Administration Bamlanivimab 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 infusion and observe patients for at least 1 hour after infusion is complete. Storage 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 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. 3 DOSAGE FORMS AND STRENGTHS Injection: 700 mg/20 mL (35 mg/mL) as a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow to slightly brown solution in a single-dose vial. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS There are limited clinical data available for bamlanivimab. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab use. 5.1 Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions There is a potential for serious hypersensitivity reaction, including anaphylaxis, with administration of bamlanivimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care. 12 Reference ID: 4699500