Immunology
Immune deficiency disorders occur when one or more components of the human immune system is deficient or not functioning properly. One of those components is immune globulins, sometimes referred to as "Ig." Because treatment of immune globulin deficiency is provided intravenously, these medicines are also called "IGIV" or "IVIG." For decades IGIV has been used to treat a variety of immune system deficiencies and disorders. The human immune system serves as a defense mechanism, protecting the body from many potentially damaging substances, such as cancer cells, blood or tissues from another person, microorganisms, or toxins. In individuals with immune deficiency disorders, their immune system is absent or is functioning incorrectly.
Immune disorders can be congenital (where the individual is born with a malfunctioning immune system), or be the result of a virus or chemotherapy. There are a wide variety of immunodeficiency disorders that affect millions of men, women, and children worldwide.
Immune globulin intravenous (human) therapies (IGIVs) can vary significantly since they are made using different production processes. Although high biological activity is the primary objective in IGIV manufacturing, these processes result in varying product features that may affect biological activity and ultimately the efficacy of the IGIV.
Gammaked is also approved to be used subcutaneously for patients with Primary Immunodeficiancy (PID). In addition to PID, Gammaked also received FDA approval for the treatment of neurological patients with CIDP.