Indication and clinical use:
SUBLOCADE^® (buprenorphine extended‑release injection) is indicated for the management of moderate to severe opioid use disorder in adult patients who have been inducted and stabilized for a minimum of 7 days on a transmucosal buprenorphine‑containing product.

•	SUBLOCADE® should be used as part of a complete treatment plan that includes counselling and psychosocial support.
•	SUBLOCADE® must only be administered subcutaneously in the abdominal region by a healthcare provider.

There were no patients ≥65 years of age in the controlled clinical trial of SUBLOCADE^®. In general, drug use for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, respiratory, and/or cardiac function, concomitant disease, or other drug therapies. If the decision is made to prescribe SUBLOCADE^® to individuals ≥65 years of age, patients should be monitored for signs and symptoms of toxicity or overdose.

Contraindications:
SUBLOCADE^® is contraindicated in patients:

•	With severe respiratory insufficiency (e.g., acute or severe bronchial asthma, chronic obstructive airway, status asthmaticus, acute respiratory depression, and/or cor‑pulmonale).
•	With severe hepatic impairment.
•	With acute alcoholism or delirium tremens.
•	With known or suspected mechanical gastrointestinal obstruction (e.g., bowel obstruction or strictures) or any diseases/conditions that affect bowel transit (e.g., ileus of any type).
•	With suspected surgical abdomen (e.g., acute appendicitis or pancreatitis).
•	With severe central nervous system depression, increased cerebrospinal or intracranial pressure, and head injury.
•	Taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy).
•	With convulsive or seizure disorders.
•	With congenital Long QT Syndrome or QT prolongation at baseline.
•	With uncorrected hypokalemia, hypomagnesemia, or hypocalcemia.

Most serious warnings and precautions:
Incorrect Administration: Do not administer intravenously, intramuscularly OR intradermally. SUBLOCADE^® forms a solid mass following subcutaneous administration. Serious harm or death could result if administered intravenously.

Limitations of Use: SUBLOCADE^® should only be administered by a healthcare provider.

Addiction, Abuse, and Misuse: Abuse and diversion of buprenorphine component of SUBLOCADE^® is possible. All patients should be monitored regularly for the development of these behaviours or conditions.

Use During Pregnancy:

•	Women of childbearing potential should use reliable and effective birth control.
•	Inform patients to tell their physician immediately should they become pregnant.
•	Consider alternative treatments to SUBLOCADE® during pregnancy.
•	If a decision is made to use SUBLOCADE® during pregnancy, or if the patient becomes pregnant while taking SUBLOCADE®, inform the patient of the potential hazard to the fetus.

Life‑Threatening Respiratory Depression: OVERDOSE: Serious, life‑threatening, or fatal respiratory depression may occur with use of SUBLOCADE^®. Infants exposed in‑utero or through breast milk are at risk of life‑threatening respiratory depression upon delivery or when nursed. Patients should be monitored for respiratory depression, especially immediately after SUBLOCADE^® injection and following a dose increase. Misuse or abuse of SUBLOCADE^® may pose a significant risk of overdose and death. Further instruct patients of the hazards related to taking opioids including fatal overdose.

Accidental Exposure: Accidental exposure to even one dose of SUBLOCADE^® by individuals not physically dependent on opioids, especially children, can result in a fatal overdose of buprenorphine.

Interaction with Alcohol: The co‑ingestion of alcohol with SUBLOCADE^® should be avoided as it may result in dangerous additive effects, causing serious injury or death.

Neonatal Opioid Withdrawal Syndrome: Prolonged maternal use of SUBLOCADE^® during pregnancy can result in a neonatal opioid withdrawal syndrome, which may be life‑threatening. Prolonged maternal use of opioids during pregnancy can also result in neonatal respiratory depression.

Interaction with Other Central Nervous System Depressants: Risks from concomitant use of opioids with benzodiazepines or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

•	Reserve concomitant prescribing of SUBLOCADE® and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
•	Consider dose reduction of CNS depressants in situations of concomitant prescribing.
•	Follow patients for signs and symptoms of respiratory depression and sedation.

Cardiac (QTc prolongation): SUBLOCADE^® should not be used in patients with a history of Long QT Syndrome or an immediate family member with this condition or those taking Class IA/IC or III antiarrhythmic medications. Particular care should be exercised when administering SUBLOCADE^® to patients who are suspected to be at an increased risk of experiencing torsade de pointes during treatment with a QTc‑prolonging drug.

Other relevant warnings and precautions:

•	Adrenal insufficiency.
•	Orthostatic hypotension.
•	Use in patients with circulatory shock.
•	Dependence and risk of opioid withdrawal following discontinuation of SUBLOCADE®.
•	Impaired mental and/or physical abilities needed for driving or operating hazardous machinery.
•	Elevation of cerebrospinal fluid pressure.
•	Effects in acute abdominal conditions.
•	Elevation of intracholedochal pressure.
•	Hepatitis and other hepatic events.
•	Use in patients with impaired hepatic function.
•	Allergic reactions/hypersensitivity.
•	Peri‑operative considerations for pain management.
•	Effect on fertility in both females and males.
•	Sleep apnea.
•	Serotonin syndrome.
•	Decreased sex hormones and related symptoms, including infertility.
•	Use in debilitated patients and patients with myxedema or hypothyroidism; adrenal cortical insufficiency (e.g., Addison’s disease); CNS depression or coma; toxic psychoses; prostatic hypertrophy or urethral stricture; acute alcoholism; delirium tremens; or kyphoscoliosis.
•	Use in opioid‑naïve patients.
•	Use in pregnant or breastfeeding women and during labour and delivery.

For more information:
Please consult the product monograph for important information relating to adverse reactions, drug interactions, and dosing, which have not been discussed in this piece. The product monograph is also available by emailing infoMIU@indivior.com or calling 1‑877‑782‑6966.