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 eva luation 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-eva luate 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 pro |
