Anpheros Search · Treatment

Rezafungin

Also known as: Rezzayo

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In short

In the European Union, rezafungin is indicated for the treatment of invasive candidiasis in adults, with consideration given to official guidance on the appropriate use of antifungal agents. In the United States, it is indicated in adults and pediatric patients 12 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis, based on limited clinical safety and efficacy data. The medicine has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

From: Source: European Medicines Agency (EMA), Rezzayo — EPAR, 15/06/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
2639155 rezafungin
EMA
EMEA/H/C/005900

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Rezzayo

Rezzayo is indicated for the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents.

Source: European Medicines Agency (EMA), Rezzayo — EPAR, 15/06/2026. © European Medicines Agency.

Document date: 15/06/2026 · Official document →

FDA (USA) REZZAYO

1 INDICATIONS AND USAGE REZZAYO is an echinocandin antifungal indicated in adults and pediatric patients 12 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 for REZZAYO. ( 1 , 12.4 , 14 ) Limitations of Use REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. ( 1 ) 1.1 Treatment of Candidemia and Invasive Candidiasis REZZAYO is indicated in adults and pediatric patients 12 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis [see Microbiology ( 12.4 )] . Approval of this indication is based on limited clinical safety and efficacy data for REZZAYO [see Clinical Studies ( 14 )] . Limitations of Use REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida . 1.2 Usage Specimens for culture and other laboratory data (e.g., histopathology, non-culture diagnostics) should be obtained prior to initiating antifungal therapy. Therapy may be initiated before the results of the cultures and other laboratory tests are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

Data provided by the U.S. Food and Drug Administration.

Document date: 20260701 · Official document →

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External resources

Questions

What is Rezafungin approved for in the European Union?

Rezzayo is indicated for the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents. (Source: European Medicines Agency (EMA), Rezzayo — EPAR, 15/06/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Rezzayo — EPAR, 15/06/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →