Description
Buprenorphine buccal film is used to relieve pain severe enough to require daily, around-the-clock, long-term opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. This medicine is not used for minor pain or pain that only sometimes occurs. It should not be used to treat pain that you only have once in a while or "as needed". Buprenorphine acts on the central nervous system (CNS) to relieve pain.
Buprenorphine sublingual tablet is used to treat opioid use disorder. When an opioid medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if the opioid is stopped suddenly. Severe withdrawal side effects can usually be prevented when a person is switched to buprenorphine. It acts on the central nervous system (CNS) to help prevent withdrawal side effects.
When buprenorphine buccal film is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using opioids to relieve their pain. Mental dependence is not likely to occur when opioids are used for this purpose under the close supervision of medical providers. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
Subutex® is available only with your healthcare provider's prescription. Belbuca® is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.
This product is available in the following dosage forms:
- Film
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart or lung problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine in order to avoid potentially serious side effects.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Naltrexone
- Pimozide
- Piperaquine
- Posaconazole
- Safinamide
- Samidorphan
- Saquinavir
- Sparfloxacin
- Terfenadine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acecainide
- Acepromazine
- Aclidinium
- Adagrasib
- Alfentanil
- Alfuzosin
- Almotriptan
- Alprazolam
- Amantadine
- Amiloride
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anagrelide
- Anileridine
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atropine
- Avacopan
- Azithromycin
- Baclofen
- Bedaquiline
- Belladonna
- Bemetizide
- Bendroflumethiazide
- Benperidol
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison disease (adrenal gland problem) or
- Alcohol use disorder, or history of or
- Brain problems (eg, tumor, increased intracranial pressure), history of or
- Breathing problems, severe (eg, hypercapnia, hypoxia, sleep apnea) or
- Chronic obstructive pulmonary disease (COPD) or
- Cor pulmonale (serious heart condition) or
- Drug dependence, especially with opioids, or history of or
- Enlarged prostate (eg, BPH, prostatic hypertrophy) or
- Gallbladder disease or gallstones or
- Head injury, history of or
- Heart disease (eg, angina, congestive heart failure) or
- Heart rhythm problems (eg, atrial fibrillation, slow heartbeat, long QT syndrome) or
- Hepatitis B or C, history of or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood), severe or
- Hypothyroidism (an underactive thyroid) or
- Hypovolemia (low blood volume) or
- Kyphoscoliosis (curvature of the spine with breathing problems) or
- Problems with passing urine—Use with caution. May increase risk for more serious side effects.
- Asthma, acute or severe or
- Respiratory depression (very slow breathing) or
- Stomach or bowel blockage (including paralytic ileus)—Belbuca® should not be used in patients with these conditions.
- Constipation or
- Hypotension (low blood pressure) or
- Pancreatitis (inflammation of the pancreas), history of or
- Seizures, history of—Use with caution. May make these conditions worse.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Mucositis (mouth sores or ulcers)—Use with caution. The effects of the Belbuca® film may be increased because of more drug being absorbed.
Proper Use
Take this medicine exactly as directed by your healthcare provider. Do not take more of it, do not take it more often, and do not take it for a longer time than your provider ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).
It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent opioid use disorder. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your healthcare provider if you have any questions.
To use the buccal film:
- Be careful not to cut or damage the film when opening the package.
- Do not place the medicine on areas of the mouth with sores or lesions.
- Use your tongue to wet the inside of your cheek or rinse your mouth with water before placing the film in your mouth.
- Place the yellow side of the film against the inside of your cheek.
- Press against the film and hold it there with clean, dry fingers for 5 seconds.
- Leave the film in place until it dissolves and do not touch or move it. Do not chew or swallow the film.
- Do not eat or drink anything until the film is completely dissolved, which is usually within 30 minutes.
- Rinse your mouth with water and swallow. Wait for at least one hour before brushing your teeth.
To use the sublingual tablet:
- Do not cut, crush, chew, or swallow it.
- Place the tablet under the tongue until it is dissolved.
- If you take more than 2 tablets at a time, place all of the tablets in different places under the tongue at the same time.
- If you cannot fit more than 2 tablets under your tongue comfortably, place 2 at a time until you have taken all of the medicine.
- Do not eat or drink anything until the tablets are completely dissolved.
- Take a sip of water, swish gently swish around your mouth, and swallow. Wait at least one hour before brushing your teeth.
Use only the brand of this medicine that your healthcare provider prescribed. Different brands may not work the same way.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For buccal dosage form (film):
- For severe pain:
- Adults—At first, 75 micrograms (mcg) as a single dose once a day or every 12 hours for at least 4 days. Your healthcare provider may adjust your dose as needed. However, the dose is usually not more than 900 mcg every 12 hours.
- Children—Use and dose must be determined by your provider.
- For severe pain:
- For sublingual dosage form (tablets):
- For treatment of opioid use disorder:
- Adults—4 to 24 milligrams (mg) once a day taken as a single dose. Your healthcare provider may adjust your dose as needed.
- Children—Use and dose must be determined by your provider.
- For treatment of opioid use disorder:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Drop off any unused tablets or buccal films at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
Precautions
It is very important that your healthcare provider check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your provider to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
It is against the law and dangerous for anyone else to use your medicine. Keep your unused tablets and buccal films in a safe and secure place. People who are addicted to drugs might want to steal this medicine.
Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
Using too much buprenorphine may cause an overdose. Symptoms of overdose include: change in consciousness, chest pain, cold and clammy skin, increased sweating coughing that sometimes produces a pink frothy sputum, difficult or trouble breathing, increased sweating, irregular, fast or slow, or shallow breathing, loss of consciousness, pale or blue lips, fingernails, or skin, sleepiness or unusual drowsiness, or swelling in legs and ankles. Your healthcare provider may give you naloxone to treat an overdose.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your healthcare provider may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
This medicine may cause serious tooth problems. Tell your dentist right away if you have cavities, tooth decay, tooth pain, tooth infection, tooth erosion, tooth fracture, or tooth loss.
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the healthcare provider or dentist that you are using this medicine. Serious unwanted effects can occur if certain medicines are given together with buprenorphine.
This medicine will add to the effects of central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, benzodiazepines, tranquilizers, or sleeping medicine, other prescription pain medicine or opioids, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Check with your healthcare provider or dentist before taking any of the medicines listed above while you are using this medicine.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help.
This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your healthcare provider right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Call your healthcare provider right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
Check with your healthcare provider right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of adrenal gland problem.
Contact your healthcare provider right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your provider knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
Belbuca® may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your healthcare provider for instructions.
Using opioids for a long time can cause severe constipation. To prevent this, your healthcare provider may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking first with your healthcare provider. Your provider may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.
Tell your healthcare provider right away if you think you are pregnant or if you plan to become pregnant while using this medicine. Do not suddenly stop using this medicine without first talking to your provider. This medicine may cause serious unwanted effects in your newborn baby, including neonatal opioid withdrawal syndrome.
For nursing mothers taking Belbuca®:
- Do not suddenly stop using this medicine without first talking to your healthcare provider. Talk to your provider if you have any questions about how this medicine may affect your baby.
- Call your provider if you become extremely tired and have difficulty caring for your baby.
- Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
- Check with your provider or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of opioid poisoning and need immediate medical attention.
Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your healthcare provider before using this medicine if you plan to have children.
Check with your healthcare provider right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Check with your healthcare provider right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Do not take other medicines unless they have been discussed with your healthcare provider. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred vision
- chest tightness
- cough producing mucus
- diarrhea
- difficult, burning, or painful urination
- difficulty breathing
- dizziness
- fever
- frequent urge to urinate
- headache
- loss of appetite
- lower back or side pain
- mouth or throat pain
- nausea
- nervousness
- pale skin
- pounding in the ears
- rapid weight gain
- slow or fast heartbeat
- stomach pain
- tingling of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Rare
- Breakdown or tearing of the skin
- chills
- irregular heartbeat, recurrent
- irritation, itching, pain, redness, swelling, tenderness, or warmth on the skin
- unusual drowsiness, dullness, or feeling of sluggishness
Incidence not known
- Agitation
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- blurred vision
- confusion
- cough
- darkening of the skin
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- headache, severe and throbbing
- hives, skin rash
- increased sensitivity to pain
- irregular, fast, slow, or shallow breathing
- mental depression
- overactive reflexes
- pale or blue lips, fingernails, or skin
- pinpoint pupils
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- relaxed and calm feeling
- restlessness
- shivering
- sleepiness
- talking or acting with excitement you cannot control
- toothache
- trembling or shaking
- twitching
- vomiting
- worsening of pain
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Change in consciousness
- chest pain
- cold and clammy skin
- increased sweating
- coughing that sometimes produces a pink frothy sputum
- difficult or trouble breathing
- increased sweating
- irregular, fast or slow, or shallow breathing
- loss of consciousness
- pale or blue lips, fingernails, or skin
- sleepiness or unusual drowsiness
- swelling in legs and ankles
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- chills
- cough
- difficulty having a bowel movement
- hoarseness
- painful or difficult urination
- runny nose
- sneezing
- stuffy nose
- trouble sleeping
Less common
- Anxiety
- back pain
- bruise
- decreased appetite
- fall
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- itching, skin rash
- muscle aches or spams
- pain or tenderness around eyes and cheekbones
- sore throat
Rare
- Lack or loss of strength
- muscle or bone pain
- neck pain
- stomach discomfort
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
