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Tacrolimus



(ta kroe' li mus)

Prograf®

FK 506

Tacrolimus should only be given under the supervision of a doctor who is experienced in treating people who have had an organ transplant and in prescribing medications that decrease the activity of the immune system.
Tacrolimus decreases the activity of your immune system. This may increase the risk that you will get a serious infection. If you experience any of the following symptoms, call your doctor immediately: sore throat; cough; fever; extreme tiredness; flu-like symptoms; warm, red, or painful skin; or other signs of infection.
When your immune system is not working normally, there may be a greater risk that you will develop cancer, especially lymphoma (a type of cancer that begins in the cells of the immune system). The longer you take tacrolimus or other medications that decrease the activity of the immune system, and the higher your doses of these medications, the more this risk may increase. If you experience any of the following symptoms of lymphoma, call your doctor immediately: swollen lymph nodes in the neck, armpits, or groin; weight loss; fever; night sweats; excessive tiredness or weakness; cough; trouble breathing; chest pain; or pain, swelling, or fullness in the stomach area.
Talk to your doctor about the risks of taking tacrolimus.

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 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.

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.
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.