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 for Acute Rejection

Jump to Safety Information

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*
Trial Design
Trial design for comparing efficacy and safety of Thymoglobulin and Basiliximab chart


  • First induction treatment was initiated prior to reperfusion of the kidney1
  • All patients received triple maintenance immunosuppression (cyclosporine, mycophenolate mofetil, and corticosteroids)1

Thymoglobulin Significantly Reduced Treatment Failure Rates Compared to Basiliximab1

Treatment failure was based on the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, or lost to follow-up within 12 months.1

Treatment Failure Rate at 12 Months
Treatment failure rate at 12 months for Thymoglobulin (25%) and Basiliximab (38%) trial chart

Thymoglobulin was associated with a 34% relative reduction in treatment failure compared with basiliximab.1

Individual Components1
Individual components of the Thymoglobulin and Basiliximab trial (including BPAR, graft loss, death, and lost to follow-up) chart


* The original primary endpoint of the trial published by Brennan et al was a composite of the first occurrence of biopsy-proven acute rejection (BPAR), delayed graft function, graft loss, or death.2 In preparation of the sBLA filing, the FDA requested a new composite endpoint, which removed DGF and included lost to follow-up, which accounts for slight differences in the Brennan et al data compared with the Thymoglobulin label.3 The composite endpoint 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
† BPAR is defined as the destruction of transplanted tissue or organ by the host’s immune system that has been confirmed clinically by decreased transplant organ function and biopsy.4
‡ 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 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.1,5§
Study Design
Trial design for comparing efficacy and safety of Thymoglobulin and Daclizumab chart


  • First induction treatment was initiated prior to the beginning of the surgical procedure1
  • All patients received triple maintenance immunosuppression (tacrolimus, mycophenolate mofetil, and corticosteroids)1

Thymoglobulin Reduced Treatment Failure Rates at 12 Months1

Treatment failure was based on the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, or lost to follow-up within 12 months.1

Treatment Failure Rate at 12 Months
Treatment failure rate at 12 months for Thymoglobulin (25%) and Daclizumab (34%) trial chart

Thymoglobulin was associated with a 26% relative reduction in treatment failure compared with daclizumab.1

Individual Components1
Individual components of the Thymoglobulin and Daclizumab trial (including BPAR, graft loss, death, and lost to follow-up) chart


§ The original primary endpoint of the trial published by Noël et al was BPAR within 1 year.5 In preparation of the sBLA filing, the FDA requested to reanalyze the data using a common composite endpoint that included BPAR (grade I-III), graft loss, death, or lost to follow-up, which was included in the Thymoglobulin prescribing information. Different endpoints account for the slight differences in the treatment failure rate between the Noël publication and the Thymoglobulin prescribing information.3
Maximum dose of 100 mg.1
# 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 Abnormalities

Jump to Efficacy Information
Adverse Reactions and Laboratory Abnormalities Reported More Frequently
(Incidence >5%) Following Thymoglobulin vs Basiliximab1
Adverse Reactions and Laboratory Abnormalities Reported Following Thymoglobulin vs. Basiliximab clinical study chart

** Adverse reactions are treatment emergent adverse events (TEAEs) reported as related in at least 1 patient.1
†† Leukopenia: white blood cell (WBC) count ≥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 for Thymoglobulin
[Anti-thymocyte Globulin (Rabbit)]:

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

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

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

Click here for full Prescribing Information including Boxed WARNING.

References:
  1. Thymoglobulin [prescribing information]. Cambridge, MA: Genzyme Corporation; 2017.
  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. Kidney Disease: Improving Global Outcomes Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009;9 Suppl 3:S1-157.
  5. 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.