Belbuca

Belbuca is a prescription medication used to relieve severe pain that requires daily, around-the-clock, long-term opioid treatment. It is used when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines are not effective or cannot be tolerated.

Belbuca belongs to a group of drugs called opioid partial agonist-antagonists, which help to relieve pain by binding to certain opioid receptors in the body. 

This medication is available as a film that is applied to the buccal mucosa (the inside lining of the cheek) once or twice a day. Avoid eating or drinking until the film has completely dissolved, usually within 30 minutes.

Common side effects of Belbuca include nausea, constipation, and headache. 

Belbuca is a prescription medication used to relieve severe pain that requires daily, around-the-clock, long-term opioid treatment. It is used for those patients which other treatment options did not provide pain relief. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Endo Pharmaceuticals, Inc.

Belbuca can cause serious side effects. See “Belbuca Precautions.”

The most common side effects of Belbuca include:

• nausea
• constipation 
• headache
• vomiting
• fatigue
• dizziness
• somnolence
• diarrhea
• dry mouth
• upper respiratory tract infection

Constipation (incomplete or hard bowel movements) is a very common side effect of all opioid medicines. Talk to your doctor about the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while using Belbuca.

Talk to your doctor about any side effect that bother you or do not go away.

These are not all the possible side effects of Belbuca. For a complete list, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with Belbuca. Sometimes, the doses of certain medicines and Belbuca need to be changed if used together.

Especially tell your doctor if you take:

• other pain medicines
• antidepressant medicines
• sleeping pills
• antihistamines
• anti-anxiety medicines
• antiretrovirals
• antifungals
• muscle relaxants
• anti-nausea medicines
• sedative or tranquilizer medicines (medicines that make you sleepy)
• a medicine for abnormal heartbeats

Ask your doctor if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist. Your doctor will tell you if it is safe to take other medicines while you are using Belbuca.

While using Belbuca DO NOT:

• Drive or operate heavy machinery, until you know how Belbuca affects you.  Belbuca can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Belbuca may cause you to overdose and die.

Belbuca is a long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, or you are feeling faint.

Do not use Belbuca if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

Grapefruit and grapefruit juice may interact with Belbuca and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before applying Belbuca, tell your healthcare provider if you have a history of:

• head injury, seizures
• heart rhythm problems (long QT syndrome)
• liver, kidney, thyroid problems
• pancreas or gallbladder problems
• problems urinating
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of Belbuca during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Not recommended during treatment with Belbuca. It may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Belbuca with certain other medicines can cause serious side effects and could lead to death.

Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking or using Belbuca call your doctor. If you use Belbuca regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth.

Tell your doctor if you are breastfeeding or plan to breastfeed. The active ingredient in Belbuca, buprenorphine, has been detected in breast milk. Because of the potential for serious adverse effects in the nursing infant, breastfeeding is not recommended during treatment with Belbuca.

Use Belbuca buccal film as follows:

1. Use your tongue to wet the inside of your cheek or rinse your mouth with water to moisten the area in your mouth before you place Belbuca.
2. Hold the Belbuca buccal film with clean, dry fingers with the yellow side facing up 
3. Using a finger, place the yellow side of the Belbuca buccal film against the inside of your moistened cheek. Press and hold the Belbuca buccal film in place for 5 seconds and then take your finger away 
4. The Belbuca buccal film will stick to the inside of your cheek
5. Leave the Belbuca buccal film in place until it has completely dissolved, usually within 30 minutes after you apply it.
   • Avoid eating food or drinking liquids until Belbuca buccal film has dissolved.
   • Avoid touching or moving Belbuca buccal film with your tongue or finger after it is in place. 
   • Do not chew or swallow Belbuca.

While using Belbuca:

• Do not change your dose. Apply Belbuca exactly as prescribed by your healthcare provider.
• Do not apply Belbuca if the package seal is broken or the film is cut, damaged, or changed in any way.
• After the film has adhered to your cheek, avoid eating or drinking until the film has completely dissolved, usually within 30 minutes.
• Avoid touching or moving the buccal film with your tongue or fingers.
• Call your healthcare provider if the dose you are using does not control your pain.
• Do not stop using Belbuca without talking to your healthcare provider.
• After you stop using Belbuca, remove any unused film from the foil pack and flush down the toilet. Throw the empty foil packaging in the trash.

Take Belbuca exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Belbuca dose your doctor recommends will be based on the following: 

• the condition being treated and the severity of your pain
• other medical conditions you have
• other medications you are taking or have taken for pain
• how you respond to this medication

The recommended starting dose for a patient that has not been taking opioid medications is one 75 mcg film once daily or, if tolerated, every 12 hours for at least 4 days, then increase dose to 150 mcg every 12 hours. The dose may be gradually increased to a dose that provides adequate pain relief and minimizes adverse reactions should proceed in increments of 150 mcg every 12 hours, no more frequently than every 4 days.

The maximum Belbuca dose is 900 mcg every 12 hours. 

Get emergency help right away if you take too much Belbuca (overdose). When you first start taking Belbuca, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.

Never give anyone else your Belbuca. They could die from taking it.

Store Belbuca away from children and in a safe place to prevent stealing or abuse. Selling or giving away Belbuca is against the law.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; AND NEONATAL OPIOID WITHDRAWAL SYNDROME

Addiction, Abuse, and Misuse

BELBUCA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing BELBUCA, and monitor patients regularly for the development of these behaviors or conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA. Monitor for respiratory depression, especially during initiation of BELBUCA or following a dose increase. Misuse or abuse of BELBUCA by chewing, swallowing, snorting or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death.

Accidental Exposure

Accidental exposure to even one dose of BELBUCA, especially in children, can result in a fatal overdose of buprenorphine.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of BELBUCA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.