Generic Name: mycophenolic acid (MYE koe phe NOLE ik AS id)
Brand Names: Myfortic

What is Myfortic?

Myfortic (mycophenolic acid) lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Myfortic is used to prevent your body from rejecting a kidney transplant. Myfortic is usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication.

Myfortic may also be used for purposes not listed in this medication guide.

Important information

Do not use Myfortic if you are pregnant. It could harm the unborn baby. You will be required to use two forms of birth control to prevent pregnancy before and during your treatment with Myfortic.

Myfortic is sometimes given to pregnant women who are unable to take other needed transplant medications. Your doctor will decide whether you should receive this medication.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Treatment with Myfortic may increase your risk of developing certain life-threatening conditions, including serious infections, cancer, or transplant failure. Talk with your doctor about the risks and benefits of using this medication.

Call your doctor right away if you have signs of infection such as: fever, swollen glands, flu symptoms, change in your mental state, problems with speech or walking, decreased vision, mouth sores, easy bruising or bleeding, pain or burning when you urinate, blood in your urine, a new skin lesion, or a mole that has changed in size or color.

Before taking this medicine

You should not use Myfortic if you are allergic to mycophenolic acid or mycophenolate mofetil (CellCept). Taking Myfortic can make it easier for you to develop serious bacterial, fungal, or viral infections, including tuberculosis, a severe brain infection, or a virus that can cause failure of a transplanted kidney. Myfortic may cause your body to produce too much of a certain type of white blood cells. This can lead to serious and sometimes fatal conditions, including cancer.

Myfortic may also cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

Talk with your doctor about the risks and benefits of using Myfortic.

To make sure you can safely take Myfortic, tell your doctor if you have any of these other conditions:

  • a stomach ulcer or other disorders of your stomach or intestines;

  • a viral, bacterial, or fungal infection; or

  • a rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.

FDA pregnancy category D. Myfortic can cause harm to an unborn baby, especially if used during the first trimester of pregnancy. Do not use Myfortic without telling your doctor if you are pregnant or if you plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

Although Myfortic may harm an unborn baby, not treating the mother after a transplant could pose a greater risk to the mother's health. Myfortic is sometimes given to pregnant women who are unable to take other needed transplant medications. Your doctor will decide whether you should receive this medication.

If you are a woman of child-bearing potential, you will be required to start using two forms of birth control 4 weeks before the start of your treatment with Myfortic. You will also need to have a negative pregnancy test within 1 week before your treatment begins.

Unless you have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. Adolescent girls who have entered puberty are also considered to be of child-bearing potential, even if not yet sexually active.

Use two non-hormone forms of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy before and during your treatment with Myfortic, and for at least 6 weeks after your treatment ends. Tell your doctor right away if you become pregnant. Myfortic can make birth control pills less effective. Ask your doctor about the most effective non-hormonal forms of birth control and which two are best for you.

It is not known whether mycophenolic acid passes into breast milk or if it could harm a nursing baby. Do not breast-feed a baby while taking Myfortic and for at least 6 weeks after your treatment ends.

How should I use Myfortic?

Take Myfortic exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Myfortic is usually given twice a day. Follow the directions on your prescription label.

Take Myfortic on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not crush, chew, or break an enteric-coated pill. Swallow it whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill will damage this coating.

Mycophenolic acid (Myfortic) tablets and mycophenolate mofetil (CellCept) capsules are not absorbed equally in the body. If you are switched from one brand to the other, take only the pills your doctor has prescribed. Always check your refills to make sure you have received the correct brand and type of medicine.

You will need regular medical tests to be sure Myfortic is not causing harmful effects. Visit your doctor regularly. Do not miss any follow up visits to your doctor for blood or urine tests.

Store Myfortic at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid?

Avoid taking an antacid together with Myfortic.

Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury.

Avoid exposure to sunlight or tanning beds. Myfortic can increase your risk of skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Do not receive a "live" vaccine while using Myfortic. The vaccine may not work as well during this time, and may not fully protect you from disease. You may still be able to receive a flu shot, but ask your doctor first.

Myfortic side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Myfortic: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Myfortic.

Call your doctor right away if you have signs of infection such as:

  • fever, flu symptoms, runny or stuffy nose, cough, sore throat, swollen glands;

  • stomach pain, vomiting, diarrhea, weight loss;

  • ear pain, headache;

  • white patches or sores in your mouth or throat;

  • pale skin, easy bruising or unusual bleeding;

  • confusion, change in your mental state, problems with vision, speech, memory, balance, or walking;

  • weakness in your legs, lack of coordination;

  • blood in your urine, pain or burning when you urinate;

  • swelling, warmth, redness, or oozing around a skin wound; or

  • a new bump or lesion on your skin, or a mole that has changed in size or color.

Call your doctor at once if you have a serious side effect while taking Myfortic such as:

  • rapid heart rate, rapid and shallow breathing, fainting;

  • coughing up blood or vomit that looks like coffee grounds;

  • bloody, black, or tarry stools;

  • thirst, increased urination, hot and dry skin;

  • chest pain, dry cough, wheezing, feeling short of breath;

  • feeling like you might pass out;

  • slow or uneven heart rate, weak pulse, tingly feeling, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or

  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate).

Less serious Myfortic side effects may include:

  • constipation, weight gain;

  • joint or muscle pain, back pain;

  • dizziness, anxiety, sleep problems (insomnia); or

  • swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Myfortic

Tell your doctor about all other medicines you use, especially:

  • cholestyramine (Questran), colesevelam (Welchol), or colestipol (Colestid);

  • acyclovir (Zovirax) or ganciclovir (Cytovene); or

  • other medicines that weaken the immune system, such as azathioprine (Imuran), or mycophenolate mofetil (CellCept).

This list is not complete and other drugs may interact with Myfortic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Myfortic.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Myfortic only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 6.01. Revision Date: 8/30/2011 11:42:32 AM.