FDA approves 20% Ig Xembify for primary immunodeficiencies

July 10, 2019 0 By FM

The US FDA has approved Xembify- a 20% immunoglobulin solution for subcutaneous injection-to treat primary immunodeficiencies in patients as young as 2 years old.

Xembify is indicated to treat congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

The product label alerts that thrombosis may occur with immune globulin products, including Xembify.

Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

For patients at risk of thrombosis, Xembify should be given at the minimum dose and infusion rate practicable, the label advises, and patients should be adequately hydrated. Patients should be monitored for signs and symptoms of thrombosis and blood viscosity assessed in patients at risk for hyperviscosity.

Xembify is developed and marketed by leading global producer of plasma-derived medicines, Grifols.