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It’s easy to learn about the unique benefits of ENVARSUS XR by joining these webinars or watching the videos
Immunosuppression in "Rapid Metabolizers" of Tacrolimus
A rapid metabolizer is defined as an expressor of the CYP3A5*1 gene variant. They have increased CYP3A5 activity, which leads to increased metabolism of tacrolimus. Patients with this gene variant require a 1.5–2.0 times higher dose of immediate-release tacrolimus (IR-Tac), which may lead to higher tacrolimus peaks. Unlike IR-Tac, the PK of ENVARSUS XR is not impacted by genotype.
Tarek Alhamad, MD, MS, FACP, FASN
St. Louis, MO
- Discuss the clinical implications for rapid metabolizers of tacrolimus and treatment
- Review ASERTAA trial, which examined the effects of rapid tacrolimus metabolism in African Americans
- Review ENVARSUS XR and provide an overview of data in de novo kidney transplant patients
- Discuss the clinical utilization of ENVARSUS XR (tacrolimus extended-release tablets)
Length: 29 minutes
A Transplant Coordinator's Perspective on ENVARSUS XR
Discover a seasoned transplant coordinator's approach to ENVARSUS XR. The prerecorded webinar includes conversion steps, patient case studies and financial support programs for ENVARSUS XR.
Andrea Markwardt, RN, CCTN, MSN
Kidney and Pancreas Transplant Coordinator
St. Louis, MO
- The impact of specific genetic mutations of the CYP3A5 allele
- Clinical implications for rapid metabolizers of tacrolimus and treatment considerations
- How to utilize ENVARSUS XR in clinical practice
- Financial support options for patients
Length: 32 minutes
Watch the Video
ENVARSUS XR is a one-of-a-kind formulation of tacrolimus supported by extensive clinical data. Examine the potential benefits for your patients.
Slide 1: Intro Screen - ENVARSUS XR is a unique formulation of tacrolimus developed by Veloxis Pharmaceuticals.
Slide 2: Please see Boxed Warning regarding malignancies and serious infections, as well as additional full Important Safety Information at the end of this video.
Slide 3: The ultimate goal of kidney transplantation is to achieve successful outcomes.
However, there are many factors that can put a graft at risk.
Reaching tacrolimus therapeutic trough concentrations as early as day 2 was correlated with a reduced risk of rejection.
CYP3A5 expression, which is of particular concern in African American patients, is a known risk factor for graft loss.
Inadequate immunosuppression is also known to affect outcomes.
Patients may struggle with complex dosing and neurotoxicities, both of which may be associated with nonadherence.
Kidney transplant patients frequently develop infections, which are a common cause of morbidity and mortality.
And, graft survival may also be impacted by nephrotoxicity.
Slide 4: ENVARSUS XR is a unique, once-daily formulation of tacrolimus designed to provide a controlled release over 24 hours. ENVARSUS XR is indicated for de novo kidney transplant recipients as well as patients who are converting from another form of tacrolimus.
ENVARSUS XR demonstrates a smooth pharmacokinetic profile across all patient types, allowing for stable tacrolimus exposure over 24 hours.
Slide 5: ENVARSUS XR is a true controlled-release tacrolimus formulation created with Proprietary MeltDose® Technology, which disperses tacrolimus in a polymeric matrix to improve the solubility of tacrolimus and enhance bioavailability.
While IR Tacrolimus is absorbed almost entirely in the proximal GI tract, ENVARSUS XR is designed for dissolution and absorption over a broad area of the GI Tract.
Slide 6: The unique properties of ENVARSUS XR allow clinicians to maintain whole blood concentrations above the target trough while overcoming some of the limitations of other tacrolimus formulations.
In a robust, three-period, crossover study, ENVARSUS XR achieved target exposure levels with a significantly lower peak than Prograf® or Astagraf XL®.
Slide 7: Even when reaching the same trough levels and exposures, rapid metabolizers experience significantly higher peak concentrations with immediate-release tacrolimus.
However, with ENVARSUS XR, rapid metabolizers and nonexpressors experience the same pharmacokinetic curve with a significantly lower peak.
In rapid metabolizers, ENVARSUS XR eliminated the high peak experienced with immediate-release tacrolimus formulations, while demonstrating a 30% reduction in Cmax.
Slide 8: ENVARSUS XR protected de novo patients and their kidney grafts against treatment failure at 2 years.
The efficacy failure rate was 23.1% in patients treated with ENVARSUS XR and 27.3% with Prograf®, with no statistically significant difference between the 2 groups. Furthermore, efficacy was similar between the 2 treatment groups across the individual endpoints, including BPAR, graft failure, death, and lost to follow-up.
Slide 9: Despite the higher trough levels achieved earlier with ENVARSUS XR, delayed graft function and eGFR were also similar between groups.
Slide 10: This Kaplan-Meier analysis of freedom from treatment failure demonstrates that efficacy with ENVARSUS XR was preserved from transplantation through 24 months.
Slide 11: Despite the higher trough levels achieved earlier with ENVARSUS XR, there were no differences in the overall population in the frequency or types of adverse events between groups.
Once-daily ENVARSUS XR offers unique features while maintaining the expected safety profile.
In de novo kidney transplant patients the most common adverse reactions with an incidence greater than or equal to 15 percent include diarrhea, anemia, urinary tract infection, hypertension, tremor, constipation, diabetes mellitus, peripheral edema, hyperkalemia, and headache.
In kidney transplant patients who were converted from immediate-release to extended-release tacrolimus the most common adverse reactions with an incidence greater than or equal to 10 percent include diarrhea and blood creatinine increased.
Slide 12: When assessing the protocols in your practice or institution, consider ENVARSUS XR for avoiding peaks, achieving efficacy and safety goals, delivering results in rapid metabolizers, and providing once-daily dosing.
Slide 13: As the only tacrolimus formulation of its kind, ENVARSUS XR offers you and your patients unique possibilities for graft protection.
ENVARSUS XR enables you to optimize tacrolimus exposure with a significantly lower peak than Prograf® or Astagraf XL®.
With ENVARSUS XR, you can experience confidence in efficacy and safety over time.
And lastly, extensive support programs give you the opportunity to prescribe ENVARSUS XR based on your clinical judgment of what’s best for your patients.
Video - MOA Video – ENVARUSUS XR
Created with MeltDose® Technology, once-daily ENVARSUS XR delivers smooth tacrolimus levels over 24 hours. Consider the potential benefits for your patients.