How Long Does ADZYNMA Last?

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ADZYNMA (rADAMTS13) is a sterile, nonpyrogenic, preservative free, white powder supplied in single-dose vials packaged with: one vial with 5 mL sterile water for injection, USP one BAXJECT II Hi-FLOW needleless transfer device one syringe one 25 gauge infusion set two individually packaged alcohol swabs one package insert ADZYNMA (rADAMTS13) is available in the following strengths: Color Code Nominal rADAMTS13 Potency rADAMTS13 vial NDC Carton NDC Syringe Fill Size Eggplant 500 IU 64764-130-01 64764-140-05 10 mL Marigold 1500 IU 64764-135-01 64764-145-05 20 mL The actual ADAMTS13 potency in international units is printed on the label of each ADZYNMA vial and carton. Components are not made with natural rubber latex. Storage and Handling Store at refrigerated temperature 2°C to 8°C (36°F to 46°F) for up to 36 months from the date of manufacture until expiration date stated on the ADZYNMA vial label and carton. Within this period, ADZYNMA may be stored at room temperature not to exceed 30°C/86°F for a period up to 6 months. After storage at room temperature, do not return to the refrigerator. Do not use beyond the expiration date printed on the ADZYNMA vial label or carton or if not stored properly. Do not freeze. Store in the original box and protect from extreme exposure to light. Use reconstituted product immediately or within 3 hours after reconstitution when stored at room temperature. Do not use if the solution in the syri