Making PROGRAF a part of your daily routine

How should I take PROGRAF?

  • Take PROGRAF exactly as your doctor tells you to take it.
  • Your doctor will tell you how many PROGRAF to take and when to take them.
  • Your doctor may change your PROGRAF dose if needed. Do not stop taking or change your dose of PROGRAF without talking to your doctor.
  • Take PROGRAF with or without food.
  • Take PROGRAF the same way everyday. For example, if you choose to take PROGRAF with food, you should always take PROGRAF with food.
  • Take PROGRAF at the same time each day, 12 hours apart. For example, if you take your first dose at 7:00 am you should take your second dose at 7:00 pm.
    • Taking PROGRAF at the same time each day helps to keep enough medicine in your body to give your transplanted organ the around-the-clock medicine it needs.
  • Do not eat grapefruit or drink grapefruit juice while taking PROGRAF.
  • If you take too much PROGRAF, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking PROGRAF?

  • While you take PROGRAF you should not receive any live vaccines such as:
    • flu vaccine through your nose
    • measles
    • mumps
    • rubella
    • polio by mouth
    • BCG (TB vaccine)
    • yellow fever
    • chicken pox (varicella)
    • typhoid
  • Avoid exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.

REMEMBER TO TAKE YOUR MORNING AND EVENING DOSES

Here are some tips to help you remember your morning and evening doses of PROGRAF:

  • Place your medication on your nightstand with a glass of water
  • Set alarms on your phone, clock, or tablet that remind you to take your PROGRAF twice a day
  • On a calendar, check off your morning and evening doses after you take them
  • When traveling, be aware of new time zones and take your medication at the same time you normally would take it at home

See the Patient Information for more information about what to tell your doctor before taking PROGRAF.

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.