Bariatric Times

BT Supplement May 2014

A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional

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A8 Bariatric Times [MAY 2014, SUPPLEMENT A] HOT TOPICS IN SURGICAL PAIN MANAGEMENT OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen- containing product. Safety data from a pooled analysis of five repeated- dose, placebo-controlled clinical studies involving adults demonstrate that when dosed appropriately, the incidence of liver function enzyme elevations was comparable to that seen with placebo (Table 2). 19 Recommended Dosing of OFIRMEV OFIRMEV is administered as a 15-minute infusion and may be given as a single or repeated dose for the treatment of acute pain or fever. For adults and adolescents weighing 50kg or more, the recommended d osage is 1,000mg every six hours or 650mg every four hours, with a maximum single dose of 1,000mg, a minimum dosing interval of four hours, and a maximum daily dose of acetaminophen not to exceed 4,000mg in 24 hours (Table 3). 16 Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that the dose in milligrams (mg) and milliliters (mL) is not confused, the dosing is based on weight for patients under 50kg, infusion pumps are properly programmed, the total daily dose of acetaminophen from all sources does not exceed maximum daily limits. Dosing for children two years of age and older and adolescents and adults less than 50kg is listed in Table 3. For doses less than 1,000mg, the appropriate dose must be withdrawn from the vial and placed into a separate container (e.g., glass bottle, plastic IV container, or syringe) prior to administration. Once the vacuum seal of the OFIRMEV glass vial has been penetrated, or the contents have been transferred to another container, administer the dose within six hours. 16 Conclusion Although there have been many developments and an increased emphasis on pain management over the past two decades, relatively little has changed with regard to the incidence of postsurgical pain or patients' perception of their pain management. 5 Postoperative pain continues to be inadequately controlled. Because of this, opioid monotherapy should no longer be viewed as an adequate strategy for postoperative pain management. 5,11 Multimodal analgesia represents a shifting paradigm in perioperative pain management and has garnered the support of numerous professional organizations, including the ASA, ASPMN, AHRQ, and The Joint Commission. 11,12,14,15 The ASA Guidelines recommend that, unless contraindicated, acetaminophen, COXIBs, or NSAIDs be considered as part of a multimodal analgesic regimen. 12 It is important to remember that surgery, opioids, anesthesia, preoperative fasting, and postoperative stress can all work together in the immediate postoperative period to produce a profound gastroparesis and delayed gastric emptying. These factors should be taken into consideration when determining the appropriate route of analgesic administration. IV acetaminophen is well suited for use in a multimodal analgesic regimen, with unique properties including rapid onset, established safety profile, and reduction in pain and fever. Include OFIRMEV as a foundational agent when establishing and implementing a multimodal analgesic regimen on standing orders in bariatric surgery. Initiate TABLE 2. Peak ALT/AST value postbaseline: % of patients in 5 pooled, repeated-dose, placebo-controlled studies in adults IV ACETAMINOPHEN (n=402) PLACEBO (n=379) ALT >3x ULN >5x ULN 1.1% (n=4) 0.3% (n=1) 1.7% (n=6) 0.6% (n=2) AST >3x ULN >5x ULN 1.0% (n=4) 0.5% (n=2) 1.1% (n=4) 0.8% (n=3) ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease. Data on file. Cadence Pharmaceuticals, Inc. TABLE 1. Treatment-emergent adverse events occurring in ≥3% of adults receiving OFIRMEV and at a greater frequency than placebo in repeated-dose studies* TREATMENT-EMERGENT ADVERSE EVENT (TEAE) OFIRMEV (N=402) n (%) PLACEBO (N=379) n (%) Nausea 138 (34%) 119 (31%) Vomiting 62 (15%) 42 (11%) Pyrexia † 22 (5%) 52 (14%) Headache 39 (10%) 33 (9%) I nsomnia 3 0 (7%) 2 1 (5%) *The differences between treatment groups were not statistically significant for any reported TEAE. † Pyrexia adverse reaction frequency data are included in order to alert healthcare practitioners that the antipyretic effects of OFIRMEV may mask fever. OFIRMEV ® (acetaminophen) injection [Prescribing Information] Cadence Pharmaceuticals, Inc.; San Diego, CA; 2013. EDITED-Cadence Ofirmez Suppl copy 2_Layout 1 4/14/14 10:14 AM Page A8

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