Adult Dosing
Replacement therapy for primary humoral immunodeficiency (PI) (Intravenous administration)
- 300-600 mg/kg IV q3-4 wks based on clinical response
- Initial infusion rate: 0.5 mL/kg/hr (0.8 mg/kg/min) for 30 minutes
- Maintenance infusion rate: Increase every 30 minutes (if tolerated) up to 5 mL/kg/hr (8 mg/kg/min)
Multifocal Motor Neuropathy (MMN) (Intravenous administration)
- 0.5-2.4 g/kg/month IV based on clinical response
- Initial infusion rate: 0.5 mL/kg/hr (0.8 mg/kg/min)
- Maintenance infusion rate: Increase (if tolerated) up to 5.4 mL/kg/hr (9 mg/kg/min)
Primary humoral immunodeficiency (PI) (Subcutaneous administration)
- Initial dose: 1.37 × previous IV dose divided by number of weeks between IV doses
40 kg bodyweight: 30 mL/site at 20 mL/hr/site- <40 kg bodyweight: 20 mL/site at 15 mL/hr/site
- Maintenance infusion rate
- 40 kg bodyweight: 30 mL/site at 20-30 mL/hr/site
- <40 kg bodyweight: 20 mL/site at 15-20 mL/hr/site
Pediatric Dosing
Replacement therapy for primary humoral immunodeficiency (PI) (Intravenous administration)
- (Child: 2 -18 years):
- 300-600 mg/kg IV q3-4 wks based on clinical response
- Initial infusion rate: 0.5 mL/kg/hr (0.8 mg/kg/min) for 30 minutes
- Maintenance infusion rate: Increase every 30 minutes (if tolerated) up to 5 mL/kg/hr (8 mg/kg/min)
- Safety and efficacy in pediatric patients below the age of 2 have not been established.
Primary humoral immunodeficiency (PI) (Subcutaneous Administration)
- (Child: 2 -18 years):
- Initial dose: 1.37 × previous IV dose divided by number of weeks between IV doses
- Initial infusion rate:
- 40 kg bodyweight: 30 mL/site at 20 mL/hr/site
- <40 kg bodyweight: 20 mL/site at 15 mL/hr/site
- Maintenance infusion rate
- 40 kg bodyweight: 30 mL/site at 20-30 mL/hr/site
- <40 kg bodyweight: 20 mL/site at 15-20 mL/hr/site
[Outline]
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death have 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. Gammagard does not contain sucrose [FDA 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
- Therapy may lead to severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure, If hypersensitivity reaction develops, discontinue infusion immediately and institute appropriate treatment.
- IgA deficient patients with known antibodies against IgA, are at greater risk of developing severe hypersensitivity and anaphylactic reactions
- Renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, should be assessed prior to therapy
- Hyperproteinemia, increased serum viscosity and hyponatremia may occur
- IGIV has been associated with thrombotic events. Patients with history of cardiovascular disease, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, coagulation disorders, prolonged periods of immobilization, known or suspected hyperviscosity, obesity, diabetes mellitus, acquired or inherited thrombophilic disorder, a history of vascular diseases may have an increased risk
- Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity
- 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
- 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
- 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
- Products made from human plasma may contain infectious agents, such as viruses, that can cause disease
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 whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.
