Belbuca

Belbuca is a prescription oral film used to treat severe and persistent pain that requires an opioid pain reliever and that cannot be adequately treated with other options, including immediate-release opioid medications. Belbuca buccal films contain buprenorphine, an opioid medication. An opioid is sometimes called a narcotic.

Belbuca buccal films are for around-the-clock treatment of moderate to severe chronic pain that is not controlled by other medicines.

Belbuca is not for use on an as-needed basis for occasional pain.

The Belbuca buccal film is placed between the gum and cheek, where it adheres to the moist buccal mucosa to deliver the medicine as the film dissolves.

Belbuca (buprenorphine) is a schedule III controlled substance.

Limitations of Use

• Belbuca is an opioid analgesic; it carries the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, Therefore, this medicine should only be used in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
• Belbuca is not indicated as an as-needed (prn) pain relief.

Belbuca has a boxed warning for serious and life-threatening risks from using this medicine. A boxed warning is the strongest safety-related warning issued by the FDA.

Belbuca Boxed Warnings

• Risk of addiction, misuse, and overdose: Belbuca use can lead to addiction and abuse, misuse, overdose, or death. Your doctor should check your risk before starting treatment and continue to monitor you during treatment.

• Serious breathing problems: This medicine can cause severe or life-threatening breathing problems, especially when you first start using it or after your dose is increased. Using Belbuca exactly as directed helps lower this risk.

• Accidental exposure can be deadly: Accidental contact with this medicine, especially by children, can cause a fatal overdose.

• Dangerous interactions with other substances: Using Belbuca with certain medicines, such as benzodiazepines, gabapentinoids (gabapentin or pregabalin], opioids, and other drugs that make you sleepy, or alcohol, can cause extreme drowsiness, severe breathing problems, coma, or death. These combinations should only be used when other treatment options are not enough.

• Risk during pregnancy: Using opioids for a long time during pregnancy can cause withdrawal symptoms in a newborn after birth (neonatal opioid withdrawal syndrome). This can be serious and may be life-threatening if not treated quickly. Ensure that management by neonatology experts will be available at delivery.

• Counseling and safe use are important: Healthcare providers should talk with patients and caregivers about the serious risks of this medicine, how to use it safely, and the importance of reading the Medication Guide each time it is prescribed.

Other Warnings

Increased pain sensitivity: In some people, opioid pain medicines can unexpectedly make pain worse or make the body more sensitive to pain. This is called opioid-induced hyperalgesia (OIH). If this happens, your doctor may lower your dose or switch you to a different pain medicine.

Serious breathing problems: Belbuca can cause life-threatening breathing problems, especially in people with long-term lung disease, older adults, or people who are very weak or frail. Your doctor should check you closely when starting this medicine and when changing your dose.

Adrenal gland problems (adrenal insufficiency): Belbuca can rarely affect your adrenal glands, which help your body make important hormones. If this happens, your doctor may treat you with steroid medicine and may slowly stop Belbuca.

Severe low blood pressure (severe hypotension): This medicine can cause blood pressure to drop too low, especially when starting treatment or increasing the dose. It should not be used in people with circulatory shock.

Higher risk in people with certain brain conditions: This medicine can increase the risk of sleepiness and serious breathing problems in people with increased pressure in the brain, brain tumors, head injury, or impaired consciousness. It should not be used in people who are unconscious or in a coma.

You should not use Belbuca if you are allergic to buprenorphine, or if you have:

• severe asthma or trouble breathing, or a blockage in your stomach or intestines.

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

• tooth problems, including a history of cavities;
• breathing problems, sleep apnea;
• kidney or liver disease (especially hepatitis B or C);
• enlarged prostate, urination problems;
• problems with your gallbladder, pancreas, or thyroid;
• a head injury, brain tumor, or seizures;
• drug addiction, methadone use, alcoholism, mental illness;
• mouth sores caused by cancer;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
• long QT syndrome, or if you take heart rhythm medication.

If you use Belbuca while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Buprenorphine can pass into breast milk and may harm a nursing baby and cause drowsiness, breathing problems, or death in a nursing baby. You should not breastfeed while you are using Belbuca.

Belbuca is not approved for use by anyone younger than 18 years old.

Do not use Belbuca if you have:

• Serious breathing problems
• Severe asthma or sudden asthma attacks, especially if you are not being closely watched by medical staff or do not have emergency equipment nearby
• Known or suspected blockage in your stomach or intestines (gastrointestinal obstruction), or a condition where your bowels stop moving normally (paralytic ileus).

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

Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.

A person caring for you should give naloxone and/or 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 if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• slow heartbeat or weak pulse;
• a light-headed feeling, like you might pass out;
• chest pain, fast heart rate, trouble breathing;
• severe constipation;
• opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain;
• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Opioid medicines can cause low blood sugar (hypoglycemia). Tell your doctor if you have symptoms such as headache, hunger, sweating, irritability, dizziness, or feeling shaky, especially if you have diabetes.

Belbuca can cause problems with your esophagus (the tube that connects your mouth to your stomach). Call your doctor if you have difficulty swallowing, food coming back up (regurgitation), or chest pain.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Belbuca side effects may include:

• constipation, nausea, vomiting;
• headache, dizziness, drowsiness;
• increased sweating;
• sleep problems (insomnia); or
• pain anywhere in your body.

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.

Use Belbuca exactly as prescribed by your doctor. Follow all directions on your prescription label. Buprenorphine can slow or stop your breathing. Never use Belbuca in larger amounts, or for longer than prescribed. Tell your doctor if Belbuca seems to stop working as well in relieving your pain.

Buprenorphine may be habit-forming, even at regular doses. Never share Belbuca with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using Belbuca without a prescription. Selling or giving away Belbuca is against the law.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Place the Belbuca film against the inside of your cheek and hold it in place for 5 seconds. Once in place, the film will dissolve completely in about 30 minutes. Avoid touching or moving the buccal film with your tongue or fingers. Rinse your mouth with water after the medicine dissolves. Wait one hour after the film dissolves to brush your teeth to prevent damage to the teeth and gums. Do not chew, swallow, snort, or inject the Belbuca film. This can cause an uncontrolled delivery of the medicine and lead to a fatal overdose.

Do not eat or drink anything until the Belbuca film has completely dissolved in your mouth.

You should receive regular dental checkups while using Belbuca.

While using Belbuca, you may need frequent blood tests to check your liver function.

If you need surgery, tell the surgeon ahead of time that you are using Belbuca.

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

Store at room temperature away from moisture and heat. Keep Belbuca in a place where a child cannot get to it. Keep track of your medicine. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using Belbuca 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.

Since Belbuca is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A buprenorphine overdose can be fatal, especially in a child or other person using Belbuca without a prescription.

Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, severe muscle weakness, pinpoint pupils, weak pulse, very slow breathing, or coma.

Keep an overdose rescue medicine on hand

Talk to your doctor about overdose rescue medicine: Patients and caregivers should learn about medicines that can reverse an opioid overdose, such as naloxone or nalmefene.Keep overdose rescue medicine available: It is important to have access to one of these medicines, especially if you have a higher risk of overdose. This includes people who take other medicines that can cause drowsiness, have a history of opioid use disorder, or have had an opioid overdose before. It is also important if there are children or others in the home who could accidentally use the medicine.Pain treatment should still be considered: Having risk factors for overdose does not mean pain should go untreated. Your doctor can help manage your pain while also taking steps to reduce risk.Know how to get it: Ask your doctor or pharmacist about ways to get an overdose rescue medicine. It may be available by prescription, over the counter, or through a community program.These medicines are not all the same: Overdose rescue medicines can differ in how they are given, how strong they are, who can use them, and how long they last. Your doctor or pharmacist should help you choose the right one and explain how to use it.

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

Avoid applying the buccal film to an area where you have a mouth sore.

Buprenorphine may impair your thinking or reactions. Avoid driving or operating machinery until you know how Belbuca 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 opioid medications - opioid pain medicine or prescription cough medicine;
• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, 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, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.