Primary immune deficiency:
Indications for: CUTAQUIG
Primary humoral immunodeficiency (eg, common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
Adults and Children:
<2yrs: not established. See full labeling. Individualize. Give by SC infusion using an infusion pump into abdomen, thigh, upper arm, and/or upper leg/hip areas. May use up to 6 infusion sites (at least 2 inches apart) simultaneously. Rotate infusion sites. Prior to initiation: obtain serum IgG trough level to guide subsequent dose adjustments. Start 1 week after last IGIV or IGSC infusion (for weekly or frequent dosing), or 1–2 weeks after last IGIV infusion or 1 week after last IGSC infusion (for biweekly dosing). ≥2yrs: Switching from IGIV: Initial weekly dose = (previous IGIV dose [in grams] x 1.30)/number of weeks between IGIV doses. Biweekly dose: multiply the calculated weekly dose by 2. Frequent dosing (2–7 times/week): divide calculated weekly dose by the desired number of infusions per week. Switching from other IGSC: maintain previous IGSC weekly dose. Dose adjustments: based on serum IgG trough levels after 2–3 months of initiation and desired clinical response (see full labeling). Risk of measles exposure and receives <245mg/kg weekly, may increase to 245mg/kg; if exposed, give as soon as possible and within 6 days of exposure.
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis; assess blood viscosity in those at risk for hyperviscosity. Ensure adequate hydration. Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Discontinue if hypersensitivity reactions occur; have epinephrine available. Monitor for aseptic meningitis, hemolysis, and delayed hemolytic anemia. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Risk of transmission of viral diseases. Elderly. Pregnancy. Nursing mothers.
Concomitant nephrotoxic drugs: increased risk of acute renal failure. Falsely elevated results with some blood glucose tests (eg, GDH-PQQ based or glucose-dye-oxidoreductase methods); use glucose-specific method only. May affect response to live virus vaccines (eg, measles, mumps, rubella, varicella). May lead to misinterpretation of serological test results.
Local infusion site reactions (eg, redness, swelling, itching), headache, fever, dermatitis, asthma, diarrhea, cough; aseptic meningitis syndrome, hemolytic anemia, TRALI, thrombosis.
Generic Drug Availability:
Single-use vial (6mL, 10mL, 12mL, 20mL, 24mL, 48mL)—1