10 OVERDOSAGE
The maximum tolerated dose of ATGAM Sterile Solution is expected to vary from patient to patient due to the biological nature of the product. The largest single daily dose known to be administered to one patient (renal allograft recipient) was 7,000 mg administered at a concentration of approximately 10 mg/mL Sodium Chloride Injection, USP, seven times the recommended total dose and infusion concentration. In this patient, the administration of ATGAM was not associated with any signs of acute intoxication or late sequelae.
A maximum therapeutic dose has not been established therefore the definition of overdose for ATGAM has not been clearly defined. Some renal allograft 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 3 more courses for the treatment of acute rejection. The incidence of toxicologic manifestations did not increase with any of these regimens; however, close monitoring of the patient is recommended.