Butrans® (buprenorphine) Transdermal System is indicated for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use: Butrans is not for use: as an as-needed (prn) analgesic; for pain that is mild or not expected to persist for an extended period of time; for acute pain; for postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

Please read additional safety information, including Boxed Warning.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential

Butrans contains buprenorphine, an opioid agonist and Schedule III controlled substance with an abuse liability similar to other Schedule III opioids, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing Butrans. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depressive disorder). Routinely monitor all patients receiving Butrans for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].

Life-Threatening Respiratory Depression

Respiratory depression, including fatal cases, may occur with use of Butrans, even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and Butrans should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of Butrans or following a dose increase.

Accidental Exposure

Accidental exposure to Butrans, especially in children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.3)].

Parentheses refer to sections in the
Full Prescribing Information.

BUTRANS TRIAL OFFER
HOME / BUTRANS TRIAL OFFER

If you have previously enrolled in the Patient Savings Program and/or are paying cash for your Butrans prescription, visit the Butrans Savings Card page instead.

Print and Activate the Card for the Butrans Trial Offer

Click here to print the card for the Butrans Trial Offer and follow the directions below to activate your card.

To activate the Butrans Trial Offer, you will need to have the number on the card handy and visit the card activation page.

The Butrans Trial Offer may cover your co-pay for up to $100 on your first 28-day prescription until 3/31/2014. The Butrans Trial Offer is only available to new commercially insured patients and cannot be used if you pay in cash for your Butrans prescriptions. After you use your one-time Trial Offer, you may use the Butrans Savings Card to save up to $50 on each eligible prescription until 3/31/2014. This card will automatically print when you print your card for the Trial Offer. If you are eligible for both offers, you only need to activate one card.

Eligibility Requirements

This card cannot be used if your prescriptions are covered by: (i) any federal or state healthcare program, including a state medical or pharmaceutical assistance program (Medicare, Medicaid, Medigap, VA, DOD, TRICARE, etc); (ii) Medicare Prescription Drug Program (Part D Program); (iii) insurance in states that have an "all payer" anti-kickback law or insurance that is paying the entire cost of the prescription. Cash-paying patients are not eligible for this offer. Patients in VT are not eligible.

Terms and Conditions

You must meet eligibility requirements. You agree to report your use of this card to any third party that reimburses you or pays for any part of the prescription price. You additionally agree that you will not submit any portion of the product dispensed pursuant to this card to a federal or state healthcare program for purposes of counting it toward your out-of-pocket expenses (such as TrOOP under Medicare Part D or Medicaid). This card is not valid with any other program, discount, or incentive involving the covered medication. This offer is not contingent upon any past, present, or future purchases of the covered drug or any other product, and this offer may be rescinded, revoked, or amended without notice. No reproductions.

This card is not insurance. This card is void where prohibited or where restricted beyond the terms herein. For questions about this card, call the Butrans Patient Savings Program at 1-866-747-9674.

WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential

Butrans contains buprenorphine, an opioid agonist and Schedule III controlled substance with an abuse liability similar to other Schedule III opioids, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing Butrans. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depressive disorder). Routinely monitor all patients receiving Butrans for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].

Life-Threatening Respiratory Depression

Respiratory depression, including fatal cases, may occur with use of Butrans, even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and Butrans should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of Butrans or following a dose increase.

Accidental Exposure

Accidental exposure to Butrans, especially in children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.3)].

Parentheses refer to sections in the Full Prescribing Information.

ADMINISTRATION OF BUTRANS

  • Butrans is for transdermal use (on intact skin) only. Each Butrans is intended to be worn for 7 days
  • Instruct patients not to use Butrans if the pouch seal is broken or the patch is cut, damaged, or changed in any way and not to cut Butrans
  • Instruct patients to apply immediately after removal from the individually sealed pouch
  • 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

CONTRAINDICATIONS

  • Butrans is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected paralytic ileus; hypersensitivity (eg, anaphylaxis) to buprenorphine

WARNINGS AND PRECAUTIONS

  • Abuse Potential
    Buprenorphine can be abused in a manner similar to other opioid agonists, legal or illicit. Assess risk for opioid abuse or addiction prior to prescribing. Routinely monitor all patients for signs of misuse, abuse, and addiction. Addiction can occur even under appropriate medical use. Misuse or abuse of Butrans by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of the opioid and pose a significant risk that could result in overdose and death
  • Life-Threatening Respiratory Depression
    Respiratory depression is the primary risk of Butrans and may lead to respiratory arrest and death. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Butrans, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression. Proper dosing and titration of Butrans are essential. Overestimating the Butrans dose when converting patients from another opioid product can result in fatal overdose with the first dose
  • Accidental Exposure
    Accidental exposure to Butrans, especially in children, can result in a fatal overdose
  • Elderly, Cachectic, and Debilitated Patients
    Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics. Monitor such patients closely, particularly when initiating and titrating Butrans and when Butrans is given concomitantly with other drugs that depress respiration
  • Use in Patients with Chronic Pulmonary Disease
    Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy and titrating with Butrans. Even usual therapeutic doses of Butrans may decrease respiratory drive to the point of apnea
  • Interactions with Alcohol, CNS Depressants, and Illicit Drugs
    Hypotension, profound sedation, coma or respiratory depression may result if Butrans is added to a regimen that includes other CNS depressants, alcohol, 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
  • Hypotensive Effects
    Butrans may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. Monitor patients after initiating or titrating
  • Use in Patients with Head Injury or Increased Intracranial Pressure
    Monitor patients who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression, particularly when initiating therapy with Butrans. Opioids may also obscure the clinical course in a patient with a head injury
  • 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
  • Application of External Heat
    Avoid exposing the Butrans application site and surrounding area to direct external heat sources. There is a potential for temperature-dependent increases in buprenorphine released from the system resulting in possible overdose and death
  • Use in Patients with Gastrointestinal Conditions
    Avoid the use of Butrans in patients with paralytic ileus and other GI obstructions. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms
  • Avoidance of Withdrawal
    When discontinuing Butrans, gradually taper the dose. Do not abruptly discontinue Butrans

ADVERSE REACTIONS

  • Most common adverse reactions (≥5%) reported by patients treated with Butrans in the clinical trials were 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 patients of the United States of America only. ©2013 Purdue Pharma L.P., Stamford, CT 06901-3431