free at least 80% of the weeks in treatment. Opioid‑free means urine sample tested negative for illicit opioids plus no self-reported use of opioids. Weeks were not always consecutive.
During the dosing period, SUBLOCADE:
- Continuously releases buprenorphine all month with no real daily ups and downs.
- Sustains the therapeutic level of buprenorphine throughout the month.
- Blocks the rewarding effects of opioids,† which are the "pleasurable feelings" that can keep people using.
- Is part of a complete treatment plan that should include counseling. The role of counseling is to help patients manage emotions and behaviors that can be linked to opioid addiction.
†In a 12‑week study of 39 non‑treatment‑seeking adults, SUBLOCADE blocked the rewarding effects of opioids.
How frequently will SUBLOCADE be given?
SUBLOCADE is a once‑monthly injection. Counseling should also be part of a treatment plan. Work with your treatment team to decide how frequently you should go to counseling.
Will an appointment be needed to have SUBLOCADE removed at the end of the month?
No. SUBLOCADE dissolves in your body over a period of time. When a person receives a SUBLOCADE injection, medication is gradually released into the bloodstream over time.
What happens if my treatment provider lowers my dose?
SUBLOCADE comes in 2 doses: 300 mg and 100 mg. Your treatment provider will start with 300 mg to help the medication reach an effective level in your body. After 2 months, many will receive a lower dose of 100 mg. Some will stay on 300 mg. Your treatment provider will decide what's best.
The level of medicine in your blood is important. Ask your treatment provider about how the delivery system used in SUBLOCADE maintains medicine levels even when the dose is lowered.
Why is counseling with SUBLOCADE important?
Treatment that combines medication and counseling has been shown to be effective, because addiction is a disease that impacts a person's behaviors.
Counseling can help people deal with the behaviors and emotions that are often linked to addiction. It can also teach long‑term skills to cope with stressful situations and help people start positive routines.
How can I find support groups?
Ask a healthcare provider for a recommendation, or visit a resource like the Substance Abuse and Mental Health Services Administration website.
Support groups may have a digital presence. Online support groups may also be an option.
Opioid addiction/Opioid Use Disorder (OUD)
What are the possible signs of Opioid Use Disorder?
Only a healthcare provider can diagnose Opioid Use Disorder. The list below includes some possible signs of the disease, but it's important to see a healthcare provider for a diagnosis.
- Needing to take more of the drug to get the same effect*
- Experiencing withdrawal symptoms when not using opioids*
- Taking larger amounts of opioids than planned, and for longer periods of time
- Craving opioids
- Persistently wanting to quit, or trying unsuccessfully to quit
- Spending a lot of time and effort to obtain, use, and recover from taking opioids
- Giving up activities because of substance use
- Continuing to use opioids in spite of physical or psychological problems
- Failing to fulfill major obligations at work, school, or home
- Continuing to use even when it puts you in danger
- Continuing to use despite social or interpersonal problems
*These signs may not apply to individuals taking opioids under appropriate medical supervision and as prescribed.
How can someone deal with relapse?
If a person experiences a relapse, he/she should talk to a healthcare provider. Together they can work on a plan of action to get him/her back on track.
Remember, there can be setbacks in treatment or relapse, but don't give up. It's possible to keep moving towards recovery.
What is withdrawal?
When someone uses a substance and becomes dependent or addicted, trying to stop can cause negative emotions and physical symptoms. Physical symptoms can include nausea, vomiting, muscle aches, and cramping.
What are the rewarding effects of opioids?
The rewarding effects of opioids are the pleasurable effects also known as the "relaxed feeling" or "high" that can keep people using.
What are triggers?
Triggers are external events or situations that can make you want to use. Triggers can include people, places, or things.
Can OUD be cured?
OUD is a chronic disease that physically changes the brain. While there is no cure, it can be treated and managed long-term. Learn why it's so hard to quit.
Who can diagnose OUD?
Only a healthcare provider can diagnose Opioid Use Disorder (OUD).