WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing serious infections and malignancies with ENVARSUS XR or other immunosuppressants that may lead to hospitalization or death

Adverse Events/Product Complaints | Please See Additional Important Safety Information Below

The only once-daily tacrolimus for kidney transplant patients converted from immediate-release tacrolimus

  • Designed for the narrow therapeutic window of tacrolimus

    Delivery Re-engineered

    30% lower Cmax (P=0.0001) with similar AUC and trough1,2*

    Clinical benefit of the differences in ENVARSUS XR pharmacokinetics has not been established.

  • Designed for the narrow therapeutic window of tacrolimus

    Delivery Re-engineered

    50% greater bioavailability than Prograf® and Astagraf XL®

    in healthy subjects at steady state1

    Clinical benefit of the differences in ENVARSUS XR pharmacokinetics has not been established.

  • Designed for the narrow therapeutic window of tacrolimus

    Delivery Re-engineered

    20% lower dose than Prograf®1 achieves comparable exposure (AUC)2* and trough2*,3†

    (P<0.0001) in adult stable kidney transplant patients at ≥3 months post-transplant3†

    Clinical benefit of the differences in ENVARSUS XR pharmacokinetics has not been established.

  • Designed for Less Peak-to-trough Fluctuation (P<0.0001) Over 24 Hours2*

    peak_trough_chart.svg

    Similar PK results were demonstrated in multiple patient types, including African-Americans2-4

    Clinical benefit of the differences in ENVARSUS XR pharmacokinetics has not been established.

Less Peak-to-trough Fluctuation
1 2 3 4
  • Study Design: Phase 2, open-label, multicenter, prospective study of adult stable kidney transplant patients (N=47) who were converted from Prograf capsules twice-daily to ENVARSUS XR tablets once-daily at least 6 months post-transplant. Primary objective of the study was to demonstrate the steady-state tacrolimus exposure and trough levels on Days 7, 14, and 21.1,2

    PK, pharmacokinetic
  • Study Design: Phase 2, open-label, multicenter, prospective study of adult stable kidney transplant patients (N=47) who were converted from Prograf capsules twice-daily to ENVARSUS XR tablets once-daily at least 6 months post-transplant. Primary objective of the study was to demonstrate the steady-state tacrolimus exposure and trough levels on Days 7, 14, and 21.1,2
  • Study Design: The efficacy and safety of ENVARSUS XR was evaluated in an internationally conducted multicenter (n=33 US, n=14 Europe) open-label study of stable adult kidney transplant recipients 3 months to 5 years post-transplant (N=326) converted from Prograf to ENVARSUS XR. According to standard of care, concomitant therapy with MMF, AZA, and corticosteroids was permitted but not required. Patients were converted to ENVARSUS XR at a reduced dose or continued Prograf at the same dose.3

References:
  1. ENVARSUS XR [prescribing information]. Edison, NJ: Veloxis Pharmaceuticals; 2015.
  2. Gaber AO, Alloway RR, Bodziak K, Kaplan B, Bunnapradist S. Conversion from twice-daily tacrolimus capsules to once-daily extended-release tacrolimus (LCPT): a phase 2 trial of stable renal transplant recipients. Transplantation. 2013;96:191-197.
  3. Bunnapradist S, Ciechanowski K, West-Thielke P, et al. Conversion from twice-daily tacrolimus to once-daily extended release tacrolimus (LCPT): the phase III randomized MELT trial. Am J Transplant. 2013;13:760-769.
  4. Trofe-Clark J, Brennan D, West-Thielke P, Milone M, Bloom R. A randomized cross-over Phase 3b study of the pharmacokinetics of once-daily extended release MeltDose® tacrolimus (Envarsus® XR) versus twice-daily tacrolimus in African-Americans (ASERTAA). Am J Transplant.
    2015; 15 (suppl 3); Poster presented at the American Transplant Congress (ATC); May 2015; Philadelphia, PA.

References:
  1. ENVARSUS XR [prescribing information]. Edison, NJ: Veloxis Pharmaceuticals; 2015.
  2. Gaber AO, Alloway RR, Bodziak K, Kaplan B, Bunnapradist S. Conversion from twice-daily tacrolimus capsules to once-daily extended-release tacrolimus (LCPT): a phase 2 trial of stable renal transplant recipients. Transplantation. 2013;96:191-197.
  3. Bunnapradist S, Ciechanowski K, West-Thielke P, et al. Conversion from twice-daily tacrolimus to once-daily extended release tacrolimus (LCPT): the phase III randomized MELT trial. Am J Transplant. 2013;13:760-769.
  4. Trofe-Clark J, Brennan D, West-Thielke P, Milone M, Bloom R. A randomized cross-over Phase 3b study of the pharmacokinetics of once-daily extended release MeltDose® tacrolimus (Envarsus® XR) versus twice-daily tacrolimus in African-Americans (ASERTAA). Am J Transplant. 2015; 15 (suppl 3); Poster presented at the American Transplant Congress (ATC); May 2015; Philadelphia, PA.