Astagraf XL (Tacrolimus)

Tacrolimus Topical (ta kroe' li mus) Protopic® A small number of patients who used tacrolimus ointment or another similar medication developed skin cancer or lymphoma (cancer in a part of the immune system). There is not enough information available to tell whether tacrolimus ointment caused these patients to develop cancer. Studies of transplant patients and laboratory animals and an understanding of the way tacrolimus works suggest that there is a possibility that people who use tacrolimus ointment have a greater risk of developing cancer. More study is needed to understand this risk. Follow these directions carefully to decrease the possible risk that you will develop cancer during your treatment with tacrolimus ointment: Use tacrolimus ointment only when you have symptoms of eczema. Stop using tacrolimus ointment when your symptoms go away or when your doctor tells you that you should stop. Do not use tacrolimus ointment continuously for a long time. Call your doctor if you have used tacrolimus ointment for 6 weeks and your eczema symptoms have not improved, or if your symptoms get worse at any time during your treatment. A different medication may be needed. Call your doctor if your eczema symptoms come back after your treatment with tacrolimus ointment. Apply tacrolimus ointment only to skin that is affected by eczema. Use the smallest amount of ointment that is needed to control your symptoms. Do not use tacrolimus ointment to treat eczema in children who are younger than 2 years old. Do not use tacrolimus ointment 0.1% to treat eczema in children who are between 2 and 15 years old. Only tacrolimus ointment 0.03% may be used to treat children in this age group. Tell your doctor if you have or have ever had cancer, especially skin cancer, or any condition that affects your immune system. Ask your doctor if you are not sure if a condition that you have has affected your immune system. Tacrolimus may not be right for you. Protect your skin from real and artificial sunlight during your treatment with tacrolimus ointment. Do not use sun lamps or tanning beds, and do not undergo ultraviolet light therapy. Stay out of the sunlight as much as possible during your treatment, even when the medication is not on your skin. If you need to be outside in the sun, wear loose fitting clothing to protect the treated skin, and ask your doctor about other ways to protect your skin from the sun. Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with tacrolimus and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide. Talk to your doctor about the risks of using tacrolimus ointment.

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.

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.

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. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tacrolimus, call your doctor. 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.

Avoid eating grapefruit or drinking grapefruit juice while taking tacrolimus.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to tacrolimus. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.