GAMMAGARD® S/D IGA

FDA INDICATION: Primary immunodeficiency disease (PIDD), idiopathic thrombocytopenic purpura (ITP), bacterial infection associated with B-cell chronic lymphocytic leukemia (CLL), and Kawasaki syndrome Package Insert

FORM: Lyophilized

DISTRIBUTOR: Shire

ROUTE OF ADMINISTRATION: Intravenous

PH (AFTER RECONSTITUTION): 6.8 ± 0.4

CONCENTRATION: 5% (for 10%, use half of supplied diluent)

IGA CONTENT: <1 μg/mL

% IGG: ≥90%

NA CONTENT: 85 mg/mL with 5% solution

DILUENT: Sterile water (96 mL for 5 gm 5%, 192 mL for 10 gm 5%)

OSMOLALITY (MOSM/L): 636 (5%), 1250 (10%)

INITIAL INFUSION RATE: 5% solution: 0.5 mL/kg/hr (0.8 mg/kg/min). Can gradually increase every 30 minutes to a rate of 4 mL/kg/hr.
10% solution: If 4 mL/kg/hr is tolerated, can increase to 10% solution starting at 0.5 mL/kg/hr to a max of 8mL/kg/hr.

SUGAR CONTENT: 20 mg/mL glucose with 5%

SHELF LIFE: 24 months

STORAGE REQUIREMENTS: Store at room temperature up to 25ºC (77ºF). Freezing should be avoided to prevent the diluent bottle from breaking.

FLUSHING COMPATIBILITY: Saline or dextrose

PATIENT SUPPORT/ASSISTANCE PROGRAMS: Gammagard Patient Support Program, MyIgSource

OTHER WEBSITES: gammagard.com, ImmuneDisease.com