Belbuca Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Belbuca Indications
Indications
Management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.
Limitations of Use
Due to risks of addiction, abuse, and misuse with opioids (can occur at any dosage or duration); increased risks of overdose and death with extended-release/long-acting opioid formulations, reserve for use in patients for whom alternative treatment options are ineffective, not tolerated, or inadequate to provide analgesia. Not indicated as an as-needed (prn) analgesic.
Belbuca Dosage and Administration
Adult
Children
Administration
Belbuca Contraindications
Contraindications
Belbuca Boxed Warnings
Boxed Warning
Serious and life-threatening risks from use of Belbuca: Addiction, abuse, and misuse; Life-threatening respiratory depression; Accidental exposure; Risks from concomitant use with benzodiazepines or other CNS depressants; Neonatal opioid withdrawal syndrome; Opioid analgesic risk evaluation and mitigation strategy (REMS).
Belbuca Warnings/Precautions
Warnings/Precautions
Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Life-threatening respiratory depression esp. during initiation or following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Opioid-induced hyperalgesia (OIH) and allodynia; consider dose reduction of current opioid or opioid rotation if OIH is suspected. 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. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. 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. Risk of QT prolongation (esp. in those with hypokalemia, bradycardia, recent conversion from atrial fibrillation, CHF, digitalis therapy, baseline QT prolongation, subclinical long-QT syndrome, severe hypomagnesemia). Advise patients to obtain regular dental checkups 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.
REMS
Belbuca Pharmacokinetics
Absorption
Absolute bioavailability: 46–65%.
Systemic exposure was reduced by 23–27% by the ingestion of liquids (cold, hot, and room temperature water) during film administration; coadministraiton with low pH liquid (eg, decaffeinated cola) reduced exposure by ~37%.
Distribution
Plasma protein bound: ~96%.
Elimination
Belbuca Interactions
Interactions
Belbuca Adverse Reactions
Adverse Reactions
Nausea, constipation, headache, vomiting, dizziness, somnolence; respiratory depression, orthostatic hypotension, syncope, hypersensitivity reactions, dental adverse events (eg, tooth fracture, tooth loss), OIH and allodynia.
Belbuca Clinical Trials
See Literature
Belbuca Note
Not Applicable
Belbuca Patient Counseling
See Literature
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