Please read additional safety information, including Boxed Warning.

IMPORTANT SAFETY INFORMATION

WARNING: IMPORTANCE OF PROPER
PATIENT SELECTION, POTENTIAL
FOR ABUSE AND LIMITATIONS

Proper Patient Selection

Butrans is a transdermal formulation of buprenorphine indicated for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. (1)

Potential for Abuse

Butrans contains buprenorphine which is a mu opioid partial agonist and a Schedule III controlled substance. Butrans can be abused in a manner similar to other opioid agonists, legal or illicit. Consider the abuse potential when prescribing or dispensing Butrans in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. (9)

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Routinely monitor all patients receiving opioids for signs of misuse, abuse, and addiction. (2.2)

Limitations of Use

Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation. (2.3)

Avoid exposing the Butrans application site and surrounding area to direct external heat sources. Temperature-dependent increases in buprenorphine release from the system may result in overdose and death. (5.11)

Parentheses refer to sections in the
Full Prescribing Information.


Butrans is indicated for the management of moderate to severe
chronic pain in patients requiring a continuous, around-the-clock
opioid analgesic for an extended period of time.

One Butrans - 7 days
       of buprenorphine delivery

DOSAGE AND ADMINISTRATION

Each Butrans is intended to be worn for 7 days.

Apply Butrans to the upper outer arm, upper chest, upper back or the side of the chest. These four sites (each present on both sides of the body) provide 8 possible application sites. Rotate Butrans among the 8 described skin sites. After Butrans removal, wait a minimum of 21 days before reapplying to the same skin site.

Apply Butrans to a hairless or nearly hairless skin site. If none are available, the hair at the site should be clipped, not shaven. Do not apply Butrans to irritated skin. If the application site must be cleaned, clean the site with water only.

Do not use soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before applying Butrans.

If problems with adhesion of Butrans occur, the edges may be taped with first aid tape. If Butrans falls off during the 7 days dosing interval, dispose of the transdermal system properly and place a new Butrans on at a different skin site (please see section 2.1 of the Full Prescribing Information and the Instructions for Use section of the Medication Guide for additional information on the proper application of Butrans).

PATIENT savings program

With the Butrans Patient Savings Program, patients may get:
  • Butrans Trial Offer to cover their co-pay for up to $75 on their first 28-day prescription
  • Butrans Savings Card for savings of up to $40 on each prescription
Both offers have specific eligibility requirements and are valid until 3/31/2013. Learn more about the Butrans Trial Offer and Butrans Savings Card and print the cards for your patients.

WARNING: IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS OF USE

Proper Patient Selection

Butrans is a transdermal formulation of buprenorphine indicated for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. (1)

Potential for Abuse

Butrans contains buprenorphine which is a mu opioid partial agonist and a Schedule III controlled substance. Butrans can be abused in a manner similar to other opioid agonists, legal or illicit. Consider the abuse potential when prescribing or dispensing Butrans in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. (9)

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Routinely monitor all patients receiving opioids for signs of misuse, abuse, and addiction. (2.2)

Limitations of Use

Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation. (2.3)

Avoid exposing the Butrans application site and surrounding area to direct external heat sources. Temperature-dependent increases in buprenorphine release from the system may result in overdose and death. (5.11)

Parentheses refer to sections in the Full Prescribing Information.

DOSAGE AND ADMINISTRATION

  • Each Butrans is intended to be worn for 7 days
  • Apply Butrans to the upper outer arm, upper chest, upper back or the side of the chest. These 4 sites (each present on both sides of the body) provide 8 possible application sites. Rotate Butrans among the 8 described skin sites. After Butrans removal, wait a minimum of 21 days before reapplying to the same skin site
  • Apply Butrans to a hairless or nearly hairless skin site. If none are available, the hair at the site should be clipped, not shaven. Do not apply Butrans to irritated skin. If the application site must be cleaned, clean the site with water only
  • Do not use soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before applying Butrans
  • If problems with adhesion of Butrans occur, the edges may be taped with first aid tape. If Butrans falls off during the 7 days dosing interval, dispose of the transdermal system properly and place a new Butrans on at a different skin site (please see section 2.1 of the Full Prescribing Information and the Instructions for Use section of the Medication Guide for additional information on the proper application of Butrans)

CONTRAINDICATIONS

  • Butrans is contraindicated in patients who have: significant respiratory depression, severe bronchial asthma, or known hypersensitivity to any of its components or the active ingredient, buprenorphine. Butrans is contraindicated in patients who have or are suspected of having paralytic ileus
  • Butrans is also contraindicated in the management of: acute pain or in patients who require opioid analgesia for a short period of time, postoperative pain, mild pain, or intermittent pain (eg, use on an as-needed basis [prn])

WARNINGS AND PRECAUTIONS

  • Respiratory Depression
    Respiratory depression is the chief hazard with Butrans. Use with extreme caution in patients at risk of respiratory depression
  • CNS Depression
    Butrans may cause somnolence, dizziness, alterations in judgment and alterations in levels of consciousness, including coma. Use with caution in patients who are receiving other central nervous system (CNS) depressants. Additive CNS effects are expected when used with alcohol, benzodiazepines, other opioids, or illicit drugs
  • QTc Prolongation
    Avoid in patients with Long QT Syndrome, family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications
  • Head Injury
    Butrans may worsen increased intracranial pressure and obscure its signs, such as level of consciousness or pupillary signs
  • Hypotensive Effects
    Butrans may cause severe hypotension. Use with caution in patients at increased risk of hypotension and in patients in circulatory shock
  • Application Site Skin Reactions
    In rare cases, severe application site skin reactions with signs of marked inflammation including “burn,” “discharge,” and “vesicles” have occurred
  • Anaphylactic/Allergic Reactions
    Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the post-marketing experience
  • Use in Pancreatic/Biliary Tract Disease and Other Gastrointestinal Conditions
    Use with caution in patients with biliary tract disease, including acute pancreatitis. Ileus may occur. Monitor for decreased bowel motility

ADVERSE REACTIONS

  • Most common adverse reactions (≥5%) included: nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash

Please read the Full Prescribing Information, including Boxed Warning.

 

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P., at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.
Intended for healthcare professionals of the United States of America only. ©2012 Purdue Pharma L.P., Stamford, CT 06901-3431