CUVITRU®

FDA INDICATION: Primary immunodeficiency disease (PIDD) Package Insert

FORM: Liquid

DISTRIBUTOR: Shire

ROUTE OF ADMINISTRATION: Subcutaneous

PH: 4.6–5.1

CONCENTRATION: 20%

IGA CONTENT: 80 mcg/mL

% IGG: ≥98%

NA CONTENT: Nondetectable

DILUENT: N/A

OSMOLALITY (MOSM/L): 280–292

INITIAL INFUSION RATE: Do not administer intravenously or intramuscularly. For the first two infusions, the manufacturer’s recommended infusion rate is 10–20 mL/hr/site. For subsequent infusions, the infusion rate may be increased to 60 mL/hr/site as tolerated (e.g., 60 mL/hr/site x 2 sites = 120 mL/hr). For patients utilizing 4 infusion sites, the maximum infusion rate for all sites combined is 240 mL/hr.

SUGAR CONTENT: No added sugars

SHELF LIFE: 36 months in the refrigerator. 12 months at room temperature within the first 24 months of date of manufacturer.

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

FLUSHING COMPATIBILITY: Saline or dextrose

PATIENT SUPPORT/ASSISTANCE PROGRAMS: MyIgSource.com

OTHER WEBSITES: ImmuneDisease.com, cuvitru.com