RECENT UPDATESMonograph added.
Indications for CUVITRU:
Replacement therapy for primary humoral immunodeficiency in patients aged ≥2 years.
Adults and Children:
For SC infusion only into abdomen, thighs, upper arms, lateral hip; may use up to 4 sites simultaneously; rotate sites with each infusion. <2yrs: not evaluated. ≥2yrs: Individualize. Administer at regular intervals daily up to every 2 weeks. Infuse as tolerated up to max 60mL per site at 10-20mL/hr/site for first 2 infusions, then up to 60mL/hr/site for subsequent infusions; max 240mL/hr (across 4 sites). Switching from IV immune globulin (IGIV) or Hyqvia: initiate 1 week after last IGIV or Hyqvia infusion; convert monthly dose into equivalent weekly dose. Initial weekly dose = (previous IGIV or Hyqvia dose [g] / number of weeks between IGIV or Hyqvia doses ) x 1.3. Switching from SC immune globulin (IGSC): use same weekly dose (g) as prior IGSC treatment. For alternative regular dosing intervals: see full labeling. Adjust dose and dosing intervals based on serum IgG trough levels; monitor regularly. See full labeling.
IgA-deficient patients with antibodies against IgA.
Discontinue immediately if hypersensitivity reaction occurs. Correct volume depletion prior to treatment initiation. Pre-existing renal insufficiency. Patients at risk of renal dysfunction or renal failure (eg, diabetes mellitus, >65yrs, volume depletion, sepsis, paraproteinemia, nephrotoxic agents); consider lower dose with frequent dosing. Monitor renal function, urine output, BUN, and serum creatinine prior to treatment and periodically thereafter; consider discontinuing if renal function deteriorates. Risk for thrombosis (eg, advanced age, prolonged immobilization, hypercoagulable conditions, venous or arterial thrombosis, estrogens, indwelling central venous catheters, hyperviscosity, cardiovascular risk factors); monitor and infuse lowest dose and rate practicable. Risk of hyperviscosity (eg, cryoglobulins, fasting chylomicronemia/markedly high triglycerides, monoclonal gammopathies); consider baseline assessment. Aseptic meningitis syndrome; conduct neurological exam to rule out other causes. Monitor for hemolysis if risk factors present (eg, high doses [≥2g/kg], non-O blood group); consider appropriate testing. Monitor for pulmonary reactions; if transfusion-related acute lung injury (TRALI) suspected, test for antibodies. Contains human plasma; monitor for possible viral disease and variant Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.
May affect response to live virus vaccines. May yield false (+) test results; may cause positive direct or indirect Coombs' test. May yield (+) readings in assays dependent on beta-D-glucan detection for fungal infections.
Local reactions, headache, nausea, fatigue, diarrhea, vomiting; hypersensitivity reaction, renal dysfunction, thrombosis, aseptic meningitis syndrome, hemolysis, TRALI.
Single-use vials (5mL, 10mL, 20mL, 40mL)—1