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Graphic with the text ‘Thymoglobulin® [Anti‑thymocyte Globulin (Rabbit)’] with an injection bottle icon on a green background with kidney line patterns behind an elderly man and a small disclaimer ‘Not an actual patient’.

Dosing

The Right Dose of Thymoglobulin® Offers Clinically Demonstrated Protection for Your Patient's New Kidney

Appropriate dosing for Thymoglobulin is different from dosing for other anti-thymocyte globulin (ATG) products, as protein composition and concentrations vary depending on the source of ATG used. Physicians should therefore exercise care to ensure that the dose prescribed is appropriate for the ATG product being administered.1

Recommended dosing chart for Thymoglobulin for both prophylaxis and treatment of acute kidney rejection
  • Thymoglobulin is used with concomitant immunosuppression. To prevent overimmunosuppression, physicians may wish to decrease the dose of the maintenance immunosuppression regimen during the period of Thymoglobulin use1
  • Thymoglobulin overdosage may result in leukopenia, including lymphopenia and neutropenia and/or thrombocytopenia, which can be managed with dose reductions1
An example dose calculation for a patient based on weight with the indicated dose of Thymoglobulin administered daily for 4-7 days.

Dosing Adjustments and Considerations

The immunodeficiency that results from immunosuppression predisposes patients to disorders of immune surveillance and response, including infection and malignancy. The increased risk of infection and malignancy are related more to the overall intensity of immunosuppression than to any specific agent.2,3

  • To prevent overimmunosuppression, physicians may wish to decrease the dose of maintenance immunosuppression regimen during the period of Thymoglobulin use1

During Thymoglobulin therapy, monitoring total lymphocyte count may help assess the degree of T-cell depletion.1

  • WBC and platelet counts should be monitored during and after therapy to assess the degree of neutropenia and thrombocytopenia, respectively1

Tailoring Thymoglobulin Dose Can Help Manage Your Patient’s Overall Immunosuppression1

In all appropriate patients, the Thymoglobulin dose should be reduced to prevent overimmunosuppression1,*

Recommended dose adjustments for Thymoglobulin chart
  • Low counts of WBCs and platelets are reversible following dose adjustments1

*Monitor for adverse reactions and total WBC and platelet counts to help identify appropriate patients.1

See How to Administer Thymoglobulin.

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See Preinfusion Considerations and Storage Information.

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Important Safety Information

WARNING: IMMUNOSUPPRESSION. Thymoglobulin should only be used by physicians experienced in immunosuppressive therapy in transplantation.
  • 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 which contraindicate any additional immunosuppression.
  • 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. Dosing for Thymoglobulin is different from dosing for other ATG products, because protein composition and concentrations vary depending on the source of ATG. Thymoglobulin should be used under strict medical supervision in a hospital setting, and patients should be carefully monitored during the infusion.
  • Immune Mediated Reactions. Serious immune-mediated reactions, including anaphylaxis or severe cytokine release syndrome (CRS), have been reported with the use of Thymoglobulin. Fatal anaphylaxis has been reported. If an anaphylactic reaction occurs, the infusion should be terminated immediately.
  • Infusion-Associated Reactions. Cases consistent with cytokine release syndrome (CRS) have been reported with rapid infusion rates. CRS is attributed to the release of cytokines by activated monocytes and lymphocytes. 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-associated reactions (IARs). Slowing the infusion rate may minimize many of these IARs. Reactions at the infusion site may include pain, swelling, and redness of the skin.
  • Hematologic Effects. Low counts of platelets and white blood cells (including low counts of lymphocytes and neutrophils) have been identified and are reversible following dose adjustments. Total white blood cell and platelet counts should be monitored.
  • Infection and Malignancy. Infections, reactivation of infection, febrile neutropenia, sepsis, malignancies including lymphoproliferative disorders (LPD) and other lymphomas as well as solid tumors have been reported after Thymoglobulin administration in combination with multiple immunosuppressive agents. These events can be fatal.
  • Immunization. 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.
  • Overdosage. Thymoglobulin overdosage may result in leukopenia (including lymphopenia and neutropenia) and/ or thrombocytopenia, which can be managed with dose reduction.
  • 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.
  • During post-marketing surveillance, arthralgia/myalgia, lymphadenopathy, proteinuria, and decreased oxygen saturation tend to occur 5 to 15 days after Thymoglobulin infusion and are consistent with serum sickness. Symptoms are manageable with corticosteroid treatment.

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Important Safety Information

Abbreviations: WBC, white blood cell.

References:

1. Thymoglobulin [prescribing information]. Cambridge, MA: Genzyme Corporation; 2020.
2. Halloran PF. Immunosuppressive drugs for kidney transplantation. N Engl J Med. 2004;351(26):2715-2729.
3. Kahan BD. Individuality: the barrier to optimal immunosuppression. Nat Rev Immunol. 2003;3(10):831-838.

MAT-US-2017967-v2.0-09/2022

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