Thymoglobulin® is indicated for the treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression.
Important Safety Information for Thymoglobulin [Anti-thymocyte Globulin (Rabbit)]:
- 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. If an anaphylactic reaction occurs, the infusion should be terminated immediately.
- Infections, reactivation of infection, febrile neutropenia, sepsis, malignancies including lymphoproliferative disorders (LPD) and other lymphomas (which may be virally mediated) as well as solid tumors have been reported after Thymoglobulin administration in combination with multiple immunosuppressive agents. These infections can be fatal.
- Thymoglobulin should be used under strict medical supervision in a hospital setting, and patients should be carefully monitored during the infusion.
- Thrombocytopenia and/or leukopenia (including lymphopenia and neutropenia) have been identified and are reversible following dose adjustments.
- Reactions at the infusion site can occur and may include pain, swelling, and erythema.
- 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, urticaria, 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.
- Prolonged use or overdose of Thymoglobulin in association with other immunosuppressive agents may cause overimmunosuppression. During Thymoglobulin therapy, monitoring the lymphocyte count may help assess the degree of T-cell depletion. WBC and platelet counts should also be monitored.
- 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.
For more information on Thymoglobulin, please see full prescribing information (PDF).