Important Safety Information & Indication
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 health care 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 100.5°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 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 health care 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 health care provider will do blood tests before you start taking myfortic and during treatment with myfortic to check your blood cell counts. Tell your health care provider right away if you have any signs of infection, or any unexpected bruising or bleeding. Also, tell your health care provider if you have unusual tiredness, dizziness, or fainting.
These are not all the possible side effects of myfortic. Your health care 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.
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.
Please click here for Important Product Information, including Boxed WARNINGS and Medication Guide.
Reference: 1. myfortic [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2015.