About Opioid Dependence: Opioid dependence is a significantly undertreated condition in the U.S., with approximately 2.5 million people dependent on prescription opioids according to the National Survey on Drug Use and Health, conducted by the U.S. Department of Health and Human Services.
Overdose Deaths Involving Opioids, United States (2002-2015)
Opioid dependence is a medical diagnosis that is characterized by the inability of an individual to stop using opioids, both prescription opioids such as morphine, hydrocodone and oxycodone, as well as illicit opioids such as heroin, even when it is in the best interest of the individual to do so. Opioid dependence is a complex medical condition that often requires long-term treatment and care. The treatment of opioid dependence is important to reduce both the associated health and social consequences and to improve the well-being and social functioning of people affected.
(buprenorphine and nalaxone buccal film)
BUNAVAIL® (buprenorphine and naloxone buccal film) is indicated for the treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Prescription use of this product is limited under the Drug Addiction and Treatment Act (DATA).
BUNAVAIL is the first and only formulation of buprenorphine and naloxone for buccal (inside of the cheek) administration. BUNAVAIL was designed using BDSI's advanced drug delivery technology, BioErodible MucoAdhesive (BEMA®), allowing for the efficient and convenient delivery of buprenorphine while potentially overcoming some of the administration challenges presented by the sublingual (under the tongue) dosage forms currently available. BUNAVAIL has twice the bioavailability (drug absorbed into the body) of buprenorphine compared to Suboxone, the market leader in this category. As a result of the improved absorption of buprenorphine with BUNAVAIL, which is the direct result of the BEMA technology, plasma concentrations of buprenorphine comparable to Suboxone can be achieved with half the dose, which may help to reduce the potential for misuse and diversion and potentially lessen the incidence of certain side effects.
BUNAVAIL® (buprenorphine and naloxone buccal film), CIII, is indicated for the treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
BUNAVAIL is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported.
Addiction, Abuse, and Misuse
- Buprenorphine can be abused in a similar manner to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits
Risk of Respiratory and Central Nervous System (CNS) Depression
- Life-threatening respiratory depression and death have occurred in association with buprenorphine use. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with BUNAVAIL.
- Use BUNAVAIL with caution in patients with compromised respiratory function.
Managing Risks from Concomitant Use of Benzodiazepines or Other CNS Depressants
- Concomitant use of buprenorphine and benzodiazepines or other CNS depressants increases the risk of adverse reactions including overdose and death. Medication-assisted treatment of opioid use disorder, however, should not be categorically denied to patients taking these drugs. Prohibiting or creating barriers to treatment can pose an even greater risk of morbidity and mortality due to the opioid use disorder alone.
Unintentional Pediatric Exposure
- Store BUNAVAIL safely and out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.
Neonatal Opioid Withdrawal Syndrome
- Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Unlike opioid withdrawal syndrome in adults, NOWS may be life-threatening if not recognized and treated in the neonate. Healthcare professionals should observe newborns for signs of NOWS and manage accordingly.
- Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.
Risk of Opioid Withdrawal with Abrupt Discontinuation
- Buprenorphine is a partial agonist at the mu-opioid receptor and chronic administration produces physical dependence of the opioid type, characterized by withdrawal signs and symptoms upon abrupt discontinuation or rapid taper. The withdrawal syndrome is typically milder than seen with full agonists and may be delayed in onset. When discontinuing BUNAVAIL, gradually taper the dosage.
Risk of Hepatitis, Hepatic Events
- Cases of cytolytic hepatitis and hepatitis with jaundice have been observed in individuals receiving buprenorphine. Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events.
Precipitation of Opioid Withdrawal Signs and Symptoms
- Because it contains naloxone, BUNAVAIL is likely to produce withdrawal signs and symptoms if misused parenterally by individuals dependent on full opioid agonists such as heroin, morphine, or methadone. Because of the partial agonist properties of buprenorphine, BUNAVAIL may precipitate opioid withdrawal signs and symptoms in such persons if administered buccally before the agonist effects of the opioid have subsided.
Risks of Overdose in Opioid Naïve Patients
- There have been reported deaths of opioid naïve individuals who received a buprenorphine dose smaller than the lowest strength of BUNAVAIL. BUNAVAIL is not appropriate as an analgesic.
- Adverse events commonly observed with buccal administration of BUNAVAIL are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.
This is not a complete list of potential adverse events associated with BUNAVAIL.
To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences International at 1-800-469-0261 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
- Lactation: Buprenorphine passes into mother’s milk.
- Geriatric Patients: Monitor for sedation and respiratory depression.
- Moderate to Severe Hepatic Impairment: Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.
Intended for healthcare professionals of the United States of America only.