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U.S. Department of Health and Human Services

Safety

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Ofirmev (acetaminophen) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

October 2013

Summary View

BOXED WARNING

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 maximum daily limits, and often involve more than one acetaminophen-containing product

WARNINGS AND PRECAUTIONS

Hepatic Injury
  • The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products.
Serious Skin Reactions
  • 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. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Risk of Medication Errors
  • Take care when prescribing, preparing, and administering OFIRMEV (acetaminophen) Injection in order 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.