Buprenorphine Transdermal Patch

IMPORTANT WARNING:

Buprenorphine patches can be habit forming, especially with prolonged use. Use buprenorphine patches exactly as directed. Do not apply more patches, apply the patches more often, or use the patches in a different way than prescribed by your doctor. While using buprenorphine patches, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse buprenorphine if you have or have ever had any of these conditions. Talk to your health care provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Buprenorphine patches may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time that your dose is increased. Your doctor will monitor you carefully during your treatment.Your doctor will adjust your dose carefully to control your pain and decrease the risk that you will experience serious breathing problems. Tell your doctor if you have or have ever had breathing difficulties, asthma, chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), or other lung disease. Your doctor may tell you not to use buprenorphine patches. Also tell your doctor if you have or have ever had a head injury, a brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may also be higher if you are an older adult or are weakened or malnourished due to disease. If you have any of the following symptoms, call your doctor immediately: difficulty breathing, shortness of breath, extreme drowsiness, fainting, or loss of consciousness.

Taking certain medications with buprenorphine patches may increase the risk of serious or life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you use buprenorphine transdermal with other medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Drinking alcohol or using street drugs during your treatment with buprenorphine transdermal also increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.

Buprenorphine patches may cause serious harm or death if used accidentally by a child or by an adult or has not been prescribed the medication. Do not allow anyone else to use your medication. Store buprenorphine patches in a safe place so that no one else can use them accidentally or on purpose. Be especially careful to keep buprenorphine patches out of the reach of children. Keep track of how many patches are left so you will know if any are missing.

Tell your doctor if you are pregnant or plan to become pregnant. If you use buprenorphine patches regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with buprenorphine patches and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using this medication.

WHY is this medicine prescribed?

Buprenorphine patches are used to relieve severe and persistent pain in people who are expected to need an opioid pain medication around the clock for a long time and who cannot be treated with other medications. Buprenorphine patches should not be used to treat mild or moderate pain, short-term pain, or pain that can be controlled by medication that is taken as needed.It is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Transdermal buprenorphine comes as a patch to apply to the skin. The patch is usually applied to the skin once every 7 days. Change your patch at about the same time of day every time you change it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Apply buprenorphine patches exactly as directed.

Your doctor may start you on a low dose buprenorphine patch and gradually increase your dose, not more often than once every 3 days. If this increase involves the use of two patches, remove your current patch and at the same time, place the two new patches next to each other at a new site. If your doctor tells you to use two patches, you should always change and apply them at the same time. Your doctor may decrease your dose if you experience side effects. Contact your doctor if the dose you are taking does not control your pain. Talk to your doctor about how you are feeling during your treatment with buprenorphine patches.

Buprenorphine skin patches are only for use on the skin. Do not place patches in your mouth or chew or swallow the patches.

Do not stop using buprenorphine patches without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop using buprenorphine patches you may have symptoms of withdrawal. Call your doctor if you experience any of these symptoms of withdrawal: restlessness, teary eyes, runny nose, yawning, sweating, chills, hair standing on end, muscle aches, large pupils (black circles in the center of the eyes), irritability, diarrhea, nausea, vomiting, anxiety, pain in the joints, weakness, fast heartbeat, or rapid breathing.

Do not use a buprenorphine patch that is cut, damaged, or changed in any way. If you use cut or damaged patches, you may receive most or all of the medication at once, instead of slowly over 7 days. This may cause serious problems, including overdose and death.

If your buprenorphine patch is exposed to extreme heat, it may release too much medication into your body at once. This can cause serious or life-threatening symptoms.Do not expose your patch or the skin around it to direct heat such as heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated water beds. Do not take long, hot baths or sunbathe while you are wearing the patch.

You may bathe or shower while you are wearing a buprenorphine patch. If the patch falls off during these activities, dispose of it properly. Then dry your skin completely and apply a new patch. Leave the new patch in place for 7 days after you apply it.

You can apply a buprenorphine patch to your upper outer arms, upper chest, upper back, or the side of your chest. Choose an area of skin that is flat and hairless. Do not apply the patch to parts of the body that irritated, broken, cut, damaged, or changed in any way. If there is hair on the skin, use scissors to clip the hair as close to the skin as possible. Do not shave the area. Wait at least 3 weeks before applying a new patch to same site.

Tell your doctor if your pain increases or gets worse or if you have new pain or an increased sensitivity to pain, especially after applying a buprenorphine patch. Do not apply more of it or apply it more often than prescribed by your doctor.

To apply the patch, follow these steps:

1. Clean the area where you plan to apply the patch with clear water and pat completely dry. Do not use any soaps, lotions, alcohols, or oils.
2. Use scissors to cut open the pouch containing the buprenorphine patch along the dotted line. Remove the patch from the pouch and peel off the protective liner from the back of the patch. Try not to touch the sticky side of the patch.
3. Immediately press the sticky side of the patch onto the chosen area of skin with the palm of your hand.
4. Press the patch firmly for at least 15 seconds. Be sure that the patch sticks well to your skin, especially around the edges. Do not rub the patch.
5. If the patch does not stick well or comes loose after it is applied, tape only the edges to your skin with first aid tape. If the patch still does not stick well, you may cover it with Bioclusive or Tegaderm brand see-through dressings. Do not cover the patch with any other type of bandages or tape. Talk to your doctor or pharmacist if your patch continues to have problems sticking to your skin.
6. If a patch falls off before it is time to remove it, dispose of the patch properly and apply a new patch at a different area of skin. Leave the new patch in place for 7 days.
7. When you are finished applying the patch, wash your hands with only clear water right away.
8. Write down the date and time that the patch is applied.
9. When it is time to change your patch, peel off the old patch and apply a new patch to a different skin area.
10. After you remove your patch, use the Patch Disposal Unit provided to you by the manufacturer to safely dispose of the used patch in the trash. Close the Patch Disposal Unit by folding the sticky sides together, then press firmly and smoothly over the entire Unit so that the patch is sealed within. Do not place used patches in the trash without first sealing them in the Patch Disposal Unit. Alternatively, you may also may fold the sticky sides of a used patch together and flush it down the toilet. Used patches may still contain some medication and may be dangerous to children, pets, or adults who have not been prescribed buprenorphine patches.

What SPECIAL PRECAUTIONS should I follow?

Before using buprenorphine patch,

• tell your doctor and pharmacist if you are allergic to buprenorphine, any other medications, or any of the ingredients in a buprenorphine patch. Ask your doctor or pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate).

• the following nonprescription or herbal products may interact with buprenorphine: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medications before you start using buprenorphine (Belbuca). Do not start this medication while using buprenorphine (Belbuca) without discussing it with your healthcare provider.

• tell your doctor if you have or have ever had conditions mentioned in the IMPORTANT WARNING section or a paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use buprenorphine patches.

• tell your doctor if you or an immediate family member have or have ever had prolonged QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause loss of consciousness, or sudden death); or if you have or ever had atrial fibrillation; heart failure; seizures; a head injury, a brain tumor, a stroke or any other condition that caused high pressure inside your skull; biliary tract disease; diabetes; slowed heartbeat; low blood pressure; low blood levels of potassium; problems urinating; or pancreas, thyroid, heart, kidney, or liver disease.

• tell your doctor if you are breastfeeding. You should not breastfeed while you are using buprenorpine patches. Buprenorphine can cause shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness in breastfed infants.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using buprenorphine patches.

• you should know that this medication may make you drowsy. Do not drive a car, operate machinery, or do other possibly dangerous activities until you know how this medication affects you.

• you should know that buprenorphine patches may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using a buprenorphine patch. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that buprenorphine patches may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using buprenorphine patches.

• you should know that if you have a fever or if you get very hot after physical activity, the amount of buprenorphine that you receive from the patch may increase and possibly cause an overdosage of medication. Avoid physical activity that might cause you to get very hot. Call your doctor right away if you have a fever. Your doctor may need to adjust your dose.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you forget to apply or change a buprenorphine patch, apply the patch as soon as you remember it. Be sure to remove your used patch before applying a new patch. Wear the new patch for the period of time prescribed by your doctor (usually 7 days) and then replace it. Do not wear two patches at once unless your doctor has told you that you should.

What SIDE EFFECTS can this medicine cause?

Buprenorphine patches may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• difficulty falling asleep or staying asleep
• headache
• dry mouth
• stomach pain
• skin irritation, itching, swelling, or redness in the area where you wore the patch

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• difficulty breathing or swallowing
• shortness of breath
• changes in heartbeat
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• inability to get or keep an erection
• irregular menstruation
• decreased sexual desire
• chest pain
• swelling of your face, tongue or throat
• rash
• hives
• itching

Buprenorphine patches may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Discard any patches that are outdated or as soon as they are no longer needed. Use a Patch Disposal Unit provided to you by the manufacturer to safely dispose of the unneeded or outdated patch(s) in the trash. Do not put unneded or outdated buprenorphine patches in a garbage can without first sealing them in a Patch Disposal Unit. Alternatively, you may dispose of the patches by carefully removing the adhesive backing, folding the sticky sides of each patch together so that it sticks to itself, and flushing the patches down the toilet. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

While using buprenorphine patches, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Symptoms of overdose may include the following:

• narrowing or widening of the pupils (black circles in the center of the eye)
• extreme sleepiness or drowsiness
• slow or shallow breathing or difficulty breathing
• unable to respond or wake up
• slow heartbeat
• cold, clammy skin
• muscle weakness
• unusual snoring

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and laboratory. Your doctor will order certain lab tests to check your body's response to buprenorphine.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using buprenorphine.

Do not let anyone else use your medication. Buprenorphine is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.