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Less pain OFIRMEV ® provided significant reductions in pain intensity 2 0.0 0.6 1.2 1.8 6 5 4 3 2 1 .75 .50 .25 0 Mean pain relief scores, single dose (Total hip or knee replacement surgery) Pain relief Time (h) Signicant improvement over placebo + PCA morphine OFIRMEV 1 g (q6h) + PCA morphine (n=49) Placebo + PCA morphine (n=52) P<0.05 at every time point 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. OFIRMEV 1 g + PCA* morphine demonstrated significant differences in pain intensity vs placebo + PCA morphine †3 • Significantly higher mean pain intensity differences at all timepoints through 5 hours • Significant improvements in time to first use of rescue medication (4.72 h vs 1.4 h; P<0.001) and in total rescue medication consumption (4.5 mg vs 9.6 mg; P=0.016) • Significantly greater percent of OFIRMEV subjects reported being pain free through 6 h (40% vs 9%; P=0.005) *Patient-controlled analgesia. † Study was prematurely terminated due to visible particulates in placebo vials. Planned enrollment was 140 subjects. INDICATIONS AND USAGE OFIRMEV ® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever. IMPORTANT RISK INFORMATION WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY 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 50 kg; • infusion pumps are properly programmed; and • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits. 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. CONTRAINDICATIONS • Acetaminophen is contraindicated in patients with: − known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (IV) formulation. − severe hepatic impairment or severe active liver disease. WARNINGS AND PRECAUTIONS • Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death. • Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤30 mL/min). • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. • Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus. • The antipyretic effects of OFIRMEV may mask fever. To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Pharmaceuticals, at 1.800.778.7898 or FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.