top the infusion if adverse reactions occur. If symptoms subsidepromptly, the infusion may be resumed at a slower rate which is comfortable for the patient.Ensure that patients with pre-existing renal insufficiency are not volume-depleted. For patients judged to be at risk for renaldysfunction or thrombotic events, administer ASCENIV at the minimum infusion rate practicable, and considerdiscontinuation of administration if renal function deteriorates (see Boxed Warning, Warnings and Precautions [5.2, 5.3]).
3 DOSAGE FORMS AND STRENGTHS
ASCENIV is a liquid solution containing 10% IgG (100 mg/mL) for intravenous infusion.
4 CONTRAINDICATIONS
ASCENIV is contraindicated in:
• patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
• IgA-deficiency patients with antibodies to IgA and a history of hypersensitivity.
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
Severe hypersensitivity reactions may occur with IGIV products, including ASCENIV. In case of hypersensitivity, discontinueASCENIV infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available fortreatment of acute hypersensitivity reactions.
ASCENIV contains trace amounts of IgA (≤ 200 micrograms per milliliter) (see Description [11]).
Patients with knownantibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
ASCENIV is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity reaction (seeContraindications [4]).
5.2 Thrombosis
Thrombosis may occur following treatment with immune globulin products, including ASCENIV.
4,5,6 Risk factors may include:advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use ofestrogens,indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of
known risk factors.
Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including patients with cryoglobulins, fastingchylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis,administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients beforeadministration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity (seeBoxed Warning, Dosage and Administration [2], Patient Counseling Information [17]).
5.3 Acute Renal Dysfunction and Acute Renal Failure
Acute renal dysfunction/failure, osmotic nephrosis, and death1,2 may occur upon use of human IGIV products. Ensure thatpatients are not volume depleted before administering ASCENIV. Periodic monitoring of renal function and urine output isparticularly important in patients judged to be at increased risk of developing acute renal failure.
2 Assess renal function, including
measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of ASCENIV and at appropriateintervals thereafter. If renal function deteriorates, consider discontinuing ASCENIV (see Patient Counseling Information [17]).
Inpatients who are at risk of developing renal dysfunction, because of pre-existing renal insufficien |
