Generic Name and Formulations:
Anti-thymocyte globulin (rabbit) 25mg/vial; lyophilized pwd for IV infusion after reconstitution; preservative-free; contains glycine, mannitol.
Sanofi Genzyme Company
Indications for THYMOGLOBULIN:
Prophylaxis and treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression.
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.
Acute or chronic infections.
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.
Concomitant live vaccines: not recommended. May interfere with rabbit antibody-based immunoassays and cross-match or panel-reactive antibody cytotoxicity assays.
Immunosuppressant (gamma immune globulin).
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.
Single-use vial (10mL)—1