Indication and Important Safety Information
At Astellas, we provide not only vital immunosuppression, but also the programs and resources that support the efforts of the countless people who make transplantation a success—including you.
What is Prograf® (tacrolimus) capsules?
PROGRAF® (tacrolimus) capsules 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.
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. PROGRAF may harm your unborn baby and 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® (tacrolimus) capsules may cause serious side effects, including:
high blood sugar (diabetes), kidney problems, nervous system problems, high
levels of potassium in your blood, high blood pressure, or 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 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
Prescribing Information and full Prescribing Information, including Boxed Warning.