REZZAYO Powder for solution for injection Ref.[107368] Active ingredients: Rezafungin

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:

^* 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 [see Warnings and Precautions (5.1)].

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

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)].