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COMMON QUESTIONS ABOUT BUNAVAIL A B O U T B U N AVA I L 2 BUNAVAIL.COM Q HOW IS BUNAVAIL DIFFERENT FROM OTHER BUPRENORPHINE MEDICATIONS LIKE SUBOXONE®? A: B UNAVAIL contains buprenorphine, the same medicine found in other medications designed for the treatment of opioid dependence. Unlike some medications you may take, BUNAVAIL does not go under your tongue. It is the only medication that uses special film technology to stick to the inside of your cheek to deliver buprenorphine. It’s discreet so no one knows you’re taking it and you can speak and swallow normally as it dissolves. The unique technology in BUNAVAIL includes a backing layer, which helps to direct medication into your bloodstream and stop it from flowing back into your mouth where you might swallow it. In fact, with BUNAVAIL, you get the same amount of medication as you do with Suboxone but from a smaller total dose.* *Relative bioavailability determined with Suboxone tablets. INDICATION BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) is a prescription medicine indicated for the maintenance treatment of opioid dependence. BUNAVAIL should be used as part of a complete treatment plan to include counseling and psychosocial support. Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA). A B O U T B U N AVA I L Q WHAT IS A BUCCAL FILM? A: B UNAVAIL is called a buccal film because it adheres to the buccal mucosa. ‘Buccal mucosa’ is a scientific term for the surface of your cheek inside your mouth. So, rather than holding BUNAVAIL under your tongue, it sticks to the inside of your cheek. BUNAVAIL buccal film is made of two layers: the top layer and the backing layer. The top layer contains the dose of buprenorphine. It sticks against the cheek and begins to deliver medication right away. The backing layer helps to direct the flow of buprenorphine into your bloodstream and stops some of it from flowing back into your mouth where you might swallow it. BUNAVAIL buccal film Top layer BN4 Backing layer The two layers in the BUNAVAIL buccal film allow for a more efficient delivery of medication. In the end, you get the same effect as you do from Suboxone® from half the amount of buprenorphine. As the film dissolves, it will remain fixed to your cheek so you can speak and swallow normally. 4 BUNAVAIL.COM Q THE DOSES OF BUNAVAIL ARE LESS THAN WHAT I’M USED TO GETTING. DOES THAT MEAN I’M GETTING LESS MEDICATION? A: B UNAVAIL has about half the overall dose of Suboxone because its unique route of administration and two-layer design allows it to deliver buprenorphine more efficiently. The same amount of buprenorphine gets into your bloodstream through your cheek and less flows back into the mouth where it could be swallowed. As a result, BUNAVAIL can have a lower dose while giving you the same amount of buprenorphine as Suboxone.* *Relative bioavailability determined with Suboxone tablets. Please see Important Safety Information, and full Prescribing Information and Medication Guide at BUNAVAIL.com. 5 TA K I N G B U N AVA I L Q WHICH SIDE OF THE FILM SHOULD I PLACE AGAINST MY CHEEK? A: The side with the dose strength, eg, BN4, printed on it should be placed against your cheek. This side is designed to stick to your cheek when it comes into contact with moisture and deliver buprenorphine as it dissolves. If you place the wrong side of the film against your cheek, BUNAVAIL will not stick. 6 BUNAVAIL.COM Q WHAT SHOULD I DO IF I CAN’T GET BUNAVAIL TO STICK TO MY CHEEK, OR IT STICKS TO MY TEETH OR FOLDS OVER ITSELF? A: If you encounter any problems while applying BUNAVAIL, don’t panic. First, readjust the film on your finger and try to reapply the film to the inside of your cheek. If the film won’t adhere, properly dispose of it and try again with a new film. Remember to make sure your mouth is moist. Try not to get frustrated if your first few attempts at applying BUNAVAIL feel awkward. You’ll get used to it with some practice. Try it with the practice films included in your starter kit. Ask your doctor for more practice films if you need them. For more practical advice, watch the How to Take BUNAVAIL video on BUNAVAIL.com. Please see Important Safety Information, and full Prescribing Information and Medication Guide at BUNAVAIL.com. 7 TA K I N G B U N AVA I L 8 BUNAVAIL.COM Q IS MY FILM SUPPOSED TO FEEL GUMMY AFTER IT HAS STARTED TO DISSOLVE? A: Some patients say that BUNAVAIL film feels sticky or gummy as it dissolves. This can be considered normal and is due to the materials in BUNAVAIL that cause it to stick to the inside of the cheek and efficiently deliver buprenorphine into the bloodstream. 9 TA K I N G B U N AVA I L Q HOW LONG DOES BUNAVAIL TAKE TO DISSOLVE? A: BUNAVAIL begins to dissolve as soon as it’s placed against the cheek. The time it takes to dissolve varies by person. You should leave it in your mouth until it is fully dissolved. During this time, you can speak and swallow normally and interact with others without them knowing you’re taking your medication. The BUNAVAIL film is made of two layers, each with a different thickness. The backing layer is thicker than the top layer, and since it’s thicker, it will take more time to dissolve. This design allows the backing layer to stop some of the buprenorphine from flowing back into your mouth where it can be swallowed. 10 BUNAVAIL.COM Q CAN I EAT AND DRINK WHILE TAKING BUNAVAIL? CAN I SMOKE? A: You can speak and swallow normally while taking BUNAVAIL. However, you shouldn’t eat or drink as that may cause the film to come off your cheek before it’s fully dissolved. Do not drink alcohol while using BUNAVAIL, as this can lead to loss of consciousness or even death. There are no restrictions regarding smoking when taking BUNAVAIL. Please see Important Safety Information, and full Prescribing Information and Medication Guide at BUNAVAIL.com. 11 B U N AVA I L A N D Y O U R T R E AT M E N T Q WHERE IS THE RIGHT PLACE TO PUT BUNAVAIL? A: BUNAVAIL should be applied comfortably to the middle of the inside of your cheek. Once BUNAVAIL adheres, try not to play with it with your tongue as this can cause it to move. As you continue to apply BUNAVAIL, you’ll find a spot that works best for you. If you are applying more than one film at a time, make sure you put them on opposite cheeks. 12 BUNAVAIL.COM Q HOW LONG DO I HAVE TO TAKE BUNAVAIL? A: BUNAVAIL is a maintenance medication. That means it should be taken on a regular basis for the treatment of opioid dependence. Work with your doctor on coming up with a treatment plan that’s right for you. Make sure you take BUNAVAIL as prescribed by your doctor. Q WHAT SHOULD I DO IF I STILL HAVE CRAVINGS OR THINK I MAY BE EXPERIENCING WITHDRAWAL SYMPTOMS? A: Continue to take your medication as prescribed and call your doctor to discuss your symptoms. Please see Important Safety Information, and full Prescribing Information and Medication Guide at BUNAVAIL.com. 13 B U N AVA I L A N D Y O U R T R E AT M E N T Q IS A FILM ON MY CHEEK GOING TO IRRITATE MY MOUTH? A: In a scientific study, 249 people who took Suboxone switched to BUNAVAIL for 12 weeks. Before they switched to BUNAVAIL, up to 6.8% of people had oral abnormalities over 2 examinations. During the 12 weeks of the study, researchers conducted more than 1000 examinations of people’s mouths. They found that 2.4% of people had an oral abnormality but no abnormalities were seen in the last 4 weeks of the study. If you do have any side effects, call your doctor right away. 14 BUNAVAIL.COM Q ARE THERE ANY PROGRAMS TO HELP ME PAY FOR MY MEDICATION? A: The BUNAVAIL Savings Program is available to help eligible patients pay for their medication. Whether you have commercial insurance or are paying cash for your medication, the BUNAVAIL Savings Program can help reduce the cost of your medication. Visit BunavailSavingsCard.com for more information and to print a card. Please see Important Safety Information, and full Prescribing Information and Medication Guide at BUNAVAIL.com. 15 INDICATION BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) is a prescription medicine indicated for the maintenance treatment of opioid dependence. BUNAVAIL should be used as part of a complete treatment plan to include counseling and psychosocial support. Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA). IMPORTANT SAFETY INFORMATION Keep BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) out of the sight and reach of children. Ingestion of BUNAVAIL by a child may cause severe breathing problems and death. If a child takes BUNAVAIL, get emergency help right away. Do not take BUNAVAIL if you are allergic to buprenorphine or naloxone, as serious negative effects including anaphylactic shock, have been reported. Do not take BUNAVAIL before the effects of other opioids (e.g., heroin, methadone, oxycodone, morphine) have lessened as you may experience withdrawal symptoms. Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how BUNAVAIL affects you. BUNAVAIL contains buprenorphine, an opioid that can cause physical dependence. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking BUNAVAIL without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine. 16 BUNAVAIL.COM Do not switch from BUNAVAIL to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of BUNAVAIL is not the same as the amount of buprenorphine in other medicines. Your doctor will prescribe a dose of BUNAVAIL that may be different than other buprenorphine-containing medicines you may have been taking. BUNAVAIL can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines, sedatives, tranquilizers or alcohol. You should not drink alcohol while taking BUNAVAIL, as this can lead to loss of consciousness or even death. Like other opioids (e.g., heroin, methadone, oxycodone, morphine), BUNAVAIL may produce orthostatic hypotension (‘dizzy spells’) in ambulatory individuals. Common side effects of BUNAVAIL include headache, drug withdrawal syndrome, lethargy (lack of energy), sweating, constipation, decrease in sleep (insomnia), fatigue and sleepiness. Because BUNAVAIL contains naloxone, injecting BUNAVAIL may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings. BUNAVAIL can be abused in a manner similar to other opioids, legal or illicit. Keep BUNAVAIL in a safe place. Do not give your BUNAVAIL to other people, it can cause them harm or even death. Selling or giving away this medicine is against the law. BUNAVAIL is not recommended in patients with severe hepatic impairment. BUNAVAIL may be used with caution for maintenance treatment in patients with moderate hepatic impairment. Before taking BUNAVAIL, tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking BUNAVAIL, tell your doctor immediately as there may be significant risks to you and your baby; your baby may have symptoms of withdrawal at birth. Before taking BUNAVAIL, talk to your doctor if you are breast-feeding or plan to breast-feed your baby. BUNAVAIL can pass into your breast milk and may harm your baby. Monitor your baby for increased sleepiness and breathing problems. Your doctor should tell you about the best way to feed your baby if you are taking BUNAVAIL. This is not a complete list of potential adverse events associated with BUNAVAIL buccal film. Please see full Prescribing Information for a complete list. To report negative side effects associated with taking BUNAVAIL buccal film, please call 1-800-469-0261. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For more information, please see full Prescribing Information and Medication Guide for BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) at www.BUNAVAIL.com. 17 For more information on using BUNAVAIL correctly, watch the How to Take BUNAVAIL video at bunavail.com. The information provided here is intended only for residents of the United States. BUNAVAIL® is a registered trademark of BioDelivery Sciences International, Inc. The BUNAVAIL and buccal film logos and BioDelivery Sciences logo are trademarks owned by BioDelivery Sciences International, Inc. All other trademarks and trade names are the property of their respective owners. © 2016 BioDelivery Sciences International, Inc. All rights reserved. 01/16 BUN-0099.1