INDICATION AND USAGE

REZZAYO^® (rezafungin for injection) 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.

Limitations of Use

REZZAYO^® has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

IMPORTANT SAFETY INFORMATION

Contraindications

REZZAYO^® is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

Warnings and Precautions

• Infusion-related Reactions: 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.
• Photosensitivity: REZZAYO^® may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
• Hepatic Adverse Reactions: 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.

Adverse Reactions

Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Please see full Prescribing Information for REZZAYO^® (rezafungin for injection).