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Atgam

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Atgam

Warnings
Precautions

WARNINGS

Only physicians experienced in immunosuppressive therapy in the treatment of renal transplant or aplastic anemia patients should use ATGAM (lymphocyte immune globulin) .

Patients receiving ATGAM (lymphocyte immune globulin) should be treated in facilities equipped and staffed with adequate laboratory and supportive medical resources.

Precise methods of determining the potency of ATGAM (lymphocyte immune globulin) have not been established, thus activity may potentially vary from lot to lot.

Discontinue treatment with ATGAM (lymphocyte immune globulin) if any of the following occurs:

  1. Symptoms of anaphylaxis (See ADVERSE REACTIONS)
  2. Severe and unremitting thrombocytopenia in renal transplant patients
  3. 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.

PRECAUTIONS

General

Because ATGAM (lymphocyte immune globulin) 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 (lymphocyte immune globulin) (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 (lymphocyte immune globulin) . 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 (lymphocyte immune globulin) will continue.

The safety and effectiveness of ATGAM (lymphocyte immune globulin) have been demonstrated only in renal transplant patients who received concomitant immunosuppressive therapy and in patients with aplastic anemia.

Dilution of ATGAM (lymphocyte immune globulin) 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.

Pregnancy

Pregnancy category C— ATGAM (lymphocyte immune globulin) has not been evaluated in either pregnant or lactating women. Animal reproduction studies have not been conducted with ATGAM (lymphocyte immune globulin) . It is also not known whether ATGAM (lymphocyte immune globulin) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Administration of ATGAM (lymphocyte immune globulin) to pregnant women is not recommended and should be considered only under exceptional circumstances.

Nursing Mothers

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 adverse reactions in nursing infants from ATGAM (lymphocyte immune globulin) Sterile Solution, caution should be exercised when ATGAM (lymphocyte immune globulin) is administered to a nursing woman.

Pediatric Use

Experience with children has been limited. ATGAM (lymphocyte immune globulin) 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.

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.

Last reviewed on RxList: 10/22/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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