BIVIGAM- human immunoglobulin g injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)

זמין מ:

KEDRION BIOPHARMA, INC.

INN (שם בינלאומי):

HUMAN IMMUNOGLOBULIN G

הרכב:

HUMAN IMMUNOGLOBULIN G 1 g in 10 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סממני תרפויטית:

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

leaflet_short:

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.

מצב אישור:

Biologic Licensing Application

מאפייני מוצר

BIVIGAM - HUMAN IMMUNOGLOBULIN G INJECTION, SOLUTION
KEDRION BIOPHARMA, INC.
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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