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
Side effects of Envarsus XR (tacrolimus)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Less Common 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
Note: Side effects were reported by people who've just received a kidney transplant and are taking Envarsus XR (tacrolimus) with other immunosuppressants.
Envarsus XR (tacrolimus) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- 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
The following Envarsus XR (tacrolimus) 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
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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.
Common questions about Envarsus XR (tacrolimus)
Yes, Envarsus XR (tacrolimus) is a CNI, or a calcineurin inhibitor. It's a type of immunosuppressant that's commonly used to prevent transplant rejection, or when the immune system attacks a newly transplanted organ. Envarsus XR (tacrolimus) blocks calcineurin, a protein that usually turns on key parts of your immune system. It prevents your immune system from becoming too active and attacking your new organ.
You'll probably need to take Envarsus XR (tacrolimus) long term. This medication works to prevent your body from rejecting your new kidney after a transplant. So, your body could start to reject the kidney if you stop taking Envarsus XR (tacrolimus). Tell your transplant team if you're having bothersome side effects while you're taking this medication. Your transplant specialist will discuss with you about which other immunosuppressants you can switch to to keep your body from rejecting your kidney transplant.
Grapefruit and Seville oranges (also called bitter or sour oranges) can interact with Envarsus XR (tacrolimus). These citrus fruits can cause more of the medication to get absorbed into the body. This can raise your risk for side effects from the medication, like tremors, headache, and kidney problems. Alcohol can also interfere with how fast Envarsus XR (tacrolimus) gets released into the body from the tablet. This can affect your risk for either organ rejection or side effects from the medication. Avoid eating grapefruit and bitter or sour oranges while you're taking Envarsus XR (tacrolimus). Also avoid drinking grapefruit juice, juices containing Seville oranges, and alcohol during treatment. Ask your transplant team about other foods to avoid with Envarsus XR (tacrolimus).
You should avoid drinking alcohol while you're taking Envarsus XR (tacrolimus). Alcohol can change how fast the medication gets released into the body from the tablet after you take it. This can put you at risk for either organ rejection or side effects from the immunosuppressant. Discuss with your transplant specialist about your drinking habits and strategies to avoid alcohol during treatment.
In clinical studies, weight gain wasn't reported as a side effect of Envarsus XR (tacrolimus). Keep in mind that some people might take Envarsus XR (tacrolimus) with a steroid like prednisone to help prevent rejection. Long-term treatment with steroids can raise the risk for weight gain. So if you're taking a steroid in addition to Envarsus XR (tacrolimus), weight gain could be due to the steroid. It's best to speak with your transplant specialist or primary care provider if you have concerning weight gain. They can examine you for other medical conditions. Talk with your transplant care team if you have concerns about your weight after transplant.
People didn't report hair loss as a side effect of taking Envarsus XR (tacrolimus) during clinical studies. Talk to your transplant specialist or primary care provider if you notice any hair loss after you start taking this medication. They can help figure out the potential cause for your hair loss.
Envarsus XR (tacrolimus) can sometimes cause kidney damage. The risk is higher if the tacrolimus level in your blood is too high. You'll need to get blood work done regularly while you're taking Envarsus XR (tacrolimus). Your blood test results help your transplant specialist check that your tacrolimus level is within a safe range and that your kidneys aren't harmed during treatment. Your transplant specialist will lower your Envarsus XR (tacrolimus) dose if they see that the level of the medication in your blood is too high. This helps lessen the risk for kidney injury and other side effects related to high tacrolimus levels (e.g., nerve problems, heart rhythm problems). Talk with your transplant specialist if you have questions about your Envarsus XR (tacrolimus) levels.
Envarsus XR and Prograf contain the same active ingredient, tacrolimus. They both work well to prevent transplant rejection. But there are several important differences between the two medications. Prograf is approved to prevent rejection after a kidney, liver, lung, or heart transplant in adults and children. But Envarsus XR is only approved for use in adults after a kidney transplant. In addition, Prograf is taken twice daily with or without food, but Envarsus XR is taken once daily on an empty stomach (Envarsus XR is an extended-release version of tacrolimus). And although Prograf is available as both a brand-name and generic medication, Envarsus XR is currently brand name only. Compare between Envarsus XR and Prograf, and discuss with your transplant specialist about which tacrolimus medication is right for you.
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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
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 0.75mg of | 60 tablets | $0.00 | $0.00 |
| 1mg of | 60 tablets | $0.00 | $0.00 |
| 4mg of | 30 tablets | $0.00 | $0.00 |
Typical dosage for Envarsus XR (tacrolimus)
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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.
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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?
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Envarsus XR (tacrolimus) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Envarsus XR (tacrolimus) will not be safe for you to take.
- Allergy to tacrolimus
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