Mallinckrodt Announces U.S. FDA Approval of OFIRMEV® IV Bag Presentation
The Prior Approval Supplement to the approved OFIRMEV New Drug Application included the addition of a new container closure and manufacturer. The polypropylene bags will be manufactured by Fresenius Kabi.
ABOUT OFIRMEV (Acetaminophen) Injection
OFIRMEV (acetaminophen) injection is the first and only intravenous (IV) formulation of acetaminophen to be approved and currently marketed in
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:
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.
- Acetaminophen is contraindicated in patients with:
- known hypersensitivity to acetaminophen or to any of the excipients in the 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.
- Serious adverse reactions may include hepatic injury, serious skin reactions, allergy and hypersensitivity, and anaphylaxis.
- Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.
USE IN SPECIFIC POPULATIONS
- Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
- Breastfeeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
- Pediatric Use: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.
For additional Important Risk Information, including complete boxed warning, see Full Prescribing Information.
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