Butrans is a transdermal system that delivers the active ingredient buprenorphine, a mu opioid partial agonist analgesic, continuously through the skin for 7 days. It comes in different strengths of 5, 7.5, 10, 15, and 20 mcg/hour and is applied directly to the skin. Inactive ingredients include levulinic acid, oleyl oleate, povidone, and polyacrylate cross-linked with aluminum.

How should I use this medication?

This medication is for external use only. Apply the patch to your skin. Select a clean, dry area of skin on your upper outer arm, upper chest, upper back, or the side of the chest. The upper back is a good spot to put the patch on people who are confused because it will be hard for them to remove the patch. Do not apply the patch to oily, broken, burned, cut, or irritated skin. Use only water to clean the area. Do not use soap or alcohol to clean the skin because this can increase the effects of the medication. If the area is hairy, clip the hair with scissors, but do not shave. Do not cut or damage the patch. A cut or damaged patch can be very dangerous because you may get too much medication. Take the patch out of its wrapper, and take off the protective strip over the sticky part. Do not use a patch if the packaging or backing is damaged. Do not touch the sticky part with your fingers. Press the sticky surface to the skin using the palm of your hand. Press the patch to the skin for 15 seconds. Wash your hands at once with soap and water. Keep patches far away from children. Do not let children see you apply the patch and do not apply it where children can see it. Do not call the patch a sticker, tattoo, or bandage, as this could encourage the child to mimic your actions. Used patches still contain medication. Children or pets can have serious side effects or die from putting used patches in their mouth or on their bodies. Take off the old patch before putting on a new patch. Apply each new patch to a different area of skin. If a patch comes off or causes irritation, remove it and apply a new patch to different site. If the edges of the patch start to loosen, apply first aid tape to the edges of the patch. If problems with the patch not sticking continue, cover the patch with a see-through adhesive dressing (like Bioclusive or Tegaderm). Never cover the patch with any other bandage or tape. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

Where should I keep my medication?

Keep this medication out of reach of children and pets. Store it out of sight in a safe place. Do not share it with others. Misuse of this medication is dangerous and against the law. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original packaging until you are ready to take it. Get rid of any unused medication after the expiration date. This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. To get rid of this medication: -Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location. -Follow the steps given to you by your pharmacy. You may be given a pre-paid mail-back envelope or disposal product to safely get rid of your medication. -If other options are not available, flush the medication down the toilet.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake -Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness -Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Constipation -Dizziness -Drowsiness -Dry mouth -Headache -Irritation at application site -Nausea -Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Brain tumor -Frequently drink alcohol -Gallbladder disease -Head injury -Heart disease -Irregular heartbeat or rhythm -Liver disease -Low adrenal gland function -Lung or breathing disease, such as asthma or COPD -Pancreatic disease -Seizures -Sleep apnea -Stomach or intestine problems -Substance use disorder -Taken an MAOI, such as Marplan, Nardil, or Parnate in the last 14 days -An unusual or allergic reaction to buprenorphine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Cisapride -Dronedarone -Pimozide -Safinamide -Samidorphan -Thioridazine This medication may also interact with the following: -Alcohol -Antihistamines for allergy, cough, and cold -Atropine -Benzodiazepines, such as alprazolam, diazepam, or lorazepam -Certain antibiotics, such as clarithromycin, erythromycin -Certain antivirals for hepatitis or HIV -Certain medications for bladder problems, such as oxybutynin or tolterodine -Certain medications for depression or mental health conditions -Certain medications for fungal infections, such as fluconazole, ketoconazole, posaconazole -Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan -Certain medications for nausea or vomiting like dolasetron, ondansetron, palonosetron -Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin -Certain medications for stomach problems, such as dicyclomine or hyoscyamine -Certain medications for travel sickness, such as scopolamine -Certain medications for Parkinson disease, such as benztropine or trihexyphenidyl -Ipratropium -Linezolid -MAOIs, such as Marplan, Nardil, and Parnate -Medications that cause drowsiness before a procedure, such as propofol -Medications that help you fall asleep -Medications that relax muscles -Methylene blue (injected into a vein) -Other medications that cause heart rhythm changes -Opioid medications for pain or cough -Phenothiazines, such as chlorpromazine, prochlorperazine -Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take this medication for a long time. Taking this medication with other substances that cause drowsiness, such as alcohol, benzodiazepines, or other opioids can cause serious side effects. Give your care team a list of all medications you use. They will tell you how much medication to take. Do not take more medication than directed. Call emergency services if you have problems breathing or staying awake. Long term use of this medication may cause your brain and body to depend on it. This can happen even when used as directed by your care team. You and your care team will work together to determine how long you will need to take this medication. If your care team wants you to stop this medication, the dose will be slowly lowered over time to reduce the risk of side effects. Naloxone is an emergency medication used for an opioid overdose. An overdose can happen if you take too much of an opioid. It can also happen if an opioid is taken with some other medications or substances such as alcohol. Know the symptoms of an overdose, such as trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where your naloxone is stored. Make sure they know how to use it. After naloxone is given, the person giving it must call emergency services. Naloxone is a temporary treatment. Repeat doses may be needed. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. This patch is sensitive to body heat changes. If your skin gets too hot, more medication will come out of the patch and can cause an overdose. Call your care team if you get a fever. Do not take hot baths. Do not sunbathe. Do not use hot tubs, saunas, hairdryers, heating pads, electric blankets, heated waterbeds, or tanning lamps. Do not engage in exercise that increases your body temperature. If you are going to need surgery, an MRI, CT scan, or other procedure, tell your care team that you are using this medication. You may need to remove the patch before the procedure. This medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team. Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe. Talk to your care team if you may be pregnant. Prolonged use of this medication during pregnancy can cause temporary withdrawal in a newborn. Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. If you breastfeed while taking this medication, seek medical care right away if you notice the child has slow or noisy breathing, is unusually sleepy or not able to wake up, or is limp. Long-term use of this medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What are the most serious risks of this medication?

Accidental ingestion of even one dose of this medicine, especially by a child, can cause a deadly overdose. Store this medicine away from children and in a safe place. Get emergency help right away if accidental ingestion occurs. Tell your healthcare provider if you are pregnant or trying to get pregnant. If you take this medicine while pregnant, your newborn baby may have withdrawal symptoms that can be life-threatening. Your baby will need special care after delivery. This medicine has a risk of overdose. Get emergency help if you take too much. Never give it to anyone else. They can have a deadly overdose from just 1 dose of this medicine. Store it in a safe place and away from children. This medicine can cause deadly breathing problems. Using this medicine, even when using it as directed, can lead to misuse, abuse, or addiction. Misuse, abuse, or addiction can result in overdose and death.