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
