Bunavail

Opioid Dependence Treatment

Bunavail is used for the maintenance treatment of opioid dependence. It is prescribed to help adults who have developed an addiction to opioid drugs, including illegal substances like heroin and prescription narcotic medications such as oxycodone, hydrocodone, or morphine.

This medication is intended to be used as one component of a comprehensive treatment plan for opioid use disorder. A complete recovery program typically includes:

• Counseling
• Behavioral therapy
• Psychological and social support

Role in Recovery

Bunavail helps individuals stay in treatment by reducing the physical symptoms of opioid withdrawal and decreasing the urge to use other opioids. It contains two active ingredients: buprenorphine, which helps manage cravings and withdrawal, and naloxone, which is included to help discourage misuse of the medication.

The medication is provided as a film that is applied to the inside of the cheek (buccal administration). It is not intended for use as a pain medication.

Mechanism of Action

Bunavail is a combination of buprenorphine and naloxone. Each ingredient plays a specific role in treating opioid dependence:

• Buprenorphine: This is a partial opioid agonist. It works by binding to the same receptors in the brain as other opioids, such as heroin or prescription pain relievers. Because it is only a partial agonist, it produces weaker effects than full opioids, which helps to satisfy cravings and prevent withdrawal symptoms without causing the same level of euphoria.
• Naloxone: This is an opioid antagonist, or blocker. It is included in the medication specifically to discourage misuse. When Bunavail is used correctly by applying it to the inside of the cheek, very little naloxone enters the bloodstream. However, if the medication is crushed, dissolved, and injected, the naloxone will block the effects of opioids and cause immediate, severe withdrawal symptoms.

By occupying the brain's opioid receptors, buprenorphine also makes it harder for other opioids to produce an effect if they are taken while on this medication. This combination helps stabilize the brain chemistry of individuals recovering from addiction.

Common Side Effects

• Headache
• Nausea and vomiting
• Constipation
• Difficulty sleeping (insomnia)
• Increased sweating
• Swelling in the arms or legs
• Mouth irritation, redness, or numbness where the film was applied

Serious Side Effects

Seek medical attention immediately if you experience any of the following serious side effects:

• Breathing problems: Slowed or shallow breathing, extreme drowsiness, or feeling like you might pass out.
• Liver issues: Symptoms such as dark urine, light-colored stools, or yellowing of the skin or eyes (jaundice).
• Dental problems: Buprenorphine-containing medicines that dissolve in the mouth have been linked to tooth decay, cavities, and gum infections.
• Adrenal insufficiency: Nausea, vomiting, loss of appetite, dizziness, and worsening tiredness or weakness.
• Allergic reactions: Severe rash, hives, or swelling of the face, lips, or tongue.
• Withdrawal symptoms: Shaking, sweating, feeling hot or cold, or muscle aches if the medication is stopped suddenly or used incorrectly.

Addiction and Misuse

Bunavail contains buprenorphine, an opioid that can be habit-forming. Misuse or abuse of this medication can lead to overdose and death. It should be stored securely to prevent accidental ingestion, which can be fatal, especially for children.

Respiratory and Central Nervous System Depression

Serious, life-threatening breathing problems may occur, particularly when Bunavail is used with alcohol, benzodiazepines, or other central nervous system depressants. Monitoring for extreme drowsiness or slowed breathing is important.

Dental Health Risks

The use of buprenorphine medicines dissolved in the mouth has been linked to serious dental problems, including tooth decay, cavities, oral infections, and tooth loss. These issues can occur even in patients with no history of dental problems.

Liver Function

There is a risk of liver injury or hepatitis while using this medication. Healthcare providers typically monitor liver function through blood tests before and during treatment.

Neonatal Opioid Withdrawal Syndrome

Prolonged use during pregnancy can cause withdrawal symptoms in the newborn, which may be life-threatening if not recognized and treated.

Adrenal Insufficiency

Long-term opioid use may lead to a condition where the adrenal glands do not produce enough cortisol. Symptoms include nausea, vomiting, loss of appetite, and worsening tiredness.

Precipitated Withdrawal

Starting Bunavail while other opioids are still in the system can trigger sudden and severe withdrawal symptoms. Conversely, stopping the medication abruptly after long-term use may also cause withdrawal.

Pregnancy

Taking Bunavail during pregnancy may cause the baby to go through withdrawal after birth, a condition called neonatal opioid withdrawal syndrome. This condition can be serious and may require medical treatment for the infant. Symptoms of withdrawal in a newborn can include:

• Irritability and high-pitched crying
• Tremors or shaking
• Problems with sleeping or feeding
• Vomiting or diarrhea
• Failure to gain weight

If you are pregnant or planning to become pregnant, it is important to talk to your doctor about the risks and benefits of continuing treatment. Stopping medication for opioid use disorder suddenly can lead to a relapse, which also poses risks to the pregnancy.

Breastfeeding

Buprenorphine, one of the active ingredients in Bunavail, passes into breast milk. While breastfeeding is often possible during treatment, the infant should be monitored closely for signs of excessive sleepiness or trouble breathing. Healthcare providers can help determine the safest way to manage treatment while nursing.

Available Forms

Bunavail is available in the following form:

• Buccal film: A thin, rectangular film designed to be placed against the inner lining of the cheek.

This medication is a combination product containing buprenorphine and naloxone. The film is designed to adhere to the moist area inside the mouth, where it dissolves and the medication is absorbed through the mucous membrane.

FDA Approval and Indication

Bunavail was approved by the U.S. Food and Drug Administration (FDA) for the maintenance treatment of opioid dependence. It is indicated for use as part of a comprehensive treatment plan that includes counseling and psychosocial support.

Controlled Substance Status

Because it contains buprenorphine, Bunavail is classified as a Schedule III controlled substance. This designation means the medication has a potential for abuse and may lead to physical or psychological dependence. Due to this status, there are specific federal requirements for how the drug is prescribed, dispensed, and monitored.

Risk Evaluation and Mitigation Strategy (REMS)

Bunavail is part of a shared Risk Evaluation and Mitigation Strategy (REMS) program. This regulatory program is designed to ensure that the benefits of the medication outweigh the risks of accidental overdose, misuse, and abuse. It provides educational materials for healthcare providers and patients to promote safe use.

FDA Safety Communications

The FDA has issued safety communications regarding buprenorphine-containing products. One significant communication urges healthcare providers to exercise caution but generally not to withhold opioid addiction medications from patients taking benzodiazepines or other central nervous system depressants. The FDA determined that the benefits of treating opioid use disorder usually outweigh the risks of respiratory depression associated with combining these medications, provided that treatment is closely monitored.

Withdrawal Symptoms

Because Bunavail contains buprenorphine, an opioid medication, your body may become physically dependent on it over time. If you stop using Bunavail abruptly, you may experience withdrawal symptoms, which can include:

• Nausea, vomiting, or diarrhea
• Muscle aches and cramps
• Anxiety, irritability, or sleep problems
• Sweating, goosebumps, or runny nose

Precipitated Withdrawal

Withdrawal can also occur if you take Bunavail while other opioids are still active in your system. This is known as precipitated withdrawal. To avoid this, your healthcare provider will usually wait until you are experiencing mild to moderate withdrawal symptoms from other opioids before starting your first dose of Bunavail.

Misuse and Withdrawal

Bunavail contains naloxone to help prevent misuse. If the film is dissolved and injected, the naloxone will trigger immediate and severe withdrawal symptoms. When used as directed by placing it on the inside of the cheek, the naloxone is not absorbed in significant amounts and does not interfere with the buprenorphine.

Safe Discontinuation

Do not stop taking Bunavail without consulting your doctor. To minimize withdrawal symptoms, your healthcare provider will likely recommend gradually reducing your dose over time rather than stopping all at once. If you experience severe withdrawal symptoms during a dose reduction, contact your doctor immediately.