Sublocade (buprenorphine)

What is Sublocade?

Sublocade (buprenorphine) is a brand-name prescription medication. It’s used in adults to treat moderate to severe opioid use disorder. An opioid is a powerful type of drug often prescribed to treat pain.

Sublocade helps prevent cravings and withdrawal symptoms that you may get if you stop taking opioid drugs. These drugs include prescription pain relievers such as morphine, oxycodone, and fentanyl, and illegal drugs such as heroin.

For your doctor to prescribe Sublocade, you must first use a form of buprenorphine that you take under your tongue or inside your cheek. (You keep the buprenorphine in your mouth until it dissolves.) You’ll need to take a dose that manages your withdrawal symptoms for at least 7 days. Then your doctor may switch you to Sublocade.

Drug details

The buprenorphine in Sublocade is part of a class of drugs called partial opioid agonists. A class of drugs is a group of medications that work in a similar way.

Sublocade is given as an injection in your belly just under your skin (subcutaneous). A healthcare professional will give you the injection once a month in a clinic. You’ll also have counseling and other support as part of your treatment. These services are meant to help you to cope with emotional challenges or social situations that might lead you to take opioids again.

Effectiveness

Sublocade has been found to be effective at reducing opioid use.

A 24-week clinical study looked at people with opioid use disorder. About 30% of people who took Sublocade and had counseling didn’t take other opioids for at least 80% of the study. This was compared to 2% of the people who took a placebo (treatment with no active drug).

Is Sublocade a controlled substance?

Yes, Sublocade is a Schedule III controlled substance. This is a type of drug that has a high risk of misuse and dependence. (With misuse, a drug is taken in a way other than how it’s prescribed. With dependence, your body needs the drug in order to function like usual.)

Because of these risks, the U.S. government has special rules for prescribing and dispensing Schedule III drugs.

Doctors who prescribe Sublocade to treat opioid use disorder must have special training and then be certified by the U.S. government.

Sublocade is a drug that’s banned in competitive sports. Traces of the drug may remain in your blood for 12 months or longer after you stop Sublocade treatment. Talk with your doctor if you plan to participate in competitive sports during or after Sublocade treatment.

Sublocade generic

Sublocade is available only as a brand-name medication.

Sublocade contains one active drug ingredient: buprenorphine. The form of buprenorphine that’s in Sublocade is injected in your belly just under your skin (subcutaneous). It’s not available as a generic. However, other forms of buprenorphine are available as generics.

Sublocade vs. Suboxone

You may wonder how Sublocade compares to other medications that are prescribed for similar uses. Here we look at how Sublocade and Suboxone are alike and different.

Sublocade contains just buprenorphine, while Suboxone contains buprenorphine and naloxone.

Uses

The Food and Drug Administration (FDA) has approved Sublocade to treat opioid use disorder.

For your doctor to prescribe Sublocade, you must first use a form of buprenorphine that you take under your tongue or inside your cheek. (You keep the buprenorphine in your mouth until it dissolves.) You’ll need to take a dose that manages your withdrawal symptoms for at least 7 days. This is called induction treatment.

Then your doctor may switch you to Sublocade, which is used for maintenance treatment. This is when you have long-term treatment with buprenorphine to help keep your cravings and withdrawal symptoms well managed.

Sublocade is used as part of a treatment program that involves counseling and other support.

Suboxone is FDA-approved to treat opioid dependence. This is another name for opioid use disorder. Suboxone is prescribed to reduce withdrawal symptoms when you first decrease or stop your use of opioids. This is the induction phase of treatment.

Suboxone is also used in the maintenance phase of treatment. This is when you keep taking Suboxone on a long-term basis. The drug helps keep your withdrawal symptoms and cravings in check as you go through your treatment program. The program will also involve counseling and other support. These are meant to help you to cope with emotional challenges or social situations that might lead you to use opioids again.

Drug forms and administration

Sublocade is given as an injection in your belly just under your skin (subcutaneous). A healthcare professional will give you the injection in a clinic.

Sublocade is available in two strengths: 100 mg/0.5 mL and 300 mg/1.5 mL.

You’ll receive Sublocade injections once a month.

Suboxone comes as an oral film that dissolves under your tongue (sublingual) or between your gums and cheek (buccal). Each film contains two drugs: buprenorphine and naloxone. The naloxone has little effect when you take the film by mouth. It’s included to discourage the misuse of Suboxone.

If you were to try to inject Suboxone, the naloxone would block the effects of any opioids in your body. This would cause instant withdrawal symptoms if you were dependent on opioids.

Suboxone films come in four strengths:

• 2 mg buprenorphine and 0.5 mg naloxone
• 4 mg buprenorphine and 1 mg naloxone
• 8 mg buprenorphine and 2 mg naloxone
• 12 mg buprenorphine and 3 mg naloxone

You’ll take Suboxone once a day.

Side effects and risks

Sublocade and Suboxone both contain buprenorphine. Suboxone also contains naloxone, although your body will absorb very little naloxone when you take Suboxone by mouth. Both Sublocade and Suboxone can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Sublocade, with Suboxone, or with both drugs (when taken individually).

• Can occur with Sublocade:
  • pain, itching, or redness at the injection site
• Can occur with Suboxone:
  • opioid withdrawal symptoms, such as body aches, belly cramps, and rapid heart rate
  • sweating
  • redness in your mouth
  • swollen or painful tongue
  • insomnia (trouble sleeping)
  • blurred vision
  • back pain
• Can occur with both Sublocade and Suboxone:
  • constipation
  • headache
  • nausea
  • vomiting
  • feeling tired or sleepy
  • dizziness, especially when getting up from sitting or lying down

Serious side effects

These lists contain examples of serious side effects that can occur with Sublocade, with Suboxone, or with both drugs (when taken individually).

• Can occur with Sublocade:
  • few unique serious side effects
• Can occur with Suboxone:
  • severe opioid withdrawal symptoms if you inject the drug
• Can occur with both Sublocade and Suboxone:
  • severe allergic reactions
  • respiratory depression (slowed breathing) and coma
  • liver damage
  • adrenal gland problems such as low hormone levels
  • physical dependence that may lead to drug misuse*

* With dependence, your body needs a drug in order to function like usual. With misuse, a drug is taken in a way other than how it’s prescribed. Physical dependence can lead to withdrawal symptoms weeks to months after you stop Sublocade treatment. (See the “Sublocade and withdrawal” section below for more information.)

Effectiveness

The only condition that both Sublocade and Suboxone are prescribed to treat is opioid use disorder. Sublocade is used only for maintenance treatment (to help keep your cravings and withdrawal symptoms managed long term). Suboxone can be used for induction treatment (to manage your withdrawal symptoms when you first stop taking other opioids) and maintenance treatment.

These drugs haven’t been directly compared for maintenance treatment yet.

The American Society of Addiction Medicine recommends buprenorphine as a treatment for opioid use disorder.

Costs

Sublocade and Suboxone are both brand-name drugs. There are currently no generic forms of Sublocade. But there are generic forms of Suboxone. Brand-name medications usually cost more than generics.

The actual price you’ll pay for either drug will depend on your insurance plan and your location.

Sublocade and withdrawal

Your body can become physically dependent on Sublocade, and it’s possible to have mild withdrawal symptoms after stopping treatment. (With dependence, your body needs a drug in order to function like usual.)

However, you may not have withdrawal symptoms until a few weeks or months after your last injection. Each injection of Sublocade provides a steady level of the drug for a month. After your last injection, the level of the drug in your body will start to slowly lower.

At some point, you and your doctor may agree that it’s time to stop treatment with Sublocade. When this happens, you should be monitored for withdrawal symptoms for a few weeks to months after your last injection. These symptoms may include:

• shaking
• goose bumps
• muscle aches
• sweating
• feeling hot or cold
• runny nose
• watery eyes
• diarrhea
• vomiting

It’s important to talk with your doctor about what to do if you have withdrawal symptoms. Sometimes other medications can help ease such symptoms.

Sublocade side effects

Sublocade can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Sublocade. These lists do not include all possible side effects.

For more information on the possible side effects of Sublocade, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Sublocade can include:

• constipation
• headache
• nausea
• vomiting
• pain, itching, or redness at the injection site
• feeling tired or sleepy
• dizziness, especially when getting up from sitting or lying down

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Sublocade aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects, explained in more detail below under “Side effect details,” can include the following:

• severe allergic reaction
• respiratory depression (slowed breathing) and coma
• liver damage
• adrenal gland problems
• physical dependence that may lead to drug misuse*

* With dependence, your body needs a drug in order to function like usual. With misuse, a drug is taken in a way other than how it’s prescribed. Physical dependence can lead to withdrawal symptoms weeks to months after you stop Sublocade treatment. (See the “Sublocade and withdrawal” section above for more information.)

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on some of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Sublocade. But it’s not known how often people have allergic reactions after they’ve taken Sublocade. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible after having a Sublocade injection. Symptoms of a severe allergic reaction can include:

• hives
• swelling of your face, typically in your eyelids, lips, tongue, mouth, or throat
• trouble breathing
• feeling dizzy or faint

One type of severe allergic reaction that may occur with Sublocade is called anaphylaxis. In addition to the symptoms above, anaphylaxis can cause a low pulse rate, rash, and sudden drop in blood pressure.

Call your doctor right away if you have a severe allergic reaction to Sublocade. Call 911 or your local emergency number if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Feeling tired, drowsy, or sleepy

While you receive Sublocade, you may feel drowsy, sleepy, or tired, or have slow reaction times. These are common side effects, especially:

• in the first few days after your first injection of Sublocade
• if your doctor increases your dose
• if you take other medications that can make you sleepy

In a clinical study, sleepiness was reported in 4.9% of people who took 300 mg of Sublocade, followed by 100 mg of Sublocade once a month. Sleepiness occurred in 2% of people who took 300 mg of Sublocade throughout the study. This was compared to 0% of people who took a placebo (treatment with no active drug).

In the same study, fatigue (lack of energy) was reported in 3.9% of people who took 300 mg of Sublocade, followed by 100 mg of Sublocade once a month. Fatigue occurred in 6% of people who took 300 mg of Sublocade throughout the study. This was compared to 3% of people who took a placebo.

Until you’re certain that Sublocade isn’t making you tired, don’t drive, operate machinery, or do other activities that may be dangerous.

If you’re concerned about feeling tired while taking Sublocade, talk with your doctor. They can suggest treatments that may help.

Constipation

You may get constipated during your Sublocade treatment. In clinical studies, constipation occurred in about 9.4% of people who took 300 mg of Sublocade, followed by 100 mg of the drug once a month. Constipation occurred in 8% of people who took 300 mg of Sublocade throughout the study. This was compared to 0% of people who took a placebo (treatment with no active drug).

If you’re concerned about constipation while taking Sublocade, talk with your doctor. They can suggest treatments that may help ease the condition and ways to help avoid constipation.

Respiratory depression and coma

If you take too much Sublocade or take it too often, you may develop respiratory depression. This is a condition in which your breathing becomes slow, shallow, weak, and may even stop.

You may also develop central nervous system (CNS) depression, a condition in which your brain activity slows. CNS depression can lead to delirium (severe confusion about what’s real) and coma. Both respiratory depression and CNS depression can be fatal.

It’s not known how often people develop respiratory or CNS depression during Sublocade treatment.

Symptoms and risks

Symptoms of respiratory depression or CNS depression can include:

• slow, shallow breathing
• extreme sleepiness
• confusion
• slurred speech
• problems with coordination
• dizziness or fainting

If you’re taking Sublocade and have symptoms of respiratory depression or CNS depression, call your doctor or 911 right away.

If you drink alcohol, avoid drinking taking certain other drugs while you’re receiving Sublocade injections can increase your risk for respiratory and CNS depression, loss of consciousness, and death. Some of these drugs include:

• benzodiazepines
• sleeping pills
• other tranquilizers or sedatives
• opioids
• muscle relaxants
• certain antidepressants
• antihistamines that cause drowsiness

Avoid drinking alcohol or taking these drugs while receiving Sublocade, unless your doctor says that it’s fine. You should also avoid these drugs for a few months after you stop treatment with Sublocade. This is because the drug can stay in your body for a few months after your last injection. (For more details about interactions that can cause respiratory depression or coma, see the “Sublocade interactions” section below.)

Liver damage

Liver problems, such as hepatitis (liver swelling) and jaundice, have been reported in people who took Sublocade. Tell your doctor if you have symptoms of liver problems, which can include:

• yellowing of your skin or the white of your eyes
• dark urine
• pale stools
• abdominal pain
• nausea
• loss of appetite

Liver damage can also reveal itself by releasing certain liver enzymes into your blood. In a clinical study, up to 12.4% of people who took Sublocade had high levels of these enzymes in their blood. This was compared to 1% of people who took a placebo (treatment with no active drug).

Your doctor will check your blood for these enzymes on a regular basis with a liver function test. If your test results show damage to your liver, you may need to stop taking Sublocade.

If you’re concerned about liver damage while taking Sublocade, talk with your doctor.

Adrenal gland problems

Taking opioid medications such as Sublocade for longer than a month can affect your adrenal glands. But it’s not known how often people develop problems with their adrenal glands during Sublocade treatment.

Adrenal glands make and release hormones, and opioids can cause the glands to stop making enough of a hormone called cortisol. This is called adrenal insufficiency, and its symptoms can include:

• nausea
• vomiting
• loss of appetite
• fatigue (lack of energy)
• weakness
• dizziness
• low blood pressure

If you have any of these symptoms, tell your doctor. You may need to take a steroid medication to help treat problems with your adrenal glands. You may also have to stop taking Sublocade.

Sublocade dosage

The following information describes Sublocade dosages that are commonly used or recommended. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Sublocade is given as an injection in your belly just under your skin (subcutaneous). A healthcare professional will give you the injection in a clinic.

Sublocade is available in two strengths: 100 mg/0.5 mL and 300 mg/1.5 mL.

You’ll receive Sublocade injections once each month.

Dosage for opioid use disorder

The usual dosage of Sublocade is a 300-mg injection once a month for 2 months. This will be followed by a 100-mg injection once per month for as long as your doctor recommends.

In some cases, the 100-mg dose may not be effective. So your doctor may increase your dosage to 300 mg once each month.

There should be at least 26 days between your doses.

What if I miss a dose?

If you miss an appointment to have an injection of Sublocade, call your doctor right away to reschedule. You should have the injection as soon as possible. If you have the injection within 2 weeks of missing your dose, there shouldn’t be any problems. However, if you have the injection later than this, you could start to have symptoms of withdrawal.

To help you remember your appointments, put them in a calendar. You can also set a reminder on your phone.

Will I need to use this drug long term?

This depends on your personal circumstances. Treatment for opioid use disorder is usually long term. If you and your doctor determine that Sublocade is safe and effective for you, you can keep using it long term as part of your treatment program. You and your doctor will decide together when you might be ready to end your treatment with Sublocade.

Alternatives to Sublocade

Other drugs are available that can treat opioid use disorder. Some may be better suited for you than others. If you’re interested in finding an alternative to Sublocade, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of other drugs used to treat opioid use disorder include:

• opioid agonists such as:
  • methadone (Dolophine, Methadose)
  • buprenorphine sublingual tablets
  • buprenorphine and naloxone sublingual tablets/films (Suboxone, Zubsolv)
• opioid antagonists such as naltrexone (Vivitrol)

Sublocade vs. Vivitrol

You may wonder how Sublocade compares to other medications that are prescribed for similar uses. Here we look at how Sublocade and Vivitrol are alike and different.

Sublocade contains buprenorphine, which is a type of drug called an opioid partial agonist. It prevents cravings and withdrawal symptoms that you get when you stop taking other opioids.

Vivitrol contains naltrexone, which is a type of drug called an opioid antagonist. It blocks the effect of opioids.

Uses

The Food and Drug Administration (FDA) has approved Sublocade to treat opioid use disorder.

For your doctor to prescribe Sublocade, you must first use a form of buprenorphine that you take under your tongue or inside your cheek. (You keep the buprenorphine in your mouth until it dissolves.) You’ll need to take a dose that manages your withdrawal symptoms for at least 7 days. Then your doctor may switch you to Sublocade.

Sublocade is prescribed as part of a treatment program that involves counseling and other support. This is to help you to cope with emotional challenges or social situations that might lead you to use opioids again.

Vivitrol is FDA-approved for treating opioid dependence, which is another name for opioid use disorder. The medication is prescribed to help keep people from taking opioids after they’ve stopped taking these drugs.

Vivitrol is also FDA-approved to treat alcohol dependence (previously called alcoholism). The drug is prescribed to help keep people from consuming alcohol after they’ve quit drinking.

Vivitrol is also prescribed as part of a treatment plan that includes counseling and other support.

Drug forms and administration

Sublocade is given as an injection in your belly just under your skin (subcutaneous). A healthcare professional will give you the injection in a clinic.

Sublocade is available in two strengths: 100 mg/0.5 mL and 300 mg/1.5 mL.

Vivitrol is given as an injection in a muscle (intramuscular). A healthcare professional will give you the injection in a clinic.

Vivitrol comes in one strength: 380 mg/4 mL.

Both Sublocade and Vivitrol injections are given once each month.

Side effects and risks

Sublocade contains buprenorphine, and Vivitrol contains naltrexone. These medications can cause some different and some similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Sublocade, with Vivitrol, or with both drugs (when taken individually).

• Can occur with Sublocade:
  • constipation
  • nausea
  • vomiting
  • feeling tired or sleepy
  • dizziness (such as when getting up from sitting or lying down)
• Can occur with Vivitrol*:
  • symptoms of colds, such as a stuffy or runny nose, sore throat, or cough
  • toothache
  • insomnia (trouble sleeping)
  • high blood pressure
• Can occur with both Sublocade and Vivitrol:
  • pain, itching or redness at the injection site
  • headache

* Side effects described for Vivitrol are those seen when the drug is used to treat opioid use disorder.

Serious side effects

These lists contain examples of serious side effects that can occur with Sublocade, with Vivitrol, or with both drugs (when taken individually).

• Can occur with Sublocade:
  • respiratory depression (slowed breathing) and coma
  • adrenal gland problems, such as low hormone levels
  • physical dependence that may lead to drug misuse*
• Can occur with Vivitrol:
  • severe injection site reactions that may require surgery
  • sudden opioid withdrawal symptoms if you’ve taken opioid drugs in the two weeks before receiving Vivitrol
  • depressed mood, sometimes leading to suicidal thoughts or behavior
  • pneumonia
• Can occur with both Sublocade and Vivitrol:
  • liver damage
  • severe allergic reactions

* With dependence, your body needs a drug in order to function like usual. With misuse, a drug is taken in a way other than how it’s prescribed. Physical dependence can lead to withdrawal symptoms weeks to months after you stop Sublocade treatment. (See the “Sublocade and withdrawal” section above for more information.)

Effectiveness

Sublocade and Vivitrol are both prescribed to treat opioid use disorder. These drugs haven’t been directly compared in clinical studies. However, studies have found both Sublocade and Vivitrol to be effective for helping people with opioid use disorder reduce or stop taking opioids.

Costs

Sublocade and Vivitrol are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

The actual price you’ll pay for either drug will depend on your insurance plan and your location.

Common questions about Sublocade

Here are answers to some frequently asked questions about Sublocade.

Does Sublocade have naloxone in it?

No, Sublocade injections contain only the drug buprenorphine.

Naloxone is a drug that blocks the effects of opioids. It’s used to treat opioid overdose. Naloxone is included in some buprenorphine medications that you take by mouth, such as Suboxone, Bunavail, and Zubsolv. When you take these drugs by mouth, your body absorbs very little of the naloxone. The naloxone is included in these medications only to help prevent people from misusing them. (With misuse, a medication is taken in a way other than how it’s prescribed.)

Sublocade doesn’t contain naloxone because the injections are given only by your healthcare professional. So there’s very little chance that anyone else could obtain the drug and misuse it.

Where will I be given Sublocade treatments?

The only way to receive Sublocade injections is from a healthcare professional at certain clinics. The clinic must be certified by the Sublocade Risk Evaluation and Mitigation Strategy (REMS) program. This drug safety program restricts access to Sublocade to help prevent the drug from being misused. (With misuse, a medication is taken in a way other than how it’s prescribed.)

See the “FDA warning: Risk of serious harm or death with injection into a vein” section at the top of this article to learn more.

If you have questions about where to receive your Sublocade injections, ask your doctor.

If I’m taking Sublocade, can I use pain relievers during an emergency or if I’m having surgery?

While you’re receiving Sublocade, it’s fine to take non-opioid medications to relieve pain. These include acetaminophen and anti-inflammatories such as ibuprofen.

However, you should avoid taking opioids to relieve pain whenever possible. Opioids can increase your risk for respiratory depression (slowed breathing), loss of consciousness, and death. Opioids can also be less effective than usual at relieving pain if you’re taking Sublocade.

In an emergency or if you’re having surgery, tell the medical staff that you’re taking Sublocade. (You can also have your family give the staff this information.) Opioid pain relievers should be taken only under the supervision of medical staff who know that you’re taking treatment for opioid dependence. They’ll need to monitor your breathing while the opioid is in your body.

This also applies for a few months after you stop receiving Sublocade. You’ll still have Sublocade in your body for a few months after your last injection.

Sublocade uses

The Food and Drug Administration (FDA) approves prescription drugs such as Sublocade to treat certain conditions.

Sublocade for opioid use disorder

Sublocade is FDA-approved to treat moderate to severe opioid use disorder in adults. Sublocade is taken after you’ve started treatment with buprenorphine tablets or films that dissolve under your tongue or inside your cheek. Your doctor will adjust your dose of this oral buprenorphine until it manages your withdrawal symptoms and cravings for at least seven days. After this, you’ll switch to injections of Sublocade.

You’ll also have counseling and other support as part of your treatment. These are meant to help you to deal with emotional challenges or social situations that might lead you to take opioids again. The type of counseling and other support offered depends on your personal circumstances. It might include:

• individual or group counseling sessions
• cognitive behavioral therapy, which helps you adjust your negative thoughts to better deal with problems
• family therapy
• access to support groups
• help with social issues such as employment or housing

With opioid use disorder, your body and mind depend on and crave opioid drugs. Opioid drugs are sometimes called opiates or narcotics. They include prescription pain relievers such as morphine, fentanyl, oxycodone, and tramadol, and illegal drugs such as heroin.

Sublocade affects the same parts of your brain as opioids do, so Sublocade helps reduce your cravings for opioids. Sublocade also helps prevent the physical withdrawal symptoms you may get when you stop taking opioids. This should make it easier for you to stop misusing other prescription or illegal opioids.

Effectiveness

Researchers have looked into how effective Sublocade is in helping treat opioid use disorder.

Results from a 12-week study

Sublocade was found to reduce the rewarding effects of other opioids in a 12-week study. Researchers looked at 39 people with opioid use disorder. First, these people were given two injections: one of an opioid called hydromorphone and one placebo (treatment with no active drug). The people were asked to rate the effects of each injection on a visual-analog scale. With this scale, personal feelings are described next to a number.

Then the people were given buprenorphine taken under the tongue (Suboxone films). After this, they were given an injection of Sublocade, followed by another Sublocade injection 4 weeks later.

While the Sublocade was in the people’s systems, they were given an injection of hydromorphone once per week. They were also given a placebo injection once each week. The people were asked to rate the effects of each injection on the same scale as before.

Before Sublocade was given, the hydromorphone injection produced much more rewarding effects than the placebo injection. While the people had Sublocade in their body, the rewarding effects of hydromorphone weren’t significantly different from those of the placebo.

Results from a 24-week study

In a 24-week clinical study, Sublocade was found to be effective at reducing opioid use. Researchers looked at 489 people with opioid use disorder. For 7 to 14 days, these people were first treated with a form of buprenorphine that you place under your tongue. Then they were split into three groups:

• Group 1 was given 300 mg of Sublocade once each month for 6 months.
• Group 2 was given 300 mg of Sublocade once each month for 2 months. This was followed by 100 mg of Sublocade once each month for 4 months.
• Group 3 was given a placebo (treatment with no active drug) once each month for 6 months.

In addition to their monthly injections, people in all three groups had counseling at least once per week. Each week, researchers checked their urine for evidence of opioid use.

People in groups 1 and 2 who were given Suboxone and counseling had more weeks during which they didn’t take other opioids. This was compared to people in group 3, who received a placebo and counseling. About 30% of people in groups 1 and 2 (the Suboxone groups) didn’t take other opioids for at least 80% of the 24-week study. This was compared to 2% of the people in group 3 (the placebo group).

Sublocade use with other treatments

It’s important that Sublocade is prescribed as part of a complete treatment program for opioid use disorder. Along with your Sublocade injections, you’ll be given counseling and various forms of emotional or behavioral therapy, or support with social issues. This aims to help you avoid or cope with situations that might lead you to take opioids again.

The type of therapy or support offered depends on your personal circumstances. It might include:

• individual or group counseling sessions
• cognitive behavioral therapy, which helps you adjust your negative thoughts to better deal with problems
• family therapy
• access to support groups
• help with social issues such as employment or housing

If you’re taking Sublocade and have questions about counseling or other forms of support, talk with your doctor.

Sublocade with Narcan

If you’re at risk of opioid overdose during Sublocade treatment, your doctor may recommend that you have naloxone (Narcan) available. This drug is taken to help reverse an opioid overdose while you’re waiting for medical help to arrive. To learn more about Narcan and how to take it, see this article.

Sublocade and alcohol

You should avoid drinking alcohol while you’re receiving Sublocade. Drinking alcohol can increase your risk for serious side effects such as:

• slowed breathing
• severe drowsiness
• slow reaction time
• loss of consciousness
• coma
• death, in rare cases

If you drink alcohol, talk with your doctor about the possible risks and whether Sublocade is right for you.

Sublocade interactions

Sublocade can interact with several other medications. It can also interact with certain supplements.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Sublocade and other medications

Below are lists of medications that can interact with Sublocade. These lists don’t contain all drugs that may interact with Sublocade.

Before taking Sublocade, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Sublocade and benzodiazepines

Taking benzodiazepines with Sublocade can increase your risk for serious side effects. (Benzodiazepines are drugs for anxiety or insomnia.) These side effects include respiratory depression (slowed breathing), severe sleepiness, loss of consciousness, coma, and death.

Examples of benzodiazepines that can increase the risk of serious side effects if taken with Sublocade include:

• alprazolam (Xanax)
• clonazepam (Klonopin)
• diazepam (Valium)
• lorazepam (Ativan)

Avoid taking benzodiazepines while you receive Sublocade and for a few months after you stop Sublocade treatment. You should take a benzodiazepine drug only if your doctor has prescribed it and knows that you’re receiving Sublocade.

Sublocade and sleeping pills

Taking sleeping pills with Sublocade can increase your risk for serious side effects. These include respiratory depression (slowed breathing), severe sleepiness, loss of consciousness, coma, and death.

Examples of sleeping pills that can increase the risk of serious side effects if taken with Sublocade include:

• eszopiclone (Lunesta)
• zaleplon (Sonata)
• zolpidem (Ambien and Ambien CR)

Avoid taking sleeping pills while you receive Sublocade and for a few months after you stop Sublocade treatment. You should take sleeping pills only if your doctor has prescribed them and knows that you’re receiving Sublocade.

Sublocade and other opioids

Taking other opioids with Sublocade can increase your risk for serious side effects. These include respiratory depression (slowed breathing), severe sleepiness, loss of consciousness, coma, and death. Sublocade may also make opioid pain relievers less effective at relieving pain.

Examples of other opioids that can increase the risk of serious side effects if taken with Sublocade include:

• codeine
• dihydrocodeine
• fentanyl (Fentora and others)
• heroin
• hydrocodone (Vicodin)
• methadone
• morphine
• oxycodone (Percocet)
• tramadol (Ultram, Conzip)

Avoid taking opioids while you receive Sublocade and for a few months after you stop Sublocade treatment. You should take an opioid pain reliever only if your doctor has prescribed it and knows that you’re receiving Sublocade.

Sublocade and certain antidepressants

Taking certain antidepressants with Sublocade can increase your risk for serotonin syndrome.

Some antidepressants increase levels of serotonin in your brain. (Serotonin is a chemical that’s involved in passing messages between nerve cells.) Sublocade also increases the level of serotonin in your brain. High levels of serotonin increase your risk for a rare but serious side effect called serotonin syndrome.

Examples of antidepressants that can increase the risk of serotonin syndrome if taken with Sublocade include:

• selective serotonin reuptake inhibitors (SSRIs), such as:
  • fluoxetine (Prozac)
  • paroxetine (Paxil, Pexeva, Brisdelle)
  • sertraline (Zoloft)
• serotonin-norepinephrine reuptake inhibitors (SNRIs), such as:
  • duloxetine (Cymbalta)
  • venlafaxine (Effexor XR)
• tricyclic antidepressants, such as:
  • amitriptyline
  • desipramine (Norpramin)
  • imipramine (Tofranil)
• monoamine oxidase inhibitors (MAOIs),* such as:
  • phenelzine (Nardil)
  • isocarboxazid (Marplan)
  • tranylcypromine (Parnate)
• mirtazapine

If you’re taking an antidepressant, talk with your doctor before you start receiving Sublocade. They may switch you to a different antidepressant.

* MAOIs can also cause respiratory depression (slowed breathing) and severe sleepiness if taken with Sublocade.

Sublocade and certain antihistamines

Taking antihistamines that can cause sleepiness with Sublocade might increase your risk for extreme sleepiness and respiratory depression (slowed breathing).

Examples of antihistamines that can cause sleepiness with Sublocade include:

• chlorpheniramine (Chlor-Trimeton)
• diphenhydramine (Benadryl)
• hydroxyzine (Atarax)

Avoid taking these drugs with Sublocade unless your doctor has prescribed them.

Sublocade and certain antifungals

Taking certain antifungal drugs with Sublocade can raise the level of buprenorphine in your body. (Antifungals treat infections caused by a fungus.) This can increase your risk for side effects such as sleepiness, respiratory depression (slowed breathing), constipation, nausea, and dizziness. However, the risk for this interaction is greater with antifungals taken by mouth than with antifungals applied to the skin.

Examples of antifungals that can increase buprenorphine levels when taken with Sublocade include:

• itraconazole (Sporanox)
• ketoconazole
• posaconazole (Noxafil)
• voriconazole (Vfend)

In some cases, you may need to take one of these antifungals during your Sublocade treatment. If you have slow and shallow breathing, severe sleepiness, confusion, slurred speech, or problems with coordination, tell your doctor right away.

Sublocade and certain antibiotics

Taking certain antibiotics with Sublocade can raise the level of buprenorphine in your body. (Antibiotics treat infections caused by bacteria.) This can increase your risk for side effects such as sleepiness, respiratory depression (slowed breathing), constipation, nausea, and dizziness.

Examples of antibiotics that can increase buprenorphine levels when taken with Sublocade include:

• clarithromycin (Biaxin)
• telithromycin

In some cases, you may need to take one of these antibiotics during your Sublocade treatment. If you have slow and shallow breathing, severe sleepiness, confusion, slurred speech, or problems with coordination, tell your doctor right away.

Sublocade and linezolid

Taking the antibiotic linezolid (Zyvox) with Sublocade can increase your risk for a rare but serious side effect called serotonin syndrome. (Serotonin is a chemical that’s involved in passing messages between nerve cells.) Serotonin syndrome can occur if your serotonin levels get too high. Both linezolid and Sublocade can increase your serotonin levels.

If you’re taking linezolid, talk with your doctor before you start receiving Sublocade. They may switch you to a different antibiotic.

Sublocade and certain drugs for HIV infection

Taking certain HIV medications with Sublocade can raise the level of buprenorphine in your body. This can increase your risk for side effects such as sleepiness, respiratory depression (slowed breathing), constipation, nausea, and dizziness.

Examples of drugs for HIV that can increase buprenorphine levels when taken with Sublocade include:

• atazanavir (Reyataz)
• cobicistat (Tybost)
• darunavir (Prezista)
• fosamprenavir (Lexiva)
• indinavir (Crixivan)
• lopinavir/ritonavir (Kaletra)
• nelfinavir (Viracept)
• ritonavir (Norvir)
• saquinavir (Invirase)

Many of these drugs also come in combination products, so be sure to tell your doctor about all of your medications.

In some cases, you may need to take one of these HIV medications during your Sublocade treatment. If you notice any of the side effects mentioned above, tell your doctor right away.

Sublocade and certain drugs for tuberculosis

Taking certain treatments for tuberculosis (TB) with Sublocade can reduce the level of buprenorphine in your body. This could make Sublocade less effective or cause withdrawal symptoms.

Examples of TB drugs that can reduce the level of buprenorphine in your body when taken with Sublocade include:

• rifabutin (Mycobutin)
• rifampin (Rifadin)
• rifapentine (Priftin)

If you’re taking a drug to treat TB, talk with your doctor before you start receiving Sublocade. They may switch you to a different TB medication.

Sublocade and certain drugs for seizures

Taking certain seizure medications with Sublocade can reduce the level of buprenorphine in your body. This could make Sublocade less effective or cause withdrawal symptoms.

Examples of seizure drugs that can reduce the level of buprenorphine in your body when taken with Sublocade include:

• carbamazepine (Carbatrol, Equetro, Tegretol)
• fosphenytoin (Cerebyx)
• oxcarbazepine (Trileptal)
• phenobarbital
• phenytoin (Dilantin, Phenytek)
• primidone (Mysoline)

If you’re taking a drug to treat seizures, talk with your doctor before you start receiving Sublocade. They may switch you to a different seizure medication.

Sublocade and certain drugs for migraine

Taking triptan medications for migraine episodes with Sublocade could increase your risk for a rare but serious side effect called serotonin syndrome. (Serotonin is a chemical that helps transmit messages between nerve cells.) Serotonin syndrome can occur if your serotonin levels get too high. Triptan medications and Sublocade can both increase serotonin levels.

Examples of triptan medications that could increase your risk for serotonin syndrome if taken with Sublocade include:

• almotriptan letriptan (Relpax)
• frovatriptan (Frova)
• naratriptan (Amerge)
• rizatriptan (Maxalt and Maxalt-MLT)
• sumatriptan (Imitrex)
• zolmitriptan (Zomig)

If you’re taking a triptan medication for migraine headaches, talk with your doctor before you start receiving Sublocade. They may switch you to a different migraine drug.

Sublocade and herbs and supplements

Some herbs and supplements have been specifically reported to interact with Sublocade.

Sublocade and St. John’s wort

Avoid taking St. John’s wort, which is also called Hypericum perforatum, while receiving Sublocade. St. John’s wort can reduce the level of buprenorphine in your body. (Buprenorphine is the drug in Sublocade.) This could make Sublocade less effective or cause withdrawal symptoms.

Taking St. John’s wort with Sublocade can also increase your risk for a rare side effect called serotonin syndrome. (Serotonin is a chemical that helps messages travel between nerve cells.) Serotonin syndrome can occur if your serotonin levels get too high. St. John’s wort and Sublocade can both increase serotonin levels.

Sublocade and herbs and supplements that cause sedation

Taking herbs or supplements that cause sleepiness while you’re also receiving Sublocade might increase your risk for sedation (extreme sleepiness). Examples of these supplements include:

• kava
• melatonin
• valerian

Be sure to check with your doctor or pharmacist before using any herbs and supplements while taking Sublocade.

Sublocade cost

As with all medications, the cost of Sublocade can vary.

The actual price you’ll pay will depend on your insurance plan and your location.

Financial and insurance assistance

If you need financial support to pay for Sublocade, or if you need help understanding your insurance coverage, assistance is available.

Indivior, the manufacturer of Sublocade, offers a copay assistance program called INSUPPORT. For more information and to find out if you’re eligible for this program, call 844-467-7778 or visit the program website.

How Sublocade is given

A healthcare professional will give you Sublocade as an injection in your belly just under your skin (subcutaneous).*

For each injection, they’ll choose a different spot on your belly. You’ll go to a clinic to receive the injections.

After you have an injection of Sublocade, you may develop a lump in the injection area. This is because Sublocade reacts with your body’s fluids to form a solid mass. Over the next month, the mass will get smaller as the drug is absorbed into your bloodstream. Keep in mind these helpful tips:

• Don’t rub or massage the lump or injection site.
• Don’t try to remove the lump.
• Avoid wearing clothing with tight waistbands or belts that may rub the injection area.

If you have any concerns about the lump after your Sublocade injection, talk with your doctor.

* Sublocade has a boxed warning regarding risks related to injection into a vein. A boxed warning is the strongest warning required by the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous. For more information see the “Risk of serious harm or death with injection into a vein” section at the beginning of this article.

When to take

Your healthcare professional will give you an injection of Sublocade once each month. The injections should be given at lease 26 days apart.

Make sure you keep your appointments to have your injections of Sublocade. To help you remember, write down your schedule on a calendar or set a reminder in your phone.

How Sublocade works

Sublocade contains the drug buprenorphine, which belongs to the drug class called partial opioid agonists.

Sublocade is prescribed to treat moderate to severe opioid use disorder in adults. To learn how Sublocade works to treat this condition, see this article.

Sublocade and pregnancy

Some animal studies have looked at the inactive ingredients in Sublocade injections. The studies suggest that using Sublocade treatment during pregnancy may harm a pregnancy.

The active ingredient in Sublocade is called buprenorphine. In studies, taking other forms of buprenorphine during pregnancy doesn’t appear to increase the risk of congenital anomalies (commonly known as birth defects).

However, using any form of buprenorphine treatment during pregnancy can cause opioid withdrawal symptoms in a newborn. This is a condition called neonatal opioid withdrawal syndrome. Symptoms can include:

• feeling irritable (easily upset or frustrated)
• shaking
• crying much more than usual
• trouble sleeping
• diarrhea
• vomiting
• not gaining weight

If you’re pregnant and considering treatment with Sublocade, talk with your doctor. They can help you decide on the best treatment plan for you and your baby, both during and after your pregnancy.

Buprenorphine and birth control

It’s not known if Sublocade is safe to take during pregnancy. If you or your sexual partner can become pregnant, talk with your doctor about your birth control needs during Sublocade treatment.

Sublocade and breastfeeding

Clinical studies have shown that the active drug in Sublocade (buprenorphine) can pass into breast milk in small amounts. Serious problems haven’t been reported in people who took Sublocade while breastfeeding.

It’s important to talk with your doctor about the best way to feed your child.

If you decide to breastfeed while having Sublocade injections, keep a close eye on your child. If they’re much sleepier than usual, have trouble breastfeeding, or aren’t gaining weight, tell your doctor.

And call 911 right away if your child:

• has trouble breathing
• has slow or shallow breathing
• becomes limp
• can’t be woken up

Sublocade precautions

This drug comes with several precautions.

FDA warning: Risk of serious harm or death with injection into a vein

Sublocade has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Sublocade must not be injected into a vein because the drug becomes a solid mass after it’s injected. If Sublocade is injected into a vein, the mass that forms can move through your bloodstream and cause tissue damage. The mass can also block the blood supply to vital organs, such as the lungs, resulting in serious harm or death.

Because of these possible risks, you can get Sublocade only from your doctor through the Sublocade Risk Evaluation and Mitigation Strategy (REMS) program. If you have questions about the program, you can visit its website or call 866-258-3905. You can also ask your doctor.

Other warnings

Before taking Sublocade, talk with your doctor about your health history. Sublocade may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

Lung disease

You’re more at risk for severe breathing problems with Sublocade if you have a condition that affects your breathing. These include chronic obstructive pulmonary disease (COPD), asthma, and sleep apnea. Ask your doctor what treatment is right for you.

Underactive adrenal glands (Addison’s disease or adrenal insufficiency)

Sublocade can sometimes cause problems with your adrenal glands, which make and release hormones. So if these glands aren’t currently producing enough hormones, you may not be able to take Sublocade. Ask your doctor what other treatments may be better for you.

Liver disease

Sublocade can cause liver problems and worsen liver problems that you already have, including hepatitis. So if you have moderate or severe liver problems, you may not be able to take Sublocade. Ask your doctor what other treatments may be better for you.

Recent head injury or brain problem

Sublocade can increase the pressure of the fluid in your spinal cord and brain. This can be dangerous if you already have a head injury or brain condition.

Sublocade can alsoshrink your pupils and make you sleepy. If your doctor can’t look at your eyes properly and you’re not fully awake, it’s harder for them to monitor you. So if you have any head injuries or brain problems, you may not be able to take Sublocade. Ask your doctor what other treatments may be better for you.

Gallbladder problems

Sublocade can worsen gallbladder problems. So if you currently have a gallbladder problem, you may not be able to take Sublocade. Ask your doctor what other treatments may be better for you.

Allergic reactions to buprenorphine

If you’ve ever had an allergic reaction to buprenorphine (the active drug in Sublocade), you shouldn’t take Sublocade. And if you don’t know whether you’ve had an allergic reaction to buprenorphine, talk with your doctor.

Abnormal heart rate or rhythm

If you or an immediate family member has had a type of abnormal heart rhythm called long QT syndrome, you shouldn’t take Sublocade. (Long QT syndrome can run in families.) You also shouldn’t use Sublocade if you’re taking medication for an abnormal heart rate or rhythm. Ask your doctor what treatment may be a better choice for you.

Pregnancy

Babies born to people who took Sublocade during pregnancy can have opioid withdrawal symptoms. For more information, see the “Sublocade and pregnancy” section above.

Breastfeeding

Sublocade can pass into breast milk and may harm in breastfed children. For more information, see the “Sublocade and breastfeeding” section above.

Note: For more information about the potential negative effects of Sublocade, see the “Sublocade side effects” section above.