Cuvitru Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 20% (200mg/mL); soln for SC infusion; sucrose-, preservative- and latex-free.
Pharmacological Class
Immune globulin.
How Supplied
Single-use vials (5mL, 10mL, 20mL, 40mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Cuvitru supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. It also contains a spectrum of antibodies capable of interacting with and altering the activity of cells of the immune system as well as antibodies capable of reacting with cells such as erythrocytes. The role of these antibodies and the mechanisms of action of IgG in Cuvitru have not been fully elucidated.
Cuvitru Indications
Indications
Replacement therapy for primary humoral immunodeficiency in patients aged ≥2 years.
Cuvitru Dosage and Administration
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.
Cuvitru Contraindications
Contraindications
IgA-deficient patients with antibodies against IgA.
Cuvitru Boxed Warnings
Boxed Warning
Thrombosis.
Cuvitru Warnings/Precautions
Warnings/Precautions
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.
Cuvitru Pharmacokinetics
See Literature
Cuvitru Interactions
Interactions
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.
Cuvitru Adverse Reactions
Adverse Reactions
Local reactions, headache, nausea, fatigue, diarrhea, vomiting; hypersensitivity reaction, renal dysfunction, thrombosis, aseptic meningitis syndrome, hemolysis, TRALI.
Cuvitru Clinical Trials
See Literature
Cuvitru Note
Not Applicable
Cuvitru Patient Counseling
See Literature