Thymoglobulin^® is indicated for the treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression.

Important Safety Information:
Medical surveillance is required during Thymoglobulin infusion. Thymoglobulin is contraindicated in patients with a history of allergy or anaphylaxis to rabbit proteins or to any product excipients, or who have active acute or chronic infections which contraindicate any additional immunosuppression. Serious immune-mediated reactions have been reported with the use of Thymoglobulin and consist of anaphylaxis or severe cytokine release syndrome (CRS). Fatal anaphylaxis has been reported. Severe, acute infusion-associated reactions (IARs) are consistent with CRS and can cause serious cardiorespiratory events and/or death. IARs may occur as soon as the first or second infusion during a single course of Thymoglobulin treatment. During post-marketing surveillance, fever, rash, arthralgia and/or myalgia have been reported to occur 5 to 15 days after onset of Thymoglobulin therapy, indicating possible serum sickness. These symptoms are manageable with corticosteroid treatment. Infections, reactivation of infection, sepsis, malignancies including post-transplant lymphoproliferative disorder (PTLD) and other lymphomas as well as solid tumors have been reported after Thymoglobulin administration in combination with multiple immunosuppressive agents.
The most frequent reported adverse events (more than 25% of patients) include: fever, chills, leukopenia, pain, headache, abdominal pain, diarrhea, hypertension, nausea, thrombocytopenia, peripheral edema, infection, dyspnea, asthenia, hyperkalemia and tachycardia.
Prolonged use or overdose of Thymoglobulin in association with other immunosuppressive agents may cause over-immunosuppression. During Thymoglobulin therapy, monitoring the lymphocyte count may help assess the degree of T-cell depletion. WBC and platelet counts should also be monitored.
For more information on Thymoglobulin, please see full prescribing information (PDF).