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

Recommended dosing of OFIRMEV for adults, adolescents, and children

Dosing of OFIRMEV for adults, adolescents, and children ≥2 years of age34

Dosing of OFIRMEV® (acetaminophen) injection for adults, adolescents, and children ≥2 years of age
  • Minimum dosing interval is every 4 hours (q4h) for adults, adolescents, and children ≥2 years of age34
  • For instructions regarding q4h dosing, please see Full Prescribing Information
  • No dose adjustment is required when transitioning to oral acetaminophen in adults and adolescents who weigh 50 kg and above34
  • OFIRMEV should be administered only as a 15-minute infusion.34 Administer only as directed
Please see Full Prescribing Information for additional administration instructions.

Recommended dosing of OFIRMEV for treatment of fever in neonates and infants34

Dosing of OFIRMEV for treatment of fever in neonates and infants

Dosing of OFIRMEV® (acetaminophen) injection for treatment of fever in neonates and infants
  • Minimum dosing interval is every 6 hours for neonates and infants

Safety Considerations

  • 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

How to administer OFIRMEV34

NON–WEIGHT-BASED DOSING
For 1000-mg (100-mL) doses, deliver from the vial or bag

Administration from 100-mL vial

Administration of OFIRMEV® (acetaminophen) injection from 100-mL vial

Administration from 100-mL bag

Administration of OFIRMEV® (acetaminophen) injection from 100-mL bag
  • DO NOT USE if particulate matter or discoloration is observed
  • OFIRMEV should be administered only as a 15-minute infusion
  • Monitor the end of the infusion in order to prevent the possibility of an air embolism
  • After the container seal is penetrated, or the contents transferred to another container, OFIRMEV should be administered within 6 hours
  • Do not add other medications to the OFIRMEV solution or infusion device
  • For bags, do not apply excessive pressure, as distortion could result in breakage of the bag
Please see Full Prescribing Information for additional administration instructions.

WEIGHT-BASED DOSING
For doses <1000 mg (<100 mL), deliver from separate container

    For 650-mg or weight-based doses
  • Using aseptic technique, withdraw the appropriate dose (650 mg or weight based) from an intact, sealed OFIRMEV container and place the measured dose in a separate, empty sterile container (eg, glass bottle, plastic IV container, or syringe)
  • OFIRMEV should be administered only as a 15-minute infusion
  • The entire 100-mL container of OFIRMEV is not intended for use in patients weighing <50 kg. OFIRMEV is supplied in a single-use container, and the unused portion must be discarded
Administration of OFIRMEV® (acetaminophen) injection for small-volume pediatric doses up to 60 mL
    For small-volume pediatric doses up to 60 mL
  • Using aseptic technique, withdraw appropriate volume from container (up to 60 mL) into a syringe and administer over 15 minutes using a syringe pump
Please see Full Prescribing Information for additional administration instructions.

OFIRMEV from the start

Consider administering OFIRMEV as foundational therapy and scheduling every 6 hours (q6h)

OFIRMEV® (acetaminophen) injection from the start

Continue with OFIRMEV if

  • Parenteral analgesia is clinically warranted
  • Patient has compromised GI absorption or inability to take oral analgesics
  • 100% bioavailability is desired

Transition to oral analgesia when

  • Patient can take and absorb oral analgesics

Safety Considerations

  • 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
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.