Rezzayo FDA Approval History
Last updated by Judith Stewart, BPharm on March 27, 2023.
FDA Approved: Yes (First approved March 22, 2023)
Brand name: Rezzayo
Generic name: rezafungin
Dosage form: Powder for Injection
Company: Cidara Therapeutics, Inc.
Treatment for: Candidemia, Systemic Candidiasis
Rezzayo (rezafungin) is an echinocandin antifungal used for the treatment of candidemia and invasive candidiasis.
- Rezzayo is 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.
- Invasive candidiasis is a serious infection caused by a yeast (a type of fungus) called Candida that can affect the blood, heart, brain, eyes, bones, or other parts of the body. The most common form of invasive candidiasis is candidemia, which is a Candida infection of the bloodstream.
- Rezzayo is an echinocandin antifungal that works by inhibiting the formation of (1-3)-β-d-glucan (BDG), which an essential component of the fungal cell wall of many fungi, including Candida.
- Rezzayo is administered by intravenous (IV) infusion once weekly. The safety of Rezzayo has not been established beyond 4 weekly doses.
- Warnings and precautions associated with Rezzayo include infusion-related reactions, photosensitivity reactions, and abnormalities in liver tests.
- Common adverse reactions include diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.
Development timeline for Rezzayo
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
