FDA OKs Immunoglobulin Xembify for Primary Immunodeficiencies

Megan Brooks

Disclosures

July 05, 2019

The US Food and Drug Administration (FDA) has approved a 20% immune globulin solution for subcutaneous injection (Xembify, Grifols) to treat primary immunodeficiencies in patients as young as 2 years old, according to a company statement.

The approval includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

The company plans to launch Xembify in the United States in the last quarter of 2019, according to the statement.

The most common adverse reactions are local adverse reactions at the infusion site, such as erythema, pain, swelling, bruising, pruritus, induration, scab, edema, and systemic reactions including cough and diarrhea.

The product label notes 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. Thrombosis may occur in the absence of known 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.

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