Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)
KEDRION BIOPHARMA, INC.
HUMAN IMMUNOGLOBULIN G
HUMAN IMMUNOGLOBULIN G 1 g in 10 mL
INTRAVENOUS
BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of patients with primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. - BIVIGAM is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. - BIVIGAM is contraindicated in IgA deficiency patients with antibodies to IgA and a history of hypersensitivity. Pregnancy Category C. Animal reproduction studies have not been conducted with BIVIGAM. It is not known whether BIVIGAM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. BIVIGAM should be given to pregnant women only if clearly needed.17,18 Use of BIVIGAM in nursing mothers has not been evaluated. BIVIGAM should be given to nursing m
BIVIGAM is supplied in a single-use, tamper-evident vial. The components used in the packaging for BIVIGAM are latex free. BIVIGAM is supplied in the following sizes: Storage Refrigerate between 2 to 8 degrees C (36 to 46 degrees F). Special Precautions for Storage Do not freeze or heat. Do not use any solutions that have been frozen or heated. Allow refrigerated product to come to room temperature before use. Do not use after expiration date. Shelf-life BIVIGAM may be stored until expiration date on vial packaging at 2 to 8 degrees C (36 to 46 degrees F). Incompatibilities Do not dilute. BIVIGAM should be infused using a separate line by itself, without mixing with other intravenous fluids or medications the patient may be receiving.
Biologic Licensing Application
BIVIGAM - HUMAN IMMUNOGLOBULIN G INJECTION, SOLUTION KEDRION BIOPHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BIVIGAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BIVIGAM. IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% LIQUID BIVIGAM INITIAL U.S. APPROVAL : 2012 WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ Thrombosis may occur with immune globulin intravenous (IGIV) products, including BIVIGAM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. [5.3] Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer BIVIGAM 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.[2.3,5.3] INDICATIONS AND USAGE BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of primary humoral immunodeficiency (PI). [1] DOSAGE AND ADMINISTRATION INTRAVENOUS USE ONLY Indication Dose Initial Infusion Rate Maintenance Infusion Rate (if tolerated) PI 300-800 mg/kg every 3- 4 weeks 0.5 mg/kg/min for the first 10 minutes. Increase every 20 minutes (if tolerated) by 0.8 mg/kg/min up to 6 mg/kg/min. Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue BIVIGAM if renal function deteriorates. [5.3] F Прочитайте повний документ