Tacrolimus (oral and injection)

Tacrolimus is used along with other medicines for people who have received a heart, kidney, liver, or lung transplant.

Tacrolimus lowers your immune system's activity to stop your body from "rejecting" the transplanted organ.

Tacrolimus may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as instructed.

You may get an injection of tacrolimus soon after your transplant. The tacrolimus injection is given until you can take the pill form of tacrolimus.

Take oral tacrolimus at the same time every day, with a full glass of water.

Swallow the tablet or capsule whole; do not crush, chew, break, or open it.

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

Take Astagraf XL or Envarsus XR in the morning on an empty stomach, at least 1 hour before or 2 hours after a meal.

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

Your dose may change if you switch to a different brand, strength, or form of tacrolimus. Not all forms of tacrolimus are the same and may not have the same dose or schedule. Prevent medication errors by using only the form and strength your doctor prescribes.

You will need regular medical tests, and your blood pressure will need to be checked frequently.

Store at room temperature, away from moisture and heat.

Tacrolimus may raise your chances of getting a serious infection, skin cancer, or lymphoma. Discuss the risks and benefits of using tacrolimus with your doctor.

Contact your doctor immediately if you notice any signs of infection, such as fever, chills, flu-like symptoms, cough, sweating, painful skin sores, warm or red skin, or muscle aches.

You should not use this medicine if you are allergic to tacrolimus or hydrogenated castor oil, or if you have used cyclosporine (Neoral, Sandimmune, Gengraf) in the last 24 hours.

Using tacrolimus may increase your risk of serious infections or certain types of cancer, like lymphoma or skin cancer. Your risk may be higher if you are treated with drugs that weaken the immune system for a long time. Ask your doctor about this risk and what symptoms to look out for.

Some people taking tacrolimus after a kidney transplant have developed diabetes. This effect is seen more often 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 like 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 included in 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 partner can become pregnant.

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

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, including serious or fatal infections. Call your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, cough, sweating, painful skin sores, skin warmth or redness, or muscle aches.

Also call your doctor at once if you have:

• 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 of tacrolimus 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.

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 Astagraf 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.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine. The vaccine may not be effective while you are taking tacrolimus. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, and varicella (chickenpox).

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

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

Tacrolimus can harm your kidneys, especially if you also take 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.