BUTRANS TRIAL OFFER


Please read additional safety information, including Boxed Warning.

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. (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.

HOME / PATIENT SUPPORT / BUTRANS TRIAL OFFER

Your New Patients May Save
on Their First 28-Day Prescription

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

The Butrans Trial Offer may cover your patients' co-pay for up to $75 on their first 28-day prescription until the offer expires 3/31/2013. The Butrans Trial Offer is only available to new commercially-insured patients and cannot be used if patients pay in cash for their Butrans prescriptions. After your patients use their one-time Trial Offer, they can use the Butrans Savings Card to save up to $40 on each prescription until 3/31/2013. This card will automatically print when your patients print their card for the Trial Offer. If patients are eligible for both offers, they only need to activate one card.

Print the card for the Butrans Trial Offer for your eligible patients now.

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 that is paying the entire cost of the prescription; or (iv) an insurer or other Third Party Payor in Massachusetts. Cash-paying patients are not eligible for this offer.

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.

Healthcare Professional Instructions

Click on the link above to print the card for the Trial offer and the Butrans Savings Card for your eligible commercial third-party patients when you write them their prescription for Butrans. A valid prescription must accompany both cards at time of first use. The Butrans Trial Offer is only valid on a patient's first prescription of Butrans. Tell your patients to retain their Butrans Savings Card for future savings during the time of offer. Make sure you treat the materials like you would a blank prescription pad. Hand them out yourself and don’t leave them in the general waiting areas of your office.

If you have any questions about this offer, please call 1-866-747-9674 8:00 am – 8:00 pm EST, Monday through Friday.

Please read the Full Prescribing Information, including Boxed Warning, by clicking the tab above. Also, please read the Eligibility Requirements and Terms and Conditions above.

One Butrans trial offer and savings card per patient. Eligible new patients can only use the Butrans trial offer on their first prescription. Patient should retain Butrans savings card for use throughout program period.

Cash-paying patients are eligible for the Savings Card, but not eligible for the Butrans Trial Offer.

Pharmacist Instructions

The card for the Butrans Trial Offer covers the patient's co-pay for up to $75 of the 28-day trial. Cards for the Butrans Trial Offer are good only with a valid first prescription for Butrans and can be used only once until the offer expires 3/31/2013. The Butrans Savings Card provides savings up to $40 on each Butrans prescription after the patient pays the first $15. Butrans Savings Cards are good only with valid prescriptions of Butrans, and can be used one time for each dosage strength every 25 days until the offer expires 3/31/2013. When you use the Butrans Trial Offer or the Butrans Savings Card, you are certifying that you have not submitted and will not submit a claim for reimbursement under any federal, state, or other governmental programs for this prescription.

  • Submit transactions to McKesson Corporation using BIN#610524
  • If primary coverage exists, input card information as secondary coverage and transmit using the COB segment of the NCPDP transaction. Applicable discounts will be displayed in the transactions
  • Acceptance of this card and your submission of claims for the Butrans Patient Savings Program are subject to the LoyaltyScript® program Terms and Condition posted at www.mckesson.com/mprstnc
  • Cash-payers are not eligible for the Butrans Trial Offer.
  • Return Butrans Savings Card to patient and remind them to retain for future use
  • For questions regarding setup, claim transmission, patient eligibility, or other issues, call LoyaltyScript® for the Butrans Patient Savings Program at 1-866-747-9674 (8:00 am – 8:00 pm, EST Monday through Friday)

By submitting this card for reimbursement to McKesson Corporation, you certify that:

  • You have dispensed the covered drug to an eligible patient in accordance with the terms of the card and accompanying prescription;
  • Other than McKesson Corporation, you have not submitted and will not submit a claim for reimbursement to any Third Party Payor that prohibits use of the card, including Medicare, Medicaid, any similar federal or state healthcare program, or any patient assistance programs; and
  • Your participation in this program is consistent with all applicable laws and with all of your contractual or other obligations
  • Cannot be combined with any other offer

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