Renal Impairment No dosage adjustment is recommended in patients with renal impairment [see Use in Specific Populations (11.5)]. Hepatic Impairment No dosage adjustment is recommended in patients with mild hepatic impairment. Bamlanivimab has not been studied in patients with moderate or severe hepatic impairment [see Use in Specific Populations (11.6)]. 2.4 Dose Preparation and Administration Preparation Bamlanivimab infusion solution should be prepared by a qualified healthcare professional using aseptic technique: • Remove bamlanivimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Do not expose to direct heat. • 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 the 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 Volume of Total Minimum Minimum of 0.9% sodium Volume Infusion Infusion Bamlanivimab chloride to for Rate Time (# of vials) Discard from Infusion a 250 mL IV bag Bamlanivimab 700 mg/20 mL 70 mL 200 mL 200 mL/hr 60 minutes (1 vial) 11 Reference ID: 4699500