OCTAGAM® 10%

Octagam® 10%

FDA INDICATION: Chronic immune thrombocytopenic purpura (ITP) Package Insert

FORM: Liquid

DISTRIBUTOR: Octapharma

ROUTE OF ADMINISTRATION: Intravenous

PH (AFTER RECONSTITUTION): 4.5–5

CONCENTRATION: 10%

IGA CONTENT: 106 μg/mL (average)

% IGG: ≥96%

NA CONTENT: <30 mmol/L

DILUENT: N/A

OSMOLALITY (MOSM/L): 310–380 mOsmol/kg

INITIAL INFUSION RATE: 1.0 mg/kg/min (0.01 mL/kg/min)

MAINTENANCE INFUSION RATE (IF TOLERATED): Up to 12.0 mg/kg/min (Up to 0.12 mL/kg/min)

SUGAR CONTENT: 90 mg/mL maltose*

SHELF LIFE: 24 months in the refrigerator. Within the first 12 months of its shelf life, the product may be stored up to 9 months at ≤25°C (77°F). After storage at ≤25°C (77°F), the product must be used or discarded.

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

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.