What is the most important information I should know about tacrolimus?
Tacrolimus may increase your risk of developing serious infection, lymphoma, or other cancers. Talk with your doctor about the risks and benefits of using this medicine.
Call your doctor right away if you have any signs of infection, such as fever, chills, body aches, skin warmth or redness, or flu symptoms.
What is tacrolimus?
Tacrolimus lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.
Tacrolimus is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.
The Astragraf XL and Envarsus XR brands of tacrolimus is generally not used for liver transplants.
Tacrolimus may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking tacrolimus?
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) within the past 24 hours.
Tacrolimus may increase your risk of developing serious infection, lymphoma, or other cancers. Talk with your doctor about the risks and benefits of using this medicine.
Using tacrolimus may also increase your risk of developing skin cancer, especially if you are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your specific risk.
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. Talk with your doctor about your individual risk of diabetes if you have concerns.
To make sure tacrolimus is safe for you, tell your doctor if you have:
- kidney or liver disease;
- heart disease, high blood pressure, high cholesterol or triglycerides (a type of fat in the blood);
- a heart rhythm disorder or history of long QT syndrome;
- if you take heart rhythm medication; or
- if you use other medications that can weaken your immune system.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Tacrolimus can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using tacrolimus.
How should I take tacrolimus?
Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
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.
Take your medicine at the same time each day. The regular tacrolimus capsule (Prograf or Hecoria) is usually taken every 12 hours. Extended-release tacrolimus (Astragraf XL, Envarsus XR) is taken only 1 time per day, usually in the morning.
Do not crush, chew, break, or dissolve an extended-release capsule or tablet (Astragraf XL, Envarsus XR). Swallow it whole.
You may take Prograf or Hecoria with or without food, but take it the same way each time.
Take Astragraf XL or Envarsus XR on an empty stomach, at least 1 hour before or 2 hours after a meal.
If your doctor changes your brand, strength, or type of tacrolimus, your dosage needs may change. The regular and extended-release forms of tacrolimus are not equivalent and may not have the same dose or schedule. Ask your pharmacist if you have any questions about the new kind of tacrolimus you receive at the pharmacy.
While using tacrolimus, you may need frequent blood tests. Your blood pressure will need to be checked often.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
For Prograf or Hecoria: Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
For Astragraf XL or Envarsus XR: If you are more than 14 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking tacrolimus?
Do not receive a "live" vaccine while using tacrolimus, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Grapefruit and grapefruit juice may interact with tacrolimus and lead to unwanted side effects. Avoid the use of grapefruit products while taking tacrolimus.
Avoid drinking alcohol. It may increase your risk of side effects.
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Avoid exposure to sunlight or tanning beds. Tacrolimus can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
What are the possible side effects of tacrolimus?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with tacrolimus. Stop using this medicine and call your doctor right away if you have signs of infection such as: sudden weakness or ill feeling, fever, chills, sweating, sore throat, painful mouth sores, skin warmth or redness, flu symptoms, muscle aches, cough, pale skin, easy bruising, or unusual bleeding.
Also call your doctor at once if you have:
- general ill feeling, pain or swelling near your transplanted organ;
- change in your mental state, problems with speech or walking, decreased vision (may start gradually and get worse quickly);
- little or no urinating; painful or difficult urination; swelling in your feet or ankles;
- headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
-
high blood pressure --severe headache, blurred vision, pounding in your neck or ears, anxiety;
-
high blood sugar --increased thirst, increased urination, hunger, fruity breath odor, nausea, loss of appetite, drowsiness, blurred vision, confusion;
-
high potassium --slow heart rate, weak pulse, muscle weakness, tingly feeling;
-
low magnesium or phosphate --bone pain, jerky muscle movements, muscle weakness or limp feeling, slow reflexes;
-
nervous system problems --confusion, headache, vision problems, tremors, numbness and tingly feeling, seizure (convulsions); or
-
signs of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Common side effects may include:
- infections, high blood pressure, low phosphate, high potassium;
- kidney problems, urination problems;
- tremors or shaking, numbness or tingling;
- nausea, diarrhea, constipation, stomach pain;
- weakness, headache, general pain;
- sleep problems (insomnia); or
- swelling in your hands 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?
Tacrolimus can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).
Many drugs can interact with tacrolimus. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
- amiodarone;
- cyclosporine;
- nelfinavir;
- sirolimus; or
- the hepatitis C medications boceprevir or telaprevir.
Many medicines can interact with tacrolimus and should not be used at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed in this medication guide. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about tacrolimus.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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