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Resources to help cultivate long-term post-transplant success

Comprehensive support that helps confidence bloom

Learn more about ENVARSUS XR with these clinical resources for US healthcare providers

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Brochures and handouts

Access downloadable resources to support your transplant team’s care decisions.

Pharmacist Brochure

Discover how the unique PK profile of ENVARSUS XR can help pharmacists support consistent tacrolimus exposure across patient types.

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Pharmacist Brochure
Pharmacist Brochure
MeltDose Brochure
MeltDose Brochure

MeltDose® Brochure

Learn how proprietary MeltDose® technology sets ENVARSUS XR apart.

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PK=pharmacokinetic.

Case study series*

Control – Daryl

This case study highlights the first days of a Daryl’s post-transplant journey to reach target tacrolimus levels as quickly as possible, despite the challenges of being a rapid metabolizer.

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Consistency – Carla

This case study highlights Carla and her care team’s experiences maintaining her tacrolimus levels at the high end of the therapeutic range.

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Convenience – Andy

This case study highlights Andy’s struggles with adherence and how the once-daily dosing of ENVARSUS XR made a difference.

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*These cases are fictional and are not based on actual patients.

Clinical Publications

Veloxis supported a robust development program for ENVARSUS XR, including 27 trials comprising more than 1657 participants. Read further to see a partial list of ENVARSUS XR studies and a brief overview of the results. To leave the ENVARSUS XR website and review the full studies, click on the associated links.

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

De Novo Data

Novel Once-Daily Extended-Release Tacrolimus (LCPT) Versus Twice-Daily Tacrolimus in de Novo Kidney Transplants: One-Year Results of Phase III, Double Blind, Randomized Trial

This study validated the efficacy and safety of ENVARSUS XR vs Prograf® in de novo kidney transplant patients (N=543) over 12 months. Results showed noninferiority with lower doses compared with Prograf®.

Budde K, Bunnapradist S, Grinyó JM, et al; Envarsus Study Group. Am J Transplant. 2014;14(12):2796-​2806.

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Novel Once-Daily Extended-Release Tacrolimus Versus Twice-Daily Tacrolimus in de Novo Kidney Transplant Recipients: Two-Year Results of Phase 3, Double-Blind, Randomized Trial

Final 24-month analysis of a 2-armed, parallel-group, randomized, double-blind, double-dummy, multicenter, Phase 3 trial further demonstrating the safety and efficacy of ENVARSUS XR.

Rostaing L, Bunnapradist S, Grinyó JM, Ciechanowski K, et al; Envarsus Study Group. Am J Kidney Disease. 2016;67(4):648-659.

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Conversion Data

Conversion From Twice-Daily Tacrolimus to Once-Daily Extended Release Tacrolimus (LCPT): The Phase III Randomized MELT Trial

This study confirmed the efficacy and safety of ENVARSUS XR in kidney transplant patients (N=326) converted from twice-daily immediate-release tacrolimus. Patients required lower doses of ENVARSUS XR to achieve target trough levels.

Bunnapradist S, Ciechanowski K, West-Thielke P, et al; MELT investigators. Am J Transplant. 2013;13(3):760-769.

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Conversion From Twice-Daily Tacrolimus Capsules to Once-Daily Extended-Release Tacrolimus (LCPT): A Phase 2 Trial of Stable Renal Transplant Recipients

Stable kidney transplant patients can be safely converted from Prograf® twice daily to ENVARSUS XR. The greater bioavailability of ENVARSUS XR allows for once-daily dosing and similar (AUC) exposure at a lower dose than Prograf® with significantly lower peak-trough fluctuations. Please note: This study was not designed or powered to support establishing differences in safety or efficacy.

Gaber AO, Alloway RR, Bodziak K, Kaplan B, Bunnapradist S. Transplantation. 2013;96(2):191-197.

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A Steady-State Head-to-Head Pharmacokinetic Comparison of All FK-506 (Tacrolimus) Formulations (ASTCOFF): An Open-Label, Prospective, Randomized, Two-Arm, Three-Period Crossover Study

This robust study was the first to examine the pharmacokinetic profiles of the 3 oral formulations of tacrolimus available in the United States, confirming that the formulations have significantly different pharmacokinetic profiles. Please note: This study was not designed or powered to support establishing differences in safety or efficacy.

Tremblay S, Nigro V, Weinberg J, Woodle ES, Alloway RR. Am J Transplant. 2017;17(2):432-442.

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Rapid-Metabolizer Data

Results of ASERTAA, a Randomized Prospective Crossover Pharmacogenetic Study of Immediate-Release Tacrolimus Versus Extended-Release Tacrolimus in African American Kidney Transplant Recipients

This study compared the pharmacokinetics of ENVARSUS XR and immediate-release tacrolimus in African American patients. In the study, ENVARSUS XR demonstrated a consistent pharmacokinetic profile across genotypes. Please note: This study was not designed or powered to support establishing differences in safety or efficacy.

Trofe-Clark J, Brennan DC, West-Thielke P, et al. Am J Kidney Dis. 2018;71(3):315-326.

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See how ENVARSUS XR works

Watch the ENVARSUS XR mechanism of delivery video
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Watch the ENVARSUS XR mechanism of delivery video

Explore the mechanism of delivery for ENVARSUS in the prophylaxis of organ rejection in de novo kidney patients in combination with other immunosuppressants and the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants.

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ENVARSUS XR Patient Resources

Explore educational and supportive resources that may help patients access ENVARSUS XR and stay on track with their medication.

Dosing Information Sheet
Dosing Information Sheet

Dosing Information Sheet

A patient’s guide to important information on taking ENVARSUS XR.

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Patient Education Brochure
Patient Education Brochure

Patient Education Brochure

A guide to help your patients understand what to expect when starting ENVARSUS XR.

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Order ENVARSUS XR

Veloxis has worked with specialty distribution teams from major wholesalers to ensure ease of ordering ENVARSUS XR.

ENVARSUS XR is available in a variety of tablet strengths and package sizes to meet the needs of patients and customers.

Download the Pharmacy Ordering Guide

tablets

0.75-mg tablet, 1-mg tablet, and 4-mg tablet of ENVARSUS XR.*

*Tablets not shown at actual size.

Medicare Billing and Coding Guide
Medicare Billing and Coding Guide

Medicare Billing and Coding Guide

ENVARSUS XR has a unique J-code: [J7503].

This guide covers the following topics:

  • ENVARSUS XR product description
  • Coding overview and payment rates
  • Medicare Part B coverage overview
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Billing and Reimbursement
Billing and Reimbursement

Billing and Reimbursement

Most insured patients have access to ENVARSUS XR.

Contact a Veloxis pharmaceuticals representative for more information about ENVARSUS XR

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INDICATIONS AND USAGE

ENVARSUS XR is indicated for the prophylaxis of organ rejection in de novo kidney transplant patients in combination with other immunosuppressants.

ENVARSUS XR is also indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants.

IMPORTANT SAFETY INFORMATION

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

CONTRAINDICATIONS

ENVARSUS XR is contraindicated in patients with known hypersensitivity to tacrolimus or to any of the ingredients in ENVARSUS XR.

WARNINGS AND PRECAUTIONS

Lymphoma and Other Malignancies: Immunosuppressants, including ENVARSUS XR, increase the risk of developing lymphomas and other malignancies, particularly of the skin. Post-transplant lymphoproliferative disorder (PTLD), associated with Epstein-Barr Virus (EBV), has been reported in immunosuppressed organ transplant patients.

Serious Infections: Immunosuppressants, including ENVARSUS XR, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes.

Not Interchangeable with Other Tacrolimus Products – Medication Errors: Medication errors, including substitution and dispensing errors, between tacrolimus capsules and tacrolimus extended-release capsules were reported outside the U.S. in some cases leading to adverse reactions. ENVARSUS XR is not interchangeable or substitutable with tacrolimus extended-release capsules, tacrolimus capsules or tacrolimus for oral suspension.

New Onset Diabetes after Transplant: ENVARSUS XR caused new onset diabetes after transplant (NODAT) in kidney transplant patients, which may be reversible in some patients. African-American and Hispanic kidney transplant patients are at an increased risk.

Nephrotoxicity due to ENVARSUS XR and Drug Interactions: ENVARSUS XR, like other calcineurin-inhibitors, can cause acute or chronic nephrotoxicity. In patients with elevated serum creatinine and tacrolimus whole blood trough concentrations greater than the recommended range, consider dosage reduction or temporary interruption of tacrolimus administration. The risk for nephrotoxicity may increase when ENVARSUS XR is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity. When tacrolimus is used concurrently with CYP3A inhibitors or other known nephrotoxic drugs, monitor renal function and tacrolimus blood concentrations, and adjust dose of both tacrolimus and/or concomitant medications during concurrent use.

Neurotoxicity: ENVARSUS XR may cause a spectrum of neurotoxicities. The most severe neurotoxicities include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremors, paresthesias, headache, mental status changes, and changes in motor and sensory functions.

Hyperkalemia: Mild to severe hyperkalemia, which may require treatment, has been reported with tacrolimus including ENVARSUS XR. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

Hypertension: Hypertension is a common adverse reaction to ENVARSUS XR therapy and may require antihypertensive therapy.

Risk of Rejection with Strong CYP3A Inducers and Risk of Serious Adverse Reactions with Strong CYP3A Inhibitors: The concomitant use of strong CYP3A inducers may increase the metabolism of tacrolimus, leading to lower whole blood trough concentrations and greater risk of rejection. In contrast, the concomitant use of strong CYP3A inhibitors may decrease the metabolism of tacrolimus, leading to higher whole blood trough concentrations and greater risk of serious adverse reactions. Therefore, adjust ENVARSUS XR dose and monitor tacrolimus whole blood trough concentrations when co-administering ENVARSUS XR with strong CYP3A inhibitors or strong CYP3A inducers. A rapid, sharp rise in tacrolimus levels has been reported after co-administration with strong CYP3A4 inhibitors despite an initial reduction of tacrolimus dose. Early and frequent monitoring of tacrolimus whole blood trough levels is recommended.

QT Prolongation: ENVARSUS XR may prolong the QT/QTc interval and cause Torsade de pointes. Avoid ENVARSUS XR in patients with congenital long QT syndrome. Consider obtaining electrocardiograms and monitoring electrolytes periodically during treatment in patients with congestive heart failure, bradyarrhythmias, those taking certain antiarrhythmic medications or other products that lead to QT prolongation, and those with electrolyte disturbances. When co-administering ENVARSUS XR with other substrates and/or inhibitors of CYP3A, especially those that also have the potential to prolong the QT interval, a reduction in ENVARSUS XR dosage, monitoring of tacrolimus whole blood concentrations, and monitoring for QT prolongation is recommended.

Immunizations: Whenever possible, administer the complete complement of vaccines before transplantation and treatment with ENVARSUS XR. Avoid the use of live attenuated vaccines during treatment with ENVARSUS XR. Inactivated vaccines noted to be safe for administration after transplantation may not be sufficiently immunogenic during treatment with ENVARSUS XR.

Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus. If PRCA is diagnosed, consider discontinuation of ENVARSUS XR.

Cannabidiol Drug Interactions: When cannabidiol and ENVARSUS XR are co-administered, closely monitor for an increase in tacrolimus blood levels and for adverse reactions suggestive of tacrolimus toxicity. A dose reduction of ENVARSUS XR should be considered as needed when ENVARSUS XR is co-administered with cannabidiol.

Thrombotic Microangiopathy (TMA) Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura: Cases of thrombotic microangiopathy (TMA), including hemolytic uremic syndrome (HUS) and thrombotic thrombocytopenic purpura (TTP), have been reported in patients treated with ENVARSUS XR. Transplant patients may have other risk factors which contribute to the risk of TMA. In patients with signs and symptoms of TMA, consider ENVARSUS XR as a risk factor. Concurrent use of ENVARSUS XR and mammalian target of rapamycin (mTOR) inhibitors may contribute to the risk of TMA.

ADVERSE REACTIONS

De Novo kidney transplant patients: Most common adverse reactions (incidence ≥15%) reported with ENVARSUS XR are diarrhea, anemia, urinary tract infection, hypertension, tremor, constipation, diabetes mellitus, peripheral edema, hyperkalemia and headache.

Conversion of kidney transplant patients from immediate-release tacrolimus: Most common adverse reactions (incidence ≥10%) reported with ENVARSUS XR include: diarrhea and blood creatinine increased.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on postmarketing surveillance, registry and animal data may cause fetal harm. Advise pregnant women of the potential risk to the fetus.

Nursing Mothers: Tacrolimus is present in human milk. Discontinue drug or nursing, taking into account the importance of drug to the mother.

Females and Males of Reproductive Potential: Advise female and male patients of reproductive potential to speak with their healthcare provider on family planning options including appropriate contraception prior to starting treatment with ENVARSUS XR. Based on animal studies, ENVARSUS XR may affect fertility in males and females.

Pediatric Use: The safety and efficacy of ENVARSUS XR in pediatric patients have not been established.

Geriatric Use: Clinical studies of ENVARSUS XR did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Renal Impairment: Frequent monitoring of renal function is recommended. Lower doses may be required.

Hepatic Impairment: Frequent monitoring of tacrolimus trough concentrations is recommended. With greater tacrolimus whole blood trough concentrations in patients with severe hepatic impairment, there is a greater risk of adverse reactions and dosage reduction is recommended.

Race: African-American patients may require higher doses to attain comparable trough concentrations compared to Caucasian patients. African-American and Hispanic kidney transplant patients are at an increased risk for new onset diabetes after transplant. Monitor blood glucose concentrations and treat appropriately.

To report SUSPECTED ADVERSE REACTIONS, contact Veloxis Pharmaceuticals, Inc. at 1-​844-​VELOXIS (835-​​6947) or FDA at 1-​​800-​​FDA-​​1088 or visit www.fda.gov/medwatch.

Please see full Prescribing Information, including Boxed Warning.