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The Food and Drug Administration (FDA) has approved IVIg products for the following labeled indications:
- Treatment of primary immunodeficiencies, including congenital agammaglobulinemia, hypogammaglobulinemia,
common variable immunodeficiency, severe combined immunodeficiency, Wiskett-Aldrich syndrome, and x-linked
immunodeficiency.
- Treatment of Idiopathic Thrombocytopenic Purpura (ITP)
- Prevention of graft-versus-host disease in bone marrow transplant patients.
- Prevention of infection in HIV infected patients, bone marrow transplant patients, patients with primary
defective antibody synthesis, and patients with hypogammaglobulinemia and/or recurrent bacterial infections
associated with B-cell chronic lymphocytic leukemia.
Intravenous immunoglobulin therapy may be considered medically necessary for the following off-label indications:
- in the treatment of refractory dermatomysitis
- Kawasaki syndrome
- Chronic inflammatory demyelinating polyneuropathy
- Guillian Barre syndrome
- Multifocal motor neuropathy in patients with anti GM1 antibodies and conduction block
- Fetal alloimmune thrombocytopenia
- Relapsing/remitting multiple sclerosis
Intravenous immunoglobulin therapy may be considered medically necessary as a second line drug for the treatment of
Myathenia Gravis for the following conditions:
- in the treatment of acutely worsening disease for which rapid improvement in strength is necessary to minimize the risk for bulbar or respiratory failure.
- For situation in which immunosuppression therapy has not begun to work, but substantial
improvement in strength is necessary to minimize an adverse outcom.
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