Your immune system is your body's defense against foreign invaders like bacteria or viruses. Unfortunately, your immune system cannot tell the difference between a harmful invader and your transplanted kidney and will try to reject it.
Rejection is dangerous because it can permanently damage your new organ and can sometimes lead to re-transplant. That is why your transplant team has intended for you to take anti-rejection medications as part of your long-term therapy.
Anti-rejection medications (also called immunosuppressants) protect your organ by slowing down your immune system. There are a variety of anti-rejection medications available, and each works in a different way to suppress the body’s immune response.
Your transplant team will determine which combination of medications is right for you and may alter your medication regimen to improve rejection prevention or reduce side effects.
Prograf is an immunosuppressant approved for the prevention of rejection in people who have received a liver, kidney, or heart transplant. Anti-rejection medications like Prograf are essential to the success of transplantation. In fact, since approval for rejection prevention for liver transplantation in 1994, for kidney transplantation in 1997, and for heart transplantation in 2006, Prograf has become a treatment that recipients and healthcare professionals alike can believe in.
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.
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® (tacrolimus) capsules?
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), 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.