May 25, 2017
Recommended Topic Related To:

Probuphine

"The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in p"...

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Probuphine

PROBUPHINE®
(buprenorphine) Implant

WARNING

IMPLANT MIGRATION, PROTRUSION, EXPULSION, and NERVE DAMAGE ASSOCIATED WITH INSERTION and REMOVAL

Risk Associated with Insertion and Removal

Insertion and removal of PROBUPHINE are associated with the risk of implant migration, protrusion, and expulsion resulting from the procedure. Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion and expulsion. Incomplete insertions or infections may lead to protrusion or expulsion. [see WARNINGS AND PRECAUTIONS].

Because of the risks associated with insertion and removal, PROBUPHINE is available only through a restricted program called the PROBUPHINE REMS Program. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified, prior to performing insertions or prescribing PROBUPHINE implants. Patients must be monitored to ensure that PROBUPHINE is removed by a healthcare provider certified to perform insertions. [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

PROBUPHINE (buprenorphine) implant is a sterile, single, off-white, soft, flexible rod-shaped drug product. It is 26 mm in length and 2.5 mm in diameter. Each implant contains 74.2 mg buprenorphine (equivalent to 80 mg buprenorphine hydrochloride) and ethylene vinyl acetate (EVA). PROBUPHINE is designed to be implanted subdermally by a trained medical professional and to provide sustained delivery of buprenorphine for up to six months.

PROBUPHINE implant - Illustration

PROBUPHINE implant (not to scale)

The drug substance used is buprenorphine hydrochloride (HCl), an opioid partial agonist. Chemically, buprenorphine HCl is 6,14-Ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-α- (1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl, hydrochloride,[5α,7α(S)]. It has the following chemical structure:

PROBUPHINE® (buprenorphine) Structural Formula Illustration

Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10.

Last reviewed on RxList: 5/8/2017
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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