Tacrolimus (ta-KROE-li-mus)

Prevents your body from rejecting an organ (including kidney, liver, heart, or lung) after transplant.

Brand Name(s):

Astagraf XL, Envarsus XR, Prograf, Tacrolimus Novaplus

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Long Acting Capsule, Liquid, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Immediate-release capsule: You may take this medicine with or without food, but take it the same way each time. If you take it with food, then always take it with food. Do not crush, open, or chew it.
• Extended-release capsule: Take it every morning on an empty stomach at least 1 hour before or 2 hours after a meal. Swallow the extended-release capsule whole. Do not crush, break, or chew it.
• Extended-release tablet: Take it on an empty stomach, at least 1 hour before or 2 hours after a meal, at the same time every day, usually in the morning. Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• Granule: You may take this medicine with or without food, but take it the same way each time. If you take it with food, then always take it with food. To prepare the oral liquid:
  • Empty the contents of the packet in a glass cup filled with 1 to 2 tablespoons (15 to 30 milliliters) of room temperature water and mix. Use a metal spoon to stir the mixture. Do not use plastic.
  • Drink it right away after preparing.
  • Refill the glass cup with the same amount of water and gently swirl to mix any remaining granules to get the full dose of this medicine.
  • You may also use an oral syringe to give this medicine.
  • Do not inhale the granules or let the oral liquid come in contact with your skin or eyes. If you get the granules or the oral liquid on your skin, wash the area well with soap and water. If you get them into your eyes, rinse with water.
  • Do not save the prepared oral liquid for later use.
• This medicine is always used together with other medicines. Make sure you understand when to take each medicine during the day.
• Use only the brand of medicine your doctor prescribed. Other brands may not work the same way.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  • Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
  • Astagraf XL® (extended-release capsule): If you miss a dose and remember within 14 hours, take the missed dose right away. If more than 14 hours have passed since your regular time, skip the missed dose and return to your regular schedule.
  • Envarsus XR® (extended-release tablet): If you miss a dose and remember within 15 hours, take the missed dose right away. If more than 15 hours have passed since your regular time, skip the missed dose and return to your regular schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with sirolimus.
• Do not use this medicine together with cyclosporine. Tacrolimus or cyclosporine should be stopped at least 24 hours before starting the other.
• There are many foods and drugs that can interact with tacrolimus. Tell your doctor if you are using cannabidiol. Make sure your doctor knows about all other medicines you are using.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• Do not drink alcohol while you are using this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, diabetes, heart disease, heart rhythm problems, high blood pressure, cystic fibrosis, or any type of infection. Tell your doctor if you are African-American or have African or Hispanic ancestry.
• This medicine may cause the following problems:
  • Increased risk of serious infections
  • Increased risk of cancer (including skin cancer, lymphoma)
  • Diabetes
  • High blood pressure, changes in heart rhythm (including QT prolongation, torsade de pointes), heart problems
  • Brain or nerve problems (including posterior reversible encephalopathy syndrome, seizures)
  • Kidney problems
  • Thrombotic microangiopathy (damage in the smallest blood vessels), hemolytic uremic syndrome, and thrombotic thrombocytopenic purpura
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, painful urination, bloody urine
• Confusion, weakness, uneven heartbeat, trouble breathing, numbness in your hands, feet, or lips
• Dizziness, lightheadedness, or fainting
• Fast, slow, or pounding heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Headache, vision changes, tremors, seizures, tingling or numbness
• Increased thirst or hunger
• Rapid weight gain, swelling in your hands, ankles, or feet
• Skin changes or growths
• Swollen glands in your armpits or groin
• Unusual bleeding, bruising, or weakness
• Weakness on one side of your body, confusion, clumsiness, trouble thinking clearly

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, constipation, nausea, vomiting
• Joint pain or back pain
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

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