EUGENE VISCUSI, MD
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:
• 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.
• Acetaminophen is contraindicated in patients with:
- known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (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, 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: Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
• Breast Feeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
• Pediatrics: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.
To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Pharmaceuticals, at 1.800.778.7898 or FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.
ANTHONY GONZALEZ, MD, FACS, FASMBS
Chief of Surgery, Baptist Hospital of Miami
Medical Director, Bariatric Surgery, South Miami Hospital
Assistant Professor of Surgery, Florida International University College of Medicine
CHRISTOPHER MANTYH, MD
Associate Professor of Surgery/Chief, Gastrointestinal and Colorectal Surgery at Duke University Medical Center
JAY REDAN, MD
Director of Minimally Invasive General Surgery at Florida Hospital—Celebration Health
Associate Professor of Surgery at University of Central Florida Medical School
PAUL LACHIEWICZ, MD
Orthopaedic surgeon at Chapel Hill Orthopedic Surgery and Sports Medicine in Chapel Hill, NC
CHRIS PASERO, MS, RN-BC, FAAN
PROFESSOR RICHARD LANGFORD, FRCA, FFPMRCA
President of the British Pain Society
Consultant in Anesthesia and Pain Management at St. Bartholomew’s Hospital in London
GRETCHEN BROPHY, PharmD, BCPS, FCCP, FCCM
Professor of Pharmacotherapy and Outcomes Science and Neurosurgery at Virginia Commonwealth University, Medical College of Virginia Campus
JO ANN BROOKS, PHD, RN, FCCP, FAAN
Vice President, System Quality & Safety at Indiana University Health
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a Mallinckrodt company © 2014 Mallinckrodt OFV1421 08/14