- Important Safety
Information - Prescribing
Information - Medical
Information - For U.S. Healthcare Professionals Only
Efficacy: Thymoglobulin® Offers Proven, Proactive Protection Against Acute Rejection in Kidney Transplant Jump to Safety Information |
Treatment failure was based on the composite end point of BPAR, graft loss, death, or lost to follow-up within 12 months.1
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 |
Treatment failure was based on the composite end point of BPAR, graft loss, death, or lost to follow-up within 12 months.1
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 Jump to Efficacy Information |
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 |
Please see additional Important Safety Information below and click here for full Prescribing Information including Boxed WARNING.
WARNING: IMMUNOSUPPRESSION. Thymoglobulin should only be used by physicians experienced in immunosuppressive therapy in transplantation.
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.
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