STEPS

New Drug Reviews

Implantable Buprenorphine (Probuphine) for Maintenance Treatment of Opioid Use Disorder

 

Am Fam Physician. 2018 May 15;97(10):668-670.

Implantable buprenorphine (Probuphine) is an implantable partial opioid agonist. It is labeled for the treatment of patients with opioid use disorder who have achieved and sustained clinical stability on a transmucosal buprenorphine product at low to moderate dosages, defined as no more than 8 mg per day.1

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DrugDosageDosage formCost

Implantable buprenorphine (Probuphine)

Four 74.2-mg implants

74.2-mg ethylene vinyl acetate subdermal implant (26 mm × 2.5 mm)

$5,175 ($1,294 per implant)


*—Estimated retail price of one month's treatment based on information obtained at http://www.drugs.com (accessed April 6, 2018).

DrugDosageDosage formCost

Implantable buprenorphine (Probuphine)

Four 74.2-mg implants

74.2-mg ethylene vinyl acetate subdermal implant (26 mm × 2.5 mm)

$5,175 ($1,294 per implant)


*—Estimated retail price of one month's treatment based on information obtained at http://www.drugs.com (accessed April 6, 2018).

Safety

Serious complications are related to improper insertion and removal of the buprenorphine implant, as well as improper initiation in patients taking other types of opioid therapy who are not already stabilized on a buprenorphine regimen. The product can be prescribed, inserted, and removed only by health care professionals who have received certification and training through the U.S. Food and Drug Administration's Probuphine Risk Evaluation and Mitigation Strategy program. Opioid withdrawal is precipitated by protrusion or expulsion of implantable buprenorphine, purposeful removal of the device, or initiation of implantable buprenorphine in patients dependent on full opioid agonists (i.e., heroin, morphine, and methadone).1

Other forms of buprenorphine are used to treat opioid use disorder in pregnant women; however, implantable buprenorphine should not be used in pregnant patients because of the inflexibility of dosing. Patients who become pregnant while receiving treatment may require augmented therapy with an additional buprenorphine product to control symptoms. Newborns of mothers treated with implantable buprenorphine may be at increased risk of neonatal opioid withdrawal syndrome and respiratory depression, as with other opioid treatments. Buprenorphine is present in low levels in breast milk and is considered compatible with breastfeeding.1 This medication has not been evaluated for teratogenicity in humans, but birth defects have not been shown to increase in animals given dosages equivalent to the recommended dosage of 8 to 16 mg per day.1

Tolerability

Implantable buprenorphine is well tolerated by patients. In clinical studies of buprenorphine and placebo implants, there were similar rates of discontinuation (5.6% vs. 6.9%)

Address correspondence to Nancy Hope Goodbar, PharmD, BCPS, at nhgoodbar@presby.edu. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

show all references

1. DailyMed. Drug label information. Probuphine—buprenorphine hydrochloride implant. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10fd7088-cc4a-4bda-a5e3-a82563540a9a. Accessed April 11, 2018....

2. Braeburn Pharmaceuticals. Probuphine (buprenorphine HCl) Implant CIII. Treatment of opioid dependence. Briefing document for the FDA Advisory Committee meeting. December 11, 2015. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM480733.pdf. Accessed October 25, 2017.

3. Rosenthal RN, Lofwall MR, Kim S, Chen M, Beebe KL, Vocci FJ; PRO-814 Study Group. Effect of buprenorphine implants on illicit opioid use among abstinent adults with opioid dependence treated with sublingual buprenorphine: a randomized clinical trial. JAMA. 2016;316(3):282–290.

4. White J, Bell J, Saunders JB, et al. Open-label dose-finding trial of buprenorphine implants (Probuphine) for treatment of heroin dependence. Drug Alcohol Depend. 2009;103(1–2):37–43.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

The series coordinator for AFP is Allen F. Shaughnessy, PharmD, Tufts University Family Medicine Residency Program at Cambridge Health Alliance, Malden, Mass.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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