Because of its mode of action and because it is a biologic substance, the maximal tolerated dose of ATGAM Sterile Solution would be expected to vary from patient to patient. To date, the largest single daily dose administered to a patient, a renal transplant recipient, was 7,000 mg administered at a concentration of approximately 10 mg/mL Sodium Chloride Injection, USP, approximately seven times the recommended total dose and infusion concentration. In this patient, administration of ATGAM was not associated with any signs of acute intoxication.

The greatest number of doses (10 to 20 mg/kg/dose) that can be administered to a single patient has not yet been determined. Some renal transplant patients have received up to 50 doses in 4 months, and others have received 28-day courses of 21 doses followed by as many as three more courses for the treatment of acute rejection. The incidence of toxicologic manifestations did not increase with any of these regimens.

Do not administer ATGAM Sterile Solution to a patient who has had a severe systemic reaction during prior administration of ATGAM or any other equine gamma globulin preparation.

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