Less Pain1-5 Less Opioids2,3 Improved Patient Satisfaction2,4

Less Pain:

more than 2x higher maximal pain relief

vs placebo + PCA morphine following total hip or knee replacement
(P<0.05)2

Less Opioids:

46% reduction in morphine consumption

vs placebo + PCA morphine over 6 hours following total hip or knee replacement
(P<0.01)2

Improved Patient Satisfaction

with treatment

vs placebo + PCA morphine at 24 hours following total hip or knee replacement
(P<0.01)2

Sinatra et al.2 The primary endpoint of this study was pain relief measured on a 5-point verbal scale over 6 hours. This was a randomized, double-blind, placebo-controlled, single- and repeated-dose 24-hour study (n=101). Patients received OFIRMEV 1 g with patient-controlled analgesia (PCA) morphine or placebo with PCA morphine the morning following total hip or knee replacement surgery. Morphine rescue was administered as needed.

Thirty-two patients in the OFIRMEV group and thirty-two patients in the placebo group experienced at least one adverse event after the first administration of the study medication. The most common adverse events reported in this study included constipation, nausea, injection site pain, anemia, pruritus, and vomiting.

The clinical benefit of reduced opioid consumption with OFIRMEV has not been evaluated or demonstrated.

The efficacy of OFIRMEV® (acetaminophen) injection has been studied in multiple clinical settings.

MULTIPLE CLINICAL SETTINGS

The efficacy of OFIRMEV has been studied in multiple clinical settings.1-6

Pivotal studies

  • Adult fever
  • Abdominal laparoscopic surgery
  • Orthopedic surgery

Supportive studies

  • Acute renal colic
  • Abdominal laparoscopic hysterectomy
Scroll down for additional important safety information

Indications and Usage

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.

Important Safety Information

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV® (acetaminophen) 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 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, 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. Discontinue OFIRMEV immediately at the first sign of skin rash.
  • Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors, which could result in accidental overdose and death.
  • 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. Discontinue OFIRMEV immediately upon occurrence of signs or symptoms associated with allergy or hypersensitivity. Do not use OFIRMEV in patients with acetaminophen allergy.
  • The antipyretic effects of OFIRMEV may mask fever.

Adverse Reactions

  • Serious adverse reactions may include hepatic injury, serious skin reactions, allergy, and hypersensitivity.
  • The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, and pruritus in pediatric patients.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see additional Important Safety Information, including Boxed Warning, in the Full Prescribing Information.