How Long Does ASCENIV Last?

16 HOW SUPPLIED/STORAGE AND HANDLING ASCENIV is supplied in a single-use, tamper-evident vial. The components used in the packaging for ASCENIV are not made with natural rubber latex. ASCENIV is supplied in 50 mL size containing 5 grams of protein (NDC 69800-0250-1). Store at 2 to 8°C (36 to 46°F) for up to 36 months from the date of manufacture. Do not freeze. Product may be stored up to 4 weeks at ≤ 25° C (77° F). After storage at room temperature product must be used or discarded. 11 DESCRIPTION ASCENIV is a purified, sterile, ready-to-use preparation of concentrated human immunoglobulin G (IgG) antibodies. The distribution of IgG subclasses is similar to that of normal plasma. The active ingredient is human immunoglobulin purified from source human plasma and processed using a modified classical Cohn Method 6 / Oncley Method 9 fractionation process as well as anion and cation exchange steps for added purification. ASCENIV contains 100 ± 10 mg/mL protein, of which not less than 96% is human immunoglobulin obtained from source human plasma. It is formulated in water for injection containing 0.100-0.140 M sodium chloride, 0.20-0.29 M glycine, 0.15–0.25% polysorbate 80, and pH 4.0–4.6. ASCENIV contains ≤ 200 µg/mL of IgA. Each plasma donation used for the manufacture of ASCENIV is collected from FDA-licensed facilities and undergoes rigorous testing. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency v