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Taking ENVARSUS XR

Protect your kidney from rejection with once-daily ENVARSUS XR.

Once-daily dosing for all adult kidney transplant patient types

ENVARSUS XR extended-release tablets are designed to work with only one dose over 24 hours.

Do not mix other brands of tacrolimus or generic tacrolimus with ENVARSUS XR. If you have been prescribed ENVARSUS XR, make sure it is the only tacrolimus medicine you are taking.

There is no substitutable generic for ENVARSUS XR.

If you are switching to ENVARSUS XR from another tacrolimus product

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 healthcare provider tells you to do so.

How do I take ENVARSUS XR?

  • Take ENVARSUS XR exactly as your healthcare provider tells you to take it.
  • Take ENVARSUS XR once-daily tablets with fluid (preferably with water) on an empty stomach, at least 1 hour before a meal or 2 hours after a meal, at the same time each day (preferably in the morning). Decide on a time with your healthcare provider so they will know what time of day to schedule your blood tests.
  • Swallow ENVARSUS XR tablets whole. Do not chew, divide, crush, or dissolve ENVARSUS XR tablets before swallowing. If you cannot swallow ENVARSUS XR tablets whole, tell your doctor.
  • Do not crush your ENVARSUS XR once-daily extended-release tabletsDo not chew your ENVARSUS XR once-daily extended-release tablets
  • 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.
  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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You may have options for saving on ENVARSUS XR*

See Savings Options

*Subject to terms and conditions. See eligibility requirements.

ENVARSUS XR is a tablet, not a capsule

Be sure to inspect your ENVARSUS XR medicine when you receive a new prescription and before taking it. Make sure your ENVARSUS XR tablet looks like the one in the picture, with the correct dosage strength number on the dose side of the tablet and the letters “TCS” on the back side. The dosage strength number on the tablet should match the dosage strength number on your pill bottle.

Dose side*

Front side of ENVARSUS XR 0.75 mg tablet

0.75-mg Tablet

Front side of ENVARSUS XR 1 mg tablet

1-mg Tablet

Front side of ENVARSUS XR 4 mg tablet

4-mg Tablet

Back side*

Back side of ENVARSUS XR 0.75 mg tablet

0.75-mg Tablet

Back side of ENVARSUS XR 1 mg tablet

1-mg Tablet

Back side of ENVARSUS XR 4 mg tablet

4-mg Tablet

*Tablets not shown at actual size.

ENVARSUS XR is not a capsule

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 healthcare provider right away.

*Tablets not shown at actual size.

ENVARSUS XR dosing information sheet

This resource contains important tips for taking your medication. Keep this around your house to quickly answer questions about taking ENVARSUS XR.

Download Dosing Guide (PDF)
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What if I miss a dose of ENVARSUS XR?

If you miss your dose of ENVARSUS XR, it should be taken as soon as possible, but no longer than 15 hours after missing your dose. If you do not notice the missed dose until more than 15 hours later, you should skip it and take the next dose 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 healthcare provider as soon as possible.

What should I share with my doctor?

Before you take ENVARSUS XR, tell your doctor if you:

  • Plan to receive any live vaccines. Ask your doctor if you are not sure if your vaccine is a live vaccine.
  • Have or have had liver, kidney, or heart problems.
  • Have any other medical conditions.
  • Are pregnant or plan to become pregnant. ENVARSUS XR may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • Are breastfeeding or plan to breastfeed. ENVARSUS XR can pass into your breast milk. You and your doctor should decide if you will breastfeed while taking ENVARSUS XR.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, natural, herbal or nutritional supplements. ENVARSUS XR may affect the way other medicines work, and other medicines may affect how ENVARSUS XR works.

Transplant care discussion guide thumbnail

Transplant care discussion guide

This transplant care discussion guide can help you plan a conversation with your doctor and help you understand what information your doctor will want to know.

Download Discussion Guide (PDF)

Get ENVARSUS XR resources

Keeping your future in focus is easier with these helpful materials.

Get Resources

Please tell us more about you:

I am expecting a kidney transplant (or am a family member/caregiver) ▶
I am an ENVARSUS XR patient (or am a family member/caregiver) ▶
I have had a kidney transplant and am not currently on ENVARSUS XR (or am a family member/caregiver) ▶
I am a healthcare professional ▶
Other ▶

What are you interested in learning about?

General information about immunosuppression ▶
Information about ENVARSUS XR ▶
Hear a transplant patient’s story ▶
General transplant resources and education ▶
Visit “About Immunosuppression” ▶
Visit “Why ENVARSUS XR?” ▶
Visit “Resources” ▶
Visit “Resources” ▶
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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ENVARSUS XR?

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 that can cause death.

Call your healthcare provider right away if you have symptoms of an infection such as:

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ENVARSUS XR?

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 that can cause death.

Call your healthcare provider right away if you have symptoms of an infection such as:

  • fever
  • cough or flu-like symptoms
  • warm, red, or painful areas on your skin
  • sweats or chills
  • muscle aches

What is ENVARSUS XR?

ENVARSUS XR is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant.

ENVARSUS XR is an extended-release tablet and is not the same as tacrolimus extended-release capsules, tacrolimus immediate-release capsules or tacrolimus for oral suspension. Your healthcare provider should decide what medicine is right for you.

Who should not take ENVARSUS XR?

Do not take ENVARSUS XR if you are allergic to tacrolimus or any of the ingredients in ENVARSUS XR.

What should I tell my healthcare provider before taking ENVARSUS XR?

Before you take ENVARSUS XR, tell your healthcare provider if you:

  • plan to receive any live vaccines. Ask your healthcare provider if you are not sure if your vaccine is a live vaccine.
  • have or have had liver, kidney or heart problems.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. ENVARSUS XR may harm your unborn baby.
    • If you are able to become pregnant, you should use effective birth control before and during treatment with ENVARSUS XR. Talk to your healthcare provider about birth control methods that may be right for you.
    • Males who have female partners that are able to become pregnant should also use effective birth control before and during treatment with ENVARSUS XR. Talk to your healthcare provider before starting treatment with ENVARSUS XR about birth control methods that may be right for you.
    • There is a pregnancy registry for females who become pregnant and males who have fathered a pregnancy during treatment with ENVARSUS XR. The purpose of this registry is to collect information about your health and of your baby. To enroll in this voluntary registry, call 1-877-955-6877.
  • are breastfeeding or plan to breastfeed. ENVARSUS XR passes into your breast milk. You and your healthcare provider should decide if you will breastfeed while taking ENVARSUS XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, natural, herbal or nutritional supplements.

ENVARSUS XR may affect the way other medicines work, and other medicines may affect how ENVARSUS XR works.

How should I take ENVARSUS XR?

Take ENVARSUS XR exactly as your healthcare provider tells you to take it.

Your healthcare provider may change your dose of ENVARSUS XR if needed. Do not stop taking or change your dose of ENVARSUS XR without talking to your healthcare provider.

Take ENVARSUS XR once daily with fluid (preferably water) on an empty stomach, at least 1 hour before or at least 2 hours after a meal, at the same time each day (preferably in the morning).

Take ENVARSUS XR tablets whole. Do not chew, divide, crush, or dissolve ENVARSUS XR tablets before swallowing. If you cannot swallow ENVARSUS XR tablets whole, tell your healthcare provider.

If you miss your dose of ENVARSUS XR, it should be taken as soon as possible, but no longer than 15 hours after missing your dose. If the time after you miss your dose is more than 15 hours, the missed dose 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.

If you take too much ENVARSUS XR, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking ENVARSUS XR?

Live vaccines such as flu vaccine through your nose, measles, mumps, rubella, polio by mouth, BCG (TB vaccine), yellow fever, chicken pox (varicella), or typhoid.

Exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.

You should not eat grapefruit or drink grapefruit juice while taking ENVARSUS XR.

You should not drink alcohol while taking ENVARSUS XR.

What are the possible side effects of ENVARSUS XR?

ENVARSUS XR may cause serious side effects, including:

See “What is the most important information I should know about ENVARSUS XR?”

Problems from medication errors such as graft rejection and other serious reactions. People who take ENVARSUS XR have sometimes been given the wrong medicine because some medicines have the same ingredient (tacrolimus) as ENVARSUS XR. Check your ENVARSUS XR when you get a new prescription to make sure you have received the right medicine.

  • Call your healthcare provider right away if you think you were given the wrong medicine.
  • Ask your healthcare provider or pharmacist if you are not sure what ENVARSUS XR should look like.

High blood sugar (diabetes). Your healthcare provider may do certain tests to check for diabetes while you take ENVARSUS XR. Call your healthcare provider right away if you have:

  • frequent urination
  • confusion
  • fruity smell on your breath
  • increased thirst or hunger
  • drowsiness
  • nausea, vomiting, or stomach pain
  • blurred vision
  • loss of appetite

Kidney problems. Kidney problems are serious and common side effects of ENVARSUS XR. Your healthcare provider may do certain tests to check for kidney function while you take ENVARSUS XR.

Nervous system problems. Nervous system problems are a serious and common side effect of ENVARSUS XR. Call your healthcare provider right away if you get any of these symptoms while taking ENVARSUS XR. These could be signs of serious nervous system problems:

  • confusion
  • numbness and tingling
  • vision changes
  • coma
  • headache
  • muscle tremors
  • seizures

High levels of potassium in your blood. Your healthcare provider may do certain tests to check your potassium level while you take ENVARSUS XR.

High blood pressure. Your healthcare provider will monitor your blood pressure while you take ENVARSUS XR.

Changes in the electrical activity of your heart (QT prolongation).

Severe low blood cell count (anemia)

The most common side effects of ENVARSUS XR are, diarrhea, urinary tract infection, low red blood cell count (anemia), high blood pressure, and constipation.

These are not all the possible side effects of ENVARSUS XR. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ENVARSUS XR?

Store ENVARSUS XR at room temperature between 68° F to 77° F (20° C to 25° C).

Safely throw away medicine that is out of date or no longer needed.

Keep ENVARSUS XR and all medicines out of reach of children.

General information about the safe and effective use of ENVARSUS XR.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ENVARSUS XR for a condition for which it was not prescribed. Do not give ENVARSUS XR to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about ENVARSUS XR. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ENVARSUS XR that is written for health professionals. For more information, go to www.ENVARSUSXR.com or call 1-844-Veloxis (1-844-835-6947).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the accompanying Medication Guide and full Prescribing Information, including Boxed Warning (PDF).