ADD THIS DRUG TO MY LIST

Select the drug indication to add to your list

PROBUPHINE
Addiction/dependence
Compare To Related Drugs
View/Edit/Compare Drugs In My List

Only 4 drugs may be compared at once

Drug Name:

PROBUPHINE CIII

Generic Name and Formulations:
Buprenorphine 74.2mg (equivalent to 80mg of buprenorphine HCl); per implant; for subdermal use.

Company:
Braeburn Pharmaceuticals

Therapeutic Use:

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)

Sign Up for Free e-newsletters



Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs