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Rezafungin (Rezzayo)

Reconstitution and dilutionFull monograph review pending

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Historical dilution reference. Verify the preparation against the label for the product in hand.

Original GlobalRPh article: REZZAYO™ -rezafungin (opens in a new tab)Original source URL: https://globalrph.com/dilution/rezzayo-rezafungin/ Retrieved 2026-11-04

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https://globalrph.com/dilution/rezzayo-rezafungin/ (opens in a new tab)
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Not established in the retrieved source
Retrieved
2026-11-04T19:50:36.387150+00:00
Source location
div.post-content
Packaged content SHA-256
32c887328055671b7bd227fb2f6ab821ca8fa4e0e8842db728f7ce90a7d9a69f
Original response SHA-256
907f64c063b9eaef9aacf0c0984f054021614950f6434f931877418a5a66e78c
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4caae980d1806e402f860198f3fc058fce8d31a133f9071a4151bfb4fcc611de

REZZAYO™ (rezafungin for injection)

PRESCRIBING HIGHLIGHTS: Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.

Drug UPDATES: [Drug information (pdf)]
PACKAGE INSERT -Dosing: Click (+) next to Dosage and Administration section (drug info link)

Usual Diluents Return to article top

0.9% Sodium Chloride Injection,
0.45% Sodium Chloride Injection,
or 5% Dextrose Injection

Standard Dilutions [Amt of drug] [Infusion vol] [Infusion rate] Return to article top

[ 400mg] [250 ml*] [60 minutes^] (loading dose)
[ 200mg] [250 ml*] [60 minutes^]

* Total volume = 250 mL.
^ Administer REZZAYO by intravenous infusion over approximately one hour (~250 mL/h). If infusion-related reactions occur, the infusion may be slowed, or paused and restarted at a lower rate

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.

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.

For the 200 mg dose, aseptically reconstitute one vial with 9.5 mL of sterile Water for Injection, to provide a concentration of 20 mg/mL.

Swirl gently to dissolve the white to pale yellow cake or powder. Avoid shaking to minimize foaming. The solution should be clear to pale yellow after dissolution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the reconstituted solution is cloudy or has precipitated. The reconstituted solution is not for direct injection and must be diluted before intravenous infusion.

Storage of the Reconstituted Solution

REZZAYO reconstituted solution can be stored between 5°C to 25°C (41°F to 77°F). Stability of the reconstituted solution has been demonstrated for 24 hours when stored at 5°C to 25°C (41°F to 77°F).

Preparation of Intravenous Infusion Solution

See TABLE 1 for the dilution requirements for infusion solution. First, aseptically withdraw and discard the appropriate volume of diluent from the intravenous bag containing 250 mL of 0.9% Sodium Chloride Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose Injection. Next, aseptically transfer the indicated volume of reconstituted solution (10 mL per vial) into the intravenous bag.

REZZAYO vials are single-dose vials. Discard any unused portion.

Table 1: Dilution Requirements for REZZAYO Prior to Administration
Dose Number of 200 mg
Vials Required		 Total Reconstituted
Volume Required		 Infusion Diluent
Volume Discarded		 Infusion Diluent
Volume Used		 Total Infusion
Volume
400 mg 2 20 mL 20 mL 230 mL 250 mL*
200 mg 1 10 mL 10 mL 240 mL 250 mL†

*Infusion solution concentration for the 400 mg dose = 1.6 mg/mL
† Infusion solution concentration for the 200 mg dose = 0.8 mg/mL

Description:

CLINICAL PHARMACOLOGY: Return to article top

Mechanism of Action:

Netu

INDICATIONS AND USAGE Return to article top

INDICATIONS AND USAGE:
1.1 Indication
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 [see Microbiology (12.4)]. Approval of this indication is based on limited clinical safety and efficacy data for REZZAYO [see Clinical Studies (14)].

Limitations of Use
REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

1.2 Usage
Specimens for culture and other laboratory data (e.g., histopathology, non-culture diagnostics) should be obtained prior to initiating antifungal therapy. Therapy may be initiated before the results of the cultures and other laboratory tests are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

CONTRAINDICATIONS Return to article top

Contraindications:

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

WARNINGS AND PRECAUTIONS:

5.1 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)].

5.2 Photosensitivity
REZZAYO may cause photosensitivity. Patients should be advised to use protection from sun exposure and other sources of UV radiation during REZZAYO treatment.

5.3 Hepatic Adverse Reactions
Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO [see Adverse Reactions (6.1)- Drug information (pdf)]. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with REZZAYO, clinically significant hepatic abnormalities have occurred. Monitor patients who develop abnormal liver tests during REZZAYO therapy and evaluate patients for their risk/benefit of continuing REZZAYO therapy.

ADVERSE REACTIONS Return to article top

ADVERSE REACTIONS:
Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. Drug information

DOSAGE AND ADMINISTRATION Return to article top

DOSAGE AND ADMINISTRATION:

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.

For the 200 mg dose, aseptically reconstitute one vial with 9.5 mL of sterile Water for Injection, to provide a concentration of 20 mg/mL.

Swirl gently to dissolve the white to pale yellow cake or powder. Avoid shaking to minimize foaming. The solution should be clear to pale yellow after dissolution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the reconstituted solution is cloudy or has precipitated. The reconstituted solution is not for direct injection and must be diluted before intravenous infusion.

Storage of the Reconstituted Solution

REZZAYO reconstituted solution can be stored between 5°C to 25°C (41°F to 77°F). Stability of the reconstituted solution has been demonstrated for 24 hours when stored at 5°C to 25°C (41°F to 77°F).

Preparation of Intravenous Infusion Solution

See TABLE 1 for the dilution requirements for infusion solution. First, aseptically withdraw and discard the appropriate volume of diluent from the intravenous bag containing 250 mL of 0.9% Sodium Chloride Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose Injection. Next, aseptically transfer the indicated volume of reconstituted solution (10 mL per vial) into the intravenous bag.

REZZAYO vials are single-dose vials. Discard any unused portion.

Table 1: Dilution Requirements for REZZAYO Prior to Administration
Dose Number of 200 mg
Vials Required		 Total Reconstituted
Volume Required		 Infusion Diluent
Volume Discarded		 Infusion Diluent
Volume Used		 Total Infusion
Volume
400 mg 2 20 mL 20 mL 230 mL 250 mL*
200 mg 1 10 mL 10 mL 240 mL 250 mL†

*Infusion solution concentration for the 400 mg dose = 1.6 mg/mL
† Infusion solution concentration for the 200 mg dose = 0.8 mg/mL

Storage of the Intravenous Infusion Solution

Store REZZAYO infusion solution between 5°C to 25°C (41°F to 77°F). Stability of the infusion solution has been demonstrated for 48 hours at 5°C to 25°C (41°F to 77°F).

The infusion solution must not be frozen.

2.4 Administration of Intravenous Infusion Solution
Administer REZZAYO by intravenous infusion over approximately one hour (~250 mL/h). If infusion-related reactions occur, the infusion may be slowed, or paused and restarted at a lower rate

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.

16.1 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)

Storage and Stability Return to article top

16.2 Storage and Handling
REZZAYO Vials

REZZAYO vials should be stored at 20°C to 25°C (68°F to 77°F). Brief exposure to 15°C to 30°C (59°F to 86°F) permitted [see USP Controlled Room Temperature].

Reconstituted Solution

REZZAYO reconstituted solution can be stored between 5°C (41°F) and 25°C (77°F) for up to 24 hours [see Dosage and Administration (2.3)].

IV Infusion Solution

REZZAYO infusion solution can be stored between 5°C (41°F) and 25°C (77°F) for up to 48 hours. Do not freeze [see Dosage and Administration (2.3)].

Open this historical article on its own

U.S. label preparation

Rezzayo · Reconstitution and dilution

Preparation
Add 9.5 mL sterile water for injection to each 200 mg vial (20 mg/mL). Prepare the dose in a 250 mL bag of 0.9% or 0.45% sodium chloride or 5% dextrose.
Administration and handling
Remove the labeled volume before adding the drug. Follow the 200 mg or 400 mg preparation row and infuse over approximately 1 hour.
Rezzayo dilution using a 250 mL bag
Prescribed doseDiluent to removeReconstituted drug to addFinal concentration
200 mg10 mL10 mL0.8 mg/mL
400 mg20 mL20 mL1.6 mg/mL

Both rows produce a total volume of 250 mL. See section 2.3, Table 1.

Product and source details

Melinta Therapeutics, LLC · NDA217417

Product NDC: 70842-240

SPL effective 2026-07-01 | SPL version 5. Checked 2026-11-13.

Source for this summary: U.S. prescribing information. Use the full label for dose selection, contraindications, preparation tables and monitoring.

Reviewed product information

Applies to

Rezzayo 200 mg lyophilized single-dose vial, adult IV preparation.

Both sources support the adult steps shown. The U.S. prescribing information controls the other product-specific instructions.

Preparation sources checked 2026-11-13.

Reconstitution

Add 9.5 mL of sterile water for injection per 200 mg vial to obtain 20 mg/mL.

Sources and exact locations

Claim ID: IVR-71-REZZAYO-001

Review basis: Separately edited institutional reference

  1. Source 1

    Rezzayo U.S. prescribing information (opens in a new tab)

    Exact location: U.S. prescribing information, section 2.3

    Publisher: Melinta Therapeutics, LLC / DailyMed

    Source family: US product labeling 90073508-6dca-4d27-aa5a-ed837737c35b

    Retrieved: 2026-11-13

  2. Source 2

    Rezafungin intravenous infusion for adults (opens in a new tab)

    Exact location: Reconstitution

    Publisher: Galway University Hospitals Medicines Information

    Source family: Galway University Hospitals

    Retrieved: 2026-11-13

Dilution

Further dilute the dose for infusion. A 250 mL preparation with 0.9% sodium chloride or 5% dextrose is supported by both sources.

Sources and exact locations

Claim ID: IVR-71-REZZAYO-002

Review basis: Separately edited institutional reference

  1. Source 1

    Rezzayo U.S. prescribing information (opens in a new tab)

    Exact location: U.S. prescribing information, section 2.3

    Publisher: Melinta Therapeutics, LLC / DailyMed

    Source family: US product labeling 90073508-6dca-4d27-aa5a-ed837737c35b

    Retrieved: 2026-11-13

  2. Source 2

    Rezafungin intravenous infusion for adults (opens in a new tab)

    Exact location: Infusion fluids and Methods of intravenous administration

    Publisher: Galway University Hospitals Medicines Information

    Source family: Galway University Hospitals

    Retrieved: 2026-11-13

Infusion

Administer the prepared adult infusion over approximately 1 hour.

Sources and exact locations

Claim ID: IVR-71-REZZAYO-003

Review basis: Separately edited institutional reference

  1. Source 1

    Rezzayo U.S. prescribing information (opens in a new tab)

    Exact location: U.S. prescribing information, section 2.4

    Publisher: Melinta Therapeutics, LLC / DailyMed

    Source family: US product labeling 90073508-6dca-4d27-aa5a-ed837737c35b

    Retrieved: 2026-11-13

  2. Source 2

    Rezafungin intravenous infusion for adults (opens in a new tab)

    Exact location: Methods of intravenous administration

    Publisher: Galway University Hospitals Medicines Information

    Source family: Galway University Hospitals

    Retrieved: 2026-11-13

Product identifiers and clinical review status

U.S. label preparation available. Full monograph review pending.

Selected product identity

U.S. vial matched for these adult preparation steps.

View product identifiers and primary-label provenance
Selected product scope
Rezzayo 200 mg lyophilized single-dose vial, adult IV preparation.
Labeler
Melinta Therapeutics, LLC
Application number(s)
NDA217417
NDC(s)
70842-240-01
DailyMed Set ID
90073508-6dca-4d27-aa5a-ed837737c35b
SPL version
5
Label printed revision date
Not established
SPL effective date
2026-07-01
Retrieved
2026-11-13
Downloaded XML SHA-256
b11728c727f9be7c726774edbf28e1be024eb82aad026874bc3bc13f6c804999
What remains to be completed
  • Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
  • Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.

Open the original GlobalRPh site monograph (historical; not revalidated) (opens in a new tab)

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