Bunavail

Bunavail Manufacturers

• Biodelivery Sciences International, Inc.
  

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  Bunavail | Biodelivery Sciences International, Inc.

  

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  BUNAVAIL buccal film is applied to the buccal mucosa as a single daily dose. BUNAVAIL buccal film should be used in patients who have been initially inducted using buprenorphine sublingual tablets.

  The difference in bioavailability of BUNAVAIL compared to SUBOXONE sublingual tablet requires a different dosage strength to be administered to the patient. A BUNAVAIL 4.2/0.7 mg buccal film provides equivalent buprenorphine exposure to a SUBOXONE 8/2 mg sublingual tablet.

  Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits.

  2.1 Maintenance BUNAVAIL buccal film is indicated for maintenance treatment. The recommended target dosage of BUNAVAIL buccal film is 8.4/1.4 mg per day as a single daily dose. The dosage of BUNAVAIL buccal film should be progressively adjusted in increments/decrements of 2.1/0.3 mg buprenorphine/naloxone to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms. The maintenance dose of BUNAVAIL buccal film is generally in the range of 2.1/0.3 mg buprenorphine/naloxone to 12.6/2.1 mg buprenorphine/naloxone per day depending on the individual patient. Dosages higher than this have not been demonstrated to provide any clinical advantage. 2.2 Method of Administration

  The patient should:

  use the tongue to wet the inside of the cheek or rinse the mouth with water to moisten the area immediately before placement of BUNAVAIL; open the BUNAVAIL package immediately prior to use as indicated by the instructions; hold the BUNAVAIL film with clean, dry fingers with the text (BN2, BN4, or BN6) facing up; place the side of the BUNAVAIL film with the text (BN2, BN4, or BN6) against the inside of the cheek; press and hold the film in place for 5 seconds.

  BUNAVAIL film(s) adheres to the moist buccal mucosa and should stay in place after this period.

  If multiple films need to be administered, the patient should immediately apply the next film according to the steps above. Note that when two films are required for one dose, the patient should place one film on the inside of one cheek and the other film on the inside of the other cheek. For doses requiring multiple films, no more than two films should be applied to the inside of one cheek at a time.

  BUNAVAIL film(s) completely dissolves after application. The patient should be instructed to avoid manipulating the film(s) with the tongue or finger(s) and avoid drinking or eating food until the film(s) dissolves. BUNAVAIL film should not be chewed or swallowed as this may result in lower peak concentrations and lower bioavailability [see Clinical Pharmacology (12.3)].

  Instruct the patient to use the entire film. BUNAVAIL should not be cut or torn.

  Proper administration technique should be demonstrated to the patient.

  2.3 Clinical Supervision

  Treatment should be initiated with supervised administration, progressing to unsupervised administration as the patient’s clinical stability permits. BUNAVAIL buccal film is subject to diversion and abuse. When determining the prescription quantity for unsupervised administration, consider the patient’s level of stability, the security of his or her home situation, and other factors likely to affect the ability to manage supplies of take-home medication.

  Ideally patients should be seen at reasonable intervals (e.g., at least weekly during the first month of treatment) based upon the individual circumstances of the patient. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. Periodic assessment is necessary to determine compliance with the dosing regimen, effectiveness of the treatment plan, and overall patient progress.

  Once a stable dosage has been achieved and patient assessment (e.g., urine drug screening) does not indicate illicit drug use, less frequent follow-up visits may be appropriate. A once-monthly visit schedule may be reasonable for patients on a stable dosage of medication who are making progress toward their treatment objectives. Continuation or modification of pharmacotherapy should be based on the physician’s evaluation of treatment outcomes and objectives such as:

  Absence of medication toxicity Absence of medical or behavioral adverse effects Responsible handling of medications by the patient Patient’s compliance with all elements of the treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities) Abstinence from illicit drug use (including problematic alcohol and/or benzodiazepine use)

  If treatment goals are not being achieved, the physician should re-evaluate the appropriateness of continuing the current treatment.

  2.4 Patients With Hepatic Impairment

  Because the doses of this fixed combination product cannot be individually titrated, severe hepatic impairment results in a reduced clearance of naloxone to a much greater extent than buprenorphine, and moderate hepatic impairment also results in a reduced clearance of naloxone to a greater extent than buprenorphine, the combination product should generally be avoided in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment [see Warnings and Precautions (5.11)].

  2.5 Unstable Patients

  Physicians will need to decide when they cannot appropriately provide further management for particular patients. For example, some patients may be abusing or dependent on various drugs, or unresponsive to psychosocial intervention such that the physician does not feel that he/she has the expertise to manage the patient. In such cases, the physician may want to assess whether to refer the patient to a specialist or more intensive behavioral treatment environment. Decisions should be based on a treatment plan established and agreed upon with the patient at the beginning of treatment. Patients who continue to misuse, abuse, or divert buprenorphine products or other opioids should be provided with, or referred to, more intensive and structured treatment.

  2.6 Stopping Treatment

  The decision to discontinue therapy with BUNAVAIL buccal film after a period of maintenance should be made as part of a comprehensive treatment plan. Taper patients to avoid opioid withdrawal signs and symptoms.

  2.7 Switching between SUBOXONE Sublingual Tablets or Films and BUNAVAIL buccal film

  The difference in bioavailability of BUNAVAIL compared to SUBOXONE sublingual tablet requires a different dosage strength to be administered to the patient. A BUNAVAIL 4.2/0.7 mg buccal film provides equivalent buprenorphine exposure to a SUBOXONE 8/2 mg sublingual tablet.

  Patients being switched between SUBOXONE dosage strengths and BUNAVAIL dosage strengths should be started on the corresponding dosage as defined below:

  Suboxone Sublingual Tablet Dosage Strength Corresponding BUNAVAIL Buccal Film
  Strength

   

  4/1 mg buprenorphine/naloxone

   

  2.1/0.3 mg buprenorphine/naloxone 8/2 mg buprenorphine/naloxone 4.2/0.7 mg buprenorphine/naloxone 12/3 mg buprenorphine/naloxone 6.3/1 mg buprenorphine/naloxone

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