REZZAYO™ (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation (NCT04368559); for more information about this ongoing trial, see ClinicalTrials.gov. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.
U.S. rights and Ex-U.S. rights to rezafungin have been partnered with Melinta Therapeutics and Mundipharma respectively. Cidara retains the rights to rezafungin in Japan.
INDICATIONS AND USE
REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.
REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
IMPORTANT SAFETY INFORMATION
REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.
REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.
Most common adverse reactions (incidence 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.
Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.
Mundipharma submitted a marketing authorization application (MAA) for rezafungin to the European Medicines Agency (EMA) for the treatment of invasive candidiasis in adult patients. The MAA was accepted on August 22, 2022, and the application review is ongoing.