Bunavail

Bunavail is a prescription medication used for the treatment of opioid addiction or dependence. Bunavail buccal films contain buprenorphine and naloxone. Buprenorphine is an opioid medication, sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Bunavail buccal films were a film designed to be applied to the inside of the cheek (buccal mucosa) as a single oral daily dose. The Bunavail brand name has been discontinued, but generic buprenorphine and naloxone sublingual films are still available.

This medicine should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Bunavail is not for use as a pain medication.

Use Bunavail buccal films exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. This medicine is not for occasional or "as needed" use. Never use Bunavail in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share Bunavail with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away Bunavail is against the law.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Rinse your mouth with water after the Bunavail film dissolves. Wait one hour after the medicine dissolves to brush your teeth to prevent damage to the teeth and gums. You should receive regular dental checkups while using Bunavail.

If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.

Do not stop using Bunavail suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

You will need frequent blood tests to check your liver function.

All your medical care providers should know that you are being treated for opioid addiction, and that you take Bunavail. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.

Take the entire dose as directed. Do not cut, chew, or swallow the film or tablet, because the medicine will not work as well. Never crush or break a pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Store Bunavail films in the foil pouch at room temperature, away from moisture and heat. Discard an empty pouch in a place children and pets cannot get to. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using Bunavail accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused films from the foil pack and flush the films down the toilet. Throw the empty foil pack into the trash.

• 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.
• Respiratory Depression: MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. 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
• 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.
• Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patients off of the opioid.
• Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately.
• Risk of Hepatitis; Hepatic Events: Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events.
• Precipitation of Opioid Withdrawal Signs and Symptoms: An opioid withdrawal syndrome is likely to occur with parenteral misuse of Bunavail by individuals physically dependent on full opioid agonists or by buccal administration before the agonist effects of other opioids have subsided.
• Risk of Overdose in Opioid-Naïve Patients: Bunavail is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a buprenorphine dose smaller than the lowest available Bunavail strength.

You should not use Bunavail if you are allergic to buprenorphine or naloxone (Narcan).

To make sure Bunavail is safe for you, tell your doctor if you have ever had:

• tooth problems, including a history of cavities;
• breathing problems, sleep apnea;
• enlarged prostate, urination problems;
• liver or kidney disease;
• abnormal curvature of the spine that affects breathing;
• problems with your gallbladder, adrenal gland, or thyroid;
• a head injury, brain tumor, seizures, or mental health problems; or
• alcoholism or drug addiction.

Pregnancy

If you use Bunavail while you are pregnant, your baby could become dependent on this medicine. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Breastfeeding

Bunavail can pass into your breast milk and harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Bunavail. Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with this medicine.

Get emergency medical help if you have signs of an allergic reaction to Bunavail: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once or seek emergency medical attention if you have:

• any problems with your teeth or gums;
• weak or shallow breathing, breathing that stops during sleep;
• a light-headed feeling, like you might pass out;
• confusion, loss of coordination, extreme weakness;
• blurred vision, slurred speech;
• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;
• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.

Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Bunavail side effects may include:

• dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;
• withdrawal symptoms;
• tongue pain, redness or numbness inside your mouth;
• nausea, vomiting, constipation;
• headache, back pain;
• fast or pounding heartbeats, increased sweating; or
• sleep problems (insomnia).
• This medicine may affect fertility (ability to have children) in both men and women. Tell your doctor if this is a concern for you.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Opiate Dependence: Buprenorphine monotherapy is generally used for induction. Bunavail may be used for induction in patients dependent on heroin or short-acting opioid products. Note - one Bunavail 4.2 mg/0.7 mg buccal film provides the equivalent buprenorphine exposure to one Suboxone 8 mg/2 mg sublingual tablet.

INDUCTION dose: Day 1: Initial dose: 2.1 mg/0.3 mg buccally; followed in intervals of approximately 2 hours with additional doses to a total dose of 4.2 mg/0.7 mg to control acute withdrawal symptomsDay 2: a single dose up to 8.4 mg/1.4 mg buccally.

MAINTENANCE Treatment: Doses should be adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms; doses should be titrated to clinical effectiveness as rapidly as possible as gradual titration may lead to higher drop-out rates.-Progressively adjust in increments/decrements of 2.1 mg/0.3 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.-Recommended target dose: 8.4 mg/1.4 mg buccally once a day; range 2.1 mg/0.3 mg to 12.6 mg/2.1 mgMaximum dose: 12.6 mg/ 2.1 mg buccally once a day.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Talk to your healthcare provider about naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose, including accidental use of BUNAVAIL by a child. If naloxone is given, you must call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how Bunavail will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids - opioid pain medicine or prescription cough medicine;
• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;
• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, gabapentinoids (such as gabapentin or pregabalin), medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with buprenorphine and naloxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

There are alternative drugs and different dosage forms available to treat opioid use disorder.

Talk with your healthcare provider which option would be best suited to you.

Buprenorphine

• IM injection (Sublocade), Implant (Probuphine), Sublingual (Subutex)

Buprenorphine and naloxone

• Sublingual (Suboxone, Zubsolv)

Lofexidine

• Tablets (Lucemyra)

Methadone

• Tablets (Dolophine)

Naltrexone

• IM injection (Vivitrol), Naltrexone tablets

For opioid overdose in an emergency situation:

Naloxone

• Nasal spray (Narcan, Kloxxado). Naloxone injection

Other related medicines:

Buprenorphine for severe pain:

• IM injection (Buprenex), Sublingual (Belbuca), Transdermal patch (Butrans)