Addiction/dependence:

Indications for SUBLOCADE:

Treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for ≥7 days, as part of a complete treatment plan to include counseling and psychosocial support.

Adult Dosage:

For SC inj into abdomen; rotate inj sites. Give as monthly inj with ≥26 days between doses. Initiate only following induction and dose-adjustment with transmucosal buprenorphine-containing product (8–24mg daily buprenorphine equivalent). 300mg monthly for first 2 months followed by maintenance dose 100mg monthly; if tolerant and inadequate response, may increase to 300mg monthly.

Children Dosage:

Not established.

Boxed Warning:

Risk of serious harm or death with intravenous administration. Sublocade REMS program.

SUBLOCADE Warnings/Precautions:

Not for IV or IM inj; risk of serious harm or death. Abuse potential (monitor). Risk of life-threatening respiratory and CNS depression; monitor. Compromised respiratory function (eg, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Adrenal insufficiency. Hypokalemia, hypomagnesemia, unstable cardiac disease (eg, AF, bradycardia, CHF); monitor ECG periodically. History of long QT syndrome: avoid. Obtain LFTs prior to initiation and monthly during treatment; evaluate if hepatic event is suspected. Avoid in opioid-naïve. Elevated CSF pressure (eg, head injury, intracranial lesions). Biliary tract dysfunction. Acute abdomen. Prescribe a non-opioid analgesic for managing acute pain; may use opioid therapy under physician supervision. Moderate-to-severe hepatic impairment: not recommended. Unintentional pediatric exposure (potential fatal respiratory depression). Acute alcoholism. Drug abusers. Reevaluate periodically. Avoid abrupt cessation. Elderly. Labor & delivery. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Nursing mothers: monitor infants.

SUBLOCADE Classification:

Opioid (partial agonist-antagonist).

SUBLOCADE Interactions:

Increased risk of hypotension, respiratory depression, sedation, coma, and death with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); discontinue these agents are preferred; or in some patients, gradually taper off or reduce to lowest effective dose may be appropriate. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor. Concomitant NNRTIs (eg, efavirenz, nevirapine, etravirine, delavirdine) or PIs (eg, atazanavir with/without ritonavir): monitor and use SL buprenorphine, if needed. Avoid concomitant Class IA (eg, quinidine, procainamide, disopyramide) or III antiarrhythmics (eg, sotalol, amiodarone, dofetilide) or drugs that prolong the QT interval. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, phenobarbital). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.

Adverse Reactions:

Constipation, headache, nausea, inj site pruritus, vomiting, increased hepatic enzymes, fatigue, inj site pain; orthostatic hypotension, miosis, hypersensitivity reactions, signs/symptoms of withdrawal.

REMS:

YES

Generic Drug Availability:

NO

How Supplied:

Single-dose prefilled syringe—1 (w. needle)