Rezafungin

Rezafungin is an echinocandin antifungal drug [see Microbiology ( 12.4 )] .

• REZZAYO is an echinocandin antifungal 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 for REZZAYO.ICD-10: B37.9

• REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Known hypersensitivity to rezafungin or other echinocandins.contraindicated

Administer the recommended dosage of REZZAYO once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter. The safety of REZZAYO has not been established beyond 4 weekly doses. ( 2.1 ) See full prescribing information for reconstitution, dilution, and administration instructions. ( 2.2 , 2.3 , 2.4 ) 2.1 Recommended Dosage Administer the recommended dosage of REZZAYO once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter. The safety of REZZAYO has not been established beyond 4 weekly doses [see Adverse Reactions ( 6.1 )] . REZZAYO is for intravenous infusion only [see Dosage and Administration ( 2.4 )] . 2.2 Missed Doses If a scheduled dose is missed (not taken on the assigned day), administer the missed dose as soon as possible. If the missed dose is administered within 3 days of the assigned day, the next weekly dose may be given on schedule. If the missed dose is administered more than 3 days after the assigned day, revise the dosing schedule to ensure there are at least 4 days before the next dose. If restarting after at least 2 weeks of missed dosing, the dosing should be started again at the 400 mg loading dose. 2.3 Preparation and Administration of REZZAYO Reconstitution REZZAYO is supplied as a single-dose vial containing 200 mg of rezafungin. For the 400 mg dose, aseptically reconstitute two vials each with 9.5 mL of sterile Water for Injection, to provide a concentration of 20 mg/mL in each vial.

Hypersensitivity Reactions, including Anaphylaxis: Cases of serious hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving REZZAYO. If these reactions occur, discontinue REZZAYO and administer appropriate treatment ( 5.1 ). Infusion-related Reactions: REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. ( 5.2 ) Photosensitivity: REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. ( 5.3 ) Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. ( 5.4 ) 5.1 Hypersensitivity Reactions, including Anaphylaxis Cases of serious hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving REZZAYO. If these reactions occur, discontinue REZZAYO and administer appropriate treatment [see Adverse Reactions ( 6.2 )] . 5.2 Infusion-Related Reactions Infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, and chest tightness have been observed in clinical trials with REZZAYO. If these reactions occur, slow or pause the infusion and restart at a lower rate [see Dosage and Administration ( 2.4 )] . 5.3 Photosensitivity REZZAYO may cause photosensitivity.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions, including Anaphylaxis [see Warnings and Precautions ( 5.1 )] Infusion-related Reactions [see Warnings and Precautions ( 5.2 )] Hepatic Adverse Reactions [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Melinta Therapeutics at 1-844-633-6568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of REZZAYO cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of REZZAYO was assessed in 76 subjects in phase 1 studies and 232 patients with candidemia and invasive candidiasis in Trials 1 and 2, who received a 400 mg loading dose followed by a 200 mg dose once weekly or higher (please note that after the loading dose of 400 mg, weekly doses higher than 200 mg are not approved). A total of 151 patients received an initial 400 mg loading dose followed by a 200 mg dose once weekly thereafter (400 mg/200 mg dose); the maximum duration of dosing was 4 weekly doses (including the loading dose).

8.1 Pregnancy Risk Summary There are no data on the use of REZZAYO during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No adverse embryofetal outcomes were observed when rezafungin was dosed intravenously to pregnant rats or rabbits during the period of organogenesis up to approximately 5 or 3 times the clinical exposure based on AUC comparison (see Data ) . In a pre- and post- natal study, there were no adverse effects on offspring growth, maturation, or measures of neurobehavioral or reproductive function in rats at doses up to about 5 times the recommended human dose based on AUC comparisons. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal development study, intravenous rezafungin was administered at doses up to 45 mg/kg, once every 3 days to female rats one week prior to pairing with untreated males, and dosing was continued through mating to gestation day 17.

Metabolism

Following single and multiple dosing, the C max and AUC of rezafungin increase in a dose-proportional manner over a dose range of 50 mg (0.125 times the approved maximum recommended loading dose) to 400 mg. Rezafungin population PK model derived pharmacokinetics (in patients with candidemia and invasive candidiasis (IC)) following administration of REZZAYO are provided in Table 3 and presented as mean ± standard deviation (SD).

No cases of overdose were reported during the clinical studies. Rezafungin is highly protein bound and not anticipated to be dialyzable.

• Mar 22, 2023NDANDA217417Mundipharma

1. 1Off Label Use3545%
2. 2Product Prescribing Issue1215%
3. 3No Adverse Event1114%
4. 4Drug Ineffective45.1%
5. 5Product Use Issue45.1%
6. 6Candida Infection33.8%
7. 7Death33.8%
8. 8Drug Ineffective For Unapproved Indication33.8%
9. 9Dyspnoea33.8%
10. 10Product Dose Omission Issue33.8%
11. 11Covid-1922.6%
12. 12Dizziness22.6%
13. 13Drug Resistance22.6%
14. 14Erythema22.6%
15. 15Extravasation22.6%

The 10 most recently updated of 11 ClinicalTrials.gov registrations naming Rezafungin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options
  Active not recruiting · Phase 2 · Interventional · 60 enrolled · Mundipharma Research Limited
  NCT06794554updated 2026-05-14
• Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
  Completed · Phase 3 · Interventional · 602 enrolled · Mundipharma Research Limited
  NCT04368559updated 2026-04-13
• Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis
  Recruiting · Observational · 20 enrolled · Central Hospital, Nancy, France
  NCT07093203updated 2026-04-01
• Rezafungin Prophylaxis in Liver Transplant
  Enrolling by invitation · Phase 3 · Interventional · 385 enrolled · Fernanda P Silveira, MD, MS
  NCT06774144updated 2025-10-20
• Pharmacokinetic Study of Rezafungin in Patients With Suspected Intra-Abdominal Candidiasis
  Not yet recruiting · Phase 4 · Interventional · 20 enrolled · Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
  NCT06985758updated 2025-06-22
• Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age
  Terminated · Phase 1 · Interventional · 32 enrolled · Mundipharma Research Limited
  NCT05534529updated 2025-04-06
• A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
  Not yet recruiting · Observational · 150 enrolled · Augusta University
  NCT06907992updated 2025-04-04
• Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults
  Recruiting · Phase 2 · Interventional · 50 enrolled · Mundipharma Research Limited
  NCT05835479updated 2025-04-03
• Rezafungin Pharmacokinetics in Patients on ECMO
  Withdrawn · Phase 1 · Interventional · 0 enrolled · Hartford Hospital
  NCT06329518updated 2024-12-17
• Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
  Completed · Phase 3 · Interventional · 199 enrolled · Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
  NCT03667690updated 2023-01-06

Frequently asked questions

How does Rezafungin work?

Rezafungin is an echinocandin antifungal drug [see Microbiology ( 12.4 )] .

What is Rezafungin used for?

According to FDA labeling, Rezafungin carries indications including: REZZAYO is an echinocandin antifungal 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 for REZZAYO.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Rezafungin?

Rezafungin is classified as Echinocandin Antifungal, Glucan Synthase Inhibitors, Decreased Cell Wall Integrity.

What are the brand names for Rezafungin?

Rezafungin is marketed under brand names including Rezzayo.

What are the contraindications for Rezafungin?

Rezafungin labeling lists contraindications including: REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Known hypersensitivity to rezafungin or other echinocandins.. Always consult the full prescribing information and a clinician.