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MEDICATION GUIDE

MYFORTIC®
(my-for-tic)
(mycophenolic acid) delayed-release tablets

Read the Medication Guide that comes with Myfortic (mycophenolic acid) before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have any questions about Myfortic (mycophenolic acid) , ask your healthcare provider.

What is the most important information I should know about Myfortic (mycophenolic acid) ?

Myfortic (mycophenolic acid) can cause serious side effects including:

• Possible loss of pregnancy and higher risk of birth defects. Women who take Myfortic (mycophenolic acid) during pregnancy, have a higher risk of losing a pregnancy (miscarriage) during the first three months (first trimester), and a higher risk that their baby will be born with birth defects.
  
  If you are a female and are able to become pregnant:
  • Your healthcare provider must talk with you about effective birth control methods (contraceptive counseling).
  • You should have a negative pregnancy test within 1 week before starting Myfortic (mycophenolic acid) therapy.
  • You must use two different types of effective birth control at the same time, for 4 weeks before you start taking Myfortic (mycophenolic acid) , during your entire Myfortic (mycophenolic acid) therapy, and for 6 weeks after stopping Myfortic (mycophenolic acid) , unless you choose to avoid sexual intercourse completely (abstinence). Myfortic (mycophenolic acid) decreases blood levels of the hormones in the birth control pills that you take by mouth. Birth control pills may not work as well while you are taking Myfortic (mycophenolic acid) , and you could get pregnant.
  • If you plan to become pregnant, talk with your healthcare provider. Your healthcare provider will decide if other medicines to prevent rejection may be right for you. In certain situations, you and your doctor may decide that taking Myfortic (mycophenolic acid) is more important to your health than the possible risks to your unborn baby.
  • If you get pregnant while taking Myfortic (mycophenolic acid) , do not stop taking Myfortic (mycophenolic acid) . Call your healthcare provider right away. You and your healthcare provider should report any cases of pregnancy to:
    • FDA MedWatch at 1-800-FDA-1088
    • Novartis Drug Safety at 1-888-669-6682

Talk to your healthcare provider about joining the National Transplantation Pregnancy Registry at: 1-877-955-6877.

• Increased risk of getting serious infections. Myfortic (mycophenolic acid) weakens the body's immune system and affects your ability to fight infections. Serious infections can happen with Myfortic (mycophenolic acid) and can lead to death. Types of infections can include:
  • Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with Myfortic (mycophenolic acid) include:
    • Shingles, other herpes infections, and cytomegalovirus (CMV). CMV can cause serious tissue and blood infections.
    • BK virus. BK virus can affect how your kidney works and cause your transplanted kidney to fail.
  • A brain infection called Progressive Multifocal Leukoencephalopathy (PML). In some patients Myfortic (mycophenolic acid) may cause an infection of the brain that may cause death. You are at risk for this brain infection because you have a weakened immune system. You should tell your healthcare provider right away if you have any of the following symptoms:
    • Weakness on one side of the body
    • You do not care about things that you usually care about (apathy)
    • You are confused or have problems thinking
    • You can not control your muscles
  • Fungal infections. Yeast and other types of fungal infections can happen with Myfortic (mycophenolic acid) and cause serious tissue and blood infections. See “What are the possible side effects of Myfortic (mycophenolic acid) ?”

Call your healthcare provider right away if you have any of these signs and symptoms of infection:

• Temperature of 100.5°F or greater
• Cold symptoms, such as a runny nose or sore throat
• Flu symptoms, such as an upset stomach, stomach pain, vomiting or diarrhea
• Earache or headache
• Pain during urination or you need to urinate often
• White patches in the mouth or throat
• Unexpected bruising or bleeding
• Cuts, scrapes or incisions that are red, warm and oozing pus
• Increased risk of getting certain cancers. People who take Myfortic (mycophenolic acid) have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your healthcare provider if you have:
  • unexplained fever, tiredness that does not go away, weight loss, or lymph node swelling
  • a brown or black skin lesion with uneven borders, or one part of the lesion does not look like other parts
  • a change in the size or color of a mole
  • a new skin lesion or bump
  • any other changes to your health

See the section “What are the possible side effects of Myfortic (mycophenolic acid) ?” for other serious side effects.

What is Myfortic (mycophenolic acid) ?

Myfortic (mycophenolic acid) is a prescription medicine given to prevent rejection (antirejection medicine) in people who have received a kidney transplant. Rejection is when the body's immune system senses the new organ as “foreign” and attacks it.

Myfortic (mycophenolic acid) is used with other medicines containing cyclosporine (Sandimmune®, Gengraf®, and Neoral®) and corticosteroids. These medicines work together to help prevent rejection to your transplanted kidney.

Myfortic (mycophenolic acid) can be used to prevent rejection in children who are 5 years or older and are stable after having a kidney transplant. It is not known if Myfortic (mycophenolic acid) is safe and works in children younger than 5 years. It is not known how Myfortic (mycophenolic acid) works in children who have just received a new kidney transplant.

Who should not take Myfortic (mycophenolic acid) ?

Do not take Myfortic (mycophenolic acid) if you are allergic to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil, or any of the ingredients in Myfortic (mycophenolic acid) . See the end of this Medication Guide for a complete list of ingredients in Myfortic (mycophenolic acid) .

What should I tell my healthcare provider before I start taking Myfortic (mycophenolic acid) ?

Tell your healthcare provider about all of your medical conditions, including if you:

• have any digestive problems, such as ulcers
• plan to receive any vaccines. You should not receive live vaccines while you take Myfortic (mycophenolic acid) . Some vaccines may not work as well during treatment with Myfortic (mycophenolic acid) .
• have Lesch-Nyhan or Kelley-Seegmiller syndrome or another rare inherited deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take Myfortic (mycophenolic acid) if you have one of these disorders.
• are pregnant or planning to become pregnant. See “What is the most important information I should know about Myfortic (mycophenolic acid) .
• are breastfeeding. It is not known if Myfortic (mycophenolic acid) passes into breast milk. You and your healthcare provider will decide if you will stop taking Myfortic (mycophenolic acid) or breast-feed. You should not do both without first talking to your healthcare provider.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect the way Myfortic (mycophenolic acid) works and Myfortic (mycophenolic acid) may affect how some medicines work. Especially tell your doctor if you take:

• birth control pills (oral contraceptives). See “What is the most important information I should know about Myfortic (mycophenolic acid) ?”
• antacids that contain aluminum or magnesium. Myfortic (mycophenolic acid) and antacids should not be taken at the same time.
• acyclovir (Zovirax®), Ganciclovir (Cytovene® IV, Valcyte®)
• azathioprine (Azasan®, Imuran®)
• cholestyramine (Questran® Light, Questran®, Locholest Light, Prevalite®)

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine. Do not take any new medicine without talking to your healthcare provider.

How should I take Myfortic (mycophenolic acid) ?

• Take Myfortic (mycophenolic acid) exactly as prescribed. Your healthcare provider will tell you how much Myfortic (mycophenolic acid) to take.
• Do not stop taking or change your dose of Myfortic (mycophenolic acid) without talking to your healthcare provider.
• Take Myfortic (mycophenolic acid) on an empty stomach, either 1 hour before or 2 hours after a meal.
• Swallow Myfortic (mycophenolic acid) whole. Do not crush, chew, or cut Myfortic (mycophenolic acid) . The Myfortic (mycophenolic acid) tablets have a coating so that the medicine will pass through your stomach and dissolve in your intestine.
  • If you forget to take Myfortic (mycophenolic acid) , take it as soon as you remember and then take your next dose at its regular time. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do.
  • If you take more than the prescribed dose of Myfortic (mycophenolic acid) , call your healthcare provider right away.
  • Do not change (substitute) between using Myfortic (mycophenolic acid) delayed-release tablets and mycophenolate mofetil tablets, capsules, or oral suspension for one another unless your healthcare provider tells you to. These medicines are absorbed differently. This may affect the amount of medicine in your blood.
  • Be sure to keep all appointments at your transplant clinic. During these visits, your healthcare provider may perform regular blood tests.

What should I avoid while taking Myfortic (mycophenolic acid) ?

Avoid pregnancy. See “What is the most important information I should know about Myfortic (mycophenolic acid) ?”

• Limit the amount of time you spend in sunlight. Avoid using tanning beds and sunlamps. People who take Myfortic (mycophenolic acid) have a higher risk of getting skin cancer. See “What is the most important information I should know about Myfortic (mycophenolic acid) ?” Wear protective clothing when you are in the sun and use a sunscreen with a high sun protection factor (SPF 30 and above). This is especially important if your skin is fair (light colored) or you have a family history of skin cancer.
• Elderly patients 65 years of age or older may have more side effects with Myfortic (mycophenolic acid) because of a weaker immune system.

What are the possible side effects of Myfortic (mycophenolic acid) ?

Myfortic (mycophenolic acid) can cause serious side effects.

See “What is the most important information I should know about Myfortic (mycophenolic acid) ?”

Stomach and intestinal bleeding can happen in people who take Myfortic (mycophenolic acid) . Bleeding can be severe and you may have to be hospitalized for treatment.

The most common side effects of taking Myfortic (mycophenolic acid) include:

• In people with a new transplant:
• low blood cell counts
  • red blood cells
  • white blood cells
  • platelets
• constipation
• nausea
• diarrhea
• vomiting
• urinary tract infections
• stomach upset

In people who take Myfortic (mycophenolic acid) for a long time (long-term) after transplant:

• low blood cell counts
  • red blood cells
  • white blood cells
• nausea
• diarrhea
• sore throat

Your healthcare provider will do blood tests before you start taking Myfortic (mycophenolic acid) and during treatment with Myfortic (mycophenolic acid) to check your blood cell counts. Tell your healthcare provider right away if you have any signs of infection (see “What is the most important information I should know about Myfortic (mycophenolic acid) ?”), or any unexpected bruising or bleeding. Also, tell your healthcare provider if you have unusual tiredness, dizziness or fainting.

These are not all the possible side effects of Myfortic (mycophenolic acid) . Your healthcare provider may be able to help you manage these side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store Myfortic (mycophenolic acid) ?

• Store Myfortic (mycophenolic acid) tablets at room temperature, 59° to 86°F (15° to 30°C). Myfortic (mycophenolic acid) does not need to be refrigerated.
• Keep the container tightly closed. Store Myfortic (mycophenolic acid) in a dry place.
• Keep Myfortic (mycophenolic acid) and all medicines out of the reach of children.

General information about Myfortic (mycophenolic acid)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Myfortic (mycophenolic acid) for a condition for which it was not prescribed. Do not give Myfortic (mycophenolic acid) to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Myfortic (mycophenolic acid) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Myfortic (mycophenolic acid) that is written for healthcare professionals. You can also call 1-888669-6682 or visit the Myfortic (mycophenolic acid) website at www.myfortic (mycophenolic acid) .com.

What are the ingredients in Myfortic?

Active ingredient: mycophenolic acid (as mycophenolate sodium)

Inactive ingredients: colloidal silicon dioxide, crospovidone, lactose anhydrous, magnesium stearate, povidone (K-30), and starch. The enteric coating of the tablet consists of hypromellose phthalate, titanium dioxide, iron oxide yellow, and indigotine (for the 180-mg tablet) or iron oxide red (for the 360-mg tablet)

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 10/27/2009
This monograph has been modified to include the generic and brand name in many instances.