Indications for BELBUCA:
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use:
Reserve for use in patients for whom alternative treatment options are ineffective, not tolerated, or inadequate to provide sufficient management of pain. Not indicated as an as-needed (prn) analgesic.
Use lowest effective dose for shortest duration. Apply against inside of cheek; do not chew or swallow. Avoid food or drinks until film dissolves. Individualize. Opioid-naive or opioid non-tolerant: initially 75mcg once daily or every 12hrs (if tolerated) for at least 4 days, then increase to 150mcg every 12hrs. Titrate in increments of 150mcg every 12hrs no sooner than every 4 days. Max 900mcg every 12hrs; consider alternate analgesic if inadequate. Conversion from other opioids: see full labeling. Use 600mcg, 750mcg, and 900mcg doses only following titration from lower doses of Belbuca. Severe hepatic impairment or oral mucositis: reduce initial and titration doses by ½. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.
Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental exposure. Neonatal opioid withdrawal syndrome. Risks from concomitant use with benzodiazepines or other CNS depressants.
Abuse potential (monitor). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. History of long QT syndrome; avoid. Hypokalemia, hypomagnesemia, unstable cardiac disease (eg, unstable atrial fibrillation, symptomatic bradycardia, unstable CHF, active MI); monitor ECG periodically. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Oral mucositis: use lower dose; monitor for toxicity. Drug abusers. Moderate or severe hepatic impairment. Hepatotoxicity: obtain baseline LFTs in at-risk patients and monitor during treatment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.
Opioid (partial agonist-antagonist).
Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. Avoid concomitant Class 1A (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmics (eg, sotalol, amiodarone, dofetilide). 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 and discontinue if suspected. Avoid concomitant mixed agonist/antagonist and partial agonist opioids (eg, butorphanol, nalbuphine, pentazocine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. Concomitant NNRTIs (eg, efavirenz, nevirapine, etravirine, delavirdine) or PIs (eg, atazanavir, ritonavir); monitor and adjust buprenorphine dose, if needed.
Nausea, constipation, headache, vomiting, dizziness, somnolence; respiratory depression, severe hypotension, syncope, hypersensitivity reactions.