Thymoglobulin

— THERAPEUTIC CATEGORIES —
  • Organ rejection prophylaxis

Thymoglobulin Generic Name & Formulations

General Description

Anti-thymocyte globulin (rabbit) 25mg/vial; lyophilized pwd for IV infusion after reconstitution; preservative-free; contains glycine, mannitol.

Pharmacological Class

Immunosuppressant (gamma immune globulin).

How Supplied

Single-use vial (10mL)—1

Manufacturer

Thymoglobulin Indications

Indications

Prophylaxis and treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression.

Thymoglobulin Dosage and Administration

Adult

Premedicate with corticosteroids, acetaminophen, and/or antihistamines 1 hour prior to each infusion. Give by IV infusion over 6 hours for first infusion into a high-flow vein, and over 4 hours on subsequent days of therapy. Prophylaxis: 1.5mg/kg once daily for 4–7 days; give first dose before reperfusion of the donor kidney. Treatment: 1.5mg/kg once daily for 7–14 days. WBC count 2000–3000 cells/mm3 or platelet count 50000–75000 cells/mm3: reduce dose by ½. WBC <2000 cells/mm3 or platelets <50000 cells/mm3: consider discontinuing therapy. When concomitant immunosuppressants: administer antifungal and antibacterial prophylaxis if clinically indicated. CMV-seropositive at the time of transplant or CMV-seronegative recipient from a CMV-seropositive donor: give antiviral prophylaxis. Consider decreasing maintenance immunosuppression therapy during Thymoglobulin use to avoid over-immunosuppression.

Children

Not established.

Thymoglobulin Contraindications

Contraindications

Acute or chronic infections.

Thymoglobulin Boxed Warnings

Boxed Warning

Immunosuppression.

Thymoglobulin Warnings/Precautions

Warnings/Precautions

Should be used by experienced physicians in immunosuppressive therapy in transplantation. Must be administered under strict supervision in a hospital setting and monitored during the infusion. Have epinephrine (1:1000) and other resuscitative measures available. Discontinue immediately if anaphylaxis occurs. Risk of cytokine release syndrome (CRS) with rapid infusions; reduce infusion rates. Monitor for infections; treat with anti-infective therapy if appropriate. Increased risk of malignancies (eg, lymphoma, lymphoproliferative disorders). Monitor CBC, WBC, platelet, lymphocyte counts during and after treatment. Pregnancy; use effective contraception during and for at least 3 months after therapy. Nursing mothers: not recommended.

Thymoglobulin Pharmacokinetics

See Literature

Thymoglobulin Interactions

Interactions

Concomitant live vaccines: not recommended. May interfere with rabbit antibody-based immunoassays and cross-match or panel-reactive antibody cytotoxicity assays.

Thymoglobulin Adverse Reactions

Adverse Reactions

UTI, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, hyperkalemia, thrombocytopenia, leukopenia; serious immune-mediated reactions (eg, anaphylaxis, CRS), infusion-site reactions, infections.

Thymoglobulin Clinical Trials

See Literature

Thymoglobulin Note

Not Applicable

Thymoglobulin Patient Counseling

See Literature