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

Frequently asked questions about ENVARSUS XR

What is ENVARSUS XR? Who should not take ENVARSUS XR? What should I tell my doctor before taking ENVARSUS XR? What are the most serious side effects with ENVARSUS XR?

 

What is ENVARSUS XR?

ENVARSUS XR is a once-daily 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 once-daily tacrolimus extended-release capsules (Astagraf XL®) or twice-daily tacrolimus immediate-release capsules (Prograf® or generic tacrolimus). Your doctor should decide what medicine is right for you. ENVARSUS XR has not been studied for safety and efficacy in children under 18 years of age who have had kidney transplants.

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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. See complete list of ingredients in ENVARSUS XR Patient Medication Guide.

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What should I tell my doctor before taking ENVARSUS XR?

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 take ENVARSUS XR or breastfeed. You should not do both.

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

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What are the most serious side effects with 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 doctor right away if you have symptoms of an infection such as: fever, cough, or flu-like symptoms, muscle aches, sweats or chills, warm, red, or painful areas on your skin.
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