Download Patient Enrollment Form (PDF)
Veloxis Transplant Support
1-844-835-6947 Monday-Friday, 9AM-7PM ET

Legal Notice - Terms of Use


Welcome to the ENVARSUS XR Web site of Veloxis Pharmaceuticals, Inc.

This Web site is produced by Veloxis Pharmaceuticals, Inc. The information provided on this site is for general information and educational purposes only and may not be used as an alternative to or supplement to healthcare. Nothing on this Web site should be considered medical advice. Please consult with your healthcare professional about any medical questions you may have.

Please read the terms and conditions before viewing or using any portion of this Web site. By accessing and using the Web site, you acknowledge that you have read, understood, and accept all the Terms of Use and will be bound by them. If you do not agree to the Terms of Use, you may not access or otherwise use the Web site.

Veloxis Pharmaceuticals, Inc. reserves the right, in its sole discretion, to change the Terms of Use at any time, as appropriate. Your continued use of the Web site following such changes shall be deemed your acceptance of the changes.

The products and product information on this Web site are intended only for residents of the United States and its territories who are 18 years of age or older. The products discussed on this Web site may not be available in all countries or may be available under different names, in different strengths or formulations. Veloxis Pharmaceuticals, Inc. products should only be used or administered consistent with approved labeling and pursuant to your healthcare professional’s direction.

The content of this site is protected under applicable copyright and trademark laws. Product names are registered trademarks of Veloxis Pharmaceuticals, Inc., its subsidiaries, affiliates, or alliance partners unless otherwise noted. The use or misuse of any copyrighted or trademarked materials, except as expressly permitted herein, is expressly prohibited and may be in violation of copyright, trademark, or other applicable law. Nothing contained on this Web site shall be considered as conferring any license or right to use any patent or trademark or copyright of Veloxis Pharmaceuticals, Inc. or any third party. Your use of information on this site is subject to the terms of this section. You may print a single copy of the content for your own personal noncommercial use, provided any copy of these documents that you make retains all copyright or other proprietary notices and any disclaimer contained thereon. The further copying, redistribution, or publication of any part of this site is prohibited. If you link to any third-party Web sites from this Web site, you should follow the copyright provisions of those sites.

Reasonable efforts have been made to provide accurate and current information on this Web site, but it is not comprehensive in scope. Veloxis Pharmaceuticals, Inc. makes no representation as to the availability, accuracy, or completeness of the content of this site.

This Web site is provided “as is” and the company makes no representations or warranties, either express or implied, including, but not limited to, the implied warranties of merchantability, fitness for a particular purpose, or non-infringement. The company does not warrant that the functions contained in the Web site will be uninterrupted or error-free, or that the Web site or the server that makes it available are free of viruses or other harmful components. Some jurisdictions do not allow the exclusion of implied warranties, so part of this above exclusion may not apply to you.

In no event and under no circumstances shall Veloxis Pharmaceuticals, Inc., its affiliates and subsidiaries, and their respective officers, directors, employees, agents, representatives, information providers and licensors, and their respective heirs and assigns be liable for any direct, indirect, incidental, consequential, special exemplary, punitive, or other damages. This is the case even if informed of the possibility of such damages resulting from your access to, or inability to access, this site or from your reliance on any information on this site. Veloxis Pharmaceuticals, Inc. shall not be liable for any damages or injury resulting from your access to, or inability to access, this site or from your reliance on any information on this site.

You agree that all access and use of this Web site and its content is at your own risk. You further agree that you will not upload, post, transmit, distribute, or otherwise publish through the Web site any materials that:  1) restrict or limit the ability of any other user to use this Web site;  2) are unlawful, threatening, abusive, libelous, defamatory, obscene, pornographic, profane, or indecent;  3) constitute or encourage conduct that would be a criminal offense, give rise to civil liability, or otherwise violate the law;  4) violate, plagiarize, or infringe on the rights of any third parties; or  5) contain a virus or other harmful or potentially harmful component.

You agree to indemnify, defend, and hold harmless Veloxis Pharmaceuticals, Inc., its affiliates, and subsidiaries, and their respective officers, directors, employees, agents, representatives, information providers and licensors, and their respective heirs and assigns from and against any and all losses, expenses, damages, and costs, including attorneys’ fees, resulting from any violation by you of the Terms of Use.

This site may provide links to other Web sites maintained by third parties over which Veloxis Pharmaceuticals, Inc. has no control. Veloxis Pharmaceuticals, Inc. is not responsible for the accuracy or any other aspect of the information contained on such sites and shall not be liable for any damages or injury arising from users' access to such sites. Links to other sites are provided only as a convenience to users of our site. Veloxis Pharmaceuticals, Inc. makes no representations or warranties of any kind as to the accuracy, completeness, or currency of any information provided on such sites.

Should any visitor to the Veloxis Pharmaceuticals, Inc. site provide information such as questions, comments, suggestions, ideas, or the like through any feedback mechanisms located herein, except as set forth in the Veloxis Pharmaceuticals, Inc. Internet Privacy Statement, Veloxis Pharmaceuticals, Inc. shall have no obligation of any kind with respect to such information and shall be free to reproduce, use, disclose, and distribute the information to others without limitation. Please refer to the Veloxis Pharmaceuticals, Inc. Privacy Policy with respect to users’ rights and information that is disclosed on this Web site. 

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.