Brand Names: Prograf

Generic Name: tacrolimus (oral) (Pronunciation: ta KROE li mus)

• What is tacrolimus (Prograf)?
• What are the possible side effects of tacrolimus (Prograf)?
• What is the most important information I should know about tacrolimus (Prograf)?
• What should I discuss with my healthcare provider before taking tacrolimus (Prograf)?
• How should I take tacrolimus (Prograf)?
• What happens if I miss a dose (Prograf)?
• What happens if I overdose (Prograf)?
• What should I avoid while taking tacrolimus (Prograf)?
• What other drugs will affect tacrolimus (Prograf)?
• Where can I get more information?

What is tacrolimus (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.

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.

Prograf 0.5 mg

yellow, imprinted with 0.5mg, LOGO 607

Prograf 1 mg

white, imprinted with 1 mg, 617

Prograf 5 mg

peach, imprinted with 5mg, LOGO 657

What are the possible side effects of tacrolimus (Prograf)?

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.

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

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.