Zynyz Injection Dosage

Recommended Dosage

The recommended dosages of ZYNYZ are provided in Table 1.

Administer ZYNYZ as an intravenous infusion after dilution, over 30 minutes, as recommended.

Dosage Modifications for Adverse Reactions

No dose reduction of ZYNYZ is recommended. In general, withhold ZYNYZ for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue ZYNYZ for life‑threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone equivalent per day within 12 weeks of initiating steroids.

Dosage modifications for ZYNYZ for adverse reactions that require management different from these general guidelines are summarized in Table 2.

Preparation and Administration

Visually inspect the vial for particulate matter and discoloration prior to administration. ZYNYZ is a clear to slightly opalescent, colorless to pale yellow solution and is free of particles. Discard the vial if the solution is cloudy, discolored, or contains particulate matter.

Do not shake the vial.

Preparation

1. Withdraw 20 mL (500 mg) of ZYNYZ from one vial and discard vial with any unused portion.
2. Dilute ZYNYZ with either 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration between 1.4 mg/mL and 10 mg/mL. Use polyvinylchloride (PVC) and di-2-ethylhexyl phthalate (DEHP), polyolefin copolymer, polyolefin with polyamide, or ethylene vinyl acetate infusion bags.
3. Mix diluted solution by gentle inversion. Do not shake.
4. Visually inspect the infusion bag for particulate matter and discoloration prior to administration. Discard if the solution is discolored or contains particulate matter.

Storage of diluted ZYNYZ solution

Protect the diluted ZYNYZ solution from light during storage.

Store diluted ZYNYZ solution:

• At room temperature [up to 25°C (77°F)] for no more than 8 hours from the time of preparation to the end of the infusion.

OR

• Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of preparation to the end of the infusion. If refrigerated, allow the diluted solution to come to room temperature prior to administration. The diluted solution must be administered within 4 hours (including infusion time) once it is removed from the refrigerator.

Do not freeze or shake diluted solution.

Administration

• Administer diluted ZYNYZ solution by intravenous infusion over 30 minutes through a polyethylene, polyurethane, or PVC with DEHP intravenous line containing a sterile, non‑pyrogenic, low-protein binding polyethersulfone, polyvinylidene fluoride, or cellulose acetate 0.2 micron to 5 micron in-line or add-on filter or 15 micron mesh in-line or add-on filter. Do NOT administer ZYNYZ as an intravenous push or bolus injection.
• Do not co‑administer other drugs through the same infusion line.