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INDICATION.

What is myfortic® (mycophenolic acid) delayed-release tablets?

myfortic is a prescription medicine given to prevent rejection (antirejection medicine) in people who have received a kidney transplant.

myfortic is used with other medicines containing cyclosporine (Sandimmune®, Gengraf®, and Neoral®) and corticosteroids. myfortic 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 is safe
and works in children younger than
5 years.

It is not known how myfortic works
in children who have just received
a new kidney transplant.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about myfortic?
myfortic can cause serious side effects, including:

  • Increased risk of loss of pregnancy (miscarriage) and higher risk of birth defects. Females who take myfortic
    during pregnancy have a higher risk of miscarriage during the first
    3 months (first trimester), and a higher risk that their baby will be born with birth defects

    If you are a female who can become pregnant:

    • Your doctor must talk with you about acceptable birth control methods (contraceptive counseling) while taking myfortic
    • You should have a pregnancy test immediately before starting myfortic and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine
      follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests
    • You must use acceptable birth control during your entire myfortic therapy and for 6
      weeks after stopping myfortic, unless at any time you choose
      to avoid sexual intercourse (abstinence) with a man completely. myfortic decreases blood levels of the hormones in birth control pills that you take
      by mouth. Birth control pills may not work as well while you take myfortic and you could become pregnant. If you decide to take birth control pills while using myfortic, you must also use another form of birth control. Talk to your doctor about other birth control methods that can
      be used while taking myfortic
    • If you plan to become pregnant, talk with your doctor. Your doctor will decide if other medicines to prevent rejection may be right for you.

    • If you become pregnant while taking myfortic, do not stop taking myfortic. Call your doctor right away. In certain situations, you and your doctor may decide that taking myfortic is more important to your health than the possible risks to your unborn baby
    • You and your doctor should report your pregnancy to
      • Mycophenolate Pregnancy Registry (1-800-617-8191)
    • The purpose of this registry is to gather information about the health of your baby
  • Increased risk of getting
    serious infections.
    myfortic weakens the body's immune system and affects your ability to fight infections. Serious infections can happen with myfortic and
    can lead to death. These serious 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 include: shingles, other herpes infections, cytomegalovirus (CMV), hepatitis B virus (HBV), and hepatitis C virus (HCV). CMV can cause serious tissue and blood infections; BK virus can affect how your kidney works and cause your transplanted kidney to fail; HBV and HCV can affect how your liver works. Talk to your doctor about how hepatitis viruses
      may affect you
    • A brain infection called Progressive Multifocal Leukoencephalopathy (PML). In some patients, myfortic 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 cannot control your muscles
    • Fungal infections. Yeast and other types of fungal infections can happen with myfortic and cause serious tissue and blood infections
  • Call your doctor right away if you have any of these signs and symptoms of infection: Temperature of 100.5F 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 have a higher risk of getting lymphoma and other cancers, especially skin cancer. Tell your doctor 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

Do not take myfortic if you are allergic to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil, or any of
the ingredients in myfortic.

Before taking myfortic, tell your doctor if you have any digestive problems, such as ulcers; plan to receive any vaccines; have
Lesch-Nyhan or Kelley-Seegmiller syndrome or another rare inherited deficiency of
hypoxanthine-guanine phosphoribosyltransferase (HGPRT); are pregnant or
planning to become pregnant; are breastfeeding or plan to
breastfeed. It is not known if
myfortic passes into breast milk. You and your doctor will decide if
you will take myfortic or
breastfeed.

Tell your doctor about all the medicines you take, including prescription and
nonprescription medicines, vitamins, and herbal supplements
. Some medicines may affect the way myfortic works and myfortic may affect how some medicines work. Especially tell
your doctor if you take: birth
control pills (oral contraceptives), antacids that contain aluminum or magnesium. myfortic 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 doctor.

What should I avoid while taking myfortic?

  • Avoid pregnancy. See "What
    is the most important information I should know about myfortic?"
  • Limit the amount of time you spend in sunlight. Avoid using tanning beds and sunlamps. People who take myfortic have a higher risk of getting skin cancer. See "What is the most important information I should know about myfortic?" 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 because of a weaker immune system

What are possible side effects
of myfortic?

myfortic can cause serious side effects: Stomach and intestinal bleeding can happen in people
who take myfortic. Bleeding can be severe and you may have to be hospitalized for treatment.

The most common side effects in people with a new transplant include: low blood cell counts (red blood cells, white blood cells, and platelets), constipation, nausea, diarrhea, vomiting, urinary tract infections, stomach upset.

In people who take myfortic 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 and during treatment with myfortic to check your blood cell counts. Tell your healthcare
provider right away if you have any signs of infection, 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. Your healthcare provider may be able to help you manage these side effects.

You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.

Please click here for Important Product Information, including Boxed WARNINGS and
Medication Guide.

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* One-time use only. All patients, regardless of the payer types, are eligible, including those with Medicare, Medicaid, or private insurance, and those without insurance coverage.

Eligibility: Prescription for myfortic. Not valid for patients whose prescriptions are paid by Medicare, Medicaid, or any other federally subsidized health care program. Not valid for Massachusetts residents. Check terms and conditions on the co-pay card.

www.fda.gov/medwatch