INFUSION SITE OF CARE REQUIREMENTS Preparation, Storage and Handling Prepare sterile infusions in a manner consistent with local laws, regulations, guidelines and policies and with National Infusion Center Association (NICA) standards for outpatient infusion.* National Infusion Center Association Parenteral Medication Preparation Guidelines According to NICA standards, prepared product is intended for immediate administration to an individual patient. Administration of parenteral medications should begin immediately, ideally within one hour of beginning preparation. If extenuating circumstances preclude immediate administration, manufacturer guidelines regarding stability and storage must be followed; however, storage should not exceed 4 hours unless the product was prepared in accordance with United States Pharmacopeia (USP) General Chapter 797 pharmacy standards for compounding sterile products. • Use aseptic technique and applicable good clinical practice for intravenous solution preparations of bamlanivimab in accordance with NICA standards. • Only use materials which are listed as compatible with bamlanivimab for preparation and administration of the infusion solutions (see Compatible Materials section below). • Gather the recommended materials for infusion: • Polyvinylchloride (PVC) infusion set containing a 0.20/0.22 micron filter. • Use new, sterile syringes and needles to prepare each dosing solution of bamlanivimab. • Refrigerate bamlanivimab drug product when not in use at 2°C to 8°C (36°F to 46°F). • Bamlanivimab should be free of any visible particulate matter. Obtain new vial(s) and/or IV bags if the drug product contains any visible particulate matter. • All medication must be stored, inventoried and destroyed according to applicable regulations. • Bamlanivimab is administered by intravenous (IV) infusion either using an infusion pump or gravity infusion. Consider use of a rate control or infusion rate monitoring device if using gravity infusion. Tubing with an integrated rate flow regulator can also be considered if an infusion pump is not available. • The IV solutions are intended for immediate patient administration. If immediate administration is not possible (and the solution has been prepared according to USP 797 guidelines), 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. The hold time includes preparation, solution hold, infusion and flush. Any solution which exceeds these time period requirements and/or is not compounded according to USP 797 guidelines MUST BE DISCARDED and a fresh solution MUST BE PREPARED. *Find more information on National Infusion Center Association (NICA) standards for outpatient infusion. Lilly Bamlanivimab Antibody Playbook | 16 PP-BM-US-0024
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