BUTRANS- buprenorphine patch, extended release 
Purdue Pharma LP

----------

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 12/2023
Medication Guide
BUTRANS® (BYOO-trans) (buprenorphine) Transdermal System, CIII
BUTRANS is:
  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine, when other pain medicines do not treat your pain well enough or you cannot tolerate them.
  • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not to be taken on an “as needed” basis.
Important information about BUTRANS:
  • Get emergency help or call 911 right away if you take too much BUTRANS (overdose). When you first start taking BUTRANS, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
  • Taking BUTRANS with other opioid medicines, benzodiazepines, and alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your BUTRANS. They could die from taking it. Selling or giving away BUTRANS is against the law.
  • Store BUTRANS securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Do not use BUTRANS if you have:
  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.
Before applying BUTRANS, tell your healthcare provider if you have a history of:
  • head injury, seizures
  • problems urinating
  • heart rhythm problems (Long QT syndrome)
  • abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems
Tell your healthcare provider if you:
  • noticing your pain getting worse. If your pain gets worse after you take BUTRANS, do not more of BUTRANS without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking BUTRANS.
  • have a fever
  • pregnant or planning to become pregnant. Use of BUTRANS for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended during treatment with BUTRANS. It may harm your baby.
  • living in a household where there are small children or someone who has abused street or prescription drugs.
  • are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking BUTRANS with certain other medicines can cause serious side effects.
When using BUTRANS:
  • Do not change your dose. Apply BUTRANS exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed.
  • See the detailed Instructions for Use for information about how to apply the BUTRANS patch.
  • Do not apply a BUTRANS patch if the pouch seal is broken, or the patch is cut, damaged, or changed in any way.
  • Do not apply more than 1 patch at the same time unless your healthcare provider tells you to.
  • You should wear 1 BUTRANS patch continuously for 7 days.
  • Call your healthcare provider if the dose you are using does not control your pain.
  • Do not stop using BUTRANS without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused BUTRANS by using the Patch-Disposal Unit. Alternatively, BUTRANS can be disposed of by folding the patch in half and promptly flushing down the toilet, if a drug take-back option is not readily available [see Instructions for Use]. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
While using BUTRANS DO NOT:
  • Take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps. These can cause an overdose that can lead to death.
  • Drive or operate heavy machinery,until you know how BUTRANS affects you. BUTRANS can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with BUTRANS may cause you to overdose and die.
The possible side effects of BUTRANS are:
constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, itching, redness or rash where the patch is applied. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if you have:
  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of BUTRANS. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Distributed by: Purdue Pharma L.P., Stamford, CT 06901-3431, www.purduepharma.com or call 1-888-726-7535

Instructions for Use
BUTRANS® (BYOO-trans) CIII
(buprenorphine)
Transdermal System

Be sure that you read, understand, and follow these Instructions for Use before you use BUTRANS. Talk to your healthcare provider or pharmacist if you have any questions.


Before Applying BUTRANS:

  • Do not use soap, alcohol, lotions, oils, or other products to remove any leftover adhesive from a patch because this may cause more BUTRANS to pass through the skin.
  • Each patch is sealed in its own protective pouch. Do not remove a patch from the pouch until you are ready to use it.
  • Do not use a patch if the seal on the protective pouch is broken or if the patch is cut, damaged or changed in any way.
  • BUTRANS patches are available in different strengths and patch sizes. Make sure you have the right strength patch that has been prescribed for you.

Where to apply BUTRANS:

  • BUTRANS should be applied to the upper outer arm, upper chest, upper back, or the side of the chest (See Figure A). These 4 sites (located on both sides of the body) provide 8 possible BUTRANS application sites.

Figure A Instructions

Figure A

  • Do not apply more than 1 patch at the same time unless your doctor tells you to. However, if your healthcare provider tells you to do so, you may use 2 patches as prescribed, applied at the same site (See Figure A for application sites) right next to each other (See Figure B for an example of patch position when applying 2 patches). Always apply and remove the two patches together at the same time.

Figure B Instructions

Figure B

  • You should change the skin site where you apply BUTRANS each week, making sure that at least 3 weeks (21 days) pass before you re-use the same skin site.
  • Apply BUTRANS to a hairless or nearly hairless skin site. If needed, you can clip the hair at the skin site (See Figure C). Do not shave the area. The skin site should not be irritated. Use only water to clean the application site. You should not use soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before you apply the patch.

Figure C Instructions

Figure C

  • The skin site should be free of cuts and irritation (rashes, swelling, redness, or other skin problems).

When to apply a new patch:

  • When you apply a new patch, write down the date and time that the patch is applied. Use this to remember when the patch should be removed.
  • Change the patch at the same time of day, one week (exactly 7 days) after you apply it.
  • After removing and disposing of the patch, write down the time it was removed and how it was disposed.

How to apply BUTRANS:

  • If you are wearing a patch, remember to remove it before applying a new one.
  • Each patch is sealed in its own protective pouch.
  • If you are using two patches, remember to apply them at the same site right next to each other. Always apply and remove the two patches together at the same time.
  • Use scissors to cut open the pouch along the dotted line (See Figure D) and remove the patch. Do not remove the patch from the pouch until you are ready to use it. Do not use patches that have been cut or damaged in any way.

Figure D Instructions

Figure D

  • Hold the patch with the protective liner facing you.
  • Gently bend the patch (See Figures E and F) along the faint line and slowly peel the larger portion of the liner, which covers the sticky surface of the patch.

Figure E Instructions

Figure E

Figure F Instructions

Figure F

  • Do not touch the sticky side of the patch with your fingers.
  • Using the smaller portion of the protective liner as a handle (See Figure G), apply the sticky side of the patch to one of the 8 body locations described above (See “Where to apply BUTRANS”).

Figure G Instructions

Figure G

  • While still holding the sticky side down, gently fold back the smaller portion of the patch. Grasp an edge of the remaining protective liner and slowly peel it off (See Figure H).

Figure H Instructions

Figure H

  • Press the entire patch firmly into place with the palm (See Figure I) of your hand over the patch, for about 15 seconds. Do not rub the patch.

Figure I Instructions

Figure I

  • Make sure that the patch firmly sticks to the skin.
  • Go over the edges with your fingers to assure good contact around the patch.
  • If you are using two patches, follow the steps in this section to apply them right next to each other.
  • Always wash your hands after applying or handling a patch.
  • After the patch is applied, write down the date and time that the patch is applied. Use this to remember when the patch should be removed.

If the patch falls off right away after applying, throw it away and put a new one on at a different skin site (See “Disposing of BUTRANS Patch”).

If a patch falls off, do not touch the sticky side of the patch with your fingers. A new patch should be applied to a different site. Patches that fall off should not be re-applied. They must be thrown away correctly.

Short-term exposure of the BUTRANS patch to water, such as when bathing or showering, is permitted.

If the edges of the BUTRANS patch start to loosen:

  • Apply first aid tape only to the edges of the patch.
  • If problems with the patch not sticking continue, cover the patch with special see-through adhesive dressings (for example Bioclusive or Tegaderm).
    • Remove the backing from the transparent adhesive dressing and place it carefully and completely over the BUTRANS patch, smoothing it over the patch and your skin.
  • Never cover a BUTRANS patch with any other bandage or tape. It should only be covered with a special see-through adhesive dressing. Talk to your healthcare provider or pharmacist about the kinds of dressing that should be used.

If your patch falls off later, but before 1 week (7 days) of use, throw it away properly (See “Disposing of a BUTRANS Patch”) and apply a new patch at a different skin site. Be sure to let your healthcare provider know that this has happened. Do not replace the new patch until 1 week (7 days) after you put it on (or as directed by your healthcare provider).

Disposing of BUTRANS Patch:

BUTRANS patches should be disposed of by using the Patch-Disposal Unit. Alternatively, the patches can be flushed down the toilet if a drug take-back option is not readily available.

To dispose of BUTRANS patches in household trash using the Patch-Disposal Unit:
Remove your patch and follow the directions printed on the Patch-Disposal Unit (See Figure J) or see complete instructions below. Use one Patch-Disposal Unit for each patch.

Figure J Instructions

Figure J

1. Peel back the disposal unit liner to show the sticky surface (See Figure K).

Figure K Instructions

Figure K

2. Place the sticky side of the used or unused patch to the indicated area on the disposal unit (See Figure L).

Figure L Instructions

Figure L

3. Close the disposal unit by folding the sticky sides together (See Figure M). Press firmly and smoothly over the entire disposal unit so that the patch is sealed within.

Figure M Instructions

Figure M

4. The closed disposal unit, with the patch sealed inside may be thrown away in the trash (See Figure N).

Figure N Instructions

Figure N

Do not put expired, unwanted or unused patches in household trash without first sealing them in the Patch-Disposal Unit.

Always remove the leftover patches from their protective pouch and remove the protective liner. The pouch and liner can be disposed of separately in the trash and should not be sealed in the Patch-Disposal Unit.

To flush your BUTRANS patches down the toilet:
Remove your BUTRANS patch, fold the sticky sides of a used patch together and flush it down the toilet right away (See Figure O).

Figure O

Figure O Instructions

When disposing of unused BUTRANS patches you no longer need, remove the leftover patches from their protective pouch and remove the protective liner. Fold the patches in half with the sticky sides together, and flush the patches down the toilet.

Do not flush the pouch or the protective liner down the toilet. These items can be thrown away in the trash.

If you prefer not to flush the used patch down the toilet, and if there is not a drug take-back option readily available, you must use the Patch-Disposal Unit provided to you to discard the patch.

Never put used BUTRANS patches in the trash without first sealing them in the Patch-Disposal Unit.

This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.

Distributed by: Purdue Pharma L.P., Stamford, CT 06901-3431

Revised: October 2019
©2019, Purdue Pharma L.P.

Bioclusive is a trademark of Systagenix Wound Management (US), Inc.
Tegaderm is a trademark of 3M.

Revised: 12/2023
Document Id: 58b7eb54-365b-f415-16d2-82f07261cd57
Set id: 794aa355-66de-41b8-aedf-f2c40f6bc664
Version: 28
Effective Time: 20231218
Purdue Pharma LP