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 Dabigatran- Pradaxa • DOSING: Recommended Dose for patients with creatinine clearance (CrCl) >30 mL/min, the recommended dose of dabigatran is 150 mg taken orally, twice daily, with or without food. For patients with CrCl 15-30 mL/min, or patients 75 years of age or older the recommended dose is 75 mg twice daily • – Instruct patients to swallow the capsules whole. Breaking, chewing, or emptying the contents of the capsule can result in increased exposure. – Pradaxa capsules will hydrolyze over time when exposed to humidity, causing a breakdown of active ingredient, and rendering the medication less effective. Pradaxa is packaged in a 30-day supply bottle with a desiccant cap or in unit-of-use blister packaging to minimize product breakdown from moisture. Rivaroxaban – Xarelto by Bayer HealthCare AG and Janssen Pharmaceuticals Rivaroxaban exhibits a linear pharmacokinetic relationship with a rapid onset of action, resulting in maximal factor Xa inhibition in approximately 3 hours. Maintenance of the anti–factor Xa effect lasted 8 to 12 hours, depending on the dose of rivaroxaban. Terminal half-life of rivaroxaban is approximately 9 hours in adults and 12 hours in elderly patients (older than 65 years of age). Elimination of rivaroxaban occurs by multiple routes: renal (onethird is excreted unchanged), biliary/fecal, and hepatic (through CYP-450 3A4). Renal function impairment may influence elevated plasma concentrations and increased anti-Xa activity; therefore, dose adjustments may be required Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Rivaroxaban - Xarelto • July 5, 2011 The FDA approved rivaroxaban a factor Xa inhibitor indicated for the prophylaxis of deep vein thrombosis (DVT) which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement. • The recommended dose of is 10 mg taken orally once daily with or without food. The initial dose should be taken at least 6 to 10 hours after surgery once hemostasis has been established. – For patients undergoing hip replacement surgery, treatment duration of 35 days is recommended. – For patients undergoing knee replacement surgery, treatment duration of 12 days is recommended. Rivaroxaban - Xarelto RECORD is a global program involving more than 12,500 patients, comparing rivaroxaban 10 mg QD with SC enoxaparin in patients following either total hip or knee replacement surgery. • RECORD comprised four pivotal Phase III clinical – RECORD 1 and 2: total hip replacement surgery • RECORD 1: Both treatments continued for 35+/-4 days (N Engl J Med. 2008;358:2765- 2775) • RECORD 2: Rivaroxaban continued for 35+/-4 days; enoxaparin 10-14 days (Lancet. 2008;372:31-39) – RECORD 3 and 4: total knee replacement surgery • RECORD 3: Both treatments continued for 10-14 days (N Engl J Med. 2008;358:2776- 2786) • RECORD 4: Both treatments continued for 10–14 days (Lancet 2009;373:1673-80) – Results of a pre-specified pooled analysis of RECORD1, 2 and 3 showed that rivaroxaban significantly reduced the composite of symptomatic VTE and all-cause mortality during the 2-week active controlled period by 56% compared with enoxaparin (0.4% versus 0.8%, respectively; odds ratio: 0.44; p=0.005) while maintaining a similar safety profile. Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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