Immune globulin subcutaneous (human), 20% solution (Cuvitru) is approved for primary immunodeficiency in patients 2 years of age and older.
In 2016, the FDA approved immune globulin subcutaneous (human), 20% solution (Cuvitru) for primary immunodeficiency (PI) in patients 2 years and older.
PI is a group of more than 300 genetic disorders where part of the body’s immune system is missing or functions improperly. It affects as many as 6 million individuals worldwide.
Cuvitru is the only 20% subcutaneous immunoglobulin (IG) treatment option without proline and with the ability to infuse up to 60 mL (12 g) per site and 60 mL per hour per site as tolerated, resulting in fewer infusion sites and shorter infusion durations compared with other conventional subcutaneous IG treatments.
Regardless of infusion rate or volume per site, the drug was generally associated with a low incidence of local adverse and systemic reactions in a phase 2/3 study among North American patients that was published in the Journal of Clinical Immunology.