About Immunosuppression 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 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 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? 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:

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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.

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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.

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?

IMPORTANT SAFETY INFORMATION

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

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

Before you take ENVARSUS XR, tell your healthcare provider about all your medical conditions, including if you: plan to receive any live vaccines, have or have had liver, kidney or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

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.

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 and cause serious side effects.

Especially tell your healthcare provider if you take a seizure (anticonvulsant) medicine, medicines to treat infections (antibacterials, antivirals, or antifungals), or other medicines that prevent rejection of a transplanted organ. Do not start or stop a medicine without telling your healthcare provider first.

While taking ENVARSUS XR, avoid live vaccines, exposure to sunlight and UV light such as tanning machines, eating grapefruit or drinking grapefruit juice, and alcohol.

ENVARSUS XR may cause serious side effects, including:

  • 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.
  • High blood sugar (diabetes). 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, or loss of appetite.
  • Kidney problems.
  • Nervous system problems. Call your healthcare provider right away if you get any of these symptoms while taking ENVARSUS XR: confusion, numbness and tingling, vision changes, coma, headache, muscle tremors, or seizures.
  • High levels of potassium in your blood.
  • High blood pressure.
  • Changes in the electrical activity of your heart (QT prolongation).
  • Severe low blood cell count (anemia).
  • Blood clotting problems. Tell your healthcare provider right away if you have fever and bruising under the skin that may appear as red dots, with or without unexplained tiredness, confusion, yellowing of the skin or eyes, decreased urination. When taken with sirolimus or everolimus, or when you develop certain infections, the risk of developing these symptoms may increase.

The most common side effects of ENVARSUS XR in people who received a kidney transplant are diarrhea, low red blood cell count (anemia), urinary tract infection, constipation, and swelling in the arms, hands, or legs (peripheral edema).

The most common side effects of ENVARSUS XR in people who are switching from immediate-release tacrolimus to ENVARSUS XR are diarrhea and high blood creatinine.

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

Approved Uses:

  • 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.

It is not known if ENVARSUS XR is safe and effective in children.

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).

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:

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