Astagraf XL (Tacrolimus)

(ta kroe' li mus)

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.

Talk to your doctor about the risks of using tacrolimus ointment.

Tacrolimus ointment is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in patients who cannot use other medications for their condition or whose eczema has not responded to another medication. Tacrolimus is in a class of medications called topical calcineurin inhibitors. It works by stopping the immune system from producing substances that may cause eczema.

Tacrolimus comes as an ointment to apply to the skin. It is usually applied twice a day to the affected area. To help you remember to apply tacrolimus ointment, apply it at around 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. Use tacrolimus exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. To use the ointment, follow these steps:

• Wash your hands with soap and water.
• Be sure that the skin in the affected area is dry.
• Apply a thin layer of tacrolimus ointment to all affected areas of your skin.
• Rub the ointment into your skin gently and completely.
• Wash your hands with soap and water to remove any leftover tacrolimus ointment. Do not wash your hands if you are treating them with tacrolimus.
• You may cover the treated areas with normal clothing, but do not use any bandages, dressings, or wraps.
• Be careful not to wash the ointment off of affected areas of your skin. Do not swim, shower, or bathe immediately after applying tacrolimus ointment.

Before using tacrolimus ointment,
• tell your doctor and pharmacist if you are allergic to tacrolimus ointment, injection, or capsules (Prograf), or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); calcium channel blockers such as diltiazem (Cardizem, Dilacor, Tiazac) and verapamil (Calan, Covera, Isoptin, Verelan); cimetidine (Tagamet); erythromycin (E.E.S., E-Mycin, Erythrocin); and other ointments, creams, or lotions. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have a skin infection and if you have or have ever had kidney disease, Netherton's syndrome (an inherited condition that causes the skin to be red, itchy, and scaly), redness and peeling of most of your skin, any other skin disease, or any type of skin infection, especially chicken pox, shingles (a skin infection in people who have had chicken pox in the past), herpes (cold sores), or eczema herpeticum (viral infection that causes fluid filled blisters to form on the skin of people who have eczema). Also tell your doctor if your eczema rash has turned crusty or blistered or you think your eczema rash is infected.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using tacrolimus ointment, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using tacrolimus ointment.
• ask your doctor about the safe use of alcoholic beverages while you are using tacrolimus ointment. Your skin or face may become flushed or red and feel hot if you drink alcohol during your treatment.
• avoid exposure to chicken pox, shingles, and other viruses. If you are exposed to one of these viruses while using tacrolimus ointment, call your doctor immediately.
• you should know that good skin care and moisturizers may help relieve the dry skin caused by eczema. Talk to your doctor about the moisturizers you should use, and always apply them after applying tacrolimus ointment.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while you are taking this medicine.

Apply 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 apply extra ointment to make up for a missed dose.

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

• skin burning, stinging, redness or soreness
• tingling skin
• increased sensitivity of the skin to hot or cold temperatures
• itching
• acne
• swollen or infected hair follicles
• headache
• muscle or back pain
• flu-like symptoms
• stuffy or runny nose
• nausea

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• swollen glands
• rash
• crusting, oozing, blistering or other signs of skin infection
• cold sores
• chicken pox or other blisters
• swelling of the hands, arms, feet, ankles, or lower legs

Tacrolimus ointment may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. Do not let anyone else use 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.