General Information
Manufacturer: Indivior
Medical Name: Buprenorphine extended-use
Purpose: Sublocade is a treatment for opioid addiction
Side Effects
| Side Effect | Percentage |
|---|---|
| Nausea | Likelihood was up to 50%, with females reporting it more often than males. |
| Headache | Likelihood was up to 34%, with some sources noting females report this more frequently than males. |
| Injection site reactions | 16.5% of patients in Phase 3 studies experienced reactions such as pain, itching, redness, or hardening at the injection site. These were generally mild to moderate in severity. |
| Dizziness | Up to 15% |
| Increased hepatic (liver) enzymes | Up to 12.4% of patients had elevated liver enzymes (ALT) in one study, which was monitored through blood tests. Elevated liver enzymes indicate that liver cells are injured or inflamed. |
| Constipation | Occurred in approximately 9.4% of patients in one study, and up to 14% in other data. |
| Vomiting | In at least 5% of subjects |
| Fatigue (tiredness) | Occurred in about 3.9% to 6% of patients in clinical studies. |
Serious but Less Common Side Effects
| Side Effect | Description |
|---|---|
| Life-threatening respiratory depression | This is a serious risk, especially if Sublocade is used with alcohol, benzodiazepines, or other central nervous system depressants. |
| Severe allergic reactions | Symptoms can include hives, swelling of the face, lips, tongue, or throat, and trouble breathing. |
| Liver problems | Can range from abnormal enzyme levels to hepatic failure. Symptoms include yellowing of the skin/eyes, dark urine, or severe abdominal pain. |
| Adrenal gland problems (adrenal insufficiency) | May occur with long-term use and can cause nausea, vomiting, dizziness, and fatigue. |
| Orthostatic hypotension | A sudden drop in blood pressure when standing, which can cause fainting or dizziness. |
| Physical dependence and withdrawal | Abrupt discontinuation can lead to withdrawal symptoms, so the patient should be monitored by a healthcare provider for several months if stopping treatment. |
| Serious harm or death from intravenous injection | Sublocade forms a solid mass if injected into a vein and can cause life-threatening blood clots (pulmonary emboli). It is only administered by a healthcare professional as a subcutaneous injection. |
Preclusions To Starting Treatment
| Condition | Description |
| Hypersensitivity | Patients with a history of an allergic reaction (e.g., rash, hives, bronchospasm, anaphylactic shock) to buprenorphine or any component of the ATRIGEL delivery system (which contains N-methyl-2-pyrrolidone (NMP) and a polymer) should not receive Sublocade. |
| Opioid-Naïve Patients | Sublocade is not appropriate for individuals who are opioid-naïve, meaning they are not currently physically dependent on full opioid agonists. Buprenorphine in opioid-naïve patients has been associated with severe, potentially fatal, respiratory depression. |
| Moderate to Severe Hepatic Impairment | Due to the long-acting nature of the injection and the inability to rapidly decrease buprenorphine levels, Sublocade is not recommended for patients with pre-existing moderate to severe liver problems (Child-Pugh B or C). |
| Acute Intoxication | Patients who are currently intoxicated with alcohol or other central nervous system (CNS) depressants (e.g., benzodiazepines, sedatives, other opioids) should not start treatment. |
| Intravenous Administration | Sublocade must only be administered as a subcutaneous injection. Intravenous administration is a strict contraindication because the medication forms a solid mass upon contact with body fluids, which can cause life-threatening pulmonary emboli and death. |
Preconditions That Should Be Met Before Starting Treatment
| Precondition | Description |
|---|---|
| Prior Stabilization on Transmucosal Buprenorphine | Patients must be initiated and stabilized on a transmucosal buprenorphine product (e.g., film or tablet) at a dose of 8-24 mg daily for at least seven days before receiving the first Sublocade injection. |
| Absence of Withdrawal | Sublocade should be initiated only when objective and clear signs of opioid withdrawal are evident (if not already on buprenorphine and being transitioned), to avoid precipitating severe withdrawal symptoms. |
Use with Caution and Close Monitoring
| Precondition | Description |
|---|---|
| Pregnancy and Breastfeeding | Sublocade can pass into breast milk and potentially harm a baby. Pregnant women should be advised of the risk of neonatal opioid withdrawal syndrome (NOWS). Healthcare providers must assess the risks and benefits, and women of childbearing potential should be counseled on using reliable birth control methods during treatment. |
| Respiratory Compromise | Use with caution in patients with pre-existing breathing or lung problems (e.g., COPD, cor pulmonale). |
| Concomitant CNS Depressants | The use of alcohol, benzodiazepines, or other CNS depressants with buprenorphine increases the risk of severe respiratory depression, coma, and death. Concomitant use should be supervised by a healthcare provider. |