Because of its mode of action and because it is a biological substance, the maximal tolerated dose of Thymogam 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 7000 mg administered at a concentration of approximately 10 mg/mL diluted with Sodium Chloride Injection, USP, approximately 7 times the recommended total dose and infusion concentration.
The maximum number of doses (10 to 20 mg/kg/dose) that can be administered of 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 3 more courses for the treatment of acute rejection. The incidence of toxicological manifestations did not increase with any of these regimens.