FDA Approves ASCENIV™ (formerly referred to as RI-002), A Novel Intravenous Immune GlobulinSee the Press Release
Human immune globulin is comprised of antibodies—Y-shaped proteins produced by B-cells that are used by the body's immune system to identify and neutralize foreign objects such as bacteria and viruses. IVIG is immune globulin purified from plasma by a manufacturing process called fractionation and administered intravenously to patients.
There are 2 types of immune globulins, standard and hyperimmune.
Standard immune globulins are manufactured using normal source plasma.
Manufactured using plasma obtained from donors who have elevated amounts [high- titers] of specific antibodies against a targeted pathogen.
Products currently available on the US market from various manufacturers include hepatitis B, tetanus, rabies, cytomegalovirus, and Rho(D) immune globulins, among others.
Additionally, IVIG is also used as therapy in a variety of other diseases that do not involve primary or secondary immune deficiencies, such as multiple sclerosis, skin diseases, and asthma. These latter uses are referred to as "off-label" or evidence-based uses because the FDA has not approved their use in these indications and promotion of such uses is not permitted by FDA unless approved by the agency.