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 [5.2], Patient
Counseling Information [17.).
• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV
products in predisposed patients..
• Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing
sucrose. ASCENIV does not contain sucrose.
• For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV 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 [2.1, 2.3], Warnings and Precautions [5.3]).
1 INDICATIONS AND USAGE
ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection,indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age).
PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common
variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severecombined immunodeficiencies (SCID).
2 DOSAGE AND ADMINISTRATION
2.1 Dose
The recommended dose of ASCENIV for replacement therapy in primary humoral immunodeficiency (PI) is 300 to 800 mg/kgbody weight administered every 3 to 4 weeks. The dose may be adjusted over time to achieve the desired trough levels andclinical response.
ASCENIV dose adjustments may be required in patients who fail to maintain trough total IgG concentrations of at least 500 mg/dLwith a target of 600 mg/dL. Starting with the second infusion, adjust the dose proportionally, targeting a trough of ≥ 600 mg/dL,based on the previous trough and the associated dose.
For intravenous use only.
Table 1
Dose Initial Infusion
Rate
Maintenance Infusion Rate
(if tolerated)
300-800 mg/kg every
3-4 weeks
0.5 mg/kg/min
(0.005 mL/kg/min)
for the first 15
minutes
Increase gradually every 15 minutes (if tolerated) up to 8
mg/kg/min (0.08 mL/kg/min)
2.2 Preparation and Handling
• ASCENIV is a clear to opalescent, colorless to pale yellow solution. Inspect visually for particulate matter anddiscoloration prior to administration. Do not use if the liquid is cloudy or turbid, or if it contains visible particulatematter.
• Allow refrigerated product to come to room temperature before use and maintain ASCENIV at room temperature duringadministration.
• DO NOT MICROWAVE.
• DO NOT SHAKE.
• DO NOT MIX with other IGIV products or other intravenous medications.
• DO NOT DILUTE.
• ASCENIV contains no preservatives. Each vial is for single use only. Do not reuse or save for future use.
• If large doses are required, several vials may be pooled using aseptic technique into sterile infusion bags and infused.
2.3 Administration
Begin with an initial infusion rate of 0.5 mg/kg/min. If there are no adverse reactions, the infusion rate for subsequent infusions can be slowly increased to the maximum rate.
Monitor patient vital signs throughout the infusion. Slow or s |
