Grifols announced that Xembify, the company’s first 20% subcutaneous immunoglobulin (IG) for primary immunodeficiency (PI) treatment, is now available in the United States.

Xembify will be made available to patients and health care professionals through a distribution network that includes the following providers: Advanced InfusionCare; Nufactor, a specialty infusion company; CVS Specialty; Optum Infusion Services; and Accredo.

The newly launched IG product features a balanced formulation for the treatment of a wide range of patients with PI, inclusive of those with risk factors, such as diabetes or cardiac impairment, according to Grifols. The FDA approved Xembify in July 2019.

According to a company press release, Xembify offers “maximum immunoglobulin G (IgG) potency and purity” due to the drug’s “unique caprylate/chromatography process.”

Additionally, the product “provides a customizable IG treatment option (from weekly to daily) that offers patients reliable protection from infections.”

“People living with PI benefit from having a number of different treatment and dosing options, ultimately giving them an opportunity to tailor treatment to meet their specific needs,” said John G. Boyle, the president and CEO of the Immune Deficiency Foundation. “Adding Xembify to the list of available treatments for PI will give members of our community greater flexibility in managing their care and reducing the impact PI has on their lives.”

Primary immunodeficiency includes rare and chronic genetic disorders that occur in people born with an impaired or absent immune system. There are approximately 150,000 patients with PI who may be appropriate for IG therapy, according to Grifols.

The most common adverse reactions in at least 5% of patients in clinical data submitted to the FDA were local adverse reactions, which included infusion site adverse events such as erythema, pain, swelling, bruising and pruritus. Systemic reactions included cough and diarrhea.

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