REZZAYO™ (rezafungin for injection)
Drug UPDATES: [Drug information (pdf)]
PACKAGE INSERT -Dosing: Click (+) next to Dosage and Administration section (drug info link)
0.45% Sodium Chloride Injection,
or 5% Dextrose Injection
[ 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
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.
| 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
Netu
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.
REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
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.
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
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.
| 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
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)
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)].
