Tacrolimus Capsules

Generic Name: Tacrolimus (tak-ROE-li-mus)Brand Name: Prograf

Tacrolimus Capsules decreases the action of the immune system. This may increase your risk of infection. It may also increase your risk for developing certain types of cancer (eg, lymphoma). Tell your doctor right away if you notice signs of infection (eg, persistent sore throat, chills, fever) or unusual growths or lumps.

Tacrolimus Capsules are 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.

Tacrolimus Capsules are 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 Tacrolimus Capsules if:

  • you are allergic to any ingredient in Tacrolimus Capsules
  • you are taking astemizole, cisapride, dofetilide, ibutilide, a potassium-sparing diuretic (eg, spironolactone), sirolimus, terfenadine, or ziprasidone
  • you have taken cyclosporine within the last 24 hours

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

Before using Tacrolimus Capsules:

Some medical conditions may interact with Tacrolimus Capsules. 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 heart, kidney, or liver problems; diabetes; or high potassium levels in your blood

Some MEDICINES MAY INTERACT with Tacrolimus Capsules. 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
  • Cyclosporine or other medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cisplatin, cyclosporine, ganciclovir, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], 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
  • Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, high cholesterol, seizures, stomach problems), multivitamin products, herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort), astemizole, cisapride, dofetilide, ibutilide,sirolimus, terfenadine, and ziprasidone may interact with Tacrolimus Capsules, 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 Tacrolimus Capsules 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 Tacrolimus Capsules:

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

  • You may take Tacrolimus Capsules by mouth on an empty stomach or with food. However, you must take it the same way each time for it to work best. If you take Tacrolimus Capsules on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food.
  • Grapefruit and grapefruit juice may increase the risk of side effects from Tacrolimus Capsules. Talk to your doctor before including grapefruit or grapefruit juice in your diet while taking Tacrolimus Capsules.
  • Tacrolimus Capsules works best if it is taken at the same time each day.
  • Continue to take Tacrolimus Capsules even if you feel well. Do not miss any doses.
  • If you miss a dose of Tacrolimus Capsules, contact your doctor right away.

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

Important safety information:

  • Tacrolimus Capsules may cause drowsiness and dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tacrolimus Capsules 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 Tacrolimus Capsules without first checking with your doctor.
  • Tacrolimus Capsules may increase your risk for developing 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 taking Tacrolimus Capsules.
  • Check with your doctor before you use a salt substitute or a product that has potassium in it.
  • Tacrolimus Capsules 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.
  • Tacrolimus Capsules 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.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Tacrolimus Capsules. Talk with your doctor before you receive any vaccine.
  • Patients who take Tacrolimus Capsules after an organ transplant may have an increased risk for 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, or thirsty. It can also make your flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Lab tests, including blood counts, blood potassium and glucose levels, kidney function, heart function, and blood pressure may be performed while you use Tacrolimus Capsules. 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 Tacrolimus Capsules in CHILDREN; they may be more sensitive to its effects, especially lymphoma.
  • PREGNANCY and BREAST-FEEDING: Tacrolimus Capsules 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 Tacrolimus Capsules while you are pregnant. Tacrolimus Capsules are found in breast milk. Do not breast-feed while taking Tacrolimus Capsules.

Possible side effects of Tacrolimus Capsules:

All medicines 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.

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); chest pain; dark urine; decreased coordination; diabetes (frequent urination, increased thirst or hunger); fast or irregular heartbeat; fever, chills, or sore throat; mental or mood changes (eg, anxiety, confusion); one-sided weakness; painful urination or changes in the amount of urine; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness or headache; shortness of breath; swelling of the hands, feet, or legs; tingling or numbness in the hands or feet; tremor; trouble speaking; unusual bruising or bleeding; unusual lumps or skin lesions; unusual weakness or tiredness; vision changes; yellowing of 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Tacrolimus Capsules:

Store Tacrolimus Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tacrolimus Capsules out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Tacrolimus Capsules. 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.

  • Tacrolimus Prescribing Information (FDA)
  • Tacrolimus Professional Patient Advice (Wolters Kluwer)
  • tacrolimus Oral, Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information
  • Prograf Prescribing Information (FDA)
  • Prograf Consumer Overview