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OPIOID PARTIAL AGONIST
Sublocade (buprenorphine extended-release) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults with moderate to severe opioid use disorder.
Sublocade contains buprenorphine, a type of opioid medicine. Buprenorphine partly activates a brain receptor called the mu-opioid receptor. It also blocks another receptor called the kappa-opioid receptor.
Doctors prescribe Sublocade to treat moderate to severe opioid use disorder in people who have received at least one dose of buprenorphine through the lining of the mouth or who are already being treated with buprenorphine. It should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Sublocade is given only by a healthcare provider. It is injected under the skin of the abdomen, thigh, buttock, or back of the upper arm.
If you are not already taking buprenorphine, your healthcare provider will first give you a dose of buprenorphine through the lining of your mouth to make sure you can tolerate it.
Sublocade is injected as a liquid. After the injection, it forms a solid deposit called a depot under the skin. You may feel a small bump at the injection site for several weeks. The bump will get smaller over time.
Do not try to remove the depot. Do not rub or massage the injection site. Try to keep tight clothing, such as belts, waistbands, or sleeves, from rubbing against the area.
The recommended first dose of Sublocade is 300 milligrams.
The recommended second dose is 300 milligrams. It may be given as early as one week and up to one month after the first injection.
After the first two injections, the recommended maintenance dose is 100 milligrams once a month. Maintenance doses should be given at least 26 days apart.
Some people who have been on long-term buprenorphine treatment and whose symptoms are well controlled may receive 100 milligrams as their second Sublocade dose after the first 300-milligram injection.
A healthcare provider may also consider increasing the monthly maintenance dose to 300 milligrams if 100 milligrams is tolerated but does not provide a satisfactory response.
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies of Sublocade, the most common side effects occurred in about 5 percent to 25 percent of people. These include:
Sublocade can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Indivior UK Limited, the manufacturer of Sublocade, offers the Sublocade Copay Assistance Program. Eligible people with commercial insurance may pay as little as $0.
The program also offers a copay member ID card.
To learn more, visit the Sublocade Copay Assistance Program website or call 844-467-7778.
Before starting Sublocade, your doctor will make sure you can tolerate buprenorphine. If you are not already taking buprenorphine, you will receive a dose through the lining of your mouth before your first Sublocade injection. Your doctor will also monitor you after the injection for worsening withdrawal or too much sleepiness.
Tell your doctor if you have any allergies to buprenorphine extended-release or any ingredients in Sublocade including the Atrigel delivery system.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Do not take Sublocade if you have had a serious allergic reaction to buprenorphine or any component of the Atrigel delivery system.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how Sublocade affects you. Sublocade may make you sleepy, dizzy, or lightheaded and may slow your reaction time. These effects may happen more often during the first few days after an injection or when your dose changes.
Do not drink alcohol or take prescription or over-the-counter medicines that contain alcohol during treatment with Sublocade. Combining alcohol with Sublocade can cause serious side effects, including loss of consciousness or death.
If you miss a maintenance dose, contact your doctor to receive your next injection as soon as possible. Your following maintenance dose should be given at least 26 days later.
If you are pregnant or plan to become pregnant, talk with your doctor. A baby exposed to Sublocade during pregnancy may have opioid withdrawal symptoms after birth. These symptoms can be serious if they are not recognized and treated.
If you are breastfeeding or plan to breastfeed, talk with your healthcare provider. Buprenorphine passes into breast milk. If you breastfeed during treatment, watch your baby for increased sleepiness or breathing problems.
Sublocade may also affect fertility in males and females. Talk with your doctor if this is a concern.
These answers are fact-checked by our editorial staff.
How effective is Sublocade for opioid use disorder?
In a 24-week study of 504 people seeking treatment for moderate to severe opioid use disorder, treatment success was higher with Sublocade than with placebo.
Treatment success meant having opioid-free weeks at least 80 percent of the time. This was reached by 28.4 percent of people who received two monthly 300-milligram doses followed by four monthly 100-milligram doses. It was also reached by 29.1 percent of people who received six monthly 300-milligram doses. In comparison, 2 percent of people who received placebo reached treatment success.
In a separate 12-week study, Sublocade blocked the subjective effects of hydromorphone, an opioid, during all 12 weeks of treatment. Complete blockade continued during the eight weeks after the second injection.
How long does Sublocade take to work for opioid use disorder?
After a Sublocade injection, buprenorphine levels in the blood reached their median peak at about 24 hours. This does not necessarily mean that 24 hours is when the medicine starts working.
In the opioid-blockade study, blockade of hydromorphone effects was seen during all 12 weeks of treatment. Buprenorphine levels reached steady state, meaning a more stable level with repeated dosing, after about four to six months.
Does Sublocade interact with other medicines?
Yes. Sublocade can interact with other medicines and substances.
Some important interactions include the following:
Before starting Sublocade, tell your healthcare provider about all prescription medicines, over-the-counter medicines, vitamins, and herbal supplements you take. Your healthcare provider may need to monitor you more closely or adjust your treatment.
On MyOpioidRecoveryTeam, people share their experiences with opioid use disorder, get advice, and find support from others who understand.
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