Drug Topics - February 2009 - (Page 40)

Continuing Education New drugs update 2008 approvals ALVIMOPAN (Adolor, GSK). Entereg FDA rating: 1-S,C (S = standard review, C = capsule). Alvimopan is the first approved treatment for post-operative ileus. It is a unique opioid antagonist because it does not antagonize central opioid receptors. Indication: Alvimopan is indicated for acceleration of the time to upper and lower gastrointestinal (GI) recovery following partial large- or smallbowel resection surgery with primary anastomosis. Pharmacology: Postoperative ileus, the impairment of GI motility after AN ONGOING CE PROGRAM OF THE UNIVERSITY certain surgeries, may potentially deOF FLORIDA COLLEGE OF PHARMACY AND DRUG TOPICS lay GI recovery and hospital discharge. Alvimopan is a selective antagonist of the mu-opioid receptor. Its activity is restricted to the GI tract; therefore, it does not interfere with the pain-relieving effects of central analgesics. Precautions: Alvimopan is contraindicated in patients who have received therapeutic doses of opioids for more than 7 consecutive days prior to starting alvimopan. These patients would be expected to be more sensitive to the effects of mu-opioid receptor antagonism (e.g., abdominal pain, Joshua G. Chestnutt, PharmD, BCPS nausea and vomiting, diarrhea). More CLINICAL PHARMACIST, COLUMBUS REGIONAL HEALTHCARE SYSTEM, COLUMBUS, GA myocardial infarctions were reported Adam D. Landers, PharmD in patients treated with alvimopan CLINICAL PHARMACIST, MISSION HOSPITALS, ASHEVILLE, NC compared with placebo in a 12-month study of patients treated with opioids for chronic pain, alhis continuing education lesson reviews the new mothough a causal relationship has not been established. Availlecular entities (NMEs) and biologics approved by the ability of alvimopan is restricted to short-term use (15 doses) Food & Drug Administration in 2008. Some 75 New in patients hospitalized in facilities that have registered with Drug Applications (NDAs) were approved, including 22 and met requirements of the ENTEREG Access Support and NMEs (see Tables 1 and 2 at www.drugtopics.com). Four Education (E.A.S.E.) program. notable biological entities were also approved. This makes Adverse effects: Most common adverse reactions in patients 2008 similar to 2007 (in terms of number of applications undergoing bowel resection were anemia, dyspepsia, hypokaapproved) and continues the trend of fewer approvals comlemia, back pain, and urinary retention. pared to previous years. Dosage and availability: The recommended adult dosage Of the 75 NDAs reviewed by the FDA in 2008, 68 received of alvimopan is 12 mg administered 30 minutes to 5 hours standard review, 7 received priority review, and 5 were grantprior to surgery, followed by 12 mg twice daily, beginning the ed orphan-drug status pursuant to Section 526 of the Orphan day after surgery, for a maximum of 7 days or until discharge. Drug Act. Among the approvals are a new antiretroviral that Alvimopan is currently available as a 12-mg capsule. shows efﬁcacy in refractory-treatment-experienced patients Patient counseling: Explain to patients that alvimopan can and a novel alkylating agent used in the treatment of chronic shorten the signs and symptoms of impaired GI motility that lymphocytic leukemia as ﬁrst-line therapy. occur after certain surgeries. Inquire about any opioid use occurring in the week prior to therapy initiation, and explain Network SEE INDEX PAGE 8 that this increases susceptibility to adverse reactions. Inform patients that alvimopan is for short-term hospital use only. T Clinical For more info on this topic, see www.drugtopics.com 40 DRUG TOPICS Februar y 2009 W W W.D R U GTO P I C S .C O M COURTESY GETTY IMAGES / DIGITAL VISION / ANDERSON ROSS http://www.drugtopics.com http://WWW.DRUGTOPICS.COM

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Drug Topics - February 2009 Contents Health-System Edition Group Attempts to Resurrect Pain Care Act HSE Business Management HSE Clinical Letters Up Front Up Front in Depth Community Practice Niche Pharmacies Serve Special Populations Special Report Oral Oncology Drugs New Drugs Update 2008 Approvals OTC New Products Viewpoint

Drug Topics - February 2009

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