New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Buprenorphine Transdermal System - Butrans Table 2. Adverse Events of Buprenorphine vs Placebo in Patients Being Treated for Chronic Pain With a Dose That Was Titrated to Effect Adverse Events Buprenorphine (n = 392) Placebo (n = 261) Nausea 23% 8% Dizziness 16% 8% Headache 16% 11% Application-site pruritus 15% 12% Constipation 14% 5% Somnolence 14% 5% Vomiting 11% 2% Peripheral edema 7% 3% Application-site erythema 7% 2% Dry mouth 7% 2% Application-site rash 6% 6% Fatigue 5% 1% Fall 4% 2% Hyperhidrosis 4% 1% Pruritus 4% 1% Buprenorphine Transdermal System - Butrans DOSING: • The transdermal system (patch) is applied every 7 days to the upper outer arm, upper chest, upper back, or side of the chest on either side of the body. – Application should be rotated among these 8 sites and a minimum of 3 weeks should elapse before applying a patch to the same site. – The patch should be applied to a hairless or nearly hairless skin site. The hair at the site should be clipped, not shaven. – If there are adhesion problems with the patch, the edges may be taped down with first aid tape or covered with see-through adhesive dressing (eg, Bioclusive, Tegaderm). – If the patch falls off during the 7-day dosing interval, a new patch should be applied at a different skin site. – The buprenorphine transdermal system should not be cut. Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Buprenorphine Transdermal System - Butrans DOSING: • In opioid-naive patients, the initial dosage should always be 5 mcg/h. The dosage should not be increased until the patient has been continuously exposed to the previous dosage for 72 hours. • Buprenorphine may precipitate withdrawal in patients who are already on opioids. – Prior to converting from another opioid to buprenorphine, the patient’s current around-the-clock opioid should be tapered to no more than morphine 30 mg or equivalent per day before beginning buprenorphine. – Following initiation of buprenorphine therapy, the dose may be titrated upward after at least 72 hours at the current dose. Individual dosage titration should be based on the patient’s requirement for supplemental short-acting analgesics. – The maximum transdermal buprenorphine dosage is one 20 mcg/h system because of potential dose-related QTc prolongation. Buprenorphine Transdermal System - Butrans Risk Evaluation and Mitigations Strategy (REMS) assessment plan stated in the FDA’s approval Including a surveillance and monitoring system to detect abuse, misuse, overdose, and addiction and any modifications in provider education and drug distribution if these problems exist The cost for 4 patches AWP is; 5 mcg -$151.20 10 mcg - $226.80 20 mcg - $401.52 Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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