Basic Information
ATGAM INJECTION 50 mg/ml
INJECTION
Regulatory Information
SIN01490P
May 23, 1988
Prescription Only
Therapeutic
INTRAVENOUS
August 10, 2023
May 30, 2025
XL04AA03
Company Information
Active Ingredients
Strength: 50 mg/ml
Detailed Information
Contraindications
**CONTRAINDICATIONS** Do not administer ATGAM to a patient who has had a severe systemic reaction (e.g., anaphylactic reaction) during prior administration of ATGAM or any other equine gamma globulin preparation.
Indication Information
**THERAPEUTIC INDICATIONS** Renal allograft recipients ATGAM sterile solution is indicated for the management of allograft rejection in renal transplant patients. When administered with conventional therapy at the time of rejection, it increases the frequency of resolution of the acute rejection episode. The drug has also been administered as an adjunct to other immunosuppressive therapy to delay the onset of the first rejection episode. Data accumulated to date have not consistently demonstrated improvement in functional graft survival associated with therapy to delay the onset of the first rejection episode. Aplastic anemia ATGAM is indicated for the treatment of moderate to severe aplastic anemia in patients who are unsuitable for bone marrow transplantation. When administered with a regimen of supportive care, ATGAM may induce partial or complete hematologic remission. In a controlled trial, patients receiving ATGAM showed a statistically significantly higher improvement rate compared with standard supportive care at 3 months. Improvement was defined in terms of sustained increase in peripheral blood counts and reduced transfusion needs. 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. To date, safety and efficacy have not been established in circumstances other than renal transplantation and aplastic anemia.