Gammaked Background

Gammaked is also Approved for Subcutaneous Administration for Primary Immunodeficiency (PI)

IN A PI STUDY (SUBCUTANEOUS ADMINISTRATION):

  • A weekly subcutaneous dose of Gammaked produced plasma levels that were noninferior to that of a regularly administered IV dose of Gammaked1
  • There were no serious bacterial infections reported during the subcutaneous phase of the study1
  • The majority of local infusion-site reactions were mild (91%) or moderate (7%) in intensity1


ADVERSE REACTIONS OBSERVED IN PI1:

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

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

Gammaked is not approved for subcutaneous use in patients with ITP or CIDP. Due to potential risk of hematoma formation, Gammaked should not be administered to a PI patient if that patient has a low platelet count.

 

Reference1. GAMMAKED [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2013.