Only physicians experienced in immunosuppressive therapy in the treatment of renal transplant or aplastic anemia patients should use ATGAM.
Patients receiving ATGAM should be treated in facilities equipped and staffed with adequate laboratory and supportive medical resources.
Precise methods of determining the potency of ATGAM have not been established, thus activity may potentially vary from lot to lot.
Discontinue treatment with ATGAM if any of the following occurs:
- Symptoms of anaphylaxis (See ADVERSE REACTIONS)
- Severe and unremitting thrombocytopenia in renal transplant patients
- Severe and unremitting leukopenia in renal transplant patients
Because this product is made using equine and human blood components, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Because ATGAM Sterile Solution is an immunosuppressive agent ordinarily given with corticosteroids and antimetabolites, watch patients carefully for signs of leukopenia, thrombocytopenia, or concurrent infection. Several studies have suggested an increase in the incidence of cytomegalovirus infection in patients receiving ATGAM(1). In one study it has been found that it may be possible to reduce this risk by decreasing the dosage of other immunosuppressive agents administered concomitantly with ATGAM. If infection occurs, institute appropriate adjunctive therapy promptly. On the basis of the clinical circumstances, a physician should decide whether or not therapy with ATGAM will continue.
The safety and effectiveness of ATGAM have been demonstrated only in renal transplant patients who received concomitant immunosuppressive therapy and in patients with aplastic anemia.
Dilution of ATGAM in dextrose injection, USP, is not recommended, as low salt concentrations may result in precipitation. The use of highly acidic infusion solutions is also not recommended because of possible physical instability over time.
When the dose of corticosteroids and other immunosuppressants is being reduced, some previously masked reactions to ATGAM may appear. Under these circumstances, observe patients especially carefully during therapy with ATGAM.
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.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious advers e reactions in nursing infants from ATGAM Sterile Solution, caution should be exercised when ATGAM is administered to a nursing woman.
Experience with children has been limited. ATGAM has been administered safely to a small number of pediatric renal allograft recipients and pediatric aplastic anemia patients at dosage levels comparable to those in adults.