Bunavail Buccal Film Dosage

Drug Addiction Treatment Act

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription 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 this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

Important Dosage and Administration Information

BUNAVAIL is administered buccally as a single daily dose. 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 mg/0.7 mg buccal film provides equivalent buprenorphine exposure to a SUBOXONE 8 mg/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.

Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose

​Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver. Because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with BUNAVAIL. Also consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose [see Warnings and Precautions (5.2)].

​Advise patients and caregivers that naloxone may also be administered for a known or suspected overdose with BUNAVAIL itself. Higher than normal doses and repeated administration of naloxone may be necessary due to the long duration of action of BUNAVAIL and its affinity for the mu receptor [see Overdosage (10)].

​Inform patients and caregivers of their options for obtaining naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) [see Patient Counseling Information (17)].

Induction

Prior to induction, consideration should be given to the type of opioid dependence (i.e., long- or short-acting opioid products), the time since last opioid use, and the degree of level of opioid dependence.

Maintenance

The dosage of BUNAVAIL from Day 3 onwards should be progressively adjusted in increments/decrements of 2.1 mg/0.3 mg buprenorphine/naloxone to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.

After treatment induction and stabilization, the maintenance dose of BUNAVAIL is generally in the range of 2.1 mg/0.3 mg buprenorphine/naloxone to 12.6 mg/2.1 mg buprenorphine/naloxone per day depending on the individual patient and clinical response. The recommended target dosage of BUNAVAIL during maintenance is 8.4 mg/1.4 mg as a single daily dose. Dosages higher than 12.6 mg/2.1 mg have not been demonstrated to provide any clinical advantage.

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.

There is no maximum recommended duration of maintenance treatment. Patients may require treatment indefinitely and should continue for as long as patients are benefitting and the use of BUNAVAIL contributes to the intended treatment goals.

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. Instruct the patient to avoid manipulating the film(s) with the tongue or finger(s) and to 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.

Clinical Supervision

Treatment should be initiated with supervised administration, progressing to unsupervised administration as the patient's clinical stability permits. BUNAVAIL 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 healthcare provider's evaluation of treatment outcomes and objectives such as:

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

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

Unstable Patients

Healthcare providers 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 healthcare provider does not feel that he/she has the expertise to manage the patient. In such cases, the healthcare provider 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.

Discontinuing Treatment

The decision to discontinue therapy with BUNAVAIL after a period of maintenance should be made as part of a comprehensive treatment plan. Advise patients of the potential to relapse to illicit drug use following discontinuation of opioid agonist/partial agonist medication-assisted treatment. Taper patients to avoid the occurrence of withdrawal signs and symptoms [see Warnings and Precautions (5.7)].

Switching between BUNAVAIL Buccal Film and Other Buprenorphine/Naloxone Combination Products

For patients being switched between BUNAVAIL and other buprenorphine/naloxone products dosage adjustments may be necessary. Patients should be monitored for over-medication as well as for withdrawal or other signs of under-dosing.

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

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