Consumer Drug Information

Mycophenolic Acid Delayed-Release Tablets

Generic Name: Mycophenolic Acid Delayed-Release Tablets (mye-koe-fe-NOLE-ik AS-id)
Brand Name: Myfortic

Mycophenolic Acid Delayed-Release Tablets weakens 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 Mycophenolic Acid Delayed-Release Tablets only under close medical supervision.

Mycophenolic Acid Delayed-Release Tablets may cause birth defects or fetal death if taken during pregnancy. Women who may become pregnant must use effective birth control while they are taking Mycophenolic Acid Delayed-Release Tablets.

Mycophenolic Acid Delayed-Release Tablets is used for:

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

Mycophenolic Acid 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 Mycophenolic Acid Delayed-Release Tablets if:

you are allergic to any ingredient in Mycophenolic Acid Delayed-Release Tablets
you are taking azathioprine, cholestyramine, colestipol, or mycophenolate mofetil
you are taking norfloxacin and metronidazole together

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

Before using Mycophenolic Acid Delayed-Release Tablets:

Some medical conditions may interact with Mycophenolic Acid 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, planning 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 immune system problems or have been taking another medicine to suppress your immune system
if you have stomach or intestinal problems (eg, 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 Mycophenolic Acid Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Acyclovir, azathioprine, ganciclovir, mycophenolate mofetil, or probenecid because they may increase Mycophenolic Acid Delayed-Release Tablets's actions and the risk of Mycophenolic Acid Delayed-Release Tablets's side effects
Antacids, calcium-free phosphate binders (eg, sevelamer), cholestyramine, colestipol, iron salts (eg, ferrous sulfate), norfloxacin along with metronidazole, or rifampin because they may decrease Mycophenolic Acid Delayed-Release Tablets's effectiveness
Oral contraceptives because their effectiveness may be decreased by Mycophenolic Acid Delayed-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mycophenolic Acid 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 Mycophenolic Acid Delayed-Release Tablets:

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

Take Mycophenolic Acid Delayed-Release Tablets by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
Swallow Mycophenolic Acid Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.
If you take an antacid that has aluminum or magnesium in it, an iron salt (eg, ferrous fumarate), or a calcium-free phosphate binder (eg, sevelamer), ask your doctor or pharmacist how to take it with Mycophenolic Acid Delayed-Release Tablets.
If you miss a dose of Mycophenolic Acid 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 Mycophenolic Acid Delayed-Release Tablets.

Important safety information:

Mycophenolic Acid Delayed-Release Tablets may cause blurred vision, drowsiness, or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Mycophenolic Acid Delayed-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Women who may become pregnant must have a negative pregnancy test within 1 week before starting Mycophenolic Acid Delayed-Release Tablets.
Women who may become pregnant must use 2 effective forms of birth control for 4 weeks before they start Mycophenolic Acid Delayed-Release Tablets, during treatment, and for 6 weeks after they stop Mycophenolic Acid Delayed-Release Tablets. Check with your doctor if you have any questions about effective birth control.
Hormonal birth control (eg, birth control pills) may not work as well while you are taking Mycophenolic Acid Delayed-Release Tablets. Discuss any questions or concerns with your doctor.
Mycophenolic Acid Delayed-Release Tablets may increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Avoid the sun, sunlamps, or tanning booths while you take Mycophenolic Acid Delayed-Release Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Some patients treated with Mycophenolic Acid Delayed-Release Tablets have developed a severe and sometimes fatal effect called progressive multifocal leukoencephalopathy (PML). Discuss any questions or concerns with your doctor. Tell your doctor right away if you notice symptoms of PML. These may include confusion or disorientation; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; or loss of balance or coordination.
Mycophenolic Acid Delayed-Release Tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
Do not receive a live vaccine (eg, measles, mumps) while you are taking Mycophenolic Acid Delayed-Release Tablets. Talk with your doctor before you receive any vaccine.
Proper dental care is important while you are taking Mycophenolic Acid Delayed-Release Tablets. Brush and floss your teeth and visit the dentist regularly.
Lab tests, including complete blood cell counts, may be performed while you use Mycophenolic Acid Delayed-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Mycophenolic Acid Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially infection, stomach or intestinal bleeding, and trouble breathing.
Caution is advised when using Mycophenolic Acid Delayed-Release Tablets in CHILDREN; they may be more sensitive to its effects.
Mycophenolic Acid Delayed-Release Tablets should be used with extreme caution in CHILDREN younger than 5 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Mycophenolic Acid Delayed-Release Tablets may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Mycophenolic Acid Delayed-Release Tablets is found in breast milk. Do not breast-feed while taking Mycophenolic Acid Delayed-Release Tablets.

Possible side effects of Mycophenolic Acid 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; diarrhea; dizziness; gas; headache; heartburn; increased hair growth; indigestion; loss of appetite; mild or moderate stomach pain; muscle cramps; muscle or joint pain; nausea; pain in arms or legs; shakiness; sleeplessness; tremor; vomiting; 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; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; bloody or black stools; change in the amount of urine produced; changes in balance, strength, speech, or vision; chest pain; confusion; decreased coordination; enlarged lymph nodes; enlarged stomach; fainting; fever, chills, cough, or sore throat; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; one-sided weakness; pounding in the chest; severe vomiting or stomach pain; shortness of breath or trouble breathing; skin growths; stiff neck; swelling of the hands, ankles, or feet; swollen glands; symptoms of urinary tract infection (eg, difficult, frequent, or painful urination; lower stomach or back pain); unusual bruising or bleeding; unusual lumps or growths; unusual tiredness or weakness; unusual weight loss; vomiting blood that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately. Symptoms may include diarrhea; nausea; vomiting.

Proper storage of Mycophenolic Acid Delayed-Release Tablets:

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

General information:

If you have any questions about Mycophenolic Acid Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Mycophenolic Acid 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 Mycophenolic Acid 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.

Issue Date: October 1, 2008

Database Edition 08.4.1.001