Adult Dosing
Primary Humoral Immunodeficiency (PI)
- 300-600 mg/kg IV every 3 to 4 weeks
Note: It is recommended that a 5% solution be initially infused at a rate of 30 mg/kg/hr for the first 30 minutes; if tolerated, advance to 60 mg/kg/hour for the second 30 minutes; and if further tolerated, advance to 120 mg/kg/hour for the third 30 minutes. Thereafter maintain the rate up to maximum 200 mg/kg/hour.
Pediatric Dosing
Primary Humoral Immunodeficiency (PI)
- 300-600 mg/kg IV every 3 to 4 weeks
[Outline]
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death has been reported with use of intravenous immune globulin [FDA 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 [FDA Black box warning]
- Patients predisposed to acute renal failure include patients with [FDA 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. Epinephrine should be available for treatment of any acute anaphylactoid reactions
- Products made from human plasma may contain infectious agents, such as viruses, that can cause disease
- On rapid infusion (greater than 2 mg/kg/min) Patients with agamma- or extreme hypogammaglobulinemia who have never before received immunoglobulin substitution treatment or whose time from last treatment is greater than 8 weeks may be at risk of developing inflammatory reactions
- 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
- 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 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
- Do not administer subcutaneously for ITP treatment due to risk of hematoma
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: It is not known if the drug is excreted in breast milk; safety unknown.
