Initiating Schedule III, 7-day Butrans in opioid-experienced patients

Starting the right patient at the right dose of Butrans

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
• Butrans is for transdermal use (on intact skin) only
• Each Butrans patch is intended to be worn for 7 days
• Initiate treatment in opioid naive patients with Butrans with a 5 mcg/hour patch
• Butrans doses of 7.5, 10, 15, and 20 mcg/hour are only for use in patients who are opioid experienced and in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid-experienced are those receiving, for one week or longer, daily opioid doses up to 80 mg/day of oral morphine or an equianalgesic dose of another opioid
• Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Butrans and following dosage increases
• Butrans should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain
• Discontinue all other around-the-clock opioid drugs when Butrans therapy is initiated
• There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids
• 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 avoid exposing Butrans to external heat sources, hot water, or prolonged direct sunlight

Starting dose for patients whose total daily dose of opioids is <30 mg of oral morphine equivalent

5 mcg/hour, q7d

(not shown at actual size)

• Initiate treatment with Butrans 5 mcg/hour at the next dosing interval

Starting dose for patients whose total daily dose of opioids is between 30 and 80 mg of oral morphine equivalents

10 mcg/hour, q7d

(not shown at actual size)

• Taper the patient’s current around-the-clock opioids for up to 7 days to no more than 30 mg of morphine or equivalent per day before beginning treatment with Butrans. Then initiate treatment with Butrans 10 mcg/hour at the next dosing interval
• Patients may use short-acting analgesics as needed until analgesic efficacy with Butrans is attained

For patients whose daily dose of opioid is >80 mg of oral morphine equivalents

• Butrans 20 mcg/hour may not provide adequate analgesia. Consider the use of an alternate analgesic

Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

Patients with hepatic impairment

• Butrans has not been evaluated in patients with severe hepatic impairment. As Butrans is only intended for 7-day application, consider use of an alternate analgesic that may permit more flexibility with dosing in patients with severe hepatic impairment