Envarsus XR
Envarsus XR is a once-daily version of the common anti-rejection medication, tacrolimus. It's an immunosuppressant that's used to prevent organ rejection in adults after they've had a kidney transplant. Envarsus XR (tacrolimus) is an extended-release tablet that's taken by mouth. Side effects can include risk of infection, diarrhea, and shaky hands. Envarsus XR (tacrolimus) is available as a brand-name medication only; there's currently no generic version yet.
What is Envarsus XR (tacrolimus)?
What is Envarsus XR (tacrolimus) used for?
Prevention of kidney transplant rejection (in combination with other immunosuppressants)
How Envarsus XR (tacrolimus) works
After you receive a kidney transplant, there's a risk for transplant rejection. This can happen when your immune system attacks your new organ, which can lead to serious complications. Immunosuppressants like Envarsus XR (tacrolimus) help lower the activity of your immune system to prevent rejection.
More specifically, Envarsus XR (tacrolimus) is a calcineurin inhibitor, or CNI for short. It works by blocking calcineurin, a protein in your body that normally turns on certain parts of your immune system. By blocking calcineurin, Envarsus XR (tacrolimus) prevents your immune system from becoming active and attacking your new organ.
Drug Facts
More on Envarsus XR (tacrolimus) essentials
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What are the side effects of Envarsus XR (tacrolimus)?
Common Side Effects
Other Side Effects
- Headache
- Nausea
- Trouble sleeping
- Low white blood cell counts
- Changes in potassium levels
- Low phosphate levels
- Low magnesium levels
- Higher creatinine levels
- Higher blood sugar levels
Serious Side Effects
- Serious infection: fever, cough, chills, sore throat, runny or stuffy nose, body aches, belly pain, nausea, dark urine
- Sudden kidney injury: feeling sick or weak; dehydration; confusion; urinating less than usual; blood in urine; swelling in the legs, ankles, or feet
- Problems affecting the nervous system: seizures, tremors, headache, dizziness, "pins and needles" sensation
- Abnormal heart rhythm (QT prolongation): chest pounding, chest pain, trouble breathing, feeling faint or lightheaded
- Bleeding: bleeding that's difficult to stop, vomiting blood, blood in the urine or stool
- Serious blood clot: chest or arm pain; trouble breathing; sweating; dizziness; confusion; headache; sudden numbness or weakness on one side of the body
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Dizziness, loss of balance or coordination, confusion or trouble speaking
- Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
- High potassium level—muscle weakness, fast or irregular heartbeat
- Increase in blood pressure
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Stomach pain, bloody diarrhea, pale skin, unusual weakness or fatigue, decrease in the amount of urine, which may be signs of hemolytic uremic syndrome
- Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
- TTP—purple spots on the skin or inside the mouth, pale skin, yellowing skin or eyes, unusual weakness or fatigue, fever, fast or irregular heartbeat, confusion, change in vision, trouble speaking, trouble walking
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Constipation
- Diarrhea
- Pain, tingling, or numbness in the hands or feet
- Tremors or shaking
- Trouble sleeping
Pros and cons of Envarsus XR (tacrolimus)
Pros
Taken once daily
Thought to help tacrolimus levels be more stable throughout the day
Adjustable dosing based on blood levels of tacrolimus, which can help lessen risk of side effects
Cons
Only approved for use after kidney transplant (not for lung, liver, or heart transplant)
Must get regular blood work done to check that your Envarsus XR (tacrolimus) dose is appropriate and safe for you
Risk of serious infections
Pharmacist tips for Envarsus XR (tacrolimus)
Be sure to regularly get your blood work done on time. Your transplant team is checking your tacrolimus levels to make sure Envarsus XR (tacrolimus) is safe for you. Having tacrolimus levels that are too low puts you at risk for organ rejection. And having tacrolimus levels that are too high puts you at risk for side effects from the medication.
Take Envarsus XR (tacrolimus) at the same time each morning. Take the medication on an empty stomach, at least 1 hour before or 2 hours after a meal. Taking the medication the same way each day helps keep your tacrolimus levels steady in your body. This helps lower the risk of side effects and make sure the medication is working well for you.
Swallow Envarsus XR (tacrolimus) tablets whole with water. Don’t cut, crush, chew, or dissolve them. Otherwise, this can affect how well the medication is released from the tablet and absorbed into the body.
Avoid drinking alcohol while you're taking Envarsus XR (tacrolimus). Alcohol can affect how fast the medication gets released into the body from the tablet. This can affect your risk for organ rejection or side effects from the immunosuppressant.
Don't eat grapefruit or Seville oranges (also called bitter or sour oranges) or drink juices containing these citrus fruits while you're getting treated with Envarsus XR (tacrolimus). These citrus fruits can cause the body to absorb more of the medication and raise your risk for side effects like confusion and chest palpitations.
Regularly check your blood pressure while you're taking Envarsus XR (tacrolimus). This medication can raise your blood pressure. Contact your transplant specialist and primary care provider if it's consistently higher than usual.
Let your transplant team and pharmacist know what medications you're taking, including over-the-counter products and supplements. Envarsus XR (tacrolimus) can interact with many medications. These interactions can raise your risk for organ rejection or for side effects from Envarsus XR (tacrolimus). Your healthcare team can make sure all your medications are safe to take together.
Before you get any vaccines, tell your primary care provider and pharmacist that you're taking Envarsus XR (tacrolimus). They can check what vaccines you can and can't get. For example, you should avoid getting live vaccines, such as the nasal spray flu vaccine, while you're taking Envarsus XR (tacrolimus). Your weakened immune system puts you at risk for getting sick from the live vaccine itself.
Envarsus XR (tacrolimus) can raise your risk for skin cancer. Cover your skin with protective clothing and sunscreen when you're outside, even on cloudy days.
If you miss your dose of Envarsus XR (tacrolimus), take your missed dose as soon as possible. But if there's only 9 hours or less until your next dose, skip the missed dose and wait to take Envarsus XR (tacrolimus) at your next normally scheduled time. Don't double up on doses to make up for a missed dose because this can raise your risk for side effects.
Frequently asked questions about Envarsus XR (tacrolimus)
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What are the risks and warnings for Envarsus XR (tacrolimus)?
Envarsus XR (tacrolimus) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Possible risk of cancer
Risk factor: Taking a high dose of an immunosuppressant | Taking immunosuppressants for a long time | History of Epstein-Barr virus (EBV) infection, such as mono
Immunosuppressants, including Envarsus XR (tacrolimus), can put people at risk of developing lymphoma (a blood cancer). Rarely, people can also develop post-transplant lymphoproliferative disorder (PTLD). This is a condition that causes your white blood cells to multiply too quickly, which can also lead to lymphoma. Call your care team right away if you have any unusual symptoms, like swollen lymph nodes, fever, tiredness that doesn't get better, or concerning changes in weight.
Immunosuppressants like Envarsus XR (tacrolimus) can also raise the risk for other cancers, particularly skin cancers. Try to limit or avoid sun exposure while you're taking Envarsus XR (tacrolimus). Wear protective clothing and sunscreen when you're outside, even on overcast days. Regularly check your skin for unusual-looking markings or spots and tell your care team if you see any concerning skin changes.
Serious infections
Immunosuppressants like Envarsus XR (tacrolimus) can lower your body's ability to fight infections. This puts you at risk for getting very sick. In studies, infections included urinary tract infections (UTIs), respiratory infections, and certain serious kidney and brain infections.
Your transplant team will check for signs and symptoms of infection during your follow-up visits. Let your transplant team know if you have any infections while you're taking Envarsus XR (tacrolimus). Watch out for symptoms like fever, chills, belly pain, nausea, dark urine, or general weakness.
High blood sugar
Risk factors: African-American | Hispanic
Taking Envarsus XR (tacrolimus) after a kidney transplant can sometimes raise your blood sugar levels and lead to diabetes. Let your transplant specialist know if you have symptoms of having high blood sugar like tiredness, unusual thirst or hunger, or needing to urinate more often. Your transplant specialist might ask you to regularly check your blood sugar while you're taking Envarsus XR (tacrolimus) to make sure the medication is safe for you.
Kidney problems and high potassium levels
Risk factors: High tacrolimus levels in the blood | Taking other medications that can cause kidney problems | Taking medications that can raise the tacrolimus levels in the blood | Taking other medications that can raise potassium levels
People who take Envarsus XR (tacrolimus) can sometimes experience sudden or long-term kidney problems. Having kidney problems can cause high potassium levels, which can lead to serious heart palpitations.
You’ll need to regularly get lab work done so your transplant specialist can check your kidney function and your potassium levels. Contact your transplant team right away if you're urinating less often than usual, have irregular heart rhythm, or feel weak. These might be signs of kidney problems or high potassium levels. You might need to stop treatment or have your Envarsus XR (tacrolimus) dose adjusted to prevent more problems.
Problems affecting the nervous system
Risk factor: High tacrolimus levels in the blood
Envarsus XR (tacrolimus) can cause different problems related to your nervous system. They can include tremors, a "pins and needles" sensation, headache, and changes to your motor skills. It can also make it harder for you to concentrate or remember things. In more serious cases, taking Envarsus XR (tacrolimus) can lead to confusion, seizure, and coma. While you're taking this medication, let your transplant specialist know if you notice any changes in mood, problems with speech, or trouble with movement.
High blood pressure
Envarsus XR (tacrolimus) can raise your blood pressure. In some cases, you might need to take blood pressure medications to help with this side effect. Certain blood pressure medications, such as lisinopril (Zestril) and diltiazem (Cardizem), can interact with Envarsus XR (tacrolimus) and raise your risk for side effects from the immunosuppressant. Tell your healthcare teams about the medications you take to make sure they're all safe for you.
Be sure to regularly check your blood pressure while you're taking Envarsus XR (tacrolimus). Keep a log of your readings. Let your transplant specialist and primary care provider know if your blood pressure is higher than usual.
Heart rhythm problem called QT prolongation
Risk factors: History of long QT syndrome | History of heart problems (e.g., slow heart rate, heart failure) | Low electrolyte levels | Taking medications that affect heart rhythm | High dose of Envarsus XR (tacrolimus)
Envarsus XR (tacrolimus) can lengthen the time period between when the heart pumps and then relaxes. This is known as QT prolongation. This can affect your heart rhythm, which can be serious and life-threatening.
Your risk for QT prolongation is higher if you have heart problems or imbalanced electrolyte levels. The risk is also higher if you take other medications that cause similar heart problems, such as amiodarone (Pacerone). If you're at risk for QT prolongation, your transplant specialist will check your heart rhythm with an electrocardiogram (EKG) and your blood work throughout treatment.
Call 911 right away if you feel your chest pounding, have breathing problems, have chest pain, or feel faint or lightheaded while you're taking Envarsus XR (tacrolimus). These might be signs of heart rhythm problems.
Blood problems
Risk factors: History of parvovirus B19 infection | Blood conditions | Taking medications that can lower red blood cell counts
In some rare cases, people who've taken Envarsus XR (tacrolimus) have had serious blood problems that can lead to a lower red blood cell count and platelet count. This can put you at risk for bleeds or anemia. Some people have also developed small blood clots that can block blood flow to organs, including the brain, kidneys, and heart. This can raise your risk for serious harm to your organs and other complications, such as stroke.
Let your transplant specialist or primary care provider know right away if you have symptoms of blood problems like abnormal bruising, extreme tiredness, pounding chest, and dizziness. Call 911 or get medical help right away if you have chest pain, trouble breathing, weakness on one side of your body, or trouble speaking or walking; these are signs of a medical emergency.
Interaction with vaccines
Risk factor: Getting a live vaccine
Before your transplant, talk with a healthcare professional or pharmacist about your vaccine history to make sure you're up to date with all your immunizations. Immunosuppressants like Envarsus XR (tacrolimus) that you take after your transplant can affect the immune system. This can affect how well and how safe certain vaccines are for you.
Some vaccines work less well during your treatment with Envarsus XR (tacrolimus). And getting live vaccines while you're taking Envarsus XR (tacrolimus) can raise your risk of infections from the live vaccine itself. This is why you should avoid getting any live vaccines, like FluMist (the nasal spray version of the flu vaccine) or MMR (measles, mumps, and rubella vaccine), while you're taking this medication.
Interaction with other medications
Some medications can interact with Envarsus XR (tacrolimus). These drug interactions can affect the amount of tacrolimus in your body. This can then affect how well the medication works and your risk for side effects.
Taking certain medications with Envarsus XR (tacrolimus) can raise the amount of tacrolimus in your body. This can put you at risk for side effects like tremors, headache, confusion, and heart rhythm problems. Interactions with other medications can lower the amount of Envarsus XR (tacrolimus) in your body and put you at risk for organ rejection.
It's important to let your transplant specialist know about all the medications you take with Envarsus XR (tacrolimus). Your transplant specialist will check whether your other medications are affecting the tacrolimus levels in your body. They might need to adjust your Envarsus XR (tacrolimus) dose to keep you safe from organ rejection and side effects.
Risk for fertility problems and harm to unborn baby
Discuss family planning with your transplant specialist before you start Envarsus XR (tacrolimus). Taking this medication can lower your ability to have children. In addition, taking Envarsus XR (tacrolimus) during pregnancy might raise the risk for birth defects, premature birth, and low birth weight.
Because of the potential risk of harm to an unborn baby, you shouldn't take Envarsus XR (tacrolimus) if you're pregnant. If you're able to have a child, your transplant specialist will recommend that you use birth control while you're taking Envarsus XR (tacrolimus).
If you or your partner becomes pregnant while you're taking Envarsus XR (tacrolimus), you’re encouraged to enroll in the Transplantation Pregnancy Registry International. This registry helps researchers learn more about the risks to your health and your baby’s health during treatment with transplant medications. Learn more about this registry by visiting their website or by calling 1-877-955-6877.
Envarsus XR (tacrolimus) dosage forms
Typical dosing for Envarsus XR (tacrolimus)
For people who've just received a kidney transplant: The starting dose is based on your body weight. It's typically 0.14 mg/kg of body weight by mouth once a day in the morning.
For people who are switching to Envarsus XR (tacrolimus) from tacrolimus immediate-release (Prograf): You'll probably start at a lower Envarsus XR (tacrolimus) dose, about 20% lower than your total daily tacrolimus immediate-release dose. Envarsus XR (tacrolimus) is taken by mouth once a day in the morning.
Your transplant specialist will adjust your dose depending on how well Envarsus XR (tacrolimus) is working to prevent rejection, whether you have any side effects, and what your tacrolimus levels are in your blood.
How much does Envarsus XR (tacrolimus) cost?
Envarsus XR (tacrolimus) contraindications
Allergy to tacrolimus
What are alternatives to Envarsus XR (tacrolimus)?
Prevention of kidney transplant rejection (in combination with other immunosuppressants)
Prevention of heart, liver, and kidney transplant rejection
Treatment of chronic (long-term) rejection in heart, liver, and kidney transplant recipients previously treated with other immunosuppressive medications
Kidney transplant
Liver or heart transplant - generic tacrolimus capsule and brand name Prograf only
Lung transplant - brand name Prograf only
What is the latest news about Envarsus XR (tacrolimus)?
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References
Best studies we foundAmerican Cancer Society. (2020). Signs and symptoms of cancer.
American Kidney Fund. (2024). Kidney rejection after transplant.
Araya, A. A., et al. (2023). Tacrolimus. StatPearls.
Azzi, J. R., et al. (2013). Calcineurin Inhibitors: 40 years later, can’t live without... The Journal of Immunology.
Carreras, E., et al. (2019). Table 31.1 CYP3A4 substrates, inhibitors, and inducers commonly used in HSCT (non-limitative list) (Flockhart 2018; Medicines Complete 2018). The EBMT Handbook: Hematopoietic Stem Cell Transplantation and Cellular Therapies.
Centers for Disease Control and Prevention. (2024). Altered immunocompetence.
Costa, C., et al. (2012). Polyomavirus-associated nephropathy. World Journal of Transplantation.
Lewis, J. L., III. (2023). Hypophosphatemia (low level of phosphate in the blood). Merck Manual Consumer Version.
MedlinePlus. (2023). Transplant rejection.
National Cancer Institute. (n.d.). Lymphoma–Patient version.
National Heart, Lung, and Blood Institute. (2022). Thrombotic thrombocytopenic purpura (TTP).
National Kidney Foundation. (n.d.). Post-transplant lymphoproliferative disorder (PTLD).
National Kidney Foundation. (2023). Potassium.
National Kidney Foundation. (2024). Diet after kidney transplant.
National Organization for Rare Disorders. (2021). Progressive multifocal leukoencephalopathy.
Rostaing, L., et al. (2016). Novel once-daily extended-release tacrolimus versus twice-daily tacrolimus in de novo kidney transplant recipients: Two-year results of phase 3, double-blind, randomized trial. American Journal of Kidney Diseases.
Veloxis Pharmaceuticals, Inc. (2024). Envarsus XR- tacrolimus tablet, extended release [package insert]. DailyMed.
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