OCTAGAM® 5%

Octagam® 5%

FDA INDICATION: Primary immunodeficiency disease (PIDD) Package Insert

FORM: Liquid

DISTRIBUTOR: Octapharma

ROUTE OF ADMINISTRATION: Intravenous

PH (AFTER RECONSTITUTION): 5.1–6

CONCENTRATION: 5%

IGA CONTENT: ≤200 μg/mL

% IGG: ≥96%

NA CONTENT: <30 mmol/L

DILUENT: N/A

OSMOLALITY (MOSM/L): 310–380

INITIAL INFUSION RATE: Initial rate of 0.5 mg/kg/min

SUGAR CONTENT: 100 mg/mL maltose*

SHELF LIFE: 24 months

STORAGE REQUIREMENTS: Store at room temperature at 2–25°C (36–77°F). Do not freeze.

FLUSHING COMPATIBILITY: Saline or dextrose

OTHER WEBSITES: octagamus.net

 

* Some types of blood glucose testing systems (for example, those based on the glucose dehydrogenase pyrroloquinolinequinone [GDH-PQQ] or glucose-dye-oxidoreductase methods) falsely interpret the maltose contained in Octagam liquid as glucose. This has resulted in falsely elevated glucose readings and, consequently, in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia. Also, cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings. Accordingly, when administering Octagam liquid, the measurement of blood glucose must be done with a glucose-specific method. The product information of the blood glucose testing system, including that of the test strips, should be carefully reviewed to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the testing system to determine if the system is appropriate for use with maltose-containing parenteral products.