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    REZZAYO® rezafungin: a next generation echinocandin with a differentiated PK/PD profile optimised for early fungicidal activity1-3a

    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.1

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      Guideline recommended
      • The Global Candidiasis Guidelines, published in 2025 and endorsed by over 70 international societies, recommend that when considering the choice of echinocandin, patient-specific pharmacokinetic factors should be taken into account, such as:4
        • Hepatic impairment
        • High body weight
        • Potential drug–drug interactions
        • The use of extracorporeal membrane oxygenation
      • Echinocandins, including rezafungin, are recommended for all forms of invasive candidiasis, excluding CNS and ocular infections, due to their broad antifungal activity and favourable safety profile4
      • REZZAYO® is strongly recommended as one of the first line options for the treatment of candidaemia4
      • For the echinocandins other than REZZAYO®, the Global Candidiasis Guidelines  recommend de-escalation to azoles after five days of first-line treatment, but only in patients who fulfill all six prerequisites:4
        • Haemodynamically stable
        • Documented clearance of Candida from the bloodstream (at least 2 negative blood cultures)
        • Non-neutropenic
        • Source control (e.g., central venous catheter removal)
        • Oral azole tolerated
        • Susceptibility confirmed
           
        Differentiated PK/PD: optimised for early fungicidal activity
        • REZZAYO® has in vitro potency and spectrum of activity comparable to the other echinocandins5
        • REZZAYO® is optimised for early fungicidal activity with a higher Cmax, AUC over 48 hours and the first week than the other echinocandins3

        Not a head-to-head comparison. This analysis compared rezafungin data from two phase 1 safety trials in healthy adults with PK characteristics in US approval data for the other echinocandins3

          Broad spectrum of activity
          • REZZAYO® has activity across a broad range of Candida species, including species with higher mortality than C. albicans, such as C. tropicalis,  and C. glabrata6,9
            Safety and tolerability profile
            • REZZAYO® was generally well tolerated in the clinical trial programme1,2,6

            Additional safety considerations1

            Contraindication

            • Hypersensitivity to the active substance or to any of its excipients (see Section 6.1 of the summary of product characteristics).
            • Hypersensitivity to other medicinal products of the echinocandin class.

            Infusion-related reactions

            • Transient infusion-related reactions have occurred with REZZAYO® , characterised by flushing, sensation of warmth, nausea, and chest tightness.
            • In clinical trials, infusion reactions resolved within minutes, some without interruption or discontinuation of the infusion.
            • Patients should be monitored during the infusion.
            • If the infusion is stopped due to a reaction, consideration may be given to restarting the infusion at a slower rate after the symptoms have resolved.

            Phototoxicity

            • REZZAYO® may cause increased risk of phototoxicity.
            • Patients should be advised to avoid sun exposure and other sources of ultraviolet radiation without adequate protection during treatment and for 7 days after the last administration of REZZAYO®.

            Hepatic effect

            • In clinical trials, elevations in liver enzymes have been seen in some patients treated with REZZAYO®.
            • In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with REZZAYO®, clinically significant hepatic dysfunction has occurred.
            • A causal relationship to REZZAYO® has not been established.
            • Patients who develop elevations in liver enzymes during REZZAYO® therapy should be monitored and the risk/benefit of continuing REZZAYO® therapy should be re-evaluated.

            Other precautions for use

            • The efficacy of REZZAYO® has only been evaluated in a limited number of neutropenic patients.
              Simple dosing for complex patients

              REZZAYO® an echinocandin optimised for early and sustained fungicidal activity, helping patients in the ICU through to discharge.1
              REZZAYO® is prescribed as a single 400 mg loading dose on Day 1, followed by 200 mg on Day 8 and once weekly thereafter.1

              No dose adjustments are required for:1

              The need for dose adjustments is considered unlikely when REZZAYO® is administered
              with other medicinal products such as:1

              • Immunosuppressants (tacrolimus, cyclosporine, mycophenolate mofetil)
              • Targeted cancer therapies (venetoclax or ibrutinib)
              • Medications that are substrates for CYP enzymes and various transporter proteins*

              *REZZAYO® had no or minimal effects on the exposure of probe substrates for the following enzymes/transporter proteins: CYP2B6 (efavirenz); CYP3A4 (midazolam and tacrolimus); CYP1A2 (caffeine); CYP2C8 (repaglinide); P-glycoprotein (P-gp) (digoxin and tacrolimus); OCT-1, OCT-2, MATE-1 and MATE-2 (metformin); organic anion transporting polypeptides (OATP) (pitavastatin, rosuvastatin and repaglinide); and BCRP (rosuvastatin). 1,10

              REFERENCES:

              • 1. REZZAYO® (rezafungin). Summary of Product Characteristics. Napp 2025.
              • 2. Thompson GR III, et al. Lancet. 2023;401(10370):49 -59.
              • 3. Sandison T, et al. Antimicrob Agents Chemother. 2017;61:e01627 -16.
              • 3a. Roepcke S, et al Antimicrob Agents Chemother. 2023 14;67(12)
              • 4. Cornely OA, et al. Lancet Infect Dis. 2025; S1473-3099(24)00749-7.
              • 5. Sofjan AK, et al. J Glob Antimicrobial Resist 2018;58-64.
              • 6. Thompson GR, et al. Lancet Infect Dis. 2024;24(3):319-328.
              • 7. Honoré PM, et al. Critical Care 2024; 28:348
              • 8. Thompson GR III, et al. Presented at ESCMID 2025; abstract 02761
              • 9. Salmanton-García J, et al. J Infect 2024; 89(3): 106229.
              • 10. Flanagan S, et al. Microbiol Spectr. 2023;11(3):e0133923

              *Stable patients in the caspofungin group who met relevant criteria could step down to fluconazole after 3 days or more.2,6
              **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 IC/C in adults. ReSTORE was first published in 2023. The data above shows ReSTORE with china extension which refers to additional patients recruited in China only as part of an extended recruitment period of the global ReSTORE study. In the 2023 publication 187 patients were included in the mITT population which 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. The primary endpoint of ReSTORE was global response (confirmed by the Data Review Committee) which was determined from clinical response, mycological response, and radiological response (for qualifying subjects with invasive candidiasis). Global response rates at day 14 in the mITT population: REZZAYO® group, 55/93 adult patients (59.1%); caspofungin group, 57/94 adult patients (60.6%). Weighted treatment difference -1.1%; 95% CI -14.9 to 12.7.1,2


              †In a pre-planned pooled analysis of ReSTORE (phase III) and STRIVE (phase II) all cause mortality at day 30 (mITT population) was 18.7% [26/139] in the REZZAYO® group and 19.4% [30/155] in the caspofungin group, difference -1.5 [95% CI - 10.7 to 7.7]. Mycological eradication at day 5 was 73% (102/139) in the REZZAYO® group and 65% (100/155) in the caspofungin group (weighted treatment difference 10.0% [95% CI −0.3 to 20.4]). At day 14 it was 72% (100/139) in the REZZAYO® group and 68% (106/155) in the caspofungin group (weighted treatment difference 4.3% [95% CI -6.2 to 14.7]). For species with low n number, descriptive statistics were provided. For Candida krusei, 2/5 patients in the REZZAYO® group and 2/3 in the caspofungin group achieved mycological eradication at day 5. At day 14, 2/5 patients in the rezafungin group and 3/3 patients in the caspofungin group achieved mycological eradication. For Candida metapsilosis, 3/3 patients in the REZZAYO® group achieved mycological eradication at day 5 and day 14. No patients in the caspofungin group were infected with Candida metapsilosis. For Candida dubliniensis, 3/3 patients in the REZZAYO® group and 2/2 patients in the caspofungin group achieved mycological eradication at day 5 and day 14. For Candida guilliermondii, 1/2 patients in the REZZAYO® group achieved mycological eradication at day 5 and day 14. No patients in the caspofungin group were infected with Candida guilliermondii. For Candida kefyr, 1/1 patients in the caspofungin group achieved mycological eradication at day 5 and day 14. No patients in the v group were infected with Candida kefyr. For Candida nivariensis, 1/1 patients in the caspofungin group achieved mycological eradication at day 5 and day 14. No patients in the REZZAYO® group were infected with Candida niviariensis. For Candida lusitaniae, 1/1 patients in the REZZAYO® group and 1/1 patients in the caspofungin group achieved mycological eradication at day 5 and day 14.6
               

                Prescribing information

                Prescribing information is available from the link below:
                UK Prescribing information

                ®: REZZAYO is a Registered Trademark of Napp Pharmaceutical Group Limited.

                UK-RZF-2500183 | December 2025

                Reporting adverse events

                Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

                Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444 or drugsafetyUKandROI@mundipharma.com.