Adult Dosing
Primary Humoral Immunodeficiency (PI)
- 300-800 mg/kg q3-4 wk
- Initial infusion rate: 0.5 mg/kg/min for 10 minutes
- Maintenance rate (if tolerated): Increase every 20 minutes by 0.8 mg/kg/min up to to 6 mg/kg/min
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death have been reported with use of intravenous immune globulin (US black box warning)
- Administer IV at minimum concentration available and minimum rate of infusion in patients predisposed to acute renal failure; IVIG products containing sucrose as a stabilizer account for reports involving renal failure. Bivigam does not contain sucrose (US black box warning)
- Patients predisposed to acute renal failure include patients with (US black box warning)
- Any degree of preexisting renal insufficiency
- Diabetes mellitus
- Age >65 years
- Volume depletion
- Sepsis
- Paraproteinemia
- Currently taking nephrotoxic drugs
- Renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, should be assessed prior to therapy
- IgA deficient patients with known antibodies against IgA, are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions.
- Products made from human plasma may contain infectious agents, such as viruses, that can cause disease
- IGIV has been associated with thrombotic events. Patients with history of cardiovascular disease, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity may have an increased risk
- For patients at increased risk of thromboembolic events, a maximum infusion rate of less 2 mg/kg/min is recommended.
- Transfusion-Related Acute Lung Injury (TRALI) characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever has been associated with administration of IGIV
- Patients should be monitored for pulmonary adverse reactions. If TRALI is suspected, tests should be performed to detect presence of anti-neutrophil antibodies in product and patient serum
- Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.
- Hemolytic anemia may occur subsequently to IGIV therapy
- IGIV products containing blood group antibodies may act as hemolysins and may induce in vivo coating of red blood cells and cause a positive direct antiglobulin reaction and, rarely, hemolysis. Monitor patients for clinical signs and symptoms of hemolysis
- Aseptic meningitis syndrome (AMS) has been reported with the use of IGIV which may be characterized by severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting. Neurological examination, including CSF studies are recommended in such patients
Cautions: Use cautiously in:
- Geriatrics
- Pre-existing renal insufficiency
- Risk of developing renal insufficiency
- Diabetes mellitus
- Volume depletion
- Paraproteinemia
- Sepsis
- Concurrent nephrotoxic drugs
Pregnancy Category:C
Breastfeeding: Safety unknown; due to the potential for possible serious adverse reactions in nursing infants a decision should be made for discontinuation of breastfeeding or discontinuation of the drug taking into account the importance of the drug to the mother.
