What are the possible side effects of PROGRAF?

PROGRAF may cause serious side effects, including:

High blood sugar (Diabetes)

Your doctor may do certain tests to check for diabetes while you take PROGRAF. Call your doctor right away if you have:

frequent urination
increased thirst or hunger
blurred vision
confusion
drowsiness
loss of appetite
fruity smell on your breath
nausea, vomiting, or stomach pain

Kidney problems

Your doctor may do certain tests to check your kidney function while you take PROGRAF.

Nervous system problems

Call your doctor right away if you get any of these symptoms while taking PROGRAF. These could be signs of a serious nervous system problem:

confusion
coma
muscle tremors
numbness and tingling
headache
seizures
vision changes

High levels of potassium in your blood

Your doctor may do certain tests to check your potassium level while you take PROGRAF.

High blood pressure

Your doctor will monitor your blood pressure while you take PROGRAF.

Heart problems (myocardial hypertrophy)

Tell your doctor right away if you get any of these symptoms of heart problems while taking PROGRAF:

  • shortness of breath
  • chest pain
  • feel lightheaded
  • feel faint

THE MOST COMMON SIDE EFFECTS OF PROGRAF

In people receiving kidney transplant are:

  • infection
  • tremors (shaking of the body)
  • high blood pressure
  • kidney problems
  • constipation
  • diarrhea
  • headache
  • stomach pain
  • trouble sleeping
  • nausea
  • low levels of phosphate in your blood
  • swelling of the hands, ankles, or legs
  • weakness
  • pain
  • high levels of fat in your blood
  • high levels of potassium in your blood
  • low red blood cell count (anemia)

The most common side effects of PROGRAF in people receiving liver transplants are:

  • shaking of the body tremors
  • headache
  • diarrhea
  • high blood pressure
  • nausea
  • kidney problems
  • stomach pain
  • trouble sleeping
  • numbness or tingling in your hands or feet
  • anemia
  • pain
  • fever
  • weakness
  • high levels of potassium in the blood
  • low levels of magnesium in the blood

The most common side effects of PROGRAF for heart transplant patients are:

  • kidney problems
  • high blood pressure

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of PROGRAF. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store PROGRAF?

  • Store PROGRAF at 59ºF to 86ºF (15°C to 30ºC).
  • Safely throw away medicine that is out of date or no longer needed.

Keep PROGRAF and all medicines out of reach of children.

General information about the safe and effective use of PROGRAF

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. Do not use PROGRAF for a condition for which it was not prescribed. Do not give PROGRAF to other people, even if they have the same symptoms that you have. It may harm them.

How Does PROGRAF Protect My New Organ?

The body’s immune system protects the body against anything that it does not recognize as part of the body. For example, when the immune system detects a virus or bacteria it tries to get rid of it to prevent infection. When a person has a liver, kidney, or heart transplant, the immune system does not recognize the new organ as a part of the body and tries to get rid of it, too. This is called “rejection”. PROGRAF protects your new organ by slowing down the body's immune system.

What are the ingredients in PROGRAF?

Active ingredient: tacrolimus

Inactive ingredients: lactose monohydrate, hypromellose, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide and ferric oxide.

What is PROGRAF?

PROGRAF is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, or heart transplant. PROGRAF is not for use with medicines called cyclosporines (Gengraf®, Neoral®, and Sandimmune®) and is not for use with a medicine called sirolimus (Rapamune®) in people who have had a liver or heart transplant. It is not known if PROGRAF is safe and effective when used with sirolimus in people who have had kidney transplants. It is not known if PROGRAF is safe and effective in children who have had kidney or heart transplants.

IMPORTANT SAFETY INFORMATION

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

PROGRAF can cause serious side effects, including:

  1. Increased risk of cancer. People who take PROGRAF have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
  2. Increased risk of infection. PROGRAF is a medicine that affects your immune system. PROGRAF can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving PROGRAF that can cause death. Call your doctor right away if you have symptoms of an infection such as fever, sweats or chills, cough or flu-like symptoms, muscle aches, and/or warm, red, or painful areas on your skin.

Do not take PROGRAF if you are allergic to tacrolimus or any of the ingredients in PROGRAF.

What should I tell my doctor before taking PROGRAF?

Before you take PROGRAF, tell your doctor if you: plan to receive any live vaccines, have or have had liver, kidney or heart problems, are pregnant or plan to become pregnant. Talk to your doctor if you are pregnant or plan to become pregnant. Tell your doctor if you are breastfeeding or plan to breastfeed. PROGRAF can pass into your breast milk. You and your doctor should decide if you will take PROGRAF or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and, herbal supplements. Especially tell your doctor if you take: cyclosporine (Gengraf®, Neoral®, and Sandimmune®), sirolimus (Rapamune®), nelfinavir (Viracept®), telaprevir (Incivek®), boceprevir (Victrelis®) or amiodarone (Cordarone®, Nexterone®, Pacerone®). PROGRAF may affect the way other medicines work, and other medicines may affect how PROGRAF works. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How Should I Take PROGRAF?

Do not eat grapefruit or drink grapefruit juice while taking PROGRAF. Take PROGRAF exactly as your doctor tells you to take it. Take PROGRAF with or without food and the same way and time every day. If you take too much PROGRAF, call your doctor or go to the nearest hospital emergency room right away.

PROGRAF may cause serious side effects, including:

  • high blood sugar (diabetes). Your doctor may do certain tests to check for diabetes.
  • kidney problems. Your doctor may do certain tests to check your kidney function.
  • nervous system problems
  • high levels of potassium in your blood. Your doctor may do certain tests to check your potassium level.
  • high blood pressure. Your doctor will monitor your blood pressure.
  • heart problems (myocardial hypertrophy)

Call your doctor right away if you have any of these symptoms: frequent urination, increased thirst or hunger, blurred vision, confusion, drowsiness, loss of appetite, fruity smell on your breath, nausea, vomiting, stomach pain, muscle tremors, numbness and tingling, headache, seizures, vision changes, shortness of breath, chest pain, feel lightheaded, or feel faint.

The most common side effects of PROGRAF are: tremors (shaking of the body); high blood pressure; kidney problems; diarrhea; headache; stomach pain; trouble sleeping; nausea; pain; weakness or low red blood cell count (anemia); infection; constipation; low levels of phosphate in your blood; swelling of the hands, ankles, or legs; high levels of fat or potassium in your blood; numbness or tingling in your hands or feet; fever; or low levels of magnesium in the blood.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of PROGRAF. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about the side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the Patient Information and full Prescribing Information, including Boxed Warnings.