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

Taking tacrolimus may increase your risk of developing certain types of cancer, especially skin cancer. The risk may be higher in people who are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your individual risk.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

There are many other medicines that can interact with tacrolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Do not consume grapefruit or grapefruit juice during treatment with tacrolimus unless your doctor has told you do. Tacrolimus can have a dangerous interaction with grapefruit or grapefruit juice.

Tacrolimus can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

Some people receiving tacrolimus after a kidney transplant have developed diabetes, most often in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes.

Warning

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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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.

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

Precautions

You should not take this medication if you are allergic to tacrolimus or hydrogenated castor oil.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking tacrolimus, tell your doctor if you have:

  • kidney disease;
  • liver disease;
  • high blood pressure; or
  • if you have used cyclosporine (Neoral, Sandimmune, Gengraf) within the past 24 hours.

Some people receiving tacrolimus after a kidney transplant have developed diabetes. This effect has been seen most often in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes if you have concerns.

Taking tacrolimus may increase your risk of developing certain types of cancer, especially skin cancer. The risk may be higher in people who are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your individual risk.

FDA pregnancy category C. It is not known whether tacrolimus is harmful to an unborn baby. Before taking tacrolimus, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Tacrolimus can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Do not consume grapefruit or grapefruit juice during treatment with tacrolimus unless your doctor has told you do. Tacrolimus can have a dangerous interaction with grapefruit or grapefruit juice.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Tacrolimus may increase the risk of skin cancer. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Do not receive a "live” vaccine while you are being treated with tacrolimus. Vaccines may not work as well during your treatment with tacrolimus.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a tacrolimus overdose are unknown.

Take the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • pain in the lower back or side;
  • urinating less than usual or not at all;
  • painful urination, blood in your urine;
  • problems with your vision, speech, or coordination;
  • tremor (shaking), headache, confusion, numbness or tingly feeling;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • slow heart rate, weak pulse, muscle weakness;
  • tiredness, fast or pounding heartbeat, mild shortness of breath; or
  • increased urination, thirst, or hunger.

Less serious side effects may include:

  • swelling in your hands or feet;
  • nausea, vomiting, diarrhea, constipation, stomach pain, loss of appetite;
  • sleep problems (insomnia); or
  • itching skin or mild rash.

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. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Tacrolimus can be harmful to the kidneys, and this effect is increased when tacrolimus is used together with other medicines that can harm the kidneys. Before taking tacrolimus, tell your doctor if you are receiving chemotherapy, or using medicines to treat a bowel disorder, antiviral medications, pain or arthritis medicines, any injected antibiotics, or other medications to prevent organ transplant rejection. You may need dose adjustments or special tests when taking any of these medications together with tacrolimus.

Many drugs can interact with tacrolimus. Below is just a partial list. Tell your doctor if you are using:

  • birth control pills or hormone replacement;
  • metoclopramide (Reglan);
  • mycophenolate mofetil (CellCept);
  • sirolimus (Rapamune);
  • St John's wort;
  • lansoprazole (Prevacid), omeprazole (Prilosec, Zegrid)
  • rifampin (Rifadin, Rimactane, Rifater) or rifabutin (Mycobutin);
  • a potassium supplement or a diuretic (water pill);
  • a calcium channel blocker such as verapamil (Calan, Verelan), diltiazem (Cardizem, Dilacor XR, Tiazac), nifedipine (Adalat, Procardia), or nicardipine (Cardene);
  • antifungal medicines such as ketoconazole (Nizoral), itraconazole (Sporanox), fluconazole (Diflucan), caspofungin (Cancidas), clotrimazole (Mycelex Troche), voriconazole (VFEND);
  • erythromycin (Ery-Tab, E-Mycin, E.E.S.), clarithromycin (Biaxin), or troleandomycin (TAO);
  • HIV medicines such as lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), or ritonavir (Norvir);
  • an antacid containing magnesium or aluminum such as Rulox, Amphojel, Milk of Magnesia; or
  • seizure medicine such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal), phenytoin (Dilantin).

This list is not complete and there are many other medicines that can interact with tacrolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04