tacrolimus (oral)

Pronunciation:	ta CRAL ih mus
Brand:	Prograf

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

Using 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.

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.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

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 purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking tacrolimus?

Do not use tacrolimus if you are also using cyclosporine (Neoral, Sandimmune, Gengraf).

Before using tacrolimus, tell your doctor if you have:

an allergy to castor oil;
kidney disease;
liver disease; or
high blood pressure.

If you have any of these conditions, you may not be able to use tacrolimus, or you may need a dosage adjustment or special tests during treatment.

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.

FDA pregnancy category C. This medication may be harmful to an unborn baby. 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.

How should I take tacrolimus?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Tacrolimus injection is given through a needle placed into a vein. You will receive this injection shortly after your transplant.

After receiving a tacrolimus injection, you may need to be checked at regular intervals to make sure you do not have an allergic reaction to the medication.

Tacrolimus injection must be given around-the-clock through an IV infusion, until you are ready to take the pill form of tacrolimus.

The tacrolimus capsule is usually taken every 12 hours. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

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.

Store tacrolimus at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while taking tacrolimus?

Do not use tacrolimus if you are also using cyclosporine (Neoral, Sandimmune, Gengraf).

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.

What are the possible side effects of tacrolimus?

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;
muscle weakness, tiredness, fast or pounding heartbeat, mild shortness of breath; or
increased urination, thirst, or hunger.

Other, less serious side effects may also occur, such as:

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

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect tacrolimus?

Before using tacrolimus, tell your doctor if you are using any of the following drugs:

a potassium supplement or a diuretic (water pill) such amiloride (Midamor), spironolactone (Aldactone), or triamterene (Dyrenium, Dyazide, Maxzide);
gentamicin (Garamycin), amikacin (Amikin), amphotericin B (Fungizone), or cisplatin (Platinol);
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), clotrimazole (Mycelex Troche), voriconazole (VFEND);
erythromycin (Ery-Tab, E-Mycin, E.E.S.), clarithromycin (Biaxin), or troleandomycin (TAO);
cisapride (Propulsid) or metoclopramide (Reglan);
bromocriptine (Parlodel);
danazol (Danocrine);
cimetidine (Tagamet, Tagamet HB);
methylprednisolone (Medrol, others);
ethinyl estradiol;
St John's wort;
sirolimus (Rapamune);
lansoprazole (Prevacid), omeprazole (Prilosec, Zegrid)
rifampin (Rifadin, Rimactane, Rifater), rifabutin (Mycobutin), caspofungin;
HIV medicines such as amprenavir (Agenerase), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept);
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).

If you are using any of these drugs, you may not be able to use tacrolimus, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect 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.

Where can I get more information?

Your pharmacist has additional information about tacrolimus written for health professionals that you may read.

What does my medication look like?

Tacrolimus is available with a prescription under the brand name Prograf. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Prograf 0.5 mg--light yellow capsules
Prograf 1 mg--white capsules
Prograf 5 mg--grayish-red capsules

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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