Primary Humoral Immunodeficiency (PI) Chronic immune thrombocytopenic purpura (ITP) in patients aged 15 years and older. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (adults).

Serums

Onset of action: Provides immediate antibody levels.Immune thrombocytopenia: Initial response: 1 to 3 days; Peak response: 2 to 7 days. Duration: Immune effect: 3 to 4 weeks (variable). Distribution: Vd: 0.05 to 0.13 L/kg. Half-life elimination: IgG (variable among patients): Healthy subjects: 14 to 24 days; Patients with congenital humoral immunodeficiencies: 26 to 40 days; hypermetabolism associated with fever and infection have coincided with a shortened half-life.

Have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin.Hyperprolinemia.IgA-deficient patients with antibodies to IgA and a history of hypersensitivity

Safety has not been established. It is known to cross the placenta. Current clinical experience indicates that the use of immune globulin is not expected to have harmful effects on pregnancy, the fetus, or the newborn.

Safety has not been established.

Common: Headache, fatigue, nausea, chills, vomiting, back pain, fever. Serious: Thrombosis, renal dysfunction, hemolysis, aseptic meningitis (AMS).

PI: 200–800 mg/kg every 3–4 weeks. ITP: 1 g/kg daily for 2 consecutive days (total 2 g/kg). CIDP: Loading dose of 2 g/kg in divided doses over 2–5 days; Maintenance dose of 1 g/kg every 3 weeks (given in 1 or 2 days). Infusion Rate: Start at 0.5 mg/kg/min; if tolerated, increase to 8 mg/kg/min (PI and CIDP) or 4 mg/kg/min (ITP).

Specific dosage adjustments for children are not detailed separately from the weight-based (mg/kg) dosing.

No dosage adjustment necessary for any degree of kidney impairment. Use the IV route with caution in patients with eGFR <60 mL/minute/1.73 m2 or those with risk factors for kidney impairment due to an increased risk of immune globulin-induced kidney dysfunction. Ensure adequate hydration, minimize the rate of infusion (eg, consider a maximum infusion rate of 100 mL/hour), and use the minimum effective dose.

Use adjusted body weight for weight-based dose calculations.

Do not freeze. Store up to 25°C. Do not shake. Use promptly after opening.