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Probuphine
Overview
What is Probuphine?
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.
The drug substance used is buprenorphine hydrochloride (HCl), an opioid partial agonist. Chemically, buprenorphine HCl is 6,14-Ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-a- (1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-a-methyl, hydrochloride,[5a,7a(S)]. It has the following chemical structure:
Buprenorphine HCl has the molecular formula CHNO HCl and the molecular weight is 504.10.
What does Probuphine look like?
What are the available doses of Probuphine?
Each PROBUPHINE implant is an ethylene vinyl acetate (EVA) implant, 26 mm in length and 2.5 mm in diameter, containing 74.2 mg of buprenorphine (equivalent to 80 mg of buprenorphine hydrochloride). ()
What should I talk to my health care provider before I take Probuphine?
How should I use Probuphine?
PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet or generic equivalent).
PROBUPHINE should be used as part of a complete treatment program to include counseling and psychosocial support.
PROBUPHINE is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged clinical stability, while being maintained on buprenorphine 8 mg per day or less of a Subutex or Suboxone sublingual tablet equivalent or generic equivalent.
Under the Drug Addiction Treatment Act (DATA) codified at 21 United States Code (U.S.C.) 823(g), use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe or dispense this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.
What interacts with Probuphine?
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What are the warnings of Probuphine?
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What are the precautions of Probuphine?
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What are the side effects of Probuphine?
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What should I look out for while using Probuphine?
PROBUPHINE is contraindicated in patients with a history of hypersensitivity to buprenorphine or any other ingredients in PROBUPHINE (e.g., EVA).
What might happen if I take too much Probuphine?
How should I store and handle Probuphine?
One PROBUPHINE implant kit consists of four individually packaged sterile implants and one individually packaged sterile disposable applicator. Each implant is 26 mm in length and 2.5 mm in diameter and contains 74.2 mg of buprenorphine (equivalent to 80 mg of buprenorphine hydrochloride).One applicator kit consists of one sterile, single patient use, disposable PROBUPHINE applicator.One PROBUPHINE implant kit consists of four individually packaged sterile implants and one individually packaged sterile disposable applicator. Each implant is 26 mm in length and 2.5 mm in diameter and contains 74.2 mg of buprenorphine (equivalent to 80 mg of buprenorphine hydrochloride).One applicator kit consists of one sterile, single patient use, disposable PROBUPHINE applicator.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
PROBUPHINE implants contain buprenorphine HCl. Buprenorphine is a partial agonist at the mu- opioid receptor and an antagonist at the kappa-opioid receptor.
Non-Clinical Toxicology
PROBUPHINE is contraindicated in patients with a history of hypersensitivity to buprenorphine or any other ingredients in PROBUPHINE (e.g., EVA).Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid cannot be recommended.
Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL and allopurinol administered concurrently.
In common with other broad-spectrum antibiotics, amoxicillin/clavulanate may reduce the efficacy of oral contraceptives.
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.
Insert PROBUPHINE in accordance with the instructions. . It is essential to insert PROBUPHINE subdermally so that each implant is palpable after insertion. It is also essential to confirm proper placement by palpation immediately after insertion. If PROBUPHINE is inserted too deeply (intramuscular or in the fascia), neural or vascular injury may occur.
Incomplete insertions or infections may lead to protrusion or expulsion. Accidental exposures to PROBUPHINE can result from protrusion or expulsion of the implants.
Improper insertion may lead to complicated removal if the implant is inserted too deeply, is not palpable, or has migrated. Deep insertions may lead to difficulty localizing the implant; additional surgical procedures may be required in order to remove the implant . Injury to deeper neural or vascular structures in the arm may occur when removing deeply inserted implants.
All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified in the PROBUPHINE REMS program, prior to performing insertions or prescribing PROBUPHINE implants. There are additional requirements and prerequisites that must be met to become certified to insert PROBUPHINE implants. Only Healthcare Providers who have performed a surgical procedure in the last 3 months and demonstrate competency in the PROBUPHINE procedures at the live training can become certified to perform insertions. Patients must be monitored to ensure that PROBUPHINE is removed by a healthcare provider certified to insert PROBUPHINE implants. .
The following adverse reactions are discussed in more detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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