Prescribing Information
Indication: Thymoglobulin® (anti-thymocyte globulin (rabbit)) is indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. Thymoglobulin is to be used in conjunction with concomitant immunosuppression.
Indication: Thymoglobulin® (anti-thymocyte globulin (rabbit)) is indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. Thymoglobulin is to be used in conjunction with concomitant immunosuppression.

Efficacy & Safety

Efficacy: Thymoglobulin® Offers Proven, Proactive Protection Against Acute Rejection in Kidney Transplant

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Thymoglobulin Demonstrated Superiority to Basiliximab in Reducing Treatment Failure1

The open-label, randomized, active-controlled trial compared the efficacy and safety of Thymoglobulin and of basiliximab in kidney transplant patients at increased risk for acute rejection or delayed graft function.1,2
Study Design
Open-label, randomized, active-controlled trial1
Graph showing the the study design for the trial comparing efficacy & safety of Thymoglobulin and Basiliximab in patients at high risk of rejection or delayed graft function


  • First induction treatment was initiated prior to reperfusion of the kidney1
  • All patients received triple-maintenance immunosuppression involving cyclosporine, MMF, and corticosteroids1
  • Patients were followed for 12 months or until they were withdrawn from the study or lost to follow-up1

Thymoglobulin Significantly Reduced Treatment Failure Rates Compared to Basiliximab1

Treatment failure was based on the composite end point of BPAR, graft loss, death, or lost to follow-up within 12 months.1

Graph chart showing treatment failure rate at 12 months for Thymoglobulin and Basiliximab

34% relative reduction in treatment failure associated with Thymoglobulin compared to Basiliximab
Composite End Point components table (including BPAR, graft loss, death, and lost to follow-up) for Thymoglobulin compared with Basiliximab


a The original primary end point of the trial published by Brennan et al was a composite of the first occurrence of BPAR, DGF, graft loss, or death.2 The FDA filing used a new composite end point, which removed DGF and included lost to follow-up, accounting for differences in the Brennan et al data compared with the Thymoglobulin label.3 The composite end point is defined as the occurrence of any of the following: BPAR (grade I-III), graft loss, death, or lost to follow-up. A patient can be counted in more than 1 category with the exception of lost to follow-up.1
b Lost to follow-up was defined as not having BPAR, graft loss, or death within 12 months post transplantation, and last visit date was prior to the lower bound of 12-month window (12 months ± 30 days after transplantation).1

Thymoglobulin Demonstrated Non-inferiority to Daclizumab in Reducing Treatment Failure1

The open-label, randomized, active-controlled, investigator-sponsored trial compared BPAR incidence in high-immunological-risk renal transplant patients receiving induction therapy with either Thymoglobulin or daclizumab.1,4
Study Design
Open-label, randomized, active-controlled trial1
Graphic showing the study design for the trial comparing efficacy & safety of Thymoglobulin and Daclizumab in patients at high risk of rejection or delayed graft function


  • First induction treatment was initiated prior to the reperfusion of the kidney1
  • All patients received triple-maintenance immunosuppression involving tacrolimus, MMF, and corticosteroids1
  • Patients were followed for 12 months or until they were withdrawn from the study or lost to follow-up1

Thymoglobulin Significantly Reduced Treatment Failure Rates Compared to Daclizumab1

Treatment failure was based on the composite end point of BPAR, graft loss, death, or lost to follow-up within 12 months.1

Graph chart showing treatment failure rate at 12 months for Thymoglobulin and Daclizumab

26% relative reduction in treatment failure associated with Thymoglobulin compared to Daclizumab
Composite End Point (including BPAR, graft loss, death, and lost to follow-up) for the Thymoglobulin and Daclizumab trial


c Maximum dose of 100 mg.1
d The original primary end point of the trial published by Noël et al was BPAR within 1 year.4 The FDA filing used a common composite end point that included BPAR (grade I-III), graft loss, death, or lost to follow-up, which was included in the Thymoglobulin prescribing information. Different end points account for the differences in the treatment failure rate between the Noël publication and the Thymoglobulin prescribing information.3
e Lost to follow-up was defined as not having BPAR, graft loss, or death within 12 months post transplantation, and last visit date was prior to the lower bound of 12-month window (12 months ± 30 days post transplantation).1

Thymoglobulin Adverse Reactions and Laboratory Abnormalities1

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Table showing higher adverse reactions & laboratory abnormalities with Thymoglobulin than Basiliximab.

f Adverse reactions are TEAEs reported as related in at least 1 patient.1
g Leukopenia:  WBC <3,000 cells /mm3;  hyperkalemia: blood potassium ≥5.5 mmol /L;  thrombocytopenia: platelet count <75,000 cells/mm3.1
  • Infections occurred in 76% of patients treated with Thymoglobulin (severe in 23%) and in 63% of patients treated with basiliximab (severe in 15%)1

Please see additional Important Safety Information below and click here for full Prescribing Information including Boxed WARNING.

See Preinfusion Considerations
and Storage Information for Thymoglobulin.
Learn More

Important Safety Information

WARNING: IMMUNOSUPPRESSION. Thymoglobulin should only be used by physicians experienced in immunosuppressive therapy in transplantation.

Important Safety Information

WARNING: IMMUNOSUPPRESSION. Thymoglobulin should only be used by physicians experienced in immunosuppressive therapy in transplantation.

Click here for full Prescribing Information including Boxed WARNING.

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Abbreviations: DGF, delayed graft function; FDA, Food and Drug Administration; MMF; Mycophenolate mofetil; TEAE, treatment-emergent adverse event; WBC, white blood cell.

References:
  1. Thymoglobulin [prescribing information]. Cambridge, MA: Genzyme Corporation; 2020.
  2. Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D; Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006;355(19):1967-1977.
  3. Data on file. sBLA Section 2.5. Sanofi Genzyme, 2015.
  4. Noel C, Abramowicz D, Durand D, et al. Daclizumab versus antithymocyte globulin in high-immunological-risk renal transplant recipients. J Am Soc Nephrol. 2009;20(6):1385-1392.