Butrans® (buprenorphine) Risk Evaluation and Mitigation Strategy (REMS)

Important Safety Information

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.

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.

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.

Limitations of Use

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

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.

Indications and Usage

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.

Contraindications

Butrans™ is contraindicated in:

patients who have significant respiratory depression
patients who have severe bronchial asthma
patients who have or are suspected of having paralytic ileus
patients who have known hypersensitivity to any of its components or the active ingredient, buprenorphine
the management of acute pain or in patients who require opioid analgesia for a short period of time
the management of post-operative pain, including use after out-patient or day surgeries
the management of mild pain
the management of intermittent pain (e.g., use on an as-needed basis [prn])

Warnings and Precautions

Use with extreme caution in patients at risk of respiratory depression.
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.
Avoid in patients with Long QT Syndrome, family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications.
Butrans may worsen increased intracranial pressure and obscure its signs, such as level of consciousness or pupillary signs.
Use with caution in patients at increased risk of hypotension and in patients in circulatory shock.
Ileus may occur. Monitor for decreased bowel motility.
Use with caution in patients with biliary tract disease, including acute pancreatitis.

Adverse Reactions

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

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/medwatch.

Welcome to the Butrans™ (buprenorphine) Transdermal System Risk Evaluation and Mitigation Strategy Web Site

A Risk Evaluation and Mitigation Strategy (REMS) has been implemented in response to a requirement of the Food and Drug Administration in order to ensure that the benefits of Butrans outweigh its risks. The REMS for Butrans includes distribution of REMS educational materials to healthcare professionals and distribution of a Medication Guide and Instructions for Use to patients and/or caregivers.

The Butrans REMS has two goals:

to inform patients and healthcare professionals about the potential for misuse,
abuse, and overdose from, and addiction to Butrans, and
to inform patients and healthcare professionals about the safe use of Butrans.

We encourage Healthcare Providers to educate themselves about the risks and safe use of Butrans by reading the Healthcare Professional Training Guide and completing the Training Confirmation Form. We encourage patients and caregivers of patients to inform themselves about the risks and safe use of Butrans by reading the Medication Guide. These materials can be found by choosing one of the links below: