Now Approved: A Once-Weekly Echinocandin – 7/10/23

Now Approved: A ONCE-WEEKLY echinocandin

Available Summer 2023

REZZAYOTM (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.

How Supplied:

NDC

Package Description

WAC Pricing

70842-240-01

200 mg as a solid (cake or powder) in a single-dose vial for reconstitution

$1950/vial

Potential Diagnosis Codes:

ICD-10-CM

Description

B37.1

Pulmonary candidiasis

B37.7

Candidal sepsis

B37.81

Candidiasis of other sites

B37.82

Candidal enteritis

B37.89

Other sites of candidiasis

INDICATION AND USAGE

REZZAYOTM (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

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

IMPORTANT SAFETY INFORMATION

Contraindications

REZZAYOTM is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

Warnings and Precautions

  • Infusion-related Reactions: REZZAYOTM 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: REZZAYOTM 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 REZZAYOTM. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYOTM 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 REZZAYOTM (rezafungin for injection) at Rezzayo.com.

©2023 Melinta Therapeutics, LLC. All Rights Reserved. 04/2023 PP-REZ-US-0101