What Is Envarsus XR?

Envarsus XR is a once-daily, extended-release tablet form of Tacrolimus, a calcineurin inhibitor immunosuppressant used to prevent organ rejection in kidney transplant patients.

It's manufactured by Veloxis Pharmaceuticals and was approved by the FDA for use in kidney transplant recipients. The active ingredient — Tacrolimus — is the same one found in Prograf (immediate-release) and Astagraf XL (extended-release capsules), but Envarsus XR uses a proprietary delivery technology called MeltDose that changes how the drug is absorbed. This means these formulations are not interchangeable — you can't simply swap one for another without your doctor's guidance.

Envarsus XR is not a controlled substance.

What Is Envarsus XR Used For?

Envarsus XR is FDA-approved for two specific uses:

1. Prevention of organ rejection in new (de novo) kidney transplant patients — taken in combination with other immunosuppressants after transplant surgery
2. Prevention of organ rejection in kidney transplant patients converting from immediate-release Tacrolimus — for patients already on Prograf or generic Tacrolimus IR who are switching to the once-daily extended-release form

In both cases, Envarsus XR is always used alongside other immunosuppressant medications — it's not a standalone treatment.

Off-Label Uses

While not FDA-approved for these conditions, Tacrolimus (the active ingredient) is sometimes used off-label for:

• Fistulizing Crohn's disease
• Refractory uveitis (eye inflammation)
• Minimal change disease exacerbations (a kidney condition)

Off-label use should only happen under close medical supervision.

How Is Envarsus XR Taken?

Envarsus XR is taken once daily, in the morning, on an empty stomach — at least 1 hour before or 2 hours after a meal. This is important because food (especially high-fat meals) affects how the drug is absorbed.

Key dosing details:

• Available strengths: 0.75 mg, 1 mg, and 4 mg tablets
• New transplant patients: Typical starting dose is 0.14 mg/kg/day, taken once daily
• Converting from IR Tacrolimus: Start at approximately 80% of your previous total daily Tacrolimus dose
• Swallow tablets whole — do not crush, split, or chew
• Missed dose: Can be taken up to 15 hours after the scheduled time. If more than 15 hours have passed, skip it and take the next dose at your regular time

Your doctor will adjust your dose based on Tacrolimus trough levels measured through regular blood tests. These levels are critical — too high and you risk toxicity; too low and you risk rejection.

Important Things to Avoid

• Grapefruit and grapefruit juice — increases Tacrolimus levels in your blood
• Alcohol — can worsen side effects
• High-fat meals at dosing time — take on an empty stomach as directed

For a full list of things to watch out for, see our guide on Envarsus XR drug interactions.

Who Should Not Take Envarsus XR?

You should not take Envarsus XR if you have a known allergy (hypersensitivity) to Tacrolimus or any of the inactive ingredients in the tablet.

Envarsus XR also carries a boxed warning about the increased risk of serious infections and malignancies (including lymphoma). Your transplant team will weigh these risks against the benefits of preventing organ rejection.

Special caution is needed for:

• Patients with liver disease — may need lower doses
• Pregnant women — Tacrolimus may harm the fetus (Pregnancy Category C)
• Breastfeeding women — not recommended
• African-American and Hispanic patients — higher risk of developing new onset diabetes after transplant

For more on side effects and risks, read our detailed guide on Envarsus XR side effects.

How Much Does Envarsus XR Cost?

Envarsus XR is a brand-name medication with no generic equivalent. Cash prices typically range from $270 to $1,500+ per month, depending on your dose and quantity.

Here's what you should know about coverage and savings:

• Insurance: Most commercial plans and Medicare cover Envarsus XR, but it's often placed on a specialty tier with higher copays. Prior authorization or step therapy (trying IR Tacrolimus first) may be required.
• Manufacturer savings: Veloxis offers a co-pay assistance card and a free trial program for eligible commercially insured patients. Visit envarsusxr.com or call 1-844-VELOXIS (1-844-835-6947).
• Patient assistance: The Veloxis Patient Assistance Program helps uninsured or underinsured patients. You can also check NeedyMeds and RxAssist.
• Generic Tacrolimus IR: If cost is a major barrier, generic immediate-release Tacrolimus capsules (the Prograf equivalent) are available for about $15 to $50 per month — but you'd need to take them twice daily, and switching requires your doctor's supervision.

For a full breakdown of savings options, see our guide on how to save money on Envarsus XR.

Final Thoughts

Envarsus XR is a critical medication for kidney transplant patients — offering the convenience of once-daily dosing with the proven anti-rejection power of Tacrolimus. Understanding how to take it properly, what side effects to watch for, and how to manage costs can make a big difference in your transplant journey.

If you're having trouble finding Envarsus XR at your pharmacy, Medfinder can help you check stock near you. And if you need a prescriber, check out our guide on finding a doctor who prescribes Envarsus XR.