tacrolimus (oral/injection)

What is the most important information I should know about tacrolimus?

What is tacrolimus?

Tacrolimus is used together with other medicines in people who have had a heart, kidney, liver, or lung transplant.

Tacrolimus weakens your immune system to prevent your body from "rejecting" the transplanted organ.

Tacrolimus may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking tacrolimus?

Using tacrolimus may increase your risk of developing serious infections or certain types of cancer, such as lymphoma or skin cancer. Your risk may be higher if you are treated over long periods of time with drugs that weaken the immune system. Ask your doctor about this risk and about symptoms to watch for.

Some people taking tacrolimus after a kidney transplant have developed diabetes. This effect has been seen most commonly in people who are Hispanic or African-American.

Tell your doctor if you have ever had:

• problems with your liver, kidney, or heart that are not related to your transplant;
• long QT syndrome (in you or a family member); or
• if you are scheduled to receive a vaccine;

Tell your doctor if you plan to get pregnant. Tacrolimus may harm an unborn baby, and can worsen conditions such as diabetes or high blood pressure in the mother. Use effective birth control before and during treatment with tacrolimus.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of tacrolimus on the baby.

If you are a man, use birth control before and during treatment with tacrolimus if your sex partner is able to get pregnant.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

How should I take tacrolimus?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may receive an injection of tacrolimus shortly after your transplant. Tacrolimus injection is given until you are ready to take the pill form of tacrolimus.

Mix tacrolimus oral granules with water right before you take them. Do not save this mixture for later use. Do not get the powder or mixture on your skin or in your eyes. If this happens, wash your skin with soap and water or rinse your eyes with water.

You may take Prograf with or without food, but take it the same way each time.

You will need frequent medical tests, and your blood pressure will need to be checked often.

What happens if I miss a dose?

For Prograf: Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.

For Astragraf XL: Take the medicine as soon as you can, but skip the missed dose if you are more than 14 hours late for the dose.

For Envarsus XR: Take the medicine as soon as you can, but skip the missed dose if you are more than 15 hours late for the dose.

Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking tacrolimus?

Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using tacrolimus. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Grapefruit may interact with tacrolimus and cause side effects. Avoid consuming grapefruit products.

What are the possible side effects of tacrolimus?

• general ill feeling, pain or swelling near your transplanted organ;
• headaches, vision changes, pounding in your neck or ears;
• confusion, behavior changes;
• tremors, a seizure;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• chest pain, cough, trouble breathing (even while lying down);
• high blood sugar --increased thirst, increased urination, hunger, fruity breath odor, nausea, loss of appetite, drowsiness, confusion;
• high potassium level --nausea, weakness, chest pain, irregular heartbeats, loss of movement;
• kidney problems --swelling, urinating less, feeling tired or short of breath;
• low magnesium or phosphate --bone pain, jerky muscle movements, muscle weakness or limp feeling, slow reflexes; or
• low blood cell counts --fever, flu symptoms, tiredness, pale skin, cold hands and feet.

Common side effects may include:

• low blood cell counts, infections;
• fever;
• nausea, diarrhea, constipation, stomach pain;
• weakness, pain;
• fluid around your heart;
• tremors;
• headache;
• cough, breathing problems;
• high blood sugar, high potassium levels, high cholesterol or triglycerides levels;
• low levels of magnesium or phosphate;
• numbness or tingling in your hands and feet;
• sleep problems (insomnia); or
• swelling in your hands, legs, ankles, or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tacrolimus?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tacrolimus can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your current medicines. Many drugs can affect tacrolimus, especially:

• amiodarone;
• cisplatin;
• cyclosporine;
• sirolimus;
• antibiotic, antifungal, or antiviral medicines; or
• heart or blood pressure medication, such as a diuretic or "water pill."

This list is not complete and many other drugs may affect tacrolimus. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about tacrolimus.