Prograf

Pronunciation: ta-KROE-li-mus
Generic Name: Tacrolimus
Brand Name: Prograf

Prograf decreases the action of the immune system. This may increase your risk of infection. It may also increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Tell your doctor right away if you notice signs of infection (eg, fever, chills, persistent sore throat) or any changes in the appearance or size of a mole, night sweats, unusual growths or lumps, or unusual tiredness or weakness.

Prograf is used for:

Preventing organ rejection in patients following liver, kidney, or heart transplant. It may be used along with other medicines. It may also be used for other conditions as determined by your doctor.

Prograf is an immunosuppressant. It blocks the action of certain blood cells (eg, T lymphocytes) that can cause the body to reject the transplanted organ.

Do NOT use Prograf if:

• you are allergic to any ingredient in Prograf, including castor oil


• you are taking astemizole, cisapride, dofetilide, ibutilide, a potassium-sparing diuretic (eg, spironolactone), sirolimus, terfenadine, or ziprasidone


• you have taken cyclosporine with the last 24 hours

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prograf:

Some medical conditions may interact with Prograf. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have an infection; heart, kidney, or liver problems; diabetes; or high potassium levels in your blood


• if you have a history of a certain type of anemia called pure red cella aplasia (PRCA)


• if you have a history of skin cancer or any other type of cancer

Some MEDICINES MAY INTERACT with Prograf. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Potassium-sparing diuretics (eg, spironolactone) because the risk of high blood potassium levels may be increased


• Astemizole, cisapride, dofetilide, ibutilide, terfenadine, or ziprasidone because the risk of serious heart problems, including a certain type of irregular heartbeat (prolonged QT interval), may be increased


• Cyclosporine or other medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cisplatin, ganciclovir, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], nucleotide reverse transcriptase inhibitors [NRTIs] [eg, tenofovir], vancomycin) or the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of kidney or liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver


• Sirolimus or many other prescription and nonprescription medicines (eg, used for allergies; birth control; cancer; endometriosis; infections; inflammation; aches and pains; irregular heartbeat, angina, or other heart problems; hepatitis C virus (HCV) infection; high blood pressure; high cholesterol; HIV infection; low blood potassium; mental or mood problems, such as depression; nausea or vomiting; Parkinson disease, seizures, stomach problems), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Prograf, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prograf may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prograf:

Use Prograf as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Prograf is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not use Prograf if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Continue to use Prograf even if you feel well. Do not miss any doses.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• Grapefruit and grapefruit juice may increase the risk of side effects from Prograf. Do not eat grapefruit or drink grapefruit juice while you use Prograf.


• If you miss a dose of Prograf, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Prograf.

Important safety information:

• Prograf may cause drowsiness and dizziness. These effects may be worse if you use it with alcohol or certain medicines. Use Prograf with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not change your dose of Prograf without first checking with your doctor.


• Prograf may increase your risk of developing skin cancer or certain other types of cancer (eg, lymphoma). To decrease your risk of skin cancer, avoid using sunlamps or tanning booths. Limit your exposure to the sun. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Check with your doctor before you drink alcohol while you are using Prograf.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• Prograf may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Prograf may increase the risk of certain infections, especially inactive viral infections, including BK virus associated nephropathy and JC virus-associated progressive multifocal leukoencephalopathy (PML). These infections can lead to serious, sometimes fatal, outcomes. Contact your doctor right away if you experience clumsiness, weakness on one side of the body, trouble speaking (eg, word-finding difficulty, slurred speech), or loss of vision.


• Some patients treated with Prograf have developed a type of anemia called PRCA. Contact your doctor right away if you experience severe or persistent tiredness or weakness, sluggishness, or unusually pale skin. Discuss any questions or concerns with your doctor.


• Do not receive a live vaccine (eg, measles, mumps) while you are taking Prograf. Talk with your doctor before you receive any vaccine.


• Patients who use Prograf after an organ transplant may have an increased risk of developing high blood sugar or diabetes. The risk is higher among black and Hispanic patients after a kidney transplant. High blood sugar may make you feel confused, drowsy, hungry, or thirsty. It can also make you flush, breathe faster, urinate more often, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Lab tests, including complete blood cell counts, blood potassium and glucose levels, kidney function, heart function, blood pressure, and blood tacrolimus levels, may be performed while you use Prograf. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Caution is advised when using Prograf in CHILDREN; they may be more sensitive to its effects, especially lymphoma.


• PREGNANCY and BREAST-FEEDING: Prograf has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prograf while you are pregnant. Prograf is found in breast milk. Do not breast-feed while using Prograf.

Possible side effects of Prograf:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; diarrhea; dizziness; headache; joint pain; loss of appetite; nausea; stomach pain or upset; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; changes in the appearance or size of a mole; chest pain; dark urine; decreased coordination; fast, slow, or irregular heartbeat; fever, chills, or sore throat; mental or mood changes (eg, anxiety, confusion); muscle cramps, pain, or weakness; night sweats; one-sided weakness; painful or difficult urination, or changes in the amount of urine; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness or headache; shortness of breath; sluggishness; swelling of the hands, feet, or legs; tremor; trouble speaking; unusual bruising or bleeding; unusual lumps or skin lesions; unusual or persistent weakness or tiredness; unusually pale skin; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Prograf side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; hives; severe dizziness or headache; sluggishness; swelling of the hands, feet, or legs; tremors.

Proper storage of Prograf:

Prograf is usually handled and stored by a health care provider. If you are using Prograf at home, store Prograf as directed by your pharmacist or health care provider. Keep Prograf out of the reach of children and away from pets.

General information:

• If you have any questions about Prograf, please talk with your doctor, pharmacist, or other health care provider.


• Prograf is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prograf. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Prograf resources

• Prograf Side Effects (in more detail)
• Prograf Use in Pregnancy & Breastfeeding
• Drug Images
• Prograf Drug Interactions
• Prograf Support Group
• 18 Reviews for Prograf - Add your own review/rating

• Prograf Prescribing Information (FDA)


• Prograf Consumer Overview


• Prograf Monograph (AHFS DI)


• Prograf Advanced Consumer (Micromedex) - Includes Dosage Information


• Tacrolimus Prescribing Information (FDA)


• Tacrolimus Professional Patient Advice (Wolters Kluwer)


• tacrolimus Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Prograf with other medications

• Organ Transplant, Rejection Prophylaxis
• Organ Transplant, Rejection Reversal