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Acute pain management in orthopaedic surgery Less opioids OFIRMEV significantly reduced opioid consumption 2 0 10 20 30 40 50 60 Reduction in morphine consumption (Total hip or knee replacement surgery) Morphine (mg) OFIRMEV 1 g (q6h) + PCA morphine (n=49) Placebo + PCA morphine (n=52) –33 % –46 % 17.8 mg 9.7 mg Over 6 h P<0.01 Over 24 h P<0.01 57.4 mg 38.3 mg Sinatra et al. (Pain Study 1) Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine or placebo + PCA morphine following total hip or knee replacement surgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed. • The clinical benefit of reduced opioid consumption was not evaluated or demonstrated From the start Consider administering pre-op for improved post-op pain control 4 0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 Mean pain intensity scores (Total abdominal hysterectomy) 1 2 4 8 12 24 Time (h) * * * * * * IV acetaminophen 1 g given 30 min prior to induction (n=28) IV acetaminophen 1 g prior to skin closure (n=27) Placebo (n=27) *P<0.05 Mean pain intensity (VAS 10 cm) Arici et al. Randomized, placebo‐controlled, parallel-group, single-site study. Patients scheduled for total abdominal hysterectomy received IV acetaminophen 1 g 30 minutes prior to induction (pre-op), IV acetaminophen 1 g prior to skin closure (intra-op), or placebo. PCA morphine was available to all patients. Pain intensity, based on VAS, at rest and with movement, and total morphine consumption were measured at 15 and 30 minutes, 1, 2, 4, 8, 12, and 24 h. • Post-op pain intensity scores were significantly lower at all time points for the IV acetaminophen groups (pre-op and intra-op) compared to placebo (P<0.05) 4 Include OFIRMEV on standing orders in orthopaedic surgery • Schedule OFIRMEV q6h for the first 24 h or as long as clinically warranted • OFIRMEV vial is ready to use and fits commonly used anesthesia/OR carts, including the Pyxis ® Anesthesia System † • Visit OFIRMEV.com to learn more ADVERSE REACTIONS • Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis. • Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis. IMPORTANT RISK INFORMATION USE IN SPECIFIC POPULATIONS • Pregnancy: Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed. • Breast Feeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration. • Pediatrics: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients <2 years of age. Please see Brief Summary of Full Prescribing Information, including complete boxed warning, on the following page. References: 1. OFIRMEV ® [package insert]. San Diego, CA: Cadence Pharmaceuticals, a Mallinckrodt company; 2013. 2. Sinatra RS, Jahr JS, Reynolds LW, et al. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005;102:822-831. 3. Viscusi G, Royal M, Leclerc A, Fong L, Breitmeyer J. Pharmacokinetics, efficacy and safety of IV acetaminophen in the treatment of pain following total hip arthroplasty: results of a double-blind, randomized, placebo-controlled, single-dose study. Poster presented at: 24th Annual Meeting of the American Academy of Pain Medicine; February 12-16, 2008; Orlando, FL. 4. Arici S, Gurbet A, Türker G, et al. Preemptive analgesic effects of intravenous paracetamol in total abdominal hysterectomy. Agri. 2009;21:54-61. †Pyxis ® Anesthesia System is a registered trademark of CareFusion. Mallinckrodt, the "M" brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company. © 2015 Mallinckrodt. OFV1525 01/15 | OFIRMEV.com