Thymoglobulin^® [Anti-thymocyte Globulin (Rabbit)]

Important Safety Information for Thymoglobulin [Anti-thymocyte Globulin (Rabbit)]:

CONTRAINDICATIONS

• 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 that contraindicate any additional immunosuppression.

WARNINGS AND PRECAUTIONS

• Management of Immunosuppression: To prevent over-immunosuppression, physicians may wish to decrease the dose of the maintenance immunosuppression regimen during the period of Thymoglobulin use.
• Hypersensitivity and Infusion-Related Reactions:  Severe hypersensitivity and infusion-related reactions, including fatal anaphylaxis and severe cytokine release syndrome (CRS), have been reported with the use of Thymoglobulin. Severe acute CRS can cause serious cardiorespiratory events and/or death. Close compliance with the recommended dosage and infusion time may reduce the incidence and severity of infusion-related reactions. Slowing the infusion rate may minimize the risk of infusion-related reactions. 
  If a hypersensitivity or infusion-related reaction occurs, terminate the infusion immediately and provide supportive treatment according to clinical practice.
• Cytopenias: Cytopenias including anemia, neutropenia, and thrombocytopenia have occurred with Thymoglobulin administration. Monitor blood counts after Thymoglobulin administration. Adjust dose accordingly to reverse cytopenias.
• Infection:  Thymoglobulin is routinely used in combination with other immunosuppressive agents. Infections (bacterial, fungal, viral and protozoal), reactivation of infection (particularly cytomegalovirus [CMV]) and sepsis have been reported after Thymoglobulin administration in combination with multiple immunosuppressive agents. These infections can be fatal.
  Monitor patients carefully and administer appropriate anti-infective treatment when indicated.
• Malignancy: Malignancies with fatal outcomes have been reported in patients treated with Thymoglobulin. Use of immunosuppressive agents, including Thymoglobulin, may increase the risk of malignancies, including lymphoma or lymphoproliferative disorders.
• Immunizations: The safety of immunization with attenuated live vaccines following Thymoglobulin therapy has not been studied; therefore, immunization with attenuated live vaccines is not recommended for patients who have recently received Thymoglobulin.
• Laboratory Tests: Thymoglobulin may interfere with rabbit antibody–based immunoassays and with cross-match or panel-reactive antibody cytotoxicity assays. Thymoglobulin has not been shown to interfere with any routine clinical laboratory tests that do not use immunoglobulins.

ADVERSE REACTIONS

• The most common adverse reactions and laboratory abnormalities (incidence >5% higher than comparator) are urinary tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, increased potassium levels in the blood, and low counts of platelets and white blood cells.

The following postmarketing adverse reactions have been reported:  

• Hepatobiliary Disorders: Hepatic dysfunction including transient reversible elevations in aminotransferases without any clinical signs or symptoms, hepatic failure, hyperbilirubinemia.
• Blood and Lymphatic System Disorders: Febrile neutropenia, coagulopathy without clinical signs or symptoms of bleeding, disseminated intravascular coagulopathy, anemia including hemolytic anemia, thrombotic microangiopathy.
• Immune System Disorders: Hypersensitivity reactions including anaphylaxis, CRS.

OVERDOSAGE

• Thymoglobulin overdosage may result in leukopenia (including lymphopenia and neutropenia) and/ or thrombocytopenia, which can be managed with dose reduction.