Gammaked Background

Primary Immunodeficiency (PI)

WHAT IS PI?

Primary Immunodeficiency, or PI, is a heterogeneous group of rare, severe, chronic diseases resulting from inherited defects in the immune system, and characterized by increased susceptibility to infection. Patients may present with recurrent, persistent, severe or unusual infections.1 PI patients can have defects in humoral immunity while retaining normal cell-mediated immunity capabilities, or defects in both components.1 Gammaked is indicated as replacement therapy of primary humoral immunodeficiency.2


 

ADVERSE REACTIONS IN PI:

The most common adverse reactions observed at a rate ≥ 5% in subjects treated with intravenous (IV) Gammaked for primary immunodeficiency (PI) were headache, injection site reaction, nausea, pharyngitis and urticaria.2

The most common adverse reactions observed at a rate ≥ 5% in subjects treated with subcutaneous (SC) dosing of Gammaked for primary immunodeficiency (PI) were infusion site reactions, headache, fatigue, arthralgia and pyrexia.2


References: 1. Chapel H, Haeney M, Misbah S and Snowden N eds. Essentials of Clinical Immunology, 6th ed. West Sussex, UK: John Wiley & Sons; 2014. 54-84. 2. Gammaked Prescribing Information. Fort Lee, NJ: Kedrion Biopharma, Inc.; 2013.