cy or predisposition to acuterenal failure (such as diabetes mellitus, hypovolemia, overweight, use of concomitant nephrotoxic medicinal products or age of>65 years), administer ASCENIV at the minimum infusion rate practicable (see Dosage and Administration [2]).
5.4 Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV treatment, includingASCENIV. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causallyrelated to hyperproteinemia with concomitant decreased calculated serum osmolality or elevated osmolar gap, becausetreatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further
increase in serum viscosity, and a possible predisposition to thrombotic events.
5.5 Aseptic Meningitis Syndrome (AMS)
AMS may occur with IGIV treatments, including ASCENIV. AMS usually begins within several hours to 2 days following IGIVtreatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.7,8,9AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.
AMS is characterized by the following signs and symptoms: severe headache, nuchal rigidity, drowsiness, fever, photophobia,painful eye movements, nausea, and vomiting (see Patient Counseling Information [17]). Cerebrospinal fluid (CSF) studiesfrequently reveal pleocytosis up to several thousand cells per cubic millimeter, predominantly from the granulocytic series, andelevated protein levels up to several hundred mg/dL, but negative culture results. Conduct a thorough neurological examination on patients exhibiting such signs and symptoms, including CSF studies, to rule out other causes of meningitis.
5.6 Hemolysis
IGIV products, including ASCENIV, may contain blood group antibodies that can act as hemolysins and induce in vivo coating ofred blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and hemolysis.
10,11,12 Delayed hemolyticanemia can develop subsequent to IGIV treatment due to enhanced RBC sequestration,13 and acute hemolysis, consistent withintravascular hemolysis, has been reported.
Monitor patients for clinical signs and symptoms of hemolysis (see Patient Counseling Information [17]).
If these are present after
ASCENIV infusion, perform appropriate confirmatory laboratory testing. If transfusion is indicated for patients who develophemolysis with clinically compromising anemia after receiving IGIV, perform adequate cross-matching to avoid exacerbatingongoing hemolysis.
5.7 Transfusion-Related Acute Lung Injury (TRALI)
Noncardiogenic pulmonary edema may occur in patients following IGIV treatment,
14 including ASCENIV. TRALI is characterized bysevere respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically appearwithin 1 to 6 hours following treatment.
Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence ofanti-neutrophil antibodies in both the product and the patient’s serum (see Patient Counseling Information [17]).
TRALI may be managed using oxygen therapy with adequate ventilatory support.
5.8 Transmissible Infectiou |
