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What are immunosuppressants?


When you receive an organ transplant, your body responds the way it does to any foreign object by going on the attack. (The only exception can be when an organ is transplanted from an identical twin.) This response is known as an immune response and is your body's natural defense mechanism from potentially harmful invaders such as viruses, infections, and more. However, if the body is able to launch an immune response against your new kidney, it can cause harm and lead to rejection of the transplant. 

The only way to stop your body from attacking an organ transplant is by taking immunosuppressive drugs. These drugs suppress your immune system, keeping it from damaging or destroying your transplanted kidney. There are different kinds of immunosuppressants that your doctor can prescribe to keep your immune system in check. It is likely that you will take a few different kinds of these drugs, which work in various ways to protect your transplanted kidney.

Do I have to keep taking immunosuppressants?

Yes. It is very important that you take your immunosuppressive medicines exactly as your doctor has prescribed. Missing even a single dose can increase the chance of your new kidney being rejected. Only skip doses if your doctor or another healthcare provider instructs you to do so. If you are not sure what to do, ask your doctor.

How do I remember to take all of these pills?

It may seem challenging to remember to take all of the medicines that you need. However, it is very important not to miss any doses. Here are some simple steps that you can take to help you stay on track with your medicines.

  • Create a schedule. It will help to take your medicine at the same time every day. It may be helpful to pair up taking your doses with everyday activities, such as brushing your teeth or going to bed.
  • Understand your drugs. When you know what each one does, you will be more likely to remember to take them.
  • Get a pillbox. These handy organizers help you plan ahead and be prepared for a day or for an entire week. They make it easier to take pills on the right day and at the right time.
  • Set alarm clocks, timers, or digital watches. They can help you remember to take your medicines.
  • Stay aware of how much medicine you have left. It helps to call the pharmacy for early refills.
  • Never stop or change the way you take a medicine without approval from your doctor.

Some immunosuppressants, such as tacrolimus, are available in once-daily formulations. Ask your doctor if a once-daily formulation could be right for you.

After getting an organ transplant, you will probably need to take medicines for the rest of your life. Always keep in mind that these medicines are necessary to help you and your kidney stay healthy.

To help transplant patients remember their medicine, doctors have created an interactive alarm application with reminders. Whenever your medications are due, Transplant Hero sends you an alert.

Transplant Hero interactive alarm app reminds patients to take their medicine

Learn more about Transplant Hero and download the app

What if I miss a dose of ENVARSUS XR?

Always take your medication as prescribed by your doctor.  ENVARSUS XR should be taken on an empty stomach every day at the same time, preferably in the morning. If you do miss a dose, take it as soon as possible, but not more than 15 hours after the scheduled time. If it is more than 15 hours after your scheduled dose time, just wait until the usual scheduled time (the following morning) to take the next regularly scheduled dose. Do not take 2 doses at the same time or double dose. Call your doctor or transplant center for instructions if you are unsure about what to do.

Are there immunosuppressant side effects?

Yes. Unfortunately, suppressing your immune system can make you susceptible to infections. That’s why it’s important to suppress your immune system enough to protect your kidney, but not suppress it so much that your risk of infection or other side effects gets too high.

There are things you can do to help protect yourself from infections. Wash your hands often and avoid or limit being around people who are sick.

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

What should I share with my doctor?

Your health care team wants you to have a good quality of life with your kidney transplant. You will meet with them on a regular basis for tests and other monitoring. Be sure to share the details of how you’re feeling and doing with your medication regimen. 

This immunosuppressive medicine is different. Why?

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 doctor 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 or tacrolimus immediate-release capsules. Your doctor 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. See the end of this leaflet for a complete list of ingredients in ENVARSUS XR.

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.

How should I take ENVARSUS XR?

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

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

Take ENVARSUS XR once daily with fluid (preferably water) on an empty stomach at the same time each day (preferably in the morning).

Take 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 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 doctor 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?

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

High blood sugar (diabetes). Your doctor may do certain tests to check for diabetes while you take ENVARSUS XR. Call your doctor 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. Your doctor may do certain tests to check for kidney function while you take ENVARSUS XR.

Nervous system problems. Call your doctor right away if you get any of these symptoms while taking ENVARSUS XR. These could be signs of a serious nervous system problem:

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

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

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

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

The most common side effects of ENVARSUS XR include, 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 doctor or pharmacist.

Call your doctor 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 doctor. You can ask your pharmacist or doctor 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).

What are the ingredients in ENVARSUS XR?

Active ingredient: tacrolimus USP

Inactive ingredients: hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF

Manufactured by: Rottendorf Pharma GmbH, 59320 Ennigerloh, North Rhine-Westphalia, Germany

Marketed by: Veloxis Pharmaceuticals, Inc. 1001 Winstead Dr, Suite 310, Cary, NC 27513, United States

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

 

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

ENVARSUS XR can cause serious side effects, including:

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 doctor 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 or tacrolimus immediate-release capsules. Your doctor 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. See the end of this leaflet for a complete list of ingredients in ENVARSUS XR.

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.

How should I take ENVARSUS XR?

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

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

Take ENVARSUS XR once daily with fluid (preferably water) on an empty stomach at the same time each day (preferably in the morning).

Take 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 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 doctor 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?

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

High blood sugar (diabetes). Your doctor may do certain tests to check for diabetes while you take ENVARSUS XR. Call your doctor 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. Your doctor may do certain tests to check for kidney function while you take ENVARSUS XR.

Nervous system problems. Call your doctor right away if you get any of these symptoms while taking ENVARSUS XR. These could be signs of a serious nervous system problem:

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

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

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

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

The most common side effects of ENVARSUS XR include, 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 doctor or pharmacist.

Call your doctor 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 doctor. You can ask your pharmacist or doctor 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).

What are the ingredients in ENVARSUS XR?

Active ingredient: tacrolimus USP

Inactive ingredients: hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF

Manufactured by: Rottendorf Pharma GmbH, 59320 Ennigerloh, North Rhine-Westphalia, Germany

Marketed by: Veloxis Pharmaceuticals, Inc. 1001 Winstead Dr, Suite 310, Cary, NC 27513, United States

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