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Invasive candidiasis contributes to a significant healthcare burden2,3
Despite current antifungal treatments, mortality rates for invasive candidiasis range from 20% to 50% globally.2
Patients with invasive candidiasis have been found to stay in hospital for a median of 61 days (range 11-400)4,6-13
Patients with invasive candidiasis are likely to spend a median of 4–33 days in the ICU5,12,14-16
- A study conducted by the ECMM in 20 European countries showed that 16% of patients with candidaemia had a prolonged hospital stay due to parenteral antifungal treatment (n=100/621)3
Explore the clinical trials supporting REZZAYO®
The benefits of REZZAYO® -
the first once-weekly echinocandin1
REZZAYO® is different from other echinocandins because of the combination of its front-loaded dosing and distinct structural features which confers greater stability, leading to a prolonged half-life (5–6 days) that allows for once-weekly dosing1,17–20
REZZAYO® brings the benefits of a once-weekly therapeutic, without compromising efficacy21,22
- In the pivotal phase III ReSTORE+ trial, once-weekly REZZAYO® demonstrated non-inferiority in global response at day 14 (as assessed by data review committee (DRC)) compared to the once-daily caspofungin group (optional step down to oral fluconazole after 3 days or more for stable patients who met relevant criteria) in the mITT population. Primary efficacy outcome met.1,21
Demonstrated activity across a broad range of Candida species, including some harder-to-treat species, such as C. glabrata and C. parapsilosis22–24
The need for dose adjustments of rezafungin is considered unlikely when co-administered with other medicinal products* and not required for special populations.1**
REZZAYO® is the first once-weekly echinocandin indicated for the treatment of invasive candidiasis in adults1,22 which could enable use across ICU, ward and outpatient healthcare settings.
+ReSTORE was a prospective, double blind, randomised, non-inferiority phase III trial of once-weekly intravenous REZZAYO® vs daily caspofungin (with an optional stepdown to oral fluconazole after 3 days or more) for the treatment of invasive candidiasis in adults, conducted at 66 tertiary care centres in 15 countries. 199 patients met inclusion criteria. 187 patients were included in the mITT population includes all subjects who had documented Candida infection based on Central Laboratory evaluation of a culture from blood or another normally sterile site obtained ≤4 days (96 hours) before randomisation and received ≥1 dose of study drug). DRC-assessed global cure consisted of clinical cure as assessed by the investigator, radiological cure (for patients with invasive candidiasis documented by radiological or imaging evidence at baseline), and mycological eradication.21
*Based on currently available data the need for dose adjustments is considered unlikely for medicinal products that are substrates for the CYP2C8, CYP3A4, CYP1A2, and CYP2B6 enzymes and P-gp, BCRP, OATP, OCT1, OCT2, MATE1, and MATE2 transporter proteins, when administered with rezafungin. The drug-drug interaction potential of rezafungin with a number of co-administered medicinal products has also been assessed clinically. The need for dose adjustments is considered unlikely for tacrolimus, cyclosporine, ibrutinib, mycophenolate mofetil, and venetoclax when administered with rezafungin.1,25
**Based on currently available data, patients with hepatic or renal impairment, elderly (≥65 years) or obese (BMI ≥30) patients, and can be administered independently of the timing of haemodialysis 1,25
Download the REZZAYO® formulary pack to learn more about the potential benefits of REZZAYO® in your hospital
- REZZAYO® (rezafungin). Summary of Product Characteristics. Napp 2024.
- WHO fungal priority pathogens list to guide research, development and public health action. Available from: https://www.who.int/publications/i/item/9789240060241. [Last accessed August 2024].
- Hoenigl M, et al. Lancet Infect Dis. 2023;23(6):751–761.
- Choi H, et al. Int J Infect Dis. 2019;83:49–55.
- Bloos F, et al. J Crit Care. 2013;28(1):2–8.
- Ha YE, et al. Antimicrob Agents Chemother. 2012;56(7):3950–3956.
- Aldardeer NF, et al. BMC Infect Dis. 2020;20(1):55.
- Kofteridis DP, et al. Mycopathologia. 2017;182(7–8):665–672.
- Li WS, et al. Front Microbiol. 2018;9:1196.
- Liu F, et al. Infect Drug Resist. 2021;14:3233–3246.
- Menichetti F, et al. J Chemother. 2018;30(5):304–309.
- Ylipalosaari P, et al. Crit Care. 2012;16(2):R62.
- Zhong L, et al. BMC Infect Dis. 2020;20(1):810.
- Armaganidis A, et al. Mycoses. 2017;60(7):454–461.
- Cui N, et al. BMC Infect Dis. 2017;17(1):93.
- Baronia A et al. Indian Journal of Critical Care Medicine. 2017 Jan;21(1):40–5.
- Caspofungin. Summary of Product Characteristics.
- Micafungin. Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/product-information/mycamine-epar-product-information_en.pdf [Last accessed August 2024].
- Anidulafungin. Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/product-information/ecalta-epar-product-information_en.pdf [Last accessed August 2024].
- Krishnan BR, et al. J Antibiot (Tokyo). 2017;70(2):130–135.
- Thompson GR III, et al. Lancet. 2023;401(10370):49–59.
- Thompson GR III, et al. Lancet Infect Dis. 2023; article in press.
- Fioriti S, et al. J. Fungi. 2022;8:1077.
- Govrins M & Lass-Flörl C. Nature Reviews Microbiology. https://doi.org/10.1038/s41579-023-00961-8 [Last accessed August 2024].
- Flanagan S, et al. Microbiol Spectr. 2023;11(3):e0133923.
Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk/.
Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444 or drugsafetyUKandROI@mundipharma.com.
®: REZZAYO is a Registered Trademark of Napp Pharmaceutical Group Limited.