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
In kidney transplant patients switched from immediate-release tacrolimus

ENVARSUS XR efficacy is proven comparable to Prograf®

Efficacy of ENVARSUS XR: Clinical study, patients switched from Prograf Clinical trial patient demographics Adverse events associated with ENVARSUS XR: Clinical study, patients switched from Prograf


Composite Primary Endpoint Outcomes at 1 Year Post Conversion1,2*

Composite primary endpoint outcomes_swtich_Rev_OL.svg

With a primary efficacy endpoint of treatment failure at 1 year, treatment difference for ENVARSUS XR vs Prograf was 0% (95% CI [–4.2%, 4.2%]), well within the 9% prespecified non-inferiority margin.2†

No acute rejection episodes in first 30 days post conversion3
 

Renal function was maintained

Mean eGFR Over 1 Year, ENVARSUS XR vs Prograf2*

Mean eGRF Converstion_3001_Rev_OL.svg


20% lower tacrolimus dose

Change From Baseline, Mean Tacrolimus Daily Dose by Study Visit2*

Mean_DailyDose_12Months_5 rev_outlines.svg

ENVARSUS XR dose was significantly reduced from baseline at each study visit (P<0.0001).2

 

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Studied in a diverse patient population2

Multicenter, multi-national trial

Conversion as early as 3 months post-transplant

Baseline Characteristics

  ENVARSUS XR
(n=162)
Prograf
(n=162)
Median Age, years 50 50
Male, n (%) 116 (72%) 101 (62%)
Race, n (%)    
   Caucasian 120 (74%) 116 (72%)
   African-American 35 (22%) 34 (21%)
   Asian 3 (2%) 3 (2%)
   Other 4 (2.5%) 9 (5.5%)

P=not significant for all values

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ENVARSUS XR demonstrated similar safety outcomes to immediate-release tacrolimus

 

In Kidney Transplant Patients: Most common (≥5%) adverse reactions through 1 year of post conversion1‡ (P=not significant for all measures)
Diarrhea 14% 9%
Blood creatinine increased 12% 9%
Urinary tract infection 9% 14%
Nasopharyngitis 9% 11%
Headache 9% 7%
Upper respiratory tract infection 7% 9%
Peripheral edema 7% 6%
Hypertension 4% 6%

There were no significant differences between the ENVARSUS XR and Prograf groups in predefined potentially clinically significant laboratory measures incidence of new onset diabetes mellitus, opportunistic infection, or malignancies.1

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  • 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 mycophenolate mofetil (MMF), azathioprine (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.2
  • Treatment failure at 12 months was a composite endpoint of death, graft failure, BPAR, and patients lost to follow-up.
  • Study was not designed to support comparative claims of ENVARSUS XR compared to tacrolimus immediate-release for the adverse reactions reported in this table.

BPAR, biopsy-proven acute rejection; CI, confidence interval; eGFR, estimated glomerular filtration rate

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References:

  1. ENVARSUS XR [prescribing information]. Edison, NJ:  Veloxis Pharmaceuticals; 2015.
  2. 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.
  3. Data on file. Veloxis Pharmaceuticals, Inc.