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TACROLIMUS

(Also Known As: PROGRAF)

Take this medicine only as directed by your doctor. Do not take more or less of it and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may lead to rejection of your transplanted organ.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day. This will also help tacrolimus work better by keeping a constant amount in the blood.

Absorption of this medicine may be changed if you change your diet. This medicine should be taken consistently with respect to meals. You should not change the type or amount of food you eat unless you discuss it with your health care professional.

Do not stop taking this medicine without first checking with your doctor. You may have to take medicine for the rest of your life to prevent your body from rejecting the transplant.

Dosing

The dose of tacrolimus will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tacrolimus. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine in the capsule and the dose prescribed by your doctor. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking tacrolimus.

• For oral dosage form (capsules):
  • Adults, teenagers, or children Dose is based on body weight. The usual dose is 0.1 to 0.3 milligrams (mg) per kilogram (kg) (0.045 to 0.14 mg per pound) of body weight a day.
• For injection dosage form:
  • Adults, teenagers, or children Dose is based on body weight. The usual dose is 0.03 to 0.05 mg per kg (0.014 to 0.0227 mg per pound) of body weight a day.

Missed dose

If you miss a dose of tacrolimus and remember it within 12 hours, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose, go back to your regular dosing schedule, and check with your doctor. Do not double doses.

Storage

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of reach of children.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tacrolimus, the following should be considered:

Allergies Tell your health care professional if you have ever had any unusual or allergic reaction to tacrolimus. Also, if you will be receiving this medicine by injection, tell your health care professional if you are allergic to any other substances, such as castor oil.

Pregnancy Some women have become pregnant and had babies while receiving tacrolimus after an organ transplantation. Some of the newborn babies had temporary kidney problems after birth. Some babies were born prematurely.

Breast-feeding Tacrolimus passes into breast milk. There is a chance that it causes the same side effects in the baby that it does in the mother. It may be necessary for you to stop breast-feeding during treatment.

Children This medicine does not cause different types of side effects or problems in children than it does in adults, although some side effects may occur more or less often than they do in adult patients.

Older adults There is no specific information comparing the use of tacrolimus in the elderly with the use in other age groups. Tacrolimus is not expected to cause different side effects or problems in older people than it does in younger adults. However, older patients may need lower doses of tacrolimus.

Dental

The effects of tacrolimus may cause increased infections and delayed healing. Dental work, whenever possible, should be completed prior to beginning this medicine.

Other medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tacrolimus, it is especially important that your health care professional knows if you are taking any of the following:

• Amiloride or
• Spironolactone (e.g., Aldactone) or
• Triamterene (e.g., Dyrenium) Since both tacrolimus and these medicines increase the amount of potassium in the body, potassium levels could become too high

• Cyclosporine (e.g., Neoral) May increase the effects of tacrolimus by increasing the amount of this medicine in the body; may cause kidney problems

• Danazol (e.g., Danocrine) or
• Erythromycin (medicine for infection) or
• Fluconazole (e.g., Diflucan) or
• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral) May increase the effects of tacrolimus by increasing the amount of this medicine in the body

• Rifampin (e.g., Rifadin) May decrease the effects of tacrolimus by decreasing the amount of this medicine in the body

• Cancer Tacrolimus can make this condition worse

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles) Risk of severe disease affecting other parts of the body

• Diabetes mellitus (sugar diabetes) Tacrolimus can increase the amount of sugar in the blood

• Hepatitis or
• Kidney disease or
• Liver disease, other Tacrolimus can have harmful effects on the kidney in patients with these conditions; a lower dose of tacrolimus may be needed in patients with these conditions

• Hyperkalemia (high amount of potassium in the blood) or
• Nervous system problems Tacrolimus can make these conditions worse

• Infection Tacrolimus decreases the body's ability to fight infection