Source: FDA, National Drug Code (US) Revision Year: 2023
REZZAYO (rezafungin for injection), for intravenous use is a sterile solid (cake or powder) that contains rezafungin acetate. Rezafungin acetate is a semisynthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. REZZAYO is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls.
REZZAYO contains 210 mg of rezafungin acetate, equivalent to 200 mg of rezafungin. REZZAYO also contains 47 mg histidine, 500 mg mannitol, 450 mg polysorbate 80, and hydrochloric acid and/or sodium hydroxide for pH adjustment. Rezafungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water, soluble in methanol, and sparingly soluble in ethanol.
Rezafungin acetate is chemically designated as Echinocandin B, 1-[(4R,5R)-4-hydroxy-N 2[[4"(pentyloxy)[1,1':4',1"-terphenyl]-4-yl]carbonyl]5[2-(trimethylammonio)ethoxy]-L-ornithine]4[(4S)-4-hydroxy-4-(4-hydroxyphenyl)-L-allothreonine]-, acetate (1:1).
The empirical formula of rezafungin acetate is C63H85N8O17 • C2H3O2, and the formula weight is 1285.46 g/mol.
The chemical structure of rezafungin acetate is:
| Dosage Forms and Strengths |
|---|
|
For injection: 200 mg of rezafungin as a sterile white to pale yellow solid (cake or powder) for reconstitution in a single-dose glass vial. |
| How Supplied |
|---|
|
REZZAYO (rezafungin for injection) is supplied as sterile white to pale yellow solid (cake or powder) in a single-dose 20 mL Type I glass vial with a stopper, an aluminum seal, and blue polypropylene flip-off cap. The vial stopper is not made with natural rubber latex. REZZAYO is available in the following packaging configuration: One single-dose vial of REZZAYO 200 mg (NDC 70842-240-01) Distributed by: Melinta Therapeutics LLC, Lincolnshire, IL 60069, USA Manufactured by: Patheon Italia S.p.A., a Thermo Fisher Scientific company, Viale Gian Battista Stucchi 110, 20900 Monza (MB), Italy |
| Drug | Countries | |
|---|---|---|
| REZZAYO | Austria, Estonia, France, Croatia, Ireland, Lithuania, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
