Indications for: ZUBSOLV
Treatment of opioid dependence, as part of a complete treatment plan including counseling and psychosocial support.
Dissolve under tongue; do not cut, chew or swallow. Avoid food or drinks until tab dissolves. Place additional tabs sublingually in different places under the tongue at the same time if needed. Rinse teeth/gums with water after tab dissolves, and swallow. Start when clear signs of withdrawal occur; individualize based on type and degree of opioid dependence. Induction (under supervision): Day 1: Initially 1.4mg/0.36mg; give the remainder of the Day 1 dose up to 4.2mg/1.08mg in divided doses (1 or 2 tabs of 1.4mg/0.36mg) at 1.5–2hr intervals; up to max 5.7mg/1.4mg. Day 2: a single daily dose of up to 11.4mg/2.9mg. Dependent on heroin or short-acting opioids: initiate induction with either Zubsolv or buprenorphine monotherapy (SL tabs) at least 6hrs after last opioid dose. Dependent on methadone or long-acting opioids: initiate induction with buprenorphine monotherapy (SL tabs), then transition to once-daily Zubsolv. Maintenance target dose: 11.4mg/2.9mg once daily; adjust in increments/decrements of 2.9mg/0.71mg or lower to hold treatment level; usual range 2.9mg/0.71mg–17.2mg/4.2mg once daily. Switching between Zubsolv and other buprenorphine/naloxone products: may need dose adjustments; monitor for over- or under-dosing. Switching between Suboxone SL tabs and Zubsolv: see full labeling. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).
Potential risk for opioid overdose; strongly consider prescribing naloxone when initiating and renewing therapy. Consider prescribing naloxone if the patient has household members (eg, children) or other close contacts at risk for accidental ingestion or overdose. Abuse potential (monitor). Risk of life-threatening respiratory 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. Unintentional pediatric exposure. Adrenal insufficiency. Obtain LFTs at baseline then monitor periodically; evaluate if hepatic event is suspected. Opioid-naïve. Elevated CSF pressure (eg, head injury, intracranial lesions). Biliary tract dysfunction. Acute abdomen. CNS depression. Hepatic impairment (severe): not recommended; (moderate): avoid use for induction. 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. Drug abusers. Reevaluate periodically. Avoid abrupt cessation. Elderly. Labor & delivery: may need additional analgesia. Pregnancy/postpartum: may need dose adjustments; monitor closely for withdrawal. Potential neonatal opioid withdrawal syndrome during prolonged use. Nursing mothers: monitor infants.
Opioid (partial agonist-antagonist) + opioid antagonist.
Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); manage concomitant use as clinically appropriate and closely monitor; strongly consider prescribing naloxone if concomitant use is warranted. 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. Concomitant NNRTIs (eg, efavirenz, nevirapine, etravirine, delavirdine) or PIs (eg, atazanavir with/without ritonavir): monitor and reduce Zubsolv dose, if needed. 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.
Headache, nausea, vomiting, hyperhidrosis, constipation, signs/symptoms of withdrawal, insomnia, pain, peripheral edema; respiratory depression, orthostatic hypotension, hepatitis, hypersensitivity reactions, dental adverse events (eg, tooth fracture, tooth loss).
Generic Drug Availability:
SL tabs—3×10 (per carton)