HYQVIA™

HyQvia™

FDA INDICATION: Primary immunodeficiency disease (PIDD) Package Insert

IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE FORM: Liquid

DISTRIBUTOR: Shire

ROUTE OF ADMINISTRATION: Subcutaneous

PH: Immune Globulin Infusion 10% (Human): 4.6–5.1
Recombinant Human Hyaluronidase: 7.4

CONCENTRATION: 10%

IGA CONTENT: 37 μg/mL

% IGG: ≥98%

NA CONTENT: 8.5 mg/mL NaCl

DILUENT: N/A

OSMOLALITY (MOSM/L): Immune Globulin Infusion 10% (Human): 240–300 mOsmol/kg
Recombinant Human Hyaluronidase: 290–350 mOsm

INITIAL INFUSION RATE (SC ONLY): Administer the Recombinant Human Hyaluronidase of HyQvia at an initial rate per site of approximately 1–2 mL per minute, or as tolerated. Administer Immune Globulin Infusion 10% (Human) of HyQvia at rates provided in package insert.

SHELF LIFE: 36 months in the refrigerator. Three months at room temperature during the first 24 months from the date of manufacture printed on the carton.

STORAGE REQUIREMENTS: Store in the refrigerator or at room temperature per shelf life. Do not freeze. Protect from light.
Refrigeration: 2–8°C (36–46°F)
Room temperature: up to 25°C (77°F)

PATIENT SUPPORT/ASSISTANCE PROGRAMSMyIgSource

OTHER WEBSITES: ImmuneDisease.comHyQvia.com