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

Acute pain management and MMA

Treatment of acute pain remains suboptimal

According to results from two independent, random patient surveys published in 1995 and 2014, patients continued to report significant post-op pain despite the availability of effective analgesics7,8

Post-op pain severity: Survey results published in 1995 and 20147,8

Post-op pain severity: Survey results published in 1995 and 2014
  • In a survey published in 2014, 86% of patients reported post-op pain, with a total of 65% reporting pain as moderate to extreme8
  • In the same survey published in 2014, of the patients who received analgesic medications and responded to questions regarding analgesic-related adverse events (AEs; n=225), 79% reported at least one AE8
    • The most common AEs reported were drowsiness (56%), constipation (35%), and nausea (28%)8

Consider multimodal analgesia for balanced acute pain management

Intervening at various points along the pain pathway9-13

Multimodal analgesia (MMA) intervening at various points along the pain pathway COXIB, cyclooxygenase-2–specific inhibitor; NMDA, N-methyl-D-aspartate.

Multimodal analgesia (MMA) combines 2 or more analgesic agents or techniques that use different mechanisms to provide better pain relief with less opioids.14,15

By combining different analgesics, MMA can optimize efficacy with a lower dose of each respective agent and may also reduce the risk for dose-related adverse events.12

Schedule non-opioid analgesics first, adding opioids for moderate to severe pain15-17

  • When used in combination with opioids, non-opioid treatments may reduce the dose of opioids required to effectively manage pain14
Scheduling non-opioid analgesics first, adding opioids for moderate to severe pain

Multimodal analgesia in practice

American Society of Anesthesiologists guidelines15

The American Society of Anesthesiologists Task Force on Acute Pain Management recommends the use of MMA whenever possible in the perioperative setting.

  • Patients should receive an around-the-clock regimen of acetaminophen, cyclooxygenase-2–specific inhibitors (COXIBs), or NSAIDs unless contraindicated
  • Dosing regimens should be administered to optimize efficacy while minimizing the risk of adverse events
“Whenever possible, anesthesiologists should use multimodal pain management therapy.... Unless contraindicated, patients should receive an around-the-clock regimen of COXIBs, NSAIDs, or acetaminophen.”

American Society of Anesthesiologists Task
Force on Acute Pain Management
Practice Guidelines for Acute Pain Management in the Perioperative Setting (2012)15

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.