Butrans

Butrans (buprenorphine) is a prescription transdermal skin patch 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. Buprenorphine is an opioid pain medication; an opioid is sometimes called a narcotic.

Butrans pain-relieving patch is applied to the skin once every 7 days.

Limitations of Use

• Butrans 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, Butrans 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.
• Butrans is not indicated as an as-needed (prn) pain relief.

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

Butrans Boxed Warnings

• Risk of addiction, misuse, and overdose: Butrans 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 Butrans exactly as directed helps lower this risk.
• Accidental exposure can be deadly: Accidental contact with Butrans, especially by children, can cause a fatal overdose.
• Dangerous interactions with other substances: Using Butrans with certain medicines, such as benzodiazepines, 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 Butrans, how to use it safely, and the importance of reading the Medication Guide each time it is prescribed.
• Risks of injection: Buprenorphine injections must only be given by a certified healthcare provider. Serious harm or death can happen if the medicine is self-injected into a vein. Because of this risk, injections are only available through a restricted program.

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: Butrans 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 Butrans and when changing your dose.

Adrenal gland problems (adrenal insufficiency): Butrans 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 Butrans.

Severe low blood pressure (severe hypotension): Butrans 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: Butrans 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.

Severe dental problems: Buprenorphine medicines that dissolve in the mouth (such as films or tablets) can cause severe tooth decay, cavities, and tooth loss. Tell your doctor if you have a history of tooth problems. After the medicine is completely dissolved, rinse your mouth with water and swallow. Wait at least one hour before brushing your teeth, and schedule regular dental checkups.

Esophagus problems: Butrans and other opioids can cause problems with the muscles in your esophagus (the tube that connects your mouth to your stomach). This can lead to difficulty swallowing, heartburn, regurgitation, or chest pain. Tell your doctor if you have any of these symptoms.

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

• breathing problems, sleep apnea;
• a blockage in your stomach or intestines.

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

• any type of breathing problem or lung disease;
• a head injury, brain tumor, or seizures;
• alcoholism, drug addiction, mental illness;
• urination problems;
• liver or kidney disease;
• heart rhythm problems, long QT syndrome; or
• problems with your gallbladder, pancreas, or thyroid.

Pregnancy

If you use Butrans 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.

Breastfeeding

Buprenorphine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby. You should not breast-feed while you are using Butrans.

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 use Butrans 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 Butrans: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. 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.

Stop using Butrans and call your doctor at once if you have:

• weak or shallow breathing, deep sighs, snoring that is new or unusual;
• breathing that stops during sleep;
• chest pain, fast heart rate, seizure (convulsions);
• a light-headed feeling, like you might pass out;
• blisters, swelling, or severe irritation where the patch was worn;
• adrenal gland problems - nausea, vomiting, loss of appetite, dizziness, feeling weak or tired; or
• liver problems - upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
• low blood sugar - headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky.

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.

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 Butrans side effects may include:

• constipation, nausea, vomiting;
• headache, dizziness, drowsiness, tiredness; or
• redness, itching, or rash where the patch was worn.

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

Buprenorphine may be habit-forming, even at regular doses. Never share Butrans 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 the medicine without a prescription. Selling or giving away Butrans is against the law.

The Butrans skin patch is for use only on the skin. Do not allow the medicine to come into contact with your eyes, nose, mouth, or lips.

Keep both used and unused Butrans patches out of the reach of children or pets. Even the amount of buprenorphine in a used skin patch could be fatal to a child or pet who accidentally sucks or chews on the patch. Seek emergency medical attention if this happens.

Use only clear water (not soap or other chemicals) to wash the skin before you apply a patch.

Apply the Butrans patch to clean, dry skin on the chest, back, side, or outer side of your upper arm. Wear the patch around the clock for 7 days. Never wear more than 1 patch at a time unless your doctor has told you to. Remove and replace the patch after 7 days. Apply the new patch to a different skin area on the chest, back, side, or upper arm.

If the sticky side of a skin patch comes into contact with your hands, wash the skin with clear water and seek medical care at once. Do not use a Butrans skin patch if it has been cut or damaged.

Do not wear a skin patch on a part of your body where a child could reach or remove the patch from your skin. Avoid allowing children to watch you put on a skin patch. Never tell a child that the buprenorphine skin patch is a "bandage".

Do not stop using this medicine suddenly or lower your dose too quickly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Butrans.

Store the Butrans skin patches at room temperature. Keep each patch in its foil pouch until you are ready to use it. Keep track of how many skin patches have been used from each new package. Buprenorphine is a drug of abuse, and you should be aware if anyone is using your medicine improperly or without a prescription.

After removing a skin patch, fold it in half firmly with the sticky side in, and flush the patch down the toilet or use the Patch-Disposal Unit provided with this medication. Do not place a used skin patch into a trash can.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, dispose of any unused skin patches in the same folded manner. Do not flush the foil pouch or patch liners; place them in a trash container out of the reach of children and pets.

If you forget to change a patch on your scheduled day, remove the patch and apply a new one as soon as you remember. Do not wear extra patches to make up a missed dose.

Use naloxone or nalmefene to reverse an opioid overdose and 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 the medicine without a prescription. Overdose symptoms may include severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, a weak pulse, very slow breathing, or coma.

See the "Keep an overdose rescue medicine on hand" section above

Buprenorphine can cause death in a child who gets hold of a skin patch and places it in the mouth or on the skin.

Avoid sources of heat while wearing the patch. Tell your doctor if you have a fever. Do not use a heating pad or electric blanket, tanning bed, or sauna. Do not sit in hot water, sunbathe, or raise your body temperature with vigorous activity. Heat can increase the amount of drug you absorb through your skin and may cause an overdose or death.

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

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how buprenorphine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications - opioid pain medicine or prescription cough medicine;
• a sedative like Valium - diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;

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• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, tranquilizer, antidepressant, antipsychotic medicine, or gabapentinoids (such as gabapentin or pregabalin); or
• drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of 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.