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Prograf and You

Your immune system is your body's defense against things that can cause infection and disease. Unfortunately, it can't tell the difference between a harmful virus or bacteria and your new organ, so its natural response is to reject it.

That's why different types of medications will be prescribed to help prevent rejection post-transplant and keep your new organ healthy. These medications are called anti-rejection medications, or immunosuppressive drugs.

For some medications, your doctor may want you to take a brand name drug. For other medications, your doctor may want you to take a generic drug. Prograf is a brand name anti-rejection medication that your transplant team may prescribe to help protect your new organ.

If Prograf is your doctor's choice for you— know about generic substitution

Be sure to check your medications as soon as you get them. In most cases, pharmacists or pharmacy personnel are not required to tell you or your doctor if they decide to substitute a generic drug for the Prograf that you and your transplant team have decided upon.

Retail and mail-order pharmacies in many states are permitted—and are sometimes required—to fill all prescriptions with generic drugs unless your doctor indicates brand name Prograf only on your prescription. You can also tell your pharmacist you want brand name Prograf.

Always check your medications

A generic drug is a copy of a brand name drug that is the same in dosage, safety, strength, way it is taken, quality, performance, and intended use. Generics have the same active ingredients as their brand counterparts, but may have differences in the inactive ingredients. A generic drug can be approved for marketing once the patent on the brand name drug has expired.

Brand name drugs have costs associated with the discovery, development, and multi-phase clinical testing required to bring a new drug to the market. Generics cost less because generic manufacturers don't have to repeat extensive clinical trial programs or take on the investment costs of researching and developing a new drug.

The Food and Drug Administration (FDA) requires brand name drugs and generic drugs to be safe—both products are expected to meet the same standards of strength, purity, effectiveness, manufacturing, and quality controls. Generic drugs are considered bioequivalent based on studies conduct in 24-36 healthy volunteers. The FDA relies on the safety and efficacy studies conducted by the manufacturer of the brand to establish the safety and efficacy of the generic medication.1,2

It is important to be aware that although generic tacrolimus products are approved based on their bioequivalence to Prograf, they are not required to show bioequivalence to each other.1

Be proactive about your medications. Find out what steps to take at your doctor's office and pharmacy. Learn more.

Download these informative brochures about Prograf and being an empowered transplant recipient.

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References: 1. US Department of Health and Human Services. Approved drug products with therapeutic equivalence evaluations (Orange Book). 31st ed. Rockville, MD: Center for Drug Evaluation and Research; 2011. 2. Vasquez EM, Min DI. Transplant pharmacists' opinions on generic product selection of critical-dose drugs. Am J Health Syst Pharm. 1999;56(7):615-621.

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.

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. 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), 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 for additional safety information.

The information provided on this website is intended for residents of the United States.