LAKE ZURICH, Ill., September 12, 2017 – Fresenius Kabi announced today the immediate availability in the United States of Caspofungin Acetate for Injection in a room-temperature stable formulation. Fresenius Kabi Caspofungin is available in two presentations: 50mg per vial and 70mg per vial.
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
“Introducing another essential medicine at lower costs for our customers and the patients they treat is fundamental to the Fresenius Kabi mission of ‘caring for life,’” said John Ducker, president and CEO of Fresenius Kabi USA. “We’re also pleased to be able to offer customers a room-temperature formulation.”
About Caspofungin Acetate for Injection
Caspofungin Acetate for Injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: empirical therapy for presumed fungal infections in febrile, neutropenic patients; treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections; treatment of esophageal candidiasis and treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.
Important Safety Information
Caspofungin is contraindicated in patients with known hypersensitivity to any component of this product. Anaphylaxis has been reported. If this occurs, discontinue Caspofungin and administer appropriate treatment. Possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm have been reported and may require discontinuation and/or administration of appropriate treatment.
Caspofungin can cause abnormalities in liver enzymes. Isolated cases of hepatic dysfunction, hepatitis, or hepatic failure have been reported. Monitor patients who develop abnormal liver enzymes for evidence of worsening hepatic function, and evaluate risk/benefit of continuing Caspofungin.
Limit use to patients for whom potential benefit outweighs potential risk when considering concomitant use with Cyclosporine as this may lead to abnormal liver enzymes. Monitor patients who develop abnormal liver function tests (LFTs) during concomitant use with Caspofungin.
In adults, the most common adverse reactions (incidence 10% or greater) are diarrhea, pyrexia, ALT/AST increased, blood alkaline phosphatase increased, and blood potassium decreased.
In pediatric patients, the most common adverse reactions (incidence 10% or greater) are pyrexia, diarrhea, rash, ALT/AST increased, blood potassium decreased, hypotension, and chills.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The Important Safety Information does not include all the information needed to use Caspofungin Acetate for Injection safely and effectively. Please see the full prescribing information for Caspofungin Acetate for Injection, including boxed warning, at http://editor.fresenius-kabi.us/PIs/Caspofungin_FK-451328A-Dec_2016-PI.pdf
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.
CANCIDAS® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.