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Atgam (Equine Thymocyte Immune Globulin) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Pregnancy

Pregnancy category C

ATGAM has not been evaluated in either pregnant or lactating women. Animal reproduction studies have not been conducted with ATGAM. It is also not known whether ATGAM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Administration of ATGAM to pregnant women is not recommended and should be considered only under exceptional circumstances.

OVERDOSAGE

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.

CONTRAINDICATIONS

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.

REFERENCES

  1. Rubin RH, Cosimi AB, Hirsch MS, Herrin JT: Effects of antithymocyte globulin on cytomegalovirus infection in renal transplant recipients. Transplantation. 1981; 31(2):143—145.
  2. Cosimi AB, Wortis HH, Delmonico FL, Russell PS: Randomized clinical trial of antithymocyte globulin in cadaver renal allograft recipients: importance of T cell monitoring. Surgery. 1976; 80: 155—163.
  3. Wechter WJ, Brodie JA, Morrell RM, Rafi M, Schultz JR: Antithymocyte globulin (ATGAM) in renal allograft recipients. Transplantation. 1979; 28(4):294—302.
  4. Kountz SL, Butt KHM, Rao TKS, Zielinski CM, Rafi M, Schultz JR: Antithymocyte globulin (ATG) dosage and graft survival in renal transplantation. Transplant. Proc. 1977; 9:1023—1025.
  5. Butt KMH, Zielinski CM, Parsa I, Elberg AJ, Wechter WJ, Kountz SL: Trends in immunosuppression for kidney transplantation. Kidney Int. 1978; 13(Suppl 8): S95–S98.
  6. Filo RS, Smith EJ, Leapman SB: Reversal of acute renal allograft rejection with adjunctive ATG therapy. Transplant. Proc. 1981; 13(1): 482—490.
  7. Nowygrod R, Appel G, Hardy M: Use of ATG for reversal of acute allograft rejection. Transplant. Proc. 1981; 13(1): 469—472.
  8. Hardy MA, Nowygrod R, Elberg A, Appel G: Use of ATG in treatment of steroid-resistant rejection. Transplantation. 1980; 29:162—164.
  9. Shield CH, Cosimi AB, Tolkoff-Rubin N, Rubin R, Herrin J, Russell PS: Use of antithymocyte globulin for reversal of acute allograft rejection. Transplantation. 1979; 28(6): 461—464.
  10. Cosimi AB: The clinical value of antilymphocyte antibodies. Transplant. Proc. 1981; 13(1): 462—468.
  11. Cosimi AB, Peters C, Harmon D, Ellman L: Treatment of severe aplastic anemia with a prolonged course of antithymocyte globulin. Transplant. Proc. 1982; 14:761—764.
  12. Champlin R, Ho W, Gale R: Antithymocyte globulin treatment in patients with aplastic anemia. N Engl J Med. 1983; 308(3):113—118.
  13. Doney K, Dahlberg S, Monroe D et al: Therapy of severe aplastic anemia with anti-human thymocyte globulin and androgens: The effect of HLA-haploidentical marrow infusion. Blood. 1984; 63(2):342—348.

LAB-0019-2.0
November 2005

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