GAMUNEX-C - human immunoglobulin g injection
Grifols Therapeutics Inc.
Immunoglobulin (also called gamma globulin or immune globulin) is a substance made from human blood plasma. The plasma, processed from donated human blood, contains antibodies that protect the body against diseases.
GAMUNEX� -C, [Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified]
WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
? Thrombosis may occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. (see Warnings and Precautions [5.4], Patient Counseling Information [17])
? For patients at risk of thrombosis, administer GAMUNEX-C at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. (see Dosage and Administration [2.5],Warnings and Precautions [5.4])
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.
Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose.(1) GAMUNEX-C does not contain sucrose.
For patients at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable. (see Warnings and Precautions [5.2])
1 INDICATIONS AND USAGE
GAMUNEX-C is an immune globulin injection (human) 10% liquid that is indicated for the treatment of:
1.1 Primary Humoral Immunodeficiency (PI)
GAMUNEX-C is indicated as replacement therapy of primary humoral immunodeficiency. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.(2-5)
1.2 Idiopathic Thrombocytopenic Purpura (ITP)
GAMUNEX-C is indicated for the treatment of patients with Idiopathic Thrombocytopenic Purpura to raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.(6,7)
1.3 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
GAMUNEX-C is indicated for the treatment of CIDP to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.
2 DOSAGE AND ADMINISTRATION
GAMUNEX-C consists of 9%�11% protein in 0.16�0.24 M glycine. The buffering capacity of GAMUNEX-C is 35.0 mEq/L (0.35 mEq/g protein). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45�50 mEq/L of blood, or 3.6 mEq/kg body weight. Thus, the acid load delivered with a dose of 1 g/kg of GAMUNEX-C would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously.
