• Inspect bamlanivimab visually for particulate matter and discoloration. o Bamlanivimab is a clear to slightly opalescent and colorless to slightly yellow to slightly brown solution. • Gently invert vial by hand approximately 10 times. Do not shake. • Dilute bamlanivimab using a 250 mL prefilled 0.9% Sodium Chloride Injection bag for intravenous infusion according to Table 1. o Withdraw and discard required volume of 0.9% Sodium Chloride Injection from infusion bag. o Withdraw required volume of bamlanivimab from the vial using an appropriately sized syringe. o Transfer bamlanivimab to the 0.9% Sodium Chloride Injection infusion bag. o Discard any product remaining in the vial. • Gently invert IV bag by hand approximately 10 times to mix. Do not shake. • This product is preservative-free and therefore, the diluted infusion solution should be administered immediately. If immediate administration is not possible, store the diluted bamlanivimab infusion solution for up to 24 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) or up to 7 hours at room temperature (20°C to 25°C [68°F to 77°F]) including infusion time. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 20 minutes prior to administration. Table 1: Recommended Dilution and Administration Instructions for Bamlanivimab Treatment Dose/Volume of Volume of Total Minimum Minimum Bamlanivimab 0.9% sodium Volume Infusion Infusion (# of vials) chloride to for Rate Time Discard from a Infusion 250 mL IV bag Bamlanivimab 700 mg/20 mL 70 mL 200 mL 200 mL/hr 60 minutes (1 vial) Administration Bamlanivimab infusion solution should be administered by a qualified healthcare professional. • Gather the recommended materials for infusion: o Polyvinylchloride (PVC) infusion set containing a 0.20/0.22 micron in-line polyethersulfone (PES) filter. • Attach the infusion set to the IV bag. • Prime the infusion set. • Administer the infusion solution via pump or gravity over at least 60 minutes (see Table 1). • Once infusion is complete, flush the infusion line to ensure delivery of the required dose. • Discard unused product. • Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete. 4 Reference ID: 4699500
FDA Letter of Authorization Page 11 Page 13