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ATGAM® (lymphocyte immune globulin, anti-thymocyte globulin [equine]) Indications and Usage

1 INDICATIONS AND USAGE

1.1 Renal Allograft Rejection

Renal transplant rejection: ATGAM is indicated for the management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection ATGAM increases the frequency of resolution of the acute rejection episode [see Clinical Studies (14.1)].

1.2 Aplastic Anemia

ATGAM is indicated for the treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation [see Clinical Studies (14.2)].

The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, Fanconi's syndrome, or in patients known to have been exposed to myelotoxic agents or radiation.

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