Envarsus XR

Envarsus XR is a prescription medication used to prevent organ rejection after kidney transplants. Envarsus XR belongs to a group of drugs called immunosuppressants, which help prevent your body from attacking the transplanted organ.

Envarsus XR comes in an extended-release tablet formulation and that is typically taken once daily on an empty stomach, preferably in the morning. Do not chew, divide, or break Envarsus XR tablets. Swallow the tablets whole. 

Common side effects of Envarsus XR include diarrhea and an increase of a substance in the blood called creatinine. 

Envarsus XR is a prescription medication used to prevent organ rejection after kidney transplants.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Envarsus XR. See the "Envarsus XR Precautions" section. 

Common side effects of Envarsus XR include the following:

• diarrhea
• an increase of a substance in the blood called creatinine
• urinary tract infection
• low red blood cell count (anemia)
• high blood pressure
• constipation

This is not a complete list of Envarsus XR side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effect that bothers you or that does not go away. 

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you are taking:

• mycophenolic acid (Myfortic)
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, John's wort, and nimodipine (Nimotop)
• medications that block a protein in the body (CYPA4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• antacids (magnesium and aluminum hydroxide antacids)
• metoclopramide (Reglan)

Do not drink alcohol while taking Envarsus XR.

This is not a complete list of Envarsus XR drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Envarsus XR including the following:

• 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
  • muscle aches
  • cough or flu-like symptoms
  • sweats or chills
  • warm, red, or painful areas on your skin
• graft rejection and other serious reactions. People who take Envarsus XR have sometimes been given another form of tacrolimus 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 experience some or all of the following symptoms:
  • 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)

Avoid drinking alcohol while taking this medication. 

Do not take Envarsus XR if you are allergic to Envarsus XR or to any of its ingredients.

Grapefruit and grapefruit juice may interact with Envarsus XR and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. 

Before taking Envarsus XR, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Envarsus XR or to any of its ingredients
• 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 you doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Envarsus XR falls into category C. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. 

Tell your doctor is you are breastfeeding or plan to breastfeed. 

Envarsus XR has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Envarsus XR, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered. 

Take Envarsus XR exactly as prescribed.

• Take Envarsus XR on an empty stomach at the same time of the day, preferably in the morning.
• Swallow Envarsus XR whole with fluid (preferably water). Do not chew, divide, or crush the tablets. If you cannot swallow Envarsus XR tablets whole, tell your doctor.
• 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.
• If you miss your dose of Envarsus XR, it should be taken as soon as possible, but no longer than 14 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. 
• Avoid eating grapefruit or drinking grapefruit juice or alcoholic beverage while taking Envarsus XR. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• how your body responds to the medication
• the dose of immunosuppressant you were previously taking
• drug level

The recommended blood concentration of Envarsus XR to prevent organ rejection is 4-11 ng/ml. When converting from tacrolimus immediate-release, 80% of the pre-conversion daily dose is recommended. 

• African American patients may need a higher dose to achieve adequate blood concentrations. 
• Patients with hepatic impairment (kidneys do not work well) may be started on a lower dose. 

If you take too much Envarsus XR, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

• Store Envarsus XR at 59 °F-86 °F (15 °C-30 °C).
• Keep this and all medicines out of the reach of children. 

WARNING: MALIGNANCIES AND SERIOUS INFECTIONS

Increased risk for developing serious infections and malignancies with ENVARSUS XR or other immunosuppressants that may lead to hospitalization or death.