Primary immune deficiency:

Indications for: HYQVIA

Primary immunodeficiency (eg, common variable immunodeficiency, congenital or X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies).

Adults and Children:

<2yrs: not established. 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. ≥2yrs: Initial interval/dosage ramp-up: 7.5g on Week 1, then 15g on Week 2, then 22.5g on Week 4, then 30g on Week 7. Switching from IGIV treatment: give at same dose and frequency as previous IV treatment after initial dose ramp-up. Exposed to measles: give 400mg/kg as soon as possible and within 6 days of exposure. At risk for future measles exposure: give at least 530mg/kg every 3 to 4 weeks. Switching from IGSC treatment or if IgG IGSC-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.

HYQVIA Contraindications:

IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immune globulin. Known hypersensitivity to hyaluronidase.

HYQVIA Warnings/Precautions:

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. Nursing mothers.

HYQVIA Classification:

Immune globulin + recombinant human hyaluronidase.

HYQVIA Interactions:

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.

Adverse Reactions:

Local reactions, headache, antibody formation against recombinant human hyaluronidase, fatigue, nausea, pyrexia, vomiting; aseptic meningitis syndrome, hemolysis, infection, TRALI.

Drug Elimination:

Mean (SD) clearance: 1.6 (0.5) mL/kg/day.

Mean (SD) terminal half-life: 59.3 (36.1) days.

How Supplied:

Dual vial unit—1