FDA Approves First Immune Globulin for Subcutaneous Use

FDA recently approved a new immune globulin product that is injected subcutaneously. The product, called Vivaglobin, is made by the German company ZLB Behring. Until now, immune globulin products have been administered either intravenously or intramuscularly. The approval of Vivaglobin provides a new way to administer antibody replacement therapy to patients with primary immune deficiency disease. This may be especially beneficial in patients who don't easily tolerate IV administration of IG because of poor venous access or serious side effects. Since Vivaglobin is injected on a weekly basis using an infusion pump, patients can self-administer the product at home. In clinical studies, Vivaglobin was well tolerated. The most common side effects were mild or moderate injection site reactions such as swelling, redness and itching. The contraindications for Vivaglobin are similar to other immune globulin products.