Indications for HYQVIA:
Primary immunodeficiency (eg, common variable immunodeficiency, congenital or X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies).
Individualize. Infuse 2 components sequentially into abdomen or thighs using an infusion pump, beginning with recombinant human hyaluronidase then immune globulin within 10 mins. Volume per site: (<40kg): may administer up to 300mL/site; (≥40kg): up to 600mL/site. Initial infusion rate (recombinant human hyaluronidase): 1–2mL/min per site or as tolerated; (immune globulin): see full labeling. Start treatment 1 week after last IgG infusion; increase dose and frequency from 1-week dose to a 3- or 4-week dose. Initial dose: 7.5g on Week 1, then 15g on Week 2, then 22.5g on Week 4, then 30g on Week 7 (see full labeling for initial ramp-up schedule). Switching from IGIV treatment: give at same dose and frequency as previous IV treatment after initial dose ramp-up. Switching from IGSC treatment or if IgG-naive: 300–600mg/kg at 3–4 week intervals after initial ramp-up. Renal dysfunction/failure or thrombosis risk: give at the minimum dose and infusion rate practicable.
IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immune globulin. Known hypersensitivity to hyaluronidase.
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular disorders: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Ensure adequate hydration prior to administration. Monitor for aseptic meningitis, hemolysis, delayed hemolytic anemia, transfusion-related acute lung injury (TRALI) (eg, pulmonary edema, dyspnea, hypoxemia). Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increase risk of renal dysfunction/failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output, before and during therapy; consider discontinuing if renal function deteriorates. Contains human plasma; monitor for possible infection transmission. Discontinue if hypersensitivity reactions occur. Pregnancy (Cat.C). Nursing mothers.
Increased risk of renal toxicity with concomitant nephrotoxic drugs. May affect response to live virus vaccinations. May interfere with serological test interpretation. May cause false (+) direct or indirect Coombs' test.
Immune globulin + recombinant human hyaluronidase.
Local reactions, headache, antibody formation against recombinant human hyaluronidase, fatigue, nausea, pyrexia, vomiting; aseptic meningitis syndrome, hemolysis, infection, TRALI.
Dual vial unit—1