In the U.S.—

In Canada—

• Immunosuppressant

Tacrolimus (ta-KROE-li-mus) belongs to a group of medicines known as immunosuppressive agents. It is used to lower the body's natural immunity in patients who receive organ (for example, kidney, liver, pancreas, lung, and heart) transplants.

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Tacrolimus works by preventing the white blood cells from getting rid of the transplanted organ.

Tacrolimus may also be used for other indications, as determined by your doctor.

Tacrolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also reduce the body's ability to fight infections. You and your doctor should talk about the good this medicine will do as well as the risks of using it.

Tacrolimus is available only with your doctor's prescription, in the following dosage forms:

Oral
• Capsules (U.S. and Canada)

Parenteral
• Injection (U.S. and Canada)

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

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 0.01 to 0.05 mg per kg (0.0045 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.

It is very important that your doctor check your progress at regular visits. Your doctor will want to do laboratory tests to make sure that tacrolimus is working properly and to check for unwanted effects.

While you are taking tacrolimus, it is important to maintain good dental hygiene and see a dentist regularly for teeth cleaning.

Raw oysters or other shellfish may contain bacteria that can cause serious illness, and possibly death. This is more likely to be a problem if these foods are eaten by patients with certain medical conditions . Even eating oysters from "clean" water or good restaurants does not guarantee that the oysters do not contain the bacteria. Symptoms of this infection include sudden chills, fever, nausea, vomiting, blood poisoning, and sometimes death. Eating raw shellfish is not a problem for most healthy people; however, patients with the following conditions may be at greater risk: cancer, immune disorders, organ transplantation, long-term corticosteroid use (as for asthma, arthritis, or organ transplantation), liver disease (including viral hepatitis), excess alcohol intake (2 to 3 drinks or more per day), diabetes, stomach problems (including previous stomach surgery and low stomach acid), and hemochromatosis (an iron disorder). Do not eat raw oysters or other shellfish while you are taking tacrolimus. Be sure oysters and shellfish are fully cooked .

While you are being treated with tacrolimus, and after you stop treatment with it, it is important to see your doctor about the immunizations (vaccinations) you should receive. Do not get any immunizations without your doctor's approval. Tacrolimus lowers your body's resistance. For some immunizations, there is a chance you might get the infection the immunization is meant to prevent. For other immunizations, it may be especially important to receive the immunization to prevent a disease. In addition, other persons living in your house should not take oral poliovirus vaccine since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have recently taken oral poliovirus vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Treatment with tacrolimus may also increase the chance of getting other infections. If you can, avoid people with colds or other infections. If you think you are getting a cold or other infection, check with your doctor.

Tacrolimus is not available in all countries. If you are traveling to another country, be sure you will have a supply of your medicine .

Grapefruits and grapefruit juice may increase the effects of tacrolimus by increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor will watch for others by doing certain tests.

Also, because of the way tacrolimus acts on the body, there is a chance that it may cause effects that may not occur until years after the medicine is used. These delayed effects may include certain types of cancer, such as lymphomas or skin cancers.

Check with your doctor or nurse immediately if any of the following side effects occur:

• More common
  • Abdominal pain;  abnormal dreams;  agitation;  anxiety;  chills;  confusion;  convulsions (seizures);  diarrhea;  dizziness ;  fever and sore throat;  flu-like symptoms;  frequent urination;  hallucinations (seeing or hearing things that are not there) ;  headache;  infection;  itching;  loss of appetite;  loss of energy or weakness;  mental depression ;  muscle trembling or twitching;  nausea;  nervousness;  pale skin;  shortness of breath;  skin rash;  swelling of feet or lower legs;  tingling;  trembling and shaking of hands ;  trouble in sleeping;  unusual bleeding or bruising;  unusual tiredness or weakness;  vomiting 
  
  

• Less common
  • Blurred vision;  chest pain;  increased sensitivity to pain;  muscle cramps;  numbness or pain in legs;  ringing in ears;  sweating 
  
  

• Rare
  • Flushing of face or neck;  general feeling of discomfort or illness;  weight loss;  wheezing 
  
  

This medicine may also cause the following side effects that your doctor will watch for:

• More common
  • Hyperkalemia (too much potassium in the blood);  hypomagnesemia (not enough magnesium in the blood);  kidney problems 
  
  

• Less common
  • Hyperlipidemia (high cholesterol);  hypertension (high blood pressure) 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in the product labeling, tacrolimus is used in certain patients with the following medical conditions:

• Bone marrow transplantation
• Uveitis, severe, refractory (an eye condition)

For patients receiving bone marrow transplantation, tacrolimus may work by preventing the cells from the transplanted bone marrow from attacking the cells of the patient. The dose of tacrolimus for patients receiving bone marrow transplantation is based on body weight. The usual dose is 0.12 to 0.3 mg per kg (0.05 to 0.14 mg per pound) of body weight a day for patients taking tacrolimus by mouth, and 0.04 to 0.1 mg per kg (0.018 to 0.045 mg per pound) of body weight a day for patients receiving tacrolimus by injection.

The dose of tacrolimus for patients with severe, refractory uveitis is based on body weight. For severe, refractory uveitis, the usual dose is 0.1 to 0.15 mg per kg (0.045 to 0.068 mg per pound) of body weight a day.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.