Prograf (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.
Prograf is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.
Prograf may also be used for purposes not listed in this medication guide.
Important information
Prograf 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.
You will need regular medical tests to be sure Prograf is not causing harmful effects. Do not miss any follow up visits to your doctor for blood or urine tests. Avoid being near people who are sick or have infections.
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.
Call your doctor right away if you have symptoms of a serious brain infection, such as a change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.
Prograf can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using Prograf, tell your doctor about all other medicines you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.
Before taking this medicine
You should not use Prograf if you are allergic to tacrolimus or hydrogenated castor oil, or if you have used cyclosporine (Neoral, Sandimmune, Gengraf) within the past 24 hours.
Prograf 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 Prograf 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 Prograf 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 this medicine is safe for you, tell your doctor if you have:
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kidney or liver disease;
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heart disease, high blood pressure, high cholesterol or triglycerides (a type of fat in the blood);
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a heart rhythm disorder or history of long QT syndrome;
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if you take heart rhythm medication; or
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if you use other medications that can weaken your immune system.
It is not known whether Prograf will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Tacrolimus can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Prograf.
How should I take Prograf?
Take Prograf exactly as prescribed by your doctor, 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 Prograf shortly after your transplant. The injection is given until you are ready to take the pill form of tacrolimus.
Take your medicine at the same time each day. Prograf capsules are usually taken every 12 hours.
You may take Prograf with or without food, but take it the same way each time.
If your doctor changes your brand, strength, or type of tacrolimus, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of tacrolimus you receive at the pharmacy.
While using Prograf, 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: 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 Prograf?
Do not receive a "live" vaccine while using Prograf, 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 Prograf.
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. Prograf can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Prograf side effects
Get emergency medical help if you have any signs of an allergic reaction to Prograf: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with Prograf. 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:
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change in your mental state, problems with speech or walking, decreased vision (may start gradually and get worse quickly);
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little or no urinating; painful or difficult urination; swelling in your feet or ankles;
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headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
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high blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety;
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high blood sugar - increased thirst, increased urination, hunger, fruity breath odor, nausea, loss of appetite, drowsiness, blurred vision, confusion;
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high potassium - slow heart rate, weak pulse, muscle weakness, tingly feeling;
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low magnesium or phosphate - bone pain, jerky muscle movements, muscle weakness or limp feeling, slow reflexes;
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nervous system problems - confusion, headache, vision problems, tremors, numbness and tingly feeling, seizure (convulsions); or
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signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Common Prograf side effects may include:
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infections, high blood pressure, low phosphate, high potassium;
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kidney problems;
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tremors or shaking, numbness or tingling;
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nausea, diarrhea, constipation, stomach pain;
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weakness, headache, general pain;
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sleep problems (insomnia); or
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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.
See also: Side effects (in more detail)
What other drugs will affect Prograf?
Prograf 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 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. Tell your doctor about all your medications and any you start or stop using during treatment with Prograf, especially:
