HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed touse ASCENIVTM safely and effectively. See full prescribinginformation for ASCENIV.
ASCENIV(immune globulin intravenous, human–slra)10% Liquid
Initial U.S. Approval: 2019
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 ASCENIV. Risk factors mayinclude: advanced age, prolonged immobilization,hypercoagulable conditions, history of venous or arterialthrombosis, use of estrogens, indwelling vascularcatheters, hyperviscosity, and cardiovascular risk factors.
• Renal dysfunction, acute renal failure, osmotic nephrosis,and death may occur with the administration of IGIVproducts in predisposed patients.
• Renal dysfunction and acute renal failure occur morecommonly in patients receiving IGIV products containingsucrose. ASCENIV does not contain sucrose. [5.3]
• For patients at risk of thrombosis, renal dysfunction orrenal failure, administer ASCENIV at the minimum dose andinfusion rate practicable. Ensure adequate hydration inpatients before administration. Monitor for signs andsymptoms of thrombosis and assess blood viscosity inpatients at risk for hyperviscosity. [2.1, 2.3, 5.3]
INDICATIONS AND USAGE
ASCENIV (immune globulin intravenous, human – slra) is a 10%immune globulin liquid for intravenous injection, indicated for thetreatment of primary humoralimmunodeficiency (PI) in adults andadolescents (12 to 17 years of age). [1]
DOSAGE AND ADMINISTRATION
For intravenous use only.
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)
• Ensure that patients with pre-existing renal insufficiency are notvolume depleted; discontinue ASCENIV if renal functiondeteriorates. [5.3]
• For patients at risk of renal dysfunction or thrombotic events,administer ASCENIV at the minimum infusion rate practicable.[5.2, 5.3]
DOSAGE FORMS AND STRENGTHS
ASCENIV is a liquid solution containing 10% IgG (100 mg/mL) forintravenous infusion; (5g in 50 mL solution). [3]
CONTRAINDICATIONS
• History of anaphylactic or severe systemic reactions tohuman immunoglobulin. [4]
• IgA-deficient patients with antibodies to IgA and ahistory of hypersensitivity. [4, 5.1]
WARNINGS AND PRECAUTIONS
• IgA-deficient patients with antibodies against IgA are atgreater risk of developing severe hypersensitivity andanaphylactic reactions. Have medications such as
epinephrine available to treat any acute severehypersensitivity reactions. [4, 5.1]
• Thrombotic events have occurred in patients receiving IGIVtreatments. Monitor patients with known risk factors forthrombotic events; consider baseline assessment of bloodviscosity for patients at risk of hyperviscosity. [5.2, 5.4]
• In patients at risk of developing acute renal failure. monitorrenal function, including blood urea nitrogen (BUN), serumcreatinine, and urine output. [5.3, 5.9]
• Hyperproteinemia, increased serum viscosity, andhyponatremia or pseudohyponatremia can occur in patien |
