DrugindexOnline^{2nd edition}

Generic Name: Mycophenolic Acid Delayed-Release Tablets (mye-koe-FEN-oh-lik ASS-id)
Brand Name: Myfortic

Myfortic Delayed-Release Tablets decreases your immune system, which may decrease your ability to fight illness or infection. It may also increase the risk of certain types of cancer (eg, lymphoma). Use Myfortic Delayed-Release Tablets only under close medical supervision.

Myfortic Delayed-Release Tablets is used for:

Preventing organ rejection following kidney, liver, or heart transplants. Myfortic Delayed-Release Tablets is used in combination with other medicines. It may also be used to treat other conditions as determined by your doctor.

Myfortic Delayed-Release Tablets is an immunosuppressant. It works by decreasing the activity of certain cells that make up part of the immune system to help reduce the risk of organ transplant rejection.

Do NOT use Myfortic Delayed-Release Tablets if:

• you are allergic to any ingredient in Myfortic Delayed-Release Tablets
• you are taking cholestyramine, colestipol, azathioprine, or mycophenolate mofetil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Myfortic Delayed-Release Tablets:

Some medical conditions may interact with Myfortic Delayed-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have stomach or intestinal problems, including ulcers; kidney problems; or a rare hereditary deficiency of hypoxanthine guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome
• if you are scheduled for a vaccination

Some MEDICINES MAY INTERACT with Myfortic Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antacids, cholestyramine, colestipol, or iron salts (eg, ferrous sulfate) because the effectiveness of Myfortic Delayed-Release Tablets may be decreased
• Azathioprine, mycophenolate mofetil, acyclovir, ganciclovir, or probenecid because the actions and side effects of Myfortic Delayed-Release Tablets may be increased
• Oral contraceptives because their effectiveness may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Myfortic Delayed-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Myfortic Delayed-Release Tablets:

Use Myfortic Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Myfortic Delayed-Release Tablets on an empty stomach at least 1 hour before or 2 hours after eating.
• Swallow whole. Do not break, crush, or chew before swallowing.
• Do not take antacids containing aluminum or magnesium or an iron salt (eg, ferrous sulfate) at the same time as you take Myfortic Delayed-Release Tablets; space the doses at least 3 to 4 hours apart.
• If you miss a dose of Myfortic Delayed-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Myfortic Delayed-Release Tablets.

Important safety information:

• Myfortic Delayed-Release Tablets may cause blurred vision, drowsiness, or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Myfortic Delayed-Release Tablets. Using Myfortic Delayed-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Myfortic Delayed-Release Tablets may increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Avoid sunlamps or tanning booths. Limit sun exposure by using a sunscreen or protective clothing if you must be outside for a prolonged period.
• Myfortic Delayed-Release Tablets may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection including fever, sore throat, rashes, or chills.
• Check with your doctor before having vaccinations while you are taking Myfortic Delayed-Release Tablets.
• While you are using Myfortic Delayed-Release Tablets, it is important to brush and floss your teeth carefully and also have regular dental check-ups.
• LAB TESTS, including complete blood cell counts, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: Do not use Myfortic Delayed-Release Tablets if you are pregnant. You must have a negative pregnancy test within 1 week before starting Myfortic Delayed-Release Tablets. To prevent pregnancy, use 2 effective forms of birth control before therapy, during therapy, and for 6 weeks after therapy is completed. The effectiveness of birth control pills may be decreased when taken with Myfortic Delayed-Release Tablets. Talk with your doctor or pharmacist to determine which forms of effective birth control are right for you. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Myfortic Delayed-Release Tablets is excreted in breast milk. Do not breast-feed while taking Myfortic Delayed-Release Tablets.

Possible side effects of Myfortic Delayed-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; anxiety; back pain; blurred vision; constipation; cough; diarrhea; dizziness; gas; headache; heartburn; incoordination; increased hair growth; indigestion; loss of appetite; mild or moderate stomach pain; muscle cramps; muscle or joint pain; nausea; pain; pain in arms or legs; shakiness; sleeplessness; tremor; vomiting; weakness; weight gain or changes in body fat.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; bloody or black stools; changes in heart rhythm; chest pain; enlarged lymph nodes; enlarged stomach; fainting; fever; frequent or infrequent urination; itching; leg pain; night sweats; pounding in the chest; severe vomiting or stomach pain; skin growths; sore throat; swelling of the hands, ankles, or feet; swollen glands; unusual bruising or bleeding; unusual lumps or growths; unusual tiredness; upper respiratory tract infection; vomiting blood that looks like coffee grounds; weight loss; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include diarrhea; nausea; vomiting.

Proper storage of Myfortic Delayed-Release Tablets:

Store Myfortic Delayed-Release Tablets in a tightly closed container at room temperature, 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Myfortic Delayed-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Myfortic Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Myfortic Delayed-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Myfortic Delayed-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.