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SUBLOCADE is a brand name for Buprenorphine, supplied as a solution (extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SUBLOCADE (buprenorphine solution (extended-release) for injection) is indicated for the management of moderate to severe opioid use disorder in adult patients. SUBLOCADE should be used as part of a complete treatment plan that includes counselling and psychosocial support. SUBLOCADE must only be administered…
Verbatim from this product's HC label. Tap a section to expand.
). 1 Pediatrics Pediatrics (˂18 years of age): No data are available in patients under 18 years of age. SUBLOCADE is not indicated in pediatric patients. 2 Geriatrics Geriatrics (≥ 65 years of age): 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 or older, patients should be monitored for signs and symptoms of toxicity or overdose.
2 CONTRAINDICATIONS SUBLOCADE is contraindicated in patients: • who are hypersensitive to this drug or any ingredient in the formulation, including any non- medicinal ingredient, or any component of Indivior’s proprietary delivery system.
For a complete listing, see
, Clinical Trial Findings, Liver Enzyme Abnormalities). Prior to initiation of SUBLOCADE, liver function tests should be conducted to establish a baseline. Periodic monitoring of liver function during treatment is also recommended. An etiological evaluation should be performed when a hepatic event is suspected.
Use in Patients with Impaired Hepatic Function The effect of hepatic impairment on the pharmacokinetics of SUBLOCADE has not been studied. In a pharmacokinetic study with sublingual buprenorphine, compared to control subjects, buprenorphine plasma levels were found to be notably higher and the half-life was found to be notably longer in subjects with moderate and severe hepatic impairment, but not in subjects with mild hepatic impairment.
Because of the long-acting nature of the product, adjustments to SUBLOCADE dosing are not rapidly reflected in plasma buprenorphine levels. Because buprenorphine levels cannot be rapidly decreased, caution should be exercised in treating patients with pre-existing moderate hepatic impairment with SUBLOCADE.
SUBLOCADE should not be given to patients with pre- existing severe hepatic impairment (see 2 CONTRAINDICATIONS). Patients with moderate hepatic impairment or those who develop moderate hepatic impairment while being treated with SUBLOCADE should be monitored for several months for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine.
3 Pharmacokinetics, Special Populations and Conditions). SUBLOCADE (buprenorphine) Page 22 of 64 Immune Allergic Reactions Cases of hypersensitivity to buprenorphine-containing products have been reported both in clinical trials and in the post-marketing experience.
Cases of bronchospasm, angioneurotic oedema, and anaphylactic shock have been reported. The most common signs and symptoms include rashes, hives, and pruritus. A history of hypersensitivity to buprenorphine is a contraindication to the use of SUBLOCADE (see 2 CONTRAINDICATIONS).
). • Limitations of Use SUBLOCADE should never be handed to patients and should only be administered by a healthcare professional. • 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 (see 7 WARNINGS AND PRECAUTIONS). • Use During Pregnancy o Women of childbearing potential should use reliable and effective birth control o Inform patients to tell their physician immediately should they become pregnant.
1 Special Populations, 16 NON-CLINICAL TOXICOLOGY). • 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 (see 7 WARNINGS AND PRECAUTIONS).
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 (see 4 DOSAGE AND ADMINISTRATION, 12 SPECIAL HANDLING INSTRUCTIONS for instructions on proper disposal).
• 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 (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). • Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of SUBLOCADE during pregnancy can result in a neonatal opioid withdrawal syndrome, which may be life threatening (see 7 WARNINGS AND PRECAUTIONS).
SUBLOCADE is contraindicated in patients: • who are hypersensitive to this drug or any ingredient in the formulation, including any non- medicinal ingredient, or any component of Indivior’s proprietary delivery system. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
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. g. g. ileus of any type).
g. acute appendicitis or pancreatitis). Patients with severe central nervous system (CNS) 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. SUBLOCADE (buprenorphine) Page 5 of 64
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Buprenorphine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Monitoring and Laboratory Tests Baseline liver function tests and documentation of viral hepatitis status should be performed prior to commencing therapy. Regular monitoring of liver function is also recommended. Patients who are positive for viral hepatitis, on concomitant medicinal products and/or have existing liver dysfunction are at greater risk of liver injury.
Neonatal Opioid Withdrawal Syndrome Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy, whether that use is medically-authorized or illicit. Unlike opioid withdrawal syndrome in adults, NOWS may be life threatening if not recognized and treated in the neonate.
1 Pregnant Women). NOWS may present as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight. Signs of neonatal withdrawal usually occur in the first days after birth.
The duration and severity of NOWS may vary. Due to the long half-life of buprenorphine, neonatal monitoring for several days should be considered to minimize the risk of respiratory depression or withdrawal syndrome in neonates. Based on the currently available data, the incidence of NOWS is not clear and there does not appear to be a dose-response relationship.
1 Pregnant Women). This risk of NOWS and the risk of exposure to SUBLOCADE during pregnancy must be balanced against the risk of untreated opioid addiction. 1 Pregnant Women). Neurologic Interactions with Central Nervous System Depressants (including benzodiazepines and alcohol) Buprenorphine should be used with caution during concomitant administration of other opioids, general anesthetics, phenothiazines and other tranquilizers, sedative-hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, benzodiazepines, gabapentin, pregabalin, baclofen, centrally active antiemetics and other CNS depressants.
Respiratory depression, hypotension and profound sedation, coma or death may result. Alcohol should not be consumed with SUBLOCADE as it may increase the chance of experiencing dangerous side effects, including death (see 2 CONTRAINDICATIONS, 8 ADVERSE REACTIONS and
2 Breast-feeding). • Interaction with other Central Nervous System Depressants SUBLOCADE (buprenorphine) Page 6 of 64 Risks from concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death (see 7 WARNINGS AND PRECAUTIONS, Neurologic and DRUG INTERACTIONS).
o Reserve concomitant prescribing of SUBLOCADE and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. o Consider dose reduction of CNS depressants in situations of concomitant prescribing.
o Follow patients for signs and symptoms of respiratory depression and sedation. • Cardiac QTc prolongation (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS, 9 DRUG INTERACTIONS, 10 CLINICAL PHARMACOLOGY). 1 Dosing Considerations • FOR SUBCUTANEOUS INJECTION ONLY.
SUBLOCADE must NOT be administered intravenously, intramuscularly OR intradermally. • SUBLOCADE should never be handed to patients and should only be administered by a healthcare professional. • SUBLOCADE is available only through a controlled distribution process and should only be prescribed by healthcare professionals who have completed the SUBLOCADE Certification Program.
ca/. More information is available by calling this toll-free phone number: 1-877-782-6966. • Women of childbearing potential should use reliable and effective birth control. Patients should tell their physician immediately should they become pregnant.
The use of a formulation allowing for dosage adjustment may be considered during pregnancy. 1 Special Populations, 16 NON-CLINICAL TOXICOLOGY). • SUBLOCADE should be administered monthly only by subcutaneous injection in the abdomen, thigh, buttock, or back of the upper arm (see 4 DOSAGE AND ADMINISTRATION).
Each injection should be administered only using the syringe and safety needle included with the product. 1 Patient Selection Patients appropriate for SUBLOCADE are adults who have agreed to be treated for opioid use disorder (See below and 1 INDICATIONS).
Periodic assessment is necessary to determine effectiveness of the treatment plan and overall patient progress. When evaluating the patient, examine the injection site for signs of infection or evidence of tampering or attempts to remove the depot (see 7 WARNINGS AND PRECAUTIONS, Addiction, Abuse and Misuse).
SUBLOCADE (buprenorphine) Page 7 of 64 Due to the chronic nature of opioid use disorder, the need for continuing medication-assisted treatment plan should be re-evaluated periodically. If considering stopping treatment plan, the clinical status of the patient should be considered.
If SUBLOCADE is discontinued, patient should be monitored for several months for signs and symptoms of withdrawal and treated appropriately. 3 Pharmacokinetics). 2 Recommended Dose and Dosage Adjustment Induction in patients not already receiving buprenorphine: Treatment with buprenorphine should be initiated when objective and clear signs […]