In the U.S.—

• Immunosuppressant

Mycophenolate ( mye-koe-FEN-oh-late) 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 transplants.

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

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Capsules (U.S.)
• Tablets (U.S.)

Parenteral
• Injection (U.S.)

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 mycophenolate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to mycophenolate. Also tell your health care professional if you are allergic to any other substances, such as food preservatives or dyes.

Pregnancy—Mycophenolate has not been studied in pregnant women. However, mycophenolate causes birth defects in animals, and it may cause birth defects in people too. If you are taking mycophenolate, you should use two forms of reliable birth control before beginning treatment with mycophenolate, while being treated with mycophenolate, and for at least 6 weeks after discontinuing mycophenolate.

Breast-feeding—It is not known whether mycophenolate passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them can be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Although there is no specific information comparing the use of mycophenolate in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mycophenolate in the elderly with use in other age groups.

Dental

The effects of mycophenolate 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 mycophenolate, it is especially important that your health care professional know if you are taking any of the following:

• Antithymocyte globulin (e.g., Atgam) or
• Azathioprine (e.g., Imuran) or
• Chlorambucil (e.g., Leukeran) or
• Corticosteroids, glucocorticoid (e.g., Cortef, Decadron, Deltasone, Medrol) or
• Cyclophosphamide (e.g., Cytoxan) or
• Cyclosporine (e.g., Neoral, Sandimmune) or
• Mercaptopurine (e.g., Purinethol) or
• Muromonab-CD3 (e.g., Orthoclone OKT3) or
• Tacrolimus (e.g., Prograf)—There may be an increased chance of developing certain kinds of cancers and infections because of increased suppression of your immune system

• Delayed kidney function following kidney transplantation or
• Kidney problems, severe—Reduced elimination of mycophenolate and increased chance of developing fever and chills, cough or hoarseness, lower back or side pain, painful or difficult urination

• Digestive system disease, active—Risk of bleeding from the stomach

This medicine should be taken on an empty stomach.

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. 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.

Do not stop taking this medicine without first checking with your doctor. Your physician will use the results of tests and your physical examination to decide how long you should take this medicine.

The capsules or tablets of mycophenolate should be swallowed whole. The tablets should not be crushed and the capsules should not be opened because it is important that other people not be exposed to mycophenolate powder.

Dosing—

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

The number of capsules or tablets that you take depends on the strength of the medicine.

• For oral dosage form (capsules or tablets):
  • For prevention of rejection of transplanted heart:
    • Adults—1.5 grams (six capsules or three tablets) two times a day.
  • For prevention of rejection of transplanted kidney:
    • Adults—1 gram (four capsules or two tablets) two times a day.
  • For prevention of rejection of transplanted liver:
    • Adults—1.5 grams (six capsules or three tablets) two times a day.

• For injection dosage form:
  • For prevention of rejection of transplanted heart:
    • Adults—1.5 grams two times a day.
  • For prevention of rejection of transplanted kidney:
    • Adults—1 gram two times a day.
  • For prevention of rejection of transplanted liver:
    • Adults—1 gram two times a day.

Missed dose—

If you miss a dose of mycophenolate 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. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the 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 mycophenolate is working properly and to check for unwanted effects.

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

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Blood in the urine;  chest pain;  cough or hoarseness;  fever or chills ;  increased cough;  lower back or side pain;  painful or difficult urination ;  shortness of breath;  swelling of feet or lower legs 
  
  

• Less common
  • Abdominal pain;  black, tarry stools ;  bloody vomit;  enlarged gums;  irregular heartbeat;  joint pain;  muscle pain;  pinpoint red spots on the skin;  red, inflamed, bleeding gums;  sores inside mouth;  trembling or shaking of hands or feet;  unusual bleeding or bruising;  white patches on the mouth, tongue, or throat 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Constipation;  diarrhea;  headache;  heartburn;  nausea;  stomach pain;  vomiting ;  weakness 
  
  

• Less common
  • Acne;  dizziness;  skin rash;  trouble in sleeping 
  
  

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 this use is not included in product labeling, mycophenolate is used in certain patients with the following medical condition:

• Lupus nephritis