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Important Safety Information
 

About CellCept

Following are answers to common questions asked about CellCept.

Why did my healthcare provider prescribe CellCept?

Can I take CellCept with my other medicines?

How do I take CellCept?

What if I forget or skip a dose?

How long will I need to take CellCept?

How should I store my medicine?

What health checks or laboratory tests do I need?

What important safety information do I need to know?

What are the most common side effects?

What if I’m a woman of childbearing age?

How can I get the most out of my treatment with CellCept?

How do I know if I’m getting CellCept?

Why did my healthcare provider prescribe CellCept?

When you receive a transplant, your body’s defense system (the immune system) may respond to the new organ as a "foreign" intruder, like a cold germ, and try to get rid of it, or “reject” it. To help prevent this from happening, your healthcare provider prescribes antirejection medicines. CellCept, one of these medicines, is taken with other antirejection drugs.

CellCept is a medicine given to people who have received kidney, heart or liver transplants to help keep their new organ(s) healthy. Antirejection medicines like CellCept are sometimes called immunosuppressants because they help hold in check the full response of the body’s immune system. Most transplant patients are prescribed several different antirejection medicines to take at the same time. The medicines work together to prevent damage to your transplant and are a vital part of protecting your new organ.

Can I take CellCept with my other medicines?

You may also need to take other prescription medicines because of your transplant, or due to another health condition. It’s important that you take your medicines regularly, and at the same time every day, according to your healthcare provider’s directions. Take only the medicines prescribed for you. Check with your healthcare provider before taking any new medicine—even ones prescribed by physicians outside your transplant team, or ordinary medicines you can buy without a prescription at the pharmacy or store. This includes herbal remedies and nutritional supplements, too. Even familiar medicines, such as cold medicines, may interfere with your treatment. Be safe. Check first!

How do I take CellCept?

You may have already been given your first dose of CellCept, intravenously (IV) or in tablet or capsule form, soon after surgery (within 3 days). CellCept comes in 250 mg blue and orange capsules, and 500 mg lavender tablets. CellCept tablets should not be crushed and capsules should not be opened or crushed. A few patients may receive CellCept in a liquid suspension.

Most patients should take CellCept on an empty stomach. However, some stable kidney transplant recipients may be able to take CellCept with food. Talk with your healthcare provider.

Your healthcare provider will also tell you how many tablets or capsules you should take, and help you figure out the best time to take them based on your schedule and daily activities. Instructions will be written on the medicine label. Be sure to read it carefully and ask your healthcare provider to explain anything you don’t understand.

What if I forget or skip a dose?

If you miss a dose of CellCept, or are not certain if you took one of your daily doses, do not double the dose.

Take only the amount prescribed for you and call your healthcare provider. Using a medicine dispensing box or container may help you stay on schedule. Also, do not stop your medicine or change the dosage without consulting your healthcare provider.

You will be taking other medicines along with CellCept, and you should follow your healthcare provider’s instructions on how and when to take them. It’s a good idea to plan out on a piece of paper your daily medicine schedule and review it with your healthcare provider. A medicine scheduler will help you easily keep track of your therapy.

Take your medicine at the same time every day. Don’t skip doses—even if you are feeling fine.

How long will I need to take CellCept?

Your transplant was a gift of life and it requires care for life. Just as you will always need regular medical checkups to monitor your health, most transplant recipients take antirejection medicines for the rest of their lives. Of course, every patient is different and only your healthcare provider can determine what is right for you. Your healthcare provider may change the dose of your medicines, or add or drop medicines based on how well the medicines are working or if you experience side effects. Your transplant coordinator and pharmacist will help you learn about your medicines and what side effects to watch for.

How should I store my medicine?

Store CellCept at room temperature, making sure the container is securely closed and out of the reach of children.

What health checks or laboratory tests do I need?

Following your transplant, you’ll need to monitor your health daily and have regular checkups. You should report even small changes in your health to your healthcare provider immediately. In addition, having regular laboratory tests is an important part of taking antirejection medicines. Blood tests should be performed on a regular basis for as long as you are taking
CellCept. A member of your transplant team will set up a schedule for you to follow.

What important safety information do I need to know?

Pregnant women who take CellCept have a higher chance of losing the baby during the first 3 months of pregnancy. There also is a higher chance the baby will have birth defects.

If you are a woman who can get pregnant, you must use 2 different reliable methods of birth control 4 weeks prior to starting and during CellCept therapy, and continue birth control for 6 weeks after you stop taking CellCept.

If you plan to become pregnant, talk with your doctor. You and your doctor can decide if other medicines to prevent rejection may be right for you.

Taking CellCept with other anti-rejection medicines may raise your chance of getting an infection. It may raise your chance of getting cancer of the immune system (lymphoma) or other cancers, such as skin cancer. Talk with your doctor right away if you have any signs of infection such as fever, tiredness, headache, redness of skin/wound or swollen lymph glands. Tell your doctor about any changes in your skin.

CellCept weakens the body's immune system and affects your ability to fight infections. Serious infections, possibly leading to death, can happen with CellCept. Types of infections can include:

  • Brain infection called progressive multifocal leukoencephalopathy (PML). PML can be fatal. Symptoms include clumsiness, weakness that keeps getting worse, not being able to move or use one side of the body, and changes in vision, speech or personality.
  • Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. These may include:
    • BK virus. This infection can damage the kidney. It can cause the new kidney to fail.
    • Cytomegalovirus (CMV). CMV can cause serious tissue and blood infections.

Please click here for full Prescribing Information, including Medication Guide, for additional important safety information.

What are the most common side effects?

The most common side effects include: diarrhea, vomiting, pain, stomach area pain, swelling of the lower legs, ankles and feet, and high blood pressure.

These are not all of the possible side effects of CellCept. Tell your doctor about any side effect that bothers you or that does not go away.

What if I’m a woman of childbearing age?

Pregnant women who take CellCept have a higher chance of losing the baby during the first 3 months of pregnancy. There also is a higher chance the baby will have birth defects.

If you are a woman who can get pregnant, you must use 2 different reliable methods of birth control 4 weeks prior to starting and during CellCept therapy, and continue birth control for 6 weeks after you stop taking CellCept.

If you plan to become pregnant, talk with your doctor. You and your doctor can decide if other medicines to prevent rejection may be right for you.

How can I get the most out of my treatment with CellCept?

CellCept is part of an overall treatment program following transplantation. Follow your transplant team’s recommendations regarding other medicines, your diet and exercise. Be sure to keep your follow-up appointments and keep on top of your health. While this site provides important information about CellCept, it does not contain all information about this medicine.

Be sure to consult your transplant team if you have any questions regarding your condition or treatment.

How do I know if I’m getting CellCept?

If your doctor decides that brand name CellCept is right for you, it’s important that you Know Your Medicine so you can help ensure that you receive CellCept every month.

   

WHO IS CELLCEPT FOR?

CellCept® (mycophenolate mofetil) is a medicine given by prescription to people who had a kidney, heart or liver transplant. CellCept can help prevent rejection of the new organ.

Your body's immune system can tell that the new heart, liver or kidney is different and tries to reject it. CellCept is taken along with other anti-rejection medicines to help control your immune system. They help keep it from rejecting the transplant.

Follow your doctor's exact orders for taking CellCept and all other medicines.

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT CELLCEPT?

  • Pregnant women who take CellCept have a higher chance of losing the baby during the first 3 months of pregnancy. There also is a higher chance the baby will have birth defects.

    If you are a woman who can get pregnant, you must use 2 different reliable methods of birth control 4 weeks prior to starting and during CellCept therapy, and continue birth control for 6 weeks after you stop taking CellCept.

    If you plan to become pregnant, talk with your doctor. You and your doctor can decide if other medicines to prevent rejection may be right for you.

  • Taking CellCept with other anti-rejection medicines may raise your chance of getting an infection. It may raise your chance of getting cancer of the immune system (lymphoma) or other cancers, such as skin cancer. Talk with your doctor right away if you have any signs of infection such as fever, tiredness, headache, redness of skin/wound or swollen lymph glands. Tell your doctor about any changes in your skin.
  • CellCept weakens the body's immune system and affects your ability to fight infections. Serious infections, possibly leading to death, can happen with CellCept. Types of infections can include:
    • Brain infection called progressive multifocal leukoencephalopathy (PML). PML can be fatal. Symptoms include clumsiness, weakness that keeps getting worse, not being able to move or use one side of the body, and changes in vision, speech or personality.
    • Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. These may include:
      • BK virus. This infection can damage the kidney. It can cause the new kidney to fail.
      • Cytomegalovirus (CMV). CMV can cause serious tissue and blood infections.

WHO SHOULD NOT TAKE CELLCEPT?

  • You should not use CellCept if you have ever had an allergic reaction to CellCept or any of its ingredients. Please discuss this with your doctor.

WHAT ADDITIONAL INFORMATION SHOULD I KNOW ABOUT CELLCEPT?

  • People taking high doses of CellCept each day may have a decrease in blood counts, including white blood cells, red blood cells and platelets.

    Your doctor will do blood tests before you start taking CellCept and during therapy with CellCept to check your blood cell counts.

    Tell your doctor right away if you have any signs of infection, or any unexpected bruising or bleeding, unusual tiredness, lack of energy, dizziness or fainting.

  • Cases of bleeding in the stomach or intestines that required hospitalization have been reported. Early signs of bleeding may include stomach pain, blood in your stool, or dark, sticky stools. Tell your doctor if you have any digestive problems, such as ulcers.
  • People taking CellCept should not take live vaccines. Some vaccines may not work as well during treatment with CellCept.
  • Tell your doctor about all the medicines you are taking including prescription and nonprescription medicines, vitamins and herbal supplements.
  • Tell your doctor if you have phenylketonuria (PKU). CellCept Oral Suspension contains aspartame (a source of phenylalanine).

WHAT ARE THE MOST COMMON SIDE EFFECTS FROM CELLCEPT?

  • The most common side effects include: diarrhea, vomiting, pain, stomach area pain, swelling of the lower legs, ankles and feet, and high blood pressure.

    These are not all of the possible side effects of CellCept. Tell your doctor about any side effect that bothers you or that does not go away.

This important safety information does not take the place of talking with your doctor about your medical condition or your treatment. Talk with your doctor if you have any questions about your health problems or treatment.

Please click here for full Prescribing Information, including Medication Guide, for additional important safety information.