LAKE ZURICH, Ill., December 10, 2020 – Fresenius Kabi announced today the immediate availability in the United States of acetaminophen injection in freeflex® bags. This is the most recent addition to the company’s anesthesia and analgesia portfolio and its most recent offering in a growing line of ready-to-use medicines.
Acetaminophen injection is used in the hospital setting for pain management and fever reduction. Acetaminophen injection is available in 1,000 mg per 100 mL freeflex bags, a preferred delivery system that helps to promote safety and convenience.
“The launch of acetaminophen injection underscores our ongoing commitment to innovation in intravenous infusion delivery systems and offering customers more ready-to-use products,” said John Ducker, president and CEO of Fresenius Kabi USA. “Treatment with acetaminophen is an important option as clinicians evaluate pain management approaches for their patients.”
Fresenius Kabi freeflex bags are preferred delivery systems that are clear, non-PVC, non-DEHP and made without natural rubber latex. Freeflex bags are designed to help minimize drug errors and maximize patient safety. They also feature leak-resistant technology and sterile ports with tamper-evident breakoff caps to help reduce the risk of contamination.
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. To learn more about Fresenius Kabi, including its expanding U.S. centers for pharmaceutical research, manufacturing and distribution, please visit www.fresenius-kabi.com/us.
INDICATIONS AND USAGE
Acetaminophen injection, for intravenous use, is indicated for the:
- Management of mild to moderate pain in adult and pediatric patients 2 years and older.
- Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older.
- Reduction of fever in adult and pediatric patients 2 years and older.
Important Safety Information
WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY
Acetaminophen is contraindicated:
- In patients with known hypersensitivity to acetaminophen or to any of the excipients in the IV formulation.
- In patients with severe hepatic impairment or severe active liver disease.
Administration of acetaminophen in doses higher than recommended (by all routes of administration and from all acetaminophen-containing products including combination products) may result in hepatic injury, including the risk of liver failure and death.
Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, in cases of 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 acetaminophen immediately at the first sign of skin rash.
Take care when prescribing, preparing, and administering acetaminophen 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 pruritis.
Discontinue acetaminophen injection immediately upon occurrence of signs or symptoms associated with allergy or hypersensitivity. Do not use acetaminophen injection in patients with acetaminophen allergy.
The antipyretic effects of acetaminophen injection may mask fever.
The most common adverse reactions in patients treated with acetaminophen were nausea, vomiting, headache, and insomnia in adult patients; nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential.
Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant.
Pediatric Use: The effectiveness of acetaminophen for the treatment of acute pain in pediatric patients younger than 2 years of age has not been established. The safety and effectiveness of acetaminophen in pediatric patients older than 2 years of age is supported by evidence from adequate and well controlled studies in adults with additional safety and pharmacokinetic data for this age group.
Geriatric Use: No overall differences in safety or effectiveness were observed between geriatric and younger subjects.
Hepatic Impairment: Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease.
Renal Impairment: In cases of severe renal impairment, longer dosing intervals and a reduced total daily dose of acetaminophen may be warranted.
This Important Safety Information does not include all the information needed to use acetaminophen injection safely and effectively. Please see full prescribing information, including BOXED WARNING, for acetaminophen injection at https://tinyurl.com/y2oz5e9g.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at https://www.fresenius-kabi.com/us/join-us.