Buprenorphine extended-release injection (Sublocade®) belongs to a group of medications called opioid agonist therapy (OAT).

What is this medication used for?

Buprenorphine extended-release injection is approved by Health Canada for management of adults with moderate to severe opioid dependence. To be able to use this medication, you must be stable with use of sublingual buprenorphine/ naloxone (Suboxone®) for a minimum of 7 days. Buprenorphine is not approved by Health Canada for use in children and adolescents.

When potential benefits outweigh risks, this medication may be prescribed “off-label” to adolescents or prior to completion of 7 days of treatment with sublingual buprenorphine/ naloxone. Learn more about off-label medication use: http://bit.ly/KMH-off-label-use

Tell your doctor or pharmacist if you:

• Have allergies or bad reactions to a medication.
• Take or plan to take other prescription or non-prescription medications (including natural medicines). Some medications interact with buprenorphine. Your doctor may adjust medication doses or monitor for side effects.
• Have a history of severe respiratory problems, liver disease, bowel obstruction, seizures, mental/mood disorders, head injury, acute appendicitis, pancreatitis, history (or family history) of heart disease, arrhythmia or "QTc prolongation".
• Miss a menstrual period, are pregnant, breast-feeding or planning a pregnancy.
• Use alcohol or street drugs. Taking this medication together with certain substances may cause a bad reaction. Learn more at www.DrugCocktails.ca

When will the medication start to work?

The first dose of buprenorphine extended-release injection is usually given after first starting treatment with sublingual buprenorphine/naloxone. It starts to work within a few hours. This medication is usually given once a month by a healthcare professional.

It is important that you continue to receive injections at regularly scheduled intervals to get the most benefit from this medication.

Talk with your doctor if you feel that buprenorphine has not been helpful or if side effects are too bothersome. Your doctor may recommend switching you to a different dose or medication.

How do I take this medication?

Buprenorphine extended-release injection is a solution available in a single dose, pre-filled syringe. Buprenorphine is a monthly injection administered just under the skin (subcutaneously) in the stomach area (abdomen) by a healthcare professional.

Buprenorphine is a liquid injection. After administration it forms a solid mass underneath the skin. You may see or feel a solid mass at the site of your injection for several weeks. Over time the mass will get smaller. Do NOT rub or massage the injection site. Avoid wearing belts or clothing with waistbands that may cause irritation of the injection site.

Possible common or serious side effects:

Side effects may be more common when starting a medication or after a dose increase. Talk to your doctor, nurse or pharmacist if any side effect concerns you.

• Dizziness, drowsiness or headache
• Weakness or difficulty falling asleep
• Dry mouth
• Nausea, vomiting, stomach ache or constipation
• Vision problems
• Dark urine or yellowing of eyes/skin
• Infertility or changes in sexual performance
• Pain, redness, bruising, swelling at injection site

Contact your doctor immediately if you experience:

• Slow, shallow, or weak breathing
• Chest pain, irregular heartbeat, or uncomfortable awareness of your heartbeat
• Unexplained rash, seizure, fever, or excessive sweating
• Severe abdominal pain, constipation or nausea
• Agitation, restlessness, loss of muscle control or muscle twitching, tremor
• Unusual changes in mood or behaviour such as ongoing sadness or seeing, hearing, or feeling things that are not there
• Thoughts of hurting yourself, suicide, increased hostility, or worsening symptoms

What precautions should my doctor and I be aware of when taking this medication?

• Many medications may interact with buprenorphine, including certain pain medications, medications that affect the heart rhythm, monoamine oxidase inhibitors, CNS depressants, sleep-aides, and several others. If you are (or begin) taking any other prescription, over-the-counter medication, natural health product or supplement, check with your doctor or pharmacist to see if they are safe to use.
• While taking this medication, if you feel dizzy, drowsy, or slowed down in the morning, do not drive a car or operate heavy machinery. Alcohol could make this worse. Try to avoid alcohol while taking buprenorphine.
• Attending counselling (as recommended by your doctor) increases the likelihood that this medication will help you continue to overcome opioid dependence.

How does this medication work?

Like other opioids, buprenorphine works by tightly binding to the same receptors in the brain as other opioids, such as heroin, morphine, and oxycodone. By doing so, it blunts intoxication with these other drugs, it prevents cravings, and allows many people to transition back from a life of addiction to a life of normalcy and safety.

What special instructions should I follow while using this medication?

Keep all your appointments with your doctor and the laboratory. Your doctor may order lab tests to check how you are responding, and to monitor for side effects. Try to keep a healthy, well-balanced diet and exercise regularly.

What should I do if I forget to take a dose of this medication?

If you take buprenorphine extended-release injection regularly and forget to receive a dose, you should make an appointment to receive the missed dose as soon as possible. The following dose should then be given at least 26 days after the make up dose.

How do I store this medication?

Buprenorphine extended-release injection will be stored by your healthcare professional. It is stored in a refrigerator and removed from the refrigerator for at least 15 minutes at room temperature prior to administration. Discard buprenorphine extended- release injection if left at room temperature for more than 7 days.

How well does the medication work in children and adolescents?

Evidence from adults shows that buprenorphine helps treat opioid dependence by preventing withdrawal symptoms (i.e., nausea, vomiting, diarrhea, anxiety, cold and clammy skin, sweating, body aches, loss of appetite).

Buprenorphine has been studied for moderate to severe opioid dependence in adults and was shown to be significantly better than placebo (an inactive injection) in preventing withdrawal symptoms and opioid use. Its use has been shown to lower the risk of fatal overdoses by approximately 50% and also reduces the risk of nonfatal overdoses which are traumatic and medically dangerous. Buprenorphine extended-release injection may be helpful for people with opioid dependence when combined with behavioural treatment.

How long should I take the medication for?

This depends on your risk of using opioids after starting treatment with buprenorphine extended-release injection. Your doctor will discuss the benefits and risks of taking this medication with you. At this time, you can also discuss how long you might need to take this medication. Once treatment has shown to be effective, your doctor may slowly reduce the maintenance dose until it can eventually be stopped.

Do not stop taking this medication without discussing it with your doctor. If you stop taking buprenorphine extended- release injection suddenly you may experience an increased occurrence of withdrawal symptoms; this may be delayed by 2-5 months as the effect of your last injection wears off. If you feel this medication is not managing your symptoms well enough, speak with your doctor about your treatment options.