Sublocade
Sublocade (buprenorphine) is an injection that's given under the skin by a healthcare provider for moderate-to-severe opioid use disorder. Treatment is given along with counseling and social and emotional support. This medication is convenient because you only need a dosage once a month. But it's only for people who've previously used another form of buprenorphine (e.g., Suboxone, buprenorphine (Subutex)). Side effects of Sublocade (buprenorphine) include headache, constipation, and injection-site reactions (e.g., pain, swelling). This medication is brand name only.
What is Sublocade (buprenorphine)?
What is Sublocade (buprenorphine) used for?
Moderate-to-severe opioid use disorder in adults who've already started treatment with a buprenorphine-containing medication
How Sublocade (buprenorphine) works
Sublocade (buprenorphine) is a partial opioid agonist. It works by attaching to the same receptors in the brain as opioids, but less strongly. This means that it can help lessen cravings and lower the risk for withdrawal symptoms, but shouldn't cause the same "high" feeling as opioid medications.
When Sublocade (buprenorphine) is injected into your body, it turns into a solid gel (called a depot) under the skin. This gel then slowly releases a steady amount of medication throughout the month.
Drug Facts
What are the risks and warnings for Sublocade (buprenorphine)?
Sublocade (buprenorphine) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Not for intravenous (IV) administration
Sublocade (buprenorphine) should only be given as an injection under the skin (subcutaneously). It should never be given as an injection into the veins (intravenously or IV) because it can cause serious harm, including death.
Because of the risk of serious harm if given as an IV injection, Sublocade (buprenorphine) is only available through the FDA's Risk Evaluation and Mitigation Strategy (REMS) program called the Sublocade REMS program. Under the REMS program, it's required that your provider(s) are trained to inject Sublocade (buprenorphine) properly and safely.
Risk for addiction and misuse
Take Sublocade (buprenorphine) only as instructed by your provider. This medication is a controlled substance because it has risks for addiction and misuse.
Dangerously slow breathing (respiratory depression)
Risk factors: Taking medications that can cause slow breathing | Drinking alcohol | Medical conditions that cause breathing problems (e.g., COPD, asthma, sleep apnea)
Sublocade (buprenorphine) can cause dangerously slow breathing, which can be life-threatening. This can happen at any time, even with recommended doses. Your risk is higher if you take other medications that can slow breathing (e.g., benzodiazepines, opioids, sedatives), drink alcohol, or have breathing problems (e.g., COPD, asthma).
Your provider will probably prescribe you naloxone (Narcan) to carry with you at all times in case you experience breathing problems and need to reverse the effects of Sublocade (buprenorphine). If you or your loved ones notice you have trouble breathing or have bluish-colored lips, fingers, or toes, give yourself naloxone (Narcan) if you have it and call 911 to get medical help right away.
Harm to newborns
Risk factors: Taking Sublocade (buprenorphine) during pregnancy
If you take Sublocade (buprenorphine) during pregnancy, you can pass the medication to your unborn baby. Long-term use during pregnancy can cause your unborn baby to become dependent on opioids and cause withdrawal symptoms at birth. Symptoms of withdrawal can include high-pitched crying, poor feeding and sucking behavior, and seizures. This condition can be life-threatening if not recognized and treated in time. Make sure to tell your provider if you've received Sublocade (buprenorphine) during pregnancy. Providers who are experts in this area will know how to treat your newborn and will make sure your baby gets the care they need once they're born.
Low adrenal hormone levels
Risk factors: Taking Sublocade (buprenorphine) for longer than 1 month
Though rare, opioids like Sublocade (buprenorphine) can cause your adrenal hormone levels to drop. This is more likely to happen after taking opioids for longer than 1 month. Symptoms include nausea, vomiting, not feeling hungry, tiredness, dizziness, and weakness. Let your provider know right away if you experience these symptoms because you might need to stop Sublocade (buprenorphine) and be treated with corticosteroids.
Risk of withdrawal symptoms
Suddenly stopping opioids like Sublocade (buprenorphine) might lead to symptoms of opioid withdrawal. While this hasn't been reported in studies with Sublocade (buprenorphine), it's important to be aware of this risk. Don't suddenly stop taking Sublocade (buprenorphine) without first talking with your provider. Discuss with your provider about what the next treatment steps are if you want to stop this medication.
Liver damage
Risk factors: History of liver damage | Hepatitis B or C infection | Taking other medications that can cause liver damage | Injection drug use
Some people taking buprenorphine have had liver damage. This medication isn't recommended for you if you already have liver problems. If you're prescribed Sublocade (buprenorphine), your provider might recommend that you get blood tests before starting the medication and monthly during treatment to make sure your liver is healthy. Let your provider know if you experience symptoms of liver problems, such as feeling tired, nausea, dark urine, pale stool, and yellowing of the whites of the eyes and skin.
Risks with treatment for pain
If you need to take pain medications for whatever reason, make sure to let your provider know that you're already taking Sublocade (buprenorphine). Since Sublocade (buprenorphine) is an opioid, it's best to start with non-opioid pain medications first. This is because opioid medications might not work as well for you and treatment can put you at risk for opioid toxicity and side effects, such as trouble breathing. If you need opioid therapy, you'll only be able to receive care under a provider's supervision.
Not for use in people who haven't taken opioids before
There have been reports of deaths from people who haven't taken opioids before and received 2 mg of buprenorphine. Sublocade (buprenorphine) is only for people who are currently taking opioids.
Life-threatening heart rhythm problems (QT prolongation)
Risk factors: Heartbeat or heart rhythm problems | Taking medications that affect your heartbeat or heart rhythm | Electrolytes (body salts) not in balance
Buprenorphine can cause QT prolongation, a potentially life-threatening heart rhythm problem. Your risk for these problems is higher if you already have heart problems or are taking other medications that can change your heartbeat and heart rhythm, such as amiodarone (Pacerone), beta-blockers, and moxifloxacin (Avelox). Make sure to tell your provider about all the medications you're taking and also check with them before you start any new medications. Call 911 right away if you feel symptoms of heart problems, such as pounding chest, trouble breathing, feeling faint or lightheaded, or chest pain while taking Sublocade (buprenorphine).
What are the side effects of Sublocade (buprenorphine)?
Common Side Effects
- Injection-site reactions (pain, itching, redness, bruising, swelling; 14-19%)
- Headache (9%)
- Constipation (8-9%)
- Nausea (8-9%)
- Vomiting (6-9%)
Other Side Effects
- Fatigue
- Sleepiness
- Dizziness
Serious Side Effects
- Dangerously slow breathing: trouble breathing; bluish-colored lips, fingers, or toes
- Opioid withdrawal: suicidal thoughts, anxiety, restlessness, runny nose, yawning, sweating, chills, wide pupils, irritability
- Heart rhythm problems: chest pounding, fluttering in the chest, difficulty breathing, chest pain, feeling faint or lightheaded
- Serious injection site reaction: skin sore or ulcer
- Serious allergic reactions: rash, hives, itchiness, shortness of breath, low blood pressure, fast heartbeat, dizziness, fatigue, flushing (feeling warm all of a sudden)
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
- Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Constipation
- Dizziness
- Drowsiness
- Dry mouth
- Headache
- Nausea
- Pain, redness, or irritation at injection site
- Vomiting
Pros and cons of Sublocade (buprenorphine)
Pros
Works well to treat moderate-to-severe opioid use disorder
Given just once per month
Injections are given only by trained healthcare providers registered with the Sublocade REMS program to make sure it's as safe for you as possible
Cons
Given as an injection under the skin
Need to go to the provider's office or clinic regularly to get injections
Has serious risks like slow breathing
Pharmacist tips for Sublocade (buprenorphine)
Make sure to mark your appointments on your calendar for when you need to see your provider and get your Sublocade (buprenorphine) injections. These appointments are important to discuss how treatment is going for you and make sure you don't miss any doses.
You might notice a lump at the injection site after you've gotten your Sublocade (buprenorphine) injection. This is the solid gel that'll slowly release the medication over time. The lump will get smaller as the medication gets released throughout the month. Don't rub this lump.
Sublocade (buprenorphine) can make you sleepy and dizzy, which can affect your ability to focus, think, or react. Don't drive or do anything requiring your full attention, especially during the first few days following treatment or a change in your dose, until you know how this medication affects you.
Let your provider know if you have constipation while you're getting treated with Sublocade (buprenorphine). They can recommend over-the-counter medications, such as senna (Sennokot), polyethylene glycol (Miralax), or docusate (Colace). They can also recommend stronger prescription medications if you need even more relief.
Sublocade (buprenorphine) levels can be detected in your blood and urine for a long time after you've stopped taking it. If you're required to get a drug test done, make sure to notify the test center that you've previously had treatment with Sublocade (buprenorphine).
Make sure to tell your providers about all of the medications you're taking or planning to take with Sublocade (buprenorphine). Benzodiazepines, sedatives, and alcohol can worsen side effects of Sublocade (buprenorphine) like slow breathing or severe sleepiness and can be life-threatening. Taking this medication with certain antidepressants can also raise your risk of serotonin syndrome, a rare but serious side effect that can lead to fast heart rate and trouble sleeping.
Don't stop taking Sublocade (buprenorphine) without talking to your provider first so they can talk with you about the safest way to do so. It's possible to get symptoms of opioid withdrawal if you stop the medication too suddenly. Since Sublocade (buprenorphine) is a long-acting medication, you might have withdrawal symptoms even 2 to 5 months after the last injection.
Tell your provider right away if you have a head injury while you're getting treated with Sublocade (buprenorphine). There's a risk that head trauma can be particularly dangerous while you're taking this medication because buprenorphine might raise the pressure inside your brain.
Frequently asked questions about Sublocade (buprenorphine)
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Sublocade (buprenorphine) dosage forms
Typical dosing for Sublocade (buprenorphine)
Sublocade (buprenorphine) should only be started in adults who've been taking a stable dose of a buprenorphine-containing medication (either dissolved under the tongue or against the inside of the cheek) for at least 7 days.
The typical starting dose for Sublocade (buprenorphine) is 300 mg injected under the skin of your stomach monthly for 2 months. Then, you'll continue on a maintenance dose of 100 mg or 300 mg monthly, depending on how you're responding to the medication.
Sublocade (buprenorphine) contraindications
Allergy to any buprenorphine product
Allergy to the Atrigel delivery system
What are alternatives to Sublocade (buprenorphine)?
Moderate-to-severe opioid use disorder in adults who've already started treatment with a buprenorphine-containing medication
Moderate to severe opioid use disorder in adults who've already started treatment with a buprenorphine-containing medication.
Opioid use disorder in adults (in addition to counseling and therapy programs)
What is the latest news about Sublocade (buprenorphine)?
Sublocade (buprenorphine) images
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References
Best studies we foundAl-Khatib, S. M., et al. (2003). What clinicians should know about the QT interval. Journal of the American Medical Association.
Centers for Disease Control and Prevention. (2022). About opioid use during pregnancy.
Farzam, K., et al. (2023). QT prolonging drugs. StatPearls.
Indivior Inc. (2023). Sublocade- buprenorphine solution [package insert]. DailyMed.
Indivior UK Limited. (n.d.). What is the Sublocade® REMS (Risk Evaluation and Mitigation Strategy)?
Ling, W., et al. (2019). Depot buprenorphine injection in the management of opioid use disorder: From development to implementation. Substance Abuse and Rehabilitation.
Lutfy, K., et al.. (2004). Buprenorphine: A unique drug with complex pharmacology. Current Neuropharmacology.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Adrenal insufficiency & Addison’s disease.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Symptoms & causes of adrenal insufficiency & Addison's disease.
Substance Abuse and Mental Health Services Administration. (2016). Sublingual and transmucosal buprenorphine for opioid use disorder: Review and update.
Substance Abuse and Mental Health Services Administration. (2023). Drug testing resources.
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