No

Immunosuppressant Agent

Prevention and treatment of acute renal and other solid organ allograft rejection; treatment of moderate to severe aplastic anemia in patients not considered suitable candidates for bone marrow transplantation; prevention of graft-versus-host disease following bone marrow transplantation

C

Known hypersensitivity to ATG, thimerosal, or other equine gamma globulins; severe, unremitting leukopenia and/or thrombocytopenia

Must be administered via central line due to chemical phlebitis; should only be used by physicians experienced in immunosuppressive therapy or management of solid organ or bone marrow transplant patients; adequate laboratory and supportive medical resources must be readily available in the facility for patient management; rash, dyspnea, hypotension, or anaphylaxis precludes further administration of the drug. Dose must be administered over at least 4 hours; patient may need to be pretreated with an antipyretic, antihistamine, and/or corticosteroid. Intradermal skin testing is recommended prior to first-dose administration.

>10%:

Central nervous system: Fever, chills

Dermatologic: Rash

Hematologic: Leukopenia, thrombocytopenia

Miscellaneous: Systemic infection

1% to 10%:

Cardiovascular: Hypotension, hypertension, tachycardia, edema, chest pain

Central nervous system: Headache, malaise, pain

Gastrointestinal: Diarrhea, nausea, stomatitis, GI bleeding

Respiratory: Dyspnea

Local: Edema or redness at injection site, thrombophlebitis

Neuromuscular & skeletal: Myalgia, back pain, arthralgia

Renal: Abnormal renal function tests

Miscellaneous: Sensitivity reactions: Anaphylaxis may be indicated by hypotension, respiratory distress; serum sickness, viral infection

<1%: Seizures, pruritus, urticaria, hemolysis, anemia, arthralgia, weakness, acute renal failure, lymphadenopathy

Ampuls must be refrigerated

Dose must be diluted in 0.45% or 0.9% sodium chloride

Diluted solution is stable for 12 hours (including infusion time) at room temperature and 24 hours (including infusion time) at refrigeration

The use of dextrose solutions is not recommended (precipitation may occur)

Standard diluent: Dose/1000 mL NS or 0.45% sodium chloride

Minimum volume: Concentration should not exceed 1 mg/mL for a peripheral line or 4 mg/mL for a central line

May involve elimination of antigen-reactive T-lymphocytes (killer cells) in peripheral blood or alteration of T-cell function

Distribution: Poorly distributed into lymphoid tissues; binds to circulating lymphocytes, granulocytes, platelets, bone marrow cells

Half-life, plasma: 1.5-12 days

Elimination: ~1% of dose excreted in urine

An intradermal skin test is recommended prior to administration of the initial dose of ATG; use 0.1 mL of a 1:1000 dilution of ATG in normal saline. A positive skin reaction consists of a wheal greater than or equal to 10 mm in diameter. If a positive skin test occurs, the first infusion should be administered in a controlled environment with intensive life support immediately available. A systemic reaction precludes further administration of the drug. The absence of a reaction does not preclude the possibility of an immediate sensitivity reaction.

Children: I.V.:

Aplastic anemia protocol: 10-20 mg/kg/day for 8-14 days; then administer every other day for 7 more doses; addition doses may be given every other day for 21 total doses in 28 days

Renal allograft: 5-25 mg/kg/day

Adults: I.V.:

Aplastic anemia protocol: 10-20 mg/kg/day for 8-14 days, then administer every other day for 7 more doses

Renal allograft:

Rejection prophylaxis: 15 mg/kg/day for 14 days followed by 14 days of alternative day therapy at the same dose; the first dose should be administered within 24 hours before or after transplantation

Rejection treatment: 10-15 mg/kg/day for 14 days, then administer every other day for 10-14 days up to 21 doses in 28 days

Lymphocyte profile, CBC with differential and platelet count, vital signs during administration

No information available to require special precautions

No effects or complications reported

This medication can only be administered by infusion. You will be monitored closely during the infusion. Do not get up alone; ask for assistance if you must get up or change position. Do not have any vaccinations for the next 3 months without consulting prescriber. Immediately report chills; persistent dizziness or nausea; itching or stinging; acute back pain; chest pain or tightness or rapid heartbeat; or difficulty breathing. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.

For I.V. use only; mild itching and erythema can be treated with antihistamines; infuse dose over at least 4 hours; any severe systemic reaction to the skin test such as generalized rash, tachycardia, dyspnea, hypotension, or anaphylaxis should preclude further therapy; epinephrine and resuscitative equipment should be nearby. Patient may need to be pretreated with an antipyretic, antihistamine, and/or corticosteroid.

Injection: 50 mg of equine IgG/mL (5 mL)

Rosenfeld SJ, Kimball J, Vining D, et al, "Intensive Immunosuppression With Antithymocyte Globulin and Cyclosporine as Treatment for Severe Acquired Aplastic Anemia," Blood, 1995, 85(11):3058-65.

Whitehead B, James I, Helms P, et al, "Intensive Care Management of Children Following Heart and Heart-Lung Transplantation," Intensive Care Med, 1990, 16(7):426-30.