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About Immunosuppression

About Immuno-
suppression

Set the stage for what you need to know about your future after transplant. Tacrolimus is an immunosuppressant medicine that helps prevent your body from rejecting your new kidney.

What are immunosuppressants?

What are immuno-
suppressants?

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Your body has a natural defense called the immune system that fights off things like bacteria and viruses to keep you from getting sick.

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When you get a kidney transplant, your immune system may think your new kidney is a foreign invader and try to attack it. This is called organ rejection.

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Immunosuppressants (im-you-no-soo-pres-ants) are a type of medicine that keep your immune system from attacking or hurting your new kidney.

Antirejection medicines, like immunosuppressants, work better when used in combination. Most patients will be on more than one antirejection medicine at the same time. These medicines work to keep your new kidney healthy. Your healthcare team will work with you to find the best medicines to keep your new kidney strong. It is important that you take your medicine as prescribed.

Do immunosuppressants have side effects?

Do immuno-
suppressants have side effects?

Yes. Your immunosuppressants will have side effects, like all medicines. Be sure to review the Medication Guides that came with your prescriptions for important safety information.

According to the American Society of Transplantation, tacrolimus (the active ingredient in ENVARSUS XR) can cause different side effects if there is too much or too little in your system.

Too much tacrolimus in your system can lead to:

  • Decreased kidney function
  • Tremors and shakiness
  • Headache
  • Trouble sleeping
  • High potassium levels
  • Low magnesium levels

Too little tacrolimus in your system can lead to:

  • Rejection of your transplanted kidney

Side effects that are not related to the level of tacrolimus in your system include:

  • High blood pressure
  • High blood sugar
  • Tingling in hands and feet
  • Hair loss or hair thinning

Your healthcare team can prescribe you medicine to help treat these side effects. For instance, if your blood pressure is too high, your healthcare team might prescribe you a medicine to help lower your blood pressure.

According to the American Society of Transplantation, people who receive a kidney transplant have a high risk of getting infections. This is because of the immunosuppressants they will be taking. Your healthcare team may prescribe you medicine to help keep you from getting sick from certain infections caused by bacteria, viruses, and fungi.

If you are having side effects, talk with your doctor as soon as possible to find out if a different treatment may be better for you.

Do I have to keep taking immunosuppressants?

Do I have to keep taking immuno-
suppressants?

Yes. The American Society of Transplantation recommends you take your medicine every day, exactly as your healthcare team has instructed. Missing even just one dose can cause your body to reject your new kidney. If you have any trouble affording the cost of your medicine, talk to your healthcare team about how you can pay for it. Never stop taking your medicine without talking to your healthcare team first.

How do I remember to take all these pills?

There are many methods you can use to remember to take your medicine. The National Kidney Foundation recommends these simple techniques:

: Icon of Calendar with a clock next to it

Create a schedule

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Set alarm clocks, timers, or digital watches

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Stay aware of how much medicine you have left

What should I share with my doctor?

Your healthcare team wants you to live well following your kidney transplant. The best way for them to help you is by letting them know what’s going on in your life and with your health.

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.
  • 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.

Also, 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.

Have questions on how ENVARSUS XR may help you direct your future?

After getting a kidney transplant, you will probably need to take immunosuppressants for the rest of your life. Always keep in mind that these medicines are necessary to help you and your kidney stay healthy. To learn more, download this list of frequently asked questions.

These resources can play a supporting role in your future

Need more information on kidney transplants? These resources can help.

See Resources

Learn how ENVARSUS XR is different from other immunosuppressants

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

Why ENVARSUS XR?

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).