Tacrolimus

Conditions Treated

Tacrolimus is used along with other medications to prevent rejection (attack of a transplanted organ by the immune system of a person receiving the organ) in people who have received kidney, liver, or heart transplants. Tacrolimus is in a class of medications called immunosupressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ.

Possible Side Effects

What Side Effects Can This Cause?

Tacrolimus may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• uncontrollable shaking of a part of the body
• diarrhea
• constipation
• nausea
• vomiting
• heartburn
• stomach pain
• loss of appetite
• difficulty falling asleep or staying asleep
• dizziness
• weakness
• back or joint pain
• burning, numbness, pain, or tingling in the hands or feet
• rash
• itching

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

• decreased urination
• pain or burning on urination
• swelling of the arms, hands, feet, ankles, or lower legs
• weight gain
• unusual bleeding or bruising
• seizures
• coma (loss of consciousness for a period of time)

Tacrolimus may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Tacrolimus comes as a capsule to take by mouth. It is usually taken twice a day. Space your doses 12 hours apart, and take tacrolimus at the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tacrolimus exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor will monitor you carefully and adjust your dose as needed. Talk to your doctor often about how you are feeling during your treatment. Ask your doctor if you have any questions about how much tacrolimus you should take. Tacrolimus can only prevent rejection of your transplant as long as you are taking the medication. Continue to take tacrolimus even if you feel well. Do not stop taking tacrolimus without talking to your doctor.

What Dietary Instructions Should I Follow

Avoid eating grapefruit or drinking grapefruit juice while taking tacrolimus.

Are There Any Special Instructions

Before taking tacrolimus, tell your doctor and pharmacist if you are allergic to tacrolimus or any other medications. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amphotericin B (Abelcet, Ambisome, Amphotec); antacids; certain antibiotics including aminoglycosides such as amikacin, gentamicin, neomycin (Neo-Fradin), streptomycin, and tobramycin (Tobi), and macrolides such as clarithromycin (Biaxin), erythromycin (EES, E-Mycin, Erythrocin), and troleandomycin (TAO) (not available in the US); antifungal medications such as clotrimazole (Lotrimin, Mycelex), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral) and voriconazole (Vfend); bromocriptine (Parlodel); calcium channel blockers such as diltiazem (Cardizem), nicardipine (Cardene), nifedipine (Adalat, Procardia), and verapamil (Calan, Covera, Isoptin); caspofungin (Cancidas); chloramphenicol; cimetidine (Tagamet); cisapride (Propulsid) (not available in the U.S.); cisplatin (Platinol); danazol (Danocrine); certain diuretics ('water pills'); ganciclovir (Cytovene); hormonal contraceptives (birth control pills, patches, rings, inserts, or injections); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir); lansoprazole (Prevacid); certain medications for seizures such as carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); methylprednisolone (Medrol); metoclopramide (Reglan); nefazodone; omeprazole (Prilosec); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); and sirolimus (Rapamune). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects. Many other medications may also interact with tacrolimus, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. tell your doctor if you are taking or have recently stopped taking cyclosporine (Gengraf, Neoral, Sandimmune). If you were taking cyclosporine, your doctor will probably tell you not to start taking tacrolimus until 24 hours after you took your last dose of cyclosporine. If you stop taking tacrolimus, your doctor will also tell you to wait 24 hours before starting to take cyclosporine. tell your doctor and pharmacist what herbal products you are taking, especially St. John's wort. tell your doctor if you have or have ever had heart, kidney, or liver disease. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tacrolimus. you should know that taking tacrolimus may increase the risk that you will develop skin cancer. Protect yourself from skin cancer by avoiding unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds) and wearing protective clothing, sunglasses, and sunscreen with a high skin protection factor (SPF). you should know that tacrolimus may cause high blood pressure. Your doctor will monitor your blood pressure carefully, and may prescribe medication to treat high blood pressure if it develops. you should know that there is a risk that you will develop diabetes during your treatment with tacrolimus. African American and Hispanic patients who have had kidney transplants have an especially high risk of developing diabetes during their treatment with tacrolimus. Tell your doctor if you or anyone in your family has or has ever had diabetes. If you experience any of the following symptoms, call your doctor immediately: excessive thirst; excessive hunger; frequent urination; blurred vision or confusion. do not have any vaccinations without talking to your doctor.