Rx Update: May 2002
Mary Ross, R.Ph., M.B.A., Barbara Mutnick, R.Ph., M.H.P., Joan
Murhammer, R.Ph., Pharmacotherapy Evaluation and Consultation
Service, Department of Pharmaceutical Care
Peer Review Status: Internally Reviewed
Immune globulin intravenous (IVIG) is a preparation of at least 90% intact IgG derived from large pools of human plasma used for the prophylaxis and treatment of a variety of medical disorders such as primary immunodeficiency, immune-mediated thrombocytopenia, Kawasaki disease, and multiple sclerosis.
There have been several recent safety updates regarding severe adverse effects of IVIG that are associated with the rate of administration and/or concentration of solution administered.
Renal adverse events (e.g., acute renal failure or renal insufficiency) have been reported following IVIG administration. Although acute renal failure was successfully managed in the majority of cases, deaths have been reported in patients. Many of the patients who died had serious underlying conditions. IVIG products containing sucrose may present a greater risk for this complication. The sucrose containing IVIG products are Sandoglobulin®, Panglobulin®, and Gammar- PIV®. To reduce the risk of acute renal failure in patients receiving IVIG infusion, there are several precautions that should be taken. Patients should not be volume depleted prior to initiation of IVIG. Caution should be used in patients at increased risk for developing acute renal failure, including patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65 years, sepsis, paraproteinemia, or concurrent nephrotoxic drugs. The recommended dose should not be exceeded. Reduction in dose, concentration, and/or rate of administration in patients at risk for renal failure is suggested to reduce the risk. For sucrose-containing IVIG products, a maximum rate of 2 mg/kg/minute of Sandoglobulin®/Panglobulin® and 1 mg/kg/minute of Gammar-PIV® should not be exceeded. Periodic monitoring of renal function and urine output is particularly important in patients at high risk for developing renal failure. If renal function deteriorates, discontinuation of the product should be considered. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention, and or shortness of breath to their physicians.
IVIG has been reported to cause thrombotic (vascular occlusive) events. These have included chest pain, myocardial infarction, congestive cardiac failure, severe headache requiring hospitalization, and pulmonary embolism. Caution should be exercised in the prescribing and infusion of IVIG in patients with thrombotic risk factors (e.g., coronary artery disease, hypertension, cerebrovascular disease, diabetes mellitus). These serious events are likely associated with the rapid infusion of IVIG. In the event that there is a possible risk of a thrombotic event, it is strongly recommended that the infusion concentration should be no more than 5% and the infusion rate should be initiated no faster than 0.5 ml/kg/hour and advanced slowly only if well tolerated to a maximum rate of 4 ml/kg/hour.
To minimize the potential for renal and thrombotic adverse events with IVIG, the rate of infusion and percent of IVIG concentration should be flexible and targeted to the safety of the patient rather than convenience.