ENVARSUS XR can cause serious side effects, including:
Increased risk of cancer. People who take ENVARSUS XR have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
Increased risk of infection. ENVARSUS XR is a medicine that affects your immune system. ENVARSUS XR can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving ENVARSUS XR.

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

How to take ENVARSUS XREnvarsus_Patient_2_HowToTakeEnvarsusXR_desktop_v2_03.png

Print Dosing Instructions

How ENVARSUS XR is different Take ENVARSUS XR tablets just once a day Be sure your tablet is ENVARSUS XR

 

How ENVARSUS XR is different

ENVARSUS XR is not the same as tacrolimus capsules that must be taken twice a day (Prograf® or generic tacrolimus)—and it is not the same as another once-daily tacrolimus product called Astagraf XL®, which is a capsule, not a tablet.

Other brands of tacrolimus or generic tacrolimus cannot be mixed with ENVARSUS XR. There is no generic substitute for ENVARSUS XR, and the dosing is different from other tacrolimus products. If you are prescribed ENVARSUS XR, be sure it is the only tacrolimus medicine you are taking.

Other tacrolimus products (such as Prograf®) you may be familiar with are taken twice a day. Do not take ENVARSUS XR more than once a day. ENVARSUS XR extended-release tablets were designed to work with just one dose all day (24 hours) for kidney transplant patients!

DO NOT take any other tacrolimus capsules while you are on ENVARSUS XR.

Your total daily dose of ENVARSUS XR may be lower than the total daily dose you were taking of another tacrolimus product. DO NOT change your dose of ENVARSUS XR unless your doctor tells you to do so.

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Take ENVARSUS XR tablets just once a day

  • Take your first dose of ENVARSUS XR the morning after you take your last evening dose of your current tacrolimus product.
  • Take once-daily ENVARSUS XR tablets with fluid (preferably with water) on an empty stomach at the same time each day (preferably in the morning). This helps to keep enough medicine in your body to give your transplanted organ the around-the-clock medicine it needs. Be sure to decide with your transplant team the best time of day to take your medicine, so that they will know what time of day to schedule your blood tests.
  • Envarsus_Patient_2_HowToTakeEnvarsusXR_desktop_v2_07.pngSwallow ENVARSUS XR tablets whole. Do not chew, divide, or crush ENVARSUS XR tablets before swallowing. If you cannot swallow ENVARSUS XR tablets whole, tell
 your doctor.
  • If you miss your dose of ENVARSUS XR, it should be taken as soon as possible, but no longer than 15 hours after the scheduled time. If the missed dose is not noticed until more than 15 hours later, it should be skipped and the next dose should be taken the following morning at your regularly scheduled time. Do not take 2 doses at the same time. Also, if you miss your dose of ENVARSUS XR, call your transplant coordinator as soon as possible.
  • If you take too much ENVARSUS XR, call your doctor or go to the nearest hospital emergency room right away.
  • You should not eat grapefruit or drink grapefruit juice while taking ENVARSUS XR.
  • You should not drink alcohol while taking ENVARSUS XR.
  • Tell your doctor if you have any side effects that bother you or that do not go away. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

To report side effects, contact Veloxis Pharmaceuticals, Inc. at 1-844-VELOXIS (835-6947) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Be sure your tablet is ENVARSUS XR

Be sure your ENVARSUS XR tablet looks like the one in the picture and has the correct dosage strength number on one side of the tablet, and TCS on the back side. The dosage strength number on the tablet should match what's on your pill bottle.

Dose Side

0.75 mg Tablet
1 mg Tablet
4 mg Tablet

Back Side

0.75 mg Tablet
1 mg Tablet
4 mg Tablet
Tablets shown are not actual size.

Your pill bottle from the pharmacy must always say ENVARSUS XR. If any of these things do not match, call your pharmacist, doctor, and/or transplant coordinator right away.

There are other important directions about taking ENVARSUS XR. Please read the full Patient Medication Guide.

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