Buprenorphine Extended-Release Subcutaneous Injection

What is this medication?

BUPRENORPHINE (byoo pre NOR feen) treats opioid use disorder. It works by reducing withdrawal symptoms and cravings to use opioids. It is most effective when used in combination with counseling and behavior therapy.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Sublocade

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Brain tumor
• Drug abuse or addiction
• Gallbladder disease
• Head injury
• Heart disease
• If you often drink alcohol
• Irregular heartbeat or rhythm
• Liver disease
• Low adrenal gland function
• Lung disease, asthma, or breathing problem
• Pancreatic disease
• Seizures
• Stomach or intestine problems
• Taken an MAOI like Marplan, Nardil, or Parnate in the last 14 days
• An unusual or allergic reaction to buprenorphine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for injection under the skin. This medication is given in a hospital or clinic setting.

A special MedGuide will be given to you by the pharmacist with each injection. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Pimozide
• Safinamide
• Samidorphan
• Thioridazine

This medication may also interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Certain antibiotics like clarithromycin, erythromycin
• Certain antivirals for hepatitis or HIV
• Certain medications for anxiety or sleep
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for depression or psychotic disorders
• Certain medications for fungal infections like fluconazole, ketoconazole, posaconazole
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for nausea or vomiting like dolasetron, ondansetron, palonosetron
• Certain medications for Parkinson's disease like benztropine, trihexyphenidyl
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Diuretics
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Ipratropium
• Linezolid
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles like cyclobenzaprine, metaxalone
• Methylene blue (injected into a vein)
• Other medications that prolong the QT interval (cause an abnormal heart rhythm)
• Other narcotic medications for pain or cough
• Phenothiazines like chlorpromazine, prochlorperazine
• Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team regularly. Attend counseling or support groups that your care team recommend. Do not try to overcome the effects of the medication by taking large amounts of narcotics. This can cause severe problems including death. Also, you may be more sensitive to lower doses of narcotics after you stop taking this medication.

Do not suddenly stop taking your medication because you may develop a severe reaction. Your body becomes used to the medication. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

Talk to your care team about naloxone and how to get it. Naloxone is an emergency medication used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other medications or substances, such as alcohol. Know the symptoms of an overdose, such as trouble breathing, being unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.

If you take other medications that also cause drowsiness such as other narcotic pain medications, benzodiazepines, or other medications for sleep, you may have more side effects. Give your care team a list of all medications you use.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

This medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.