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Pronunciation:

(an te THY moe site GLOB yu lin, E kwine)

U.S. Brand Names:

Atgam®

Synonyms:

Antithymocyte Immunoglobulin; ATG; Horse Antihuman Thymocyte Gamma Globulin; Lymphocyte Immune Globulin

Generic Available:

Canadian Brand Names:

Atgam®

Use:

Prevention and treatment of acute renal allograft rejection; treatment of moderate to severe aplastic anemia in patients not considered suitable candidates for bone marrow transplantation

Use - Unlabeled/Investigational:

Prevention and treatment of other solid organ allograft rejection; prevention of graft-versus-host disease following bone marrow transplantation

Pregnancy Risk Factor:

Pregnancy Implications:

Reproduction studies have not been conducted; use during pregnancy is not recommended. Women exposed to Atgam® during pregnancy may be enrolled in the National Transplantation Pregnancy Registry (877-955-6877).

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to lymphocytic immune globulin, any component of the formulation, or other equine gamma globulins

Warnings/Precautions:

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. Discontinue if severe and unremitting thrombocytopenia and/or leukopenia occur. 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.

Adverse Reactions:

>10%:

Central nervous system: Fever, chills

Dermatologic: Pruritus, rash, urticaria

Hematologic: Leukopenia, thrombocytopenia

1% to 10%:

Cardiovascular: Bradycardia, chest pain, CHF, edema, encephalitis, hyper-/hypotension, myocarditis, tachycardia

Central nervous system: Agitation, headache, lethargy, lightheadedness, listlessness, seizure

Gastrointestinal: Diarrhea, nausea, stomatitis, vomiting

Hepatic: Hepatosplenomegaly, liver function tests abnormal

Local: Pain at injection site, phlebitis, thrombophlebitis, burning soles/palms

Neuromuscular & skeletal: Myalgia, back pain, arthralgia

Ocular: Periorbital edema

Renal: Abnormal renal function tests

Respiratory: Dyspnea, respiratory distress

Miscellaneous: Anaphylaxis, serum sickness, viral infection, night sweats, diaphoresis, lymphadenopathy

<1%: Dizziness, epigastric pain, faintness, herpes simplex reactivation, hiccoughs, hyperglycemia, iliac vein obstruction, infection, laryngospasm, malaise, paresthesia, pulmonary edema, renal artery thrombosis, serum sickness, toxic epidermal necrosis, weakness, wound dehiscence

Postmarketing and/or case reports: Acute renal failure, anemia, aplasia, confusion, cough, deep vein thrombosis, disorientation, GI bleeding, granulocytopenia, hemolysis, kidney enlarged, neutropenia, nosebleed, pancytopenia, vasculitis

Stability:

Ampuls must be refrigerated; do not freeze. Dilute into inverted bottle of sterile vehicle to ensure that undiluted lymphocyte immune globulin does not contact air. Gently rotate or swirl to mix. Final concentration should be 4 mg/mL. May be diluted in NS, D51/4NS, D51/2NS. Diluted solution is stable for 24 hours (including infusion time) at refrigeration.

Mechanism of Action:

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

Pharmacodynamics/Kinetics:

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

Half-life elimination, plasma: 1.5-12 days

Excretion: Urine (~1%)

Dosage:

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 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.

Premedication with diphenhydramine, hydrocortisone, and acetaminophen is recommended prior to first dose.

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, for a total of 21 doses in 28 days

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

Administration:

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. Mild itching and erythema can be treated with antihistamines. Infuse into a vascular shunt, arterial venous fistula or high-flow central vein through a 0.2-1 micron in-line filter

First dose: Premedicate with diphenhydramine orally 30 minutes prior to and hydrocortisone I.V. 15 minutes prior to infusion and acetaminophen 2 hours after start of infusion.

Monitoring Parameters:

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

Patient Education:

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, tightness, or rapid heartbeat; or respiratory difficulty. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Stomatitis.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause malaise

Mental Health: Effects on Psychiatric Treatment:

Leukopenia is common use caution with clozapine and carbamazepine

Oncology: Emetic Potential:

Very low (<10%)

Oncology: Vesicant:

Dosage Forms:

Injection, solution: 50 mg/mL (5 mL)

International Brand Names:

Atgam® (CA)

References

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.

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