Immune Globulin

Treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression

Patients with history of allergy or anaphylaxis to rabbit proteins, or who have an acute viral illness

Infusion may produce fever and chills. To minimize, the first dose should be infused over a minimum of 6 hours into a high-flow vein. Also, premedication with corticosteroids, acetaminophen, and/or an antihistamine and/or slowing the infusion rate may reduce reaction incidence and intensity.

Thymoglobulin® should only be used by physicians experienced in immunosuppressive therapy for the treatment of renal transplant patients. Medical surveillance is required during the infusion. In rare circumstances, anaphylaxis has been reported with use. In such cases, the infusion should be terminated immediately. Medical personnel should be available to treat patients who experience anaphylaxis. Emergency treatment such as 0.3-0.5 mL aqueous epinephrine (1:1000 dilution) subcutaneously and other resuscitative measures including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated, should be provided. Thymoglobulin® or other rabbit immunoglobulins should not be administered again for such patients. Thrombocytopenia or neutropenia may result from cross-reactive antibodies and is reversible following dose adjustments.

>10%:

Central nervous system: Fever, chills, headache

Dermatologic: Rash

Endocrine & metabolic: Hyperkalemia

Gastrointestinal: Abdominal pain, diarrhea

Hematologic: Leukopenia, thrombocytopenia

Neuromuscular & skeletal: Weakness

Respiratory: Dyspnea

Miscellaneous: Systemic infection, pain

1% to 10%:

Gastrointestinal: Gastritis

Respiratory: Pneumonia

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

Store intact vials under refrigeration (2°C to 8°C/36°F to 46°F); protect from light and do not freeze

Allow Thymoglobulin® and diluent (sterile WFI) to reach room temperature before reconstituting the lyophilized product. Reconstitute Thymoglobulin® with the supplied diluent, sterile water for injection immediately before use. Thymoglobulin® should be used within 4 hours of reconstitution if kept at room temperature.

Reconstitute each vial of Thymoglobulin® lyophilized powder with 5 mL of sterile diluent to yield a concentration of 5 mg/mL of Thymoglobulin®.

The calculated dosage of Thymoglobulin® should be should be further diluted in 50-500 mL of 0.9% sodium chloride or 5% dextrose in water. Each vial of Thymoglobulin® should be further diluted to 50 mL of infusion solution.

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

Half-life, plasma: 2-3 days

I.V.: 1.5 mg/kg/day for 7-14 days

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

For I.V. use only; mild itching and erythema can be treated with antihistamines; infuse first dose over at least 6 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: 25 mg vials (with diluent)