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Generic Name: Tacrolimus Injection (ta-KROE-li-mus)
Brand Name: Prograf

Tacrolimus may leave you less able to fight infection and could also cause lymphoma. Tacrolimus must be used in an appropriate setting. Notify your doctor if you develop signs of infection (eg, persistent sore throat, fever) or unusual growths or lumps. Check with your doctor for instructions on your follow-up care.

Tacrolimus is used for:

Preventing organ rejection in patients who received liver or kidney transplants. It may also be used for other conditions as determined by your doctor.

Tacrolimus is an immunosuppressant. How it works is not fully understood. It is thought to decrease the immune response by blocking the function of certain cells that reject transplants in the body.

Do NOT use Tacrolimus if:

  • you are allergic to any ingredient in this medicine
  • you are taking astemizole, cisapride, cyclosporine, terfenadine, voriconazole, or ziprasidone

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

Before using Tacrolimus :

Some medical conditions may interact with Tacrolimus . 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 or high potassium levels in your blood

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

  • Corticosteroids (eg, hydrocortisone), hydantoins (eg, phenytoin), rifampin, or St. John"s wort because the effectiveness of Tacrolimus may be decreased
  • Androgens (eg, testosterone), chloramphenicol, cyclosporine, diltiazem, felodipine, HIV protease inhibitors (eg, ritonavir), imidazoles (eg, ketoconazole), macrolides and ketolides (eg, erythromycin, azithromycin), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), nefazodone, potassium-sparing diuretics (eg, triamterene), streptogramins (eg, mikamycin), theophyllines (eg, aminophylline), or voriconazole because side effects, such as kidney problems, may be increased
  • Arsenic, astemizole, cisapride, dofetilide, irinotecan, mibefradil, sildenafil, sirolimus, terfenadine, or ziprasidone because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tacrolimus 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 :

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

  • Tacrolimus is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Tacrolimus at home, carefully follow the injection procedures taught to you by your health care provider.
  • Tacrolimus comes with an additional patient leaflet. Read it carefully and reread it each time you get Tacrolimus refilled.
  • If Tacrolimus contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • Continue to use Tacrolimus 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 away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of Tacrolimus , contact your doctor immediately.

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

Important safety information:

  • Tacrolimus may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tacrolimus . Using Tacrolimus alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • This medicine should not be taken within 24 hours of taking cyclosporine.
  • Tacrolimus may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tacrolimus . Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
  • Ask your doctor before drinking alcohol.
  • Do not use a salt substitute or a potassium supplement without checking with your doctor.
  • Tacrolimus may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
  • Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Tacrolimus . Vaccinations may be less effective.
  • LAB TESTS, including blood tests, kidney function, and blood pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Tacrolimus may cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Tacrolimus during pregnancy. Tacrolimus is excreted in breast milk. Do not breast-feed while taking Tacrolimus .

Possible side effects of Tacrolimus :

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:

Constipation; diarrhea; headache; loss of appetite; nausea; trouble sleeping.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; changes in heartbeat; change in coordination; chest pain; diabetes (frequent urination, increased thirst or hunger); dizziness; fever or chills; mental or mood changes (eg, anxiety, confusion); seizures; shortness of breath; stomach pain; swelling of the feet or legs; tingling or numbness in the hands or feet; tremor; unusual bruising or bleeding; unusual lumps or skin lesions; unusual weakness or tiredness; vision changes or blurred vision; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately.

Proper storage of Tacrolimus :

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

General information:

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

This information is a summary only. It does not contain all information about Tacrolimus . 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: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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