NOTE: Depending on the supplier/strength selected, the products shipped may have different packaging.

Why is Envarsus XR prescribed?

Envarsus XR (Tacrolimus) is often prescribed to prevent organ rejection following specific organ transplants.

What does it do?

Tacrolimus works by suppressing certain immune cells called T-cells, which are part of your immune system. This reduces the activity of your immune system, making it less likely to reject a transplanted organ, such as a kidney.

How should I take it?

Swallow Envarsus XR (Tacrolimus) tablets whole with water. Do not cut, crush, chew, or dissolve the tablets, as this may impact how the medication is released and absorbed by your body. Take the medication on an empty stomach, at least 1 hour before or 2 hours after eating. Note that extended-release capsules is different from capsule form.

What if I missed a dose?

If you miss a dose of Envarsus XR (Tacrolimus), take it as soon as you remember. However, if there are less than 9 hours until your next dose, skip the missed dose and take your next dose at the usual time. Do not double dose as this could increase the risk of side effects.

What are the special precautions before taking Envarsus XR?

Discuss with your healthcare provider any vaccines you may need. Certain vaccines should not be given right before or while taking tacrolimus. Inform your healthcare provider about any vaccines you've recently received or have scheduled.

Current and Past Health Conditions: Let your healthcare provider know if you have any of the following:

• Cancer
• Cystic fibrosis
• High blood pressure
• High blood sugar
• Kidney or liver problems
• Infections
• Heart conditions, including heart failure

Grapefruit and grapefruit juice can increase the level of tacrolimus in your body. Avoid consuming grapefruit or drinking grapefruit juice while taking Tacrolimus.

Tacrolimus may impact fertility, making it more difficult to get pregnant or have your partner become pregnant in the future. If you have concerns, talk to your healthcare provider.

Does it have any side effects?

The most common side effects of Envarsus XR in kidney transplant recipients.

Common side effects may include:
• Anemia
• Constipation
• Diarrhea
• Urinary tract infections
• Peripheral edema

Serious side effects may include:
• Changes in heart electrical activity (QT prolongation).
• Kidney problems.
• High blood pressure.
• Elevated potassium levels in your blood.
• Nervous system issues.
• Severe low blood cell count (anemia).

In you are switching from immediate-release tacrolimus to Envarsus XR, the most common side effects are diarrhea and high blood creatinine.

These are not all possible side effects of Envarsus XR. For more information, consult your healthcare provider or pharmacist.

Is it safe to take it with another drug?

Tacrolimus interacts with many other medications. Always inform your healthcare provider about any prescription and supplements you are using.

Specifically, make sure to discuss if you are taking any of the following before using Tacrolimus:

• Certain antibiotics, including Aminoglycosides
• Medications for HIV or AIDS
• Medications for high blood pressure
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as Ibuprofen (Motrin, Advil)
• Angiotensin-converting enzyme (ACE) inhibitors, such as Enalapril or Lisinopril
• Calcium channel blockers, such as Diltiazem (Cardizem CD)
• Amiodarone (Pacerone), used to treat irregular heart rhythms
• Rifabutin (Mycobutin), used to prevent Mycobacterium avium complex infections
• Diuretics (water pills), used to reduce fluid retention and manage blood pressure

Many other medications can affect the blood levels of Tacrolimus. Always inform your healthcare provider about any medications you are currently taking or have recently taken.

How should I store it?

Store at room temperature and keep out of reach of children.

What action should I take in case of overdose?

If you or someone else has taken too much Tacrolimus, seek medical assistance immediately by calling your doctor or go immediately to the emergency department as it may lead to serious adverse reactions.

Is it safe for pregnant or breastfeeding women?

Tacrolimus can harm an unborn baby. If you are capable of becoming pregnant or can get your partner pregnant, use effective birth control before and during treatment with tacrolimus. Inform your healthcare provider if you or your partner are pregnant or planning to become pregnant.

Tacrolimus is present in breast milk. Let your healthcare provider know if you are breastfeeding or planning to breastfeed. They will guide you on whether you should use tacrolimus while breastfeeding.

Why is Envarsus XR prescribed?

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