IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT CELLCEPT?
CELLCEPT CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take CellCept 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) to use while taking CellCept. You should have 1 pregnancy test immediately before starting CellCept 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 CellCept treatment and for 6 weeks after stopping CellCept, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. CellCept 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 CellCept, and you could become pregnant. If you take birth control pills while using CellCept you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking CellCept.
- If you are a sexually active male whose female partner can become pregnant while you are taking CellCept, use effective contraception during treatment and for at least 90 days after stopping CellCept.
- 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 CellCept, do not stop taking CellCept. Call your doctor right away. You and your doctor may decide that other medicines to prevent rejection may be right for you. You and your doctor should report your pregnancy to the Mycophenolate Pregnancy Registry either:
- by phone at 1-800-617-8191 or
- by visiting the Risk Evaluation and Mitigation Strategy (REMS) website at www.mycophenolateREMS.com
The purpose of this registry is to gather information about the health of you and your baby.
Increased risk of getting certain cancers. People who take CellCept have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have:
- unexplained fever, prolonged tiredness, 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 the other
- a change in the size and color of a mole
- a new skin lesion or bump
- any other changes to your health
Increased risk of getting serious infections. CellCept weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with CellCept and can lead to hospitalizations and 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 CellCept 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
- hepatitis B and C viruses. Hepatitis viruses 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, CellCept 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. Call your doctor 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. Yeasts and other types of fungal infections can happen with CellCept and can cause serious tissue and blood infections (See “What are the possible side effects of CellCept?”).
Call your doctor right away if you have any of the following 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
- white patches in the mouth or throat
- unexpected bruising or bleeding
- cuts, scrapes or incisions that are red, warm and oozing pus
See “What are the possible side effects of CellCept?” for information about other serious side effects.