PROBUPHINE CIII

Indications for PROBUPHINE:

Maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of transmucosal buprenorphine-containing product (eg, ≤8mg/day Subutex, Suboxone, or generic equivalent), as part of a complete treatment plan to include counseling and psychosocial support.

Adult:

See full labeling. For opioid-tolerant patients only. Insert 4 implants subdermally in the upper arm for 6 months, then remove. Examine insertion site 1 week after procedure for infection or impaired wound healing. After first 6-month cycle, implants may be replaced by new implants at time of removal in the contralateral arm, if continuing treatment; maintain on previous dose of transmucosal buprenorphine if not inserted on same day as removal.

Children:

<16yrs: not established.

Boxed Warning:

Implant migration, protrusion, expulsion, and nerve damage associated with insertion and removal.

Warnings/Precautions:

Risk of serious complications (eg, nerve damage, migration, others) from insertion/removal of implants; see full labeling. Risk of significant respiratory depression; monitor. Compromised respiratory function (eg, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression). Abuse potential (monitor). Accidental exposure may cause fatal overdose (esp. in children). 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. Moderate or severe hepatic impairment: not recommended. 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.

Pharmacological Class:

Opioid (partial agonist-antagonist).

Interactions:

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. 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, 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. May be potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors): monitor and may need dose adjustments or discontinuation. May be antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, phenobarbital): monitor for opioid withdrawal and consider dose adjustments or discontinuation. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.

Adverse Reactions:

Implant-site pain/pruritus/erythema, headache, depression, constipation, nausea, vomiting, back pain, toothache, oropharyngeal pain; respiratory depression, signs/symptoms of opioid withdrawal, insertion/removal complications (eg, neural/vascular injury, protrusion, expulsion, infection), orthostatic hypotension, hepatitis, hypersensitivity reactions.

REMS:

YES

Generic Availability:

NO

How Supplied:

Kit—1 (4 implants w. applicator)