itors or inducers for potential over or under dosing. (7.1)
Use caution in prescribing BUNAVAIL buccal film for patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant self-administration/misuse. (7.3)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
Nursing mothers: Caution should be exercised when administered to a nursing woman. (8.3)
Safety and effectiveness of BUNAVAIL buccal film in patients below the age of 16 has not been established. (8.4)
Administer BUNAVAIL buccal film with caution to elderly or debilitated patients. (8.5)
Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. (8.6)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 6/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
BUNAVAIL buccal film is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
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 physicians 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.
2 DOSAGE AND ADMINISTRATION
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; |
