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Tacrolimus is a prescription medication used to prevent organ rejection in patients who have had a kidney, liver, or heart transplant. Tacrolimus belongs to a group of drugs called immunosupressants, which help prevent your body from attacking the transplanted organ.

This medication comes in an injectable (IV) form and capsule form. You will receive tacrolimus injections until you are able to take the oral capsule. The capsule form is taken twice daily, with or without food.

Common side effects of tacrolimus include body tremors, high blood pressure, and kidney problems.

Tacrolimus is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, or heart transplant.

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

• Astellas Pharma US, Inc.

Tacrolimus may cause serious side effects, including:

• See “Drug Precautions”
• high blood sugar (diabetes). Your doctor may do certain tests to check for diabetes while you take tacrolimus. Call your doctor right away if you have:
  • frequent urination
  • increased thirst or hunger
  • blurred vision
  • confusion
  • drowsiness
  • loss of appetite
  • fruity smell on your breath
  • nausea, vomiting, or stomach pain
• kidney problems. Your doctor may do certain tests to check your kidney function while you take tacrolimus.
• nervous system problems. Call your doctor right away if you get any of these symptoms while taking tacrolimus. These could be signs of a serious nervous system problem:
  • confusion
  • coma
  • muscle tremors
  • numbness and tingling
  • headache
  • seizures
  • vision changes
• high levels of potassium in your blood. Your doctor may do certain tests to check your potassium level while you take tacrolimus.
• high blood pressure. Your doctor will monitor your blood pressure while you take tacrolimus.
• heart problems (myocardial hypertrophy). Tell your doctor right away if you get any of these symptoms of heart problems while taking tacrolimus:
  • shortness of breath
  • chest pain
  • feel lightheaded
  • feel faint

The most common side effects of tacrolimus in people receiving kidney transplant are:

• tremors (shaking of the body)
• infection
• high blood pressure
• kidney problems
• constipation
• diarrhea
• headache
• stomach pain
• trouble sleeping
• nausea
• low levels of phosphate in your blood
• swelling of the hands, ankles, or legs
• weakness
• pain
• high levels of fat in your blood
• high levels of potassium in your blood
• low red blood cell count (anemia)

The most common side effects of tacrolimus in people receiving liver transplants are:

• shaking of the body tremors
• headache
• diarrhea
• high blood pressure
• nausea
• kidney problems
• stomach pain
• trouble sleeping
• numbness or tingling in your hands or feet
• anemia
• pain
• fever
• weakness
• high levels of potassium in the blood
• low levels of magnesium in the blood

The most common side effects of tacrolimus for heart transplant patients are:

• kidney problems
• high blood pressure

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

These are not all the possible side effects of tacrolimus. For more information, ask your doctor or pharmacist.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

• cyclosporine (Gengraf, Neoral, and Sandimune)
• sirolimus (Rapamune)
• nelfinavir (Viracept)
• telaprevir (Incivek)
• boceprevir (Victrelis)
• amiodarone (Cordarone, Nexterone, Pacerone)

Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above.

Tacrolimus may affect the way other medicines work, and other medicines may affect how tacrolimus works.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Tacrolimus can cause serious side effects, including:

1. Increased risk of cancer. People who take tacrolimus have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).

2. Increased risk of infection. Tacrolimus is a medicine that affects your immune system. Tacrolimus can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving tacrolimus that can cause death. Call your doctor right away if you have symptoms of an infection such as:

• fever
• sweats or chills
• cough or flu-like symptoms
• muscle aches
• warm, red, or painful areas on your skin

Do not take tacrolimus if you are allergic to tacrolimus or any of the ingredients in tacrolimus.

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

Before you take tacrolimus, tell your doctor if you:

• plan to receive any live vaccines
• have or have had liver, kidney or heart problems
• are pregnant or plan to become pregnant. Tacrolimus may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. Tacrolimus can pass into your breast milk. You and your doctor should decide if you will take tacrolimus or breastfeed. You should not do both. 

Tell your 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. Tacrolimus may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed. Tacrolimus can pass into your breast milk. You and your doctor should decide if you will take tacrolimus or breastfeed. You should not do both.

• Take tacrolimus exactly as your doctor tells you to take it.
• Your doctor will tell you how many tacrolimus to take and when to take them.
• Your doctor may change your tacrolimus dose if needed. Do not stop taking or change your dose of tacrolimus without talking to your doctor.
• Take tacrolimus with or without food.
• Take tacrolimus the same way everyday. For example, if you choose to take tacrolimus with food, you should always take tacrolimus with food.
• Take tacrolimus at the same time each day, 12 hours apart. For example, if you take your first dose at 7:00 a.m. you should take your second dose at 7:00 p.m.
  • Taking tacrolimus at the same time each day helps to keep enough medicine in your body to give your transplanted organ the around-the-clock medicine it needs.
• Do not eat grapefruit or drink grapefruit juice while taking tacrolimus.

What to avoid while taking tacrolimus:

• While you take tacrolimus you should not receive any live vaccines such as:
  • flu vaccine through your nose
  • measles
  • mumps
  • rubella
  • polio by mouth
  • BCG (TB vaccine)
  • yellow fever
  • chicken pox (varicella)
  • typhoid
• Avoid exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.

If you take too much tacrolimus, call your doctor or go to the nearest hospital emergency room right away.

• Store tacrolimus at 59º F to 86ºF (15°C to 30º C).
• Safely throw away medicine that is out of date or no longer needed.
• Keep tacrolimus and all medicines out of reach of children. 

BOX WARNING - MALIGNANCIES AND SERIOUS INFECTIONS

• Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression.
• Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections.
• Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe tacrolimus. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.