Prograf

Prograf is a prescription medication used to prevent organ rejection in patients who have had a kidney, liver, or heart transplant. Prograf belongs to a group of drugs called immunosupressants, which help prevent your body from attacking the transplanted organ.

This medication comes in an injectable (IV) form and capsule form. You will receive Prograf injections until you are able to tolerate the oral capsule. The capsule form is taken twice daily, with or without food.

Common side effects of Prograf include body tremors, high blood pressure, and kidney problems.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Astellas Pharma US, Inc.

Serious side effects have been reported with Prograf. See the "Prograf Precautions" section. 

The most common side effects of Prograf in people receiving kidney transplant are:

• tremors (shaking of the body)
• infection
• 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.

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:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (erythromycin, clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• cyclosporine (Gengraf, Neoral, and Sandimmune)
• sirolimus (Rapamune)
• nelfinavir (Viracept)
• telaprevir (Incivek)
• boceprevir (Victrelis)
• mycophenolic acid (Myfortic)
• bromocriptine (Parlodel)
• metoclopramide (Reglan)
• danazol (Danocrine)
• ethinyl estradiol
• amiodarone (Cordarone)
• methylprednisolone (Medrol)
• calcium channel blockers such as verapamil, diltiazem, nifedipine, and nicardipine
• St. john's Wort
• cimetidine
• proton pump inhibitors such as lansoprazole and omeprazole

Prograf can cause serious side effects, including:

• 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).
• 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
  • warm, red, or painful areas on your skin

Do not take Prograf if you are allergic to Prograf or any of the ingredients in Prograf including HCO-60 (polyoxyl 60 hydrogenated castor oil).

While you take Prograf you should not receive any live vaccines such as:

Avoid exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.

• flu vaccine through your nose
• measles
• mumps
• rubella
• polio by mouth
• BCG (TB vaccine)
• yellow fever
• chicken pox (varicella)
• typhoid

Grapefruit and grapefruit juice may interact with Prograf and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

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. Talk to your doctor if you are pregnant or plan to become pregnant.
• 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Prograf  falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Prograf may harm your unborn baby. Prograf should be given to a pregnant woman only if clearly needed.

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.

Take Prograf exactly as your doctor tells you to take it.

• Your doctor will tell you how many capsules of 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, but make sure to take it the same way every time. 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 a.m. you should take your second dose at 7:00 p.m.
  • 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.

• Avoid exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

The dose you doctor recommends may be based on the type of transplant you are receiving.

The recommended initial dose of Prograf capsules in adults to prevent rejection of a:

• kidney transplant in combination with azathioprine is 0.2 mg/kg/day
• kidney transplant in combination with MMF/IL-2 receptor blocker is 0.1 mg/kg/day
• liver transplant is 0.10- 0.15mg/kg/day
• heart transplant is 0.075 mg/kg/day

The recommended initial dose of Prograf injection is 0.03-0.05 mg/kg/day in kidney and liver transplant and 0.01 mg/kg/day in heart transplant given as a continuous infusion into a vein (IV). 

The recommended initial dose of Prograf capsules in children for preventing rejection of a liver transplant is 0.15 - 0.20 mg/kg/day.

Doses will then be adjusted based on assessment of organ rejection and how you are handling the medicine. 

If you take too much Prograf, call your doctor or go to the nearest hospital emergency room right away.

• Store Prograf at 59º F to 86ºF (15°C to 30º C).
• Safely throw away medicine that is out of date or no longer needed. Ask your pharmacist how to properly and safely get rid of expired medication.
• Keep Prograf and all medicines out of reach of children. 

BOX WARNING - MALIGNANCIES AND SERIOUS INFECTIONS

• Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression.
• Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections.
• Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Prograf. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.