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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.

    You should have one 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.

    If you are a woman who can get pregnant, you must use acceptable birth control during your entire CellCept therapy, and continue birth control for 6 weeks after you stop taking CellCept, unless you choose to abstain from sexual intercourse with a man completely. Talk to your doctor about other birth control methods that you can use while 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.

    If you become pregnant while taking CellCept, do not stop taking CellCept. Call your doctor right away. In certain situations, you and your doctor may decide that taking CellCept 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 you and your baby.

  • 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. These serious infections can include:

    • Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. These viruses or infections may include:

      • Cytomegalovirus (CMV), shingles, other herpes infections. CMV can cause serious tissue and blood infections.

      • BK virus. This virus can damage the kidney. It can cause the new 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.

    • 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 (such as not caring about things that you usually care about and confusion).

    • Fungal infections. Yeasts and other types of fungal infections can happen with CellCept and 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 Boxed WARNING and Medication Guide, for additional Important Safety Information.

IMPORTANT CONTACT INFORMATION

GENENTECH TRANSPLANT ACCESS SERVICES

1–888–754–7651

9:00 AM to 7:00 PM ET

Monday – Friday

CELLCEPT® CO–PAY CARD PROGRAM CONTACT INFORMATION

Questions? Call 1–855–SAV-CELL | (1–855–728–2355)

24 hours a day

If you’d like to speak with an operator,

call 8:00 AM to 8:00 PM ET | Monday – Friday

FAQ QUICK LINKS

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.

FAQ Quick Links

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.

    You should have one 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.

    If you are a woman who can get pregnant, you must use acceptable birth control during your entire CellCept therapy, and continue birth control for 6 weeks after you stop taking CellCept, unless you choose to abstain from sexual intercourse with a man completely. Talk to your doctor about other birth control methods that you can use while 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.

    If you become pregnant while taking CellCept, do not stop taking CellCept. Call your doctor right away. In certain situations, you and your doctor may decide that taking CellCept 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 you and your baby.

  • 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. These serious infections can include:

    • Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. These viruses or infections may include:

      • Cytomegalovirus (CMV), shingles, other herpes infections. CMV can cause serious tissue and blood infections.

      • BK virus. This virus can damage the kidney. It can cause the new 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.

    • 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 (such as not caring about things that you usually care about and confusion).

    • Fungal infections. Yeasts and other types of fungal infections can happen with CellCept and can cause serious tissue and blood infections.

FAQ Quick Links

Who should not take CellCept?

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

FAQ Quick Links

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).

FAQ Quick Links

What are the most common side effects of 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.

FAQ Quick Links

Can I take CellCept with my other medicines?

Tell your healthcare provider about all of the medicines you are taking including prescription and nonprescription medicines, vitamins and herbal supplements. Some medicines may affect the way CellCept works, and CellCept 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 CellCept?”

  • sevelamer (Renagel®, Renvela). These products should be taken 2 hours after taking CellCept

  • acyclovir (Zovirax®), valacyclovir (Valtrex®), ganciclovir (CYTOVENE®-IV, Vitrasert®), valganciclovir (VALCYTE®)

  • rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)

  • antacids that contain magnesium and aluminum (CellCept and the antacid should not be taken at the same time)

  • proton pump inhibitors (PPIs) (Prevacid®, Protonix®)

  • sulfamethoxazole/trimethoprim (BACTRIM®, BACTRIM DS®)

  • norfloxacin (Noroxin®) and metronidazole (Flagyl®, Flagyl® ER, Flagyl® IV, Metro IV, Helidac®, Pylera®)

  • ciprofloxacin (Cipro®, Cipro® XR, Ciloxan®, Proquin® XR) and amoxicillin plus clavulanic acid (Augmentin®, Augmentin XR)

  • azathioprine (Azasan®, Imuran®)

  • cholestyramine (Questran Light®, Questran®, Locholest Light, Locholest, Prevalite®)

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

FAQ Quick Links

How should I take CellCept?

Take CellCept exactly as prescribed.

Do not stop taking CellCept or change the dose unless your doctor tells you to.

If you miss a dose of CellCept, or are not sure when you took your last dose, take the regular amount of CellCept prescribed as soon as you remember. If it is time for your next dose, skip the missed dose and take your next dose at your normal scheduled time. Do not take 2 doses at the same time. Call your doctor if you are not sure what to do.

Take CellCept capsules, tablets and oral suspension on an empty stomach, either 1 hour before or 2 hours after a meal, unless your healthcare provider tells you otherwise. With the approval of your healthcare provider, in stable kidney transplant patients, CellCept can be taken with food if necessary.

Most people take CellCept by mouth either as blue and brown capsules or lavender tablets. Some people may get CellCept soon after their transplant surgery as an infusion into a vein.

Do not crush CellCept tablets. Do not open or crush CellCept capsules.

If you are not able to swallow CellCept tablets or capsules, your doctor may prescribe CellCept Oral Suspension. This is a pquid form of CellCept. Your pharmacist will mix the medicine before giving it to you.

Do not mix CellCept Oral Suspension with any other medicine.

If you take too much CellCept, call your doctor or the poison control center right away.

FAQ Quick Links

How should I store my medicine?

Store CellCept capsules and tablets at room temperature, between 59°F to 86°F (15°C to 30°C). Keep the container closed tightly. Store the prepared CellCept Oral Suspension at room temperature, between 59°F to 86°F (15°C to 30°C), for up to 60 days. You can also store CellCept Oral Suspension in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze CellCept Oral Suspension.

Keep CellCept and all medicines out of the reach of children.

FAQ Quick Links

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 anti-rejection 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.

FAQ Quick Links

What if I'm a woman of childbearing age?

CellCept can cause serious side effects.

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 one pregnancy test immmediately 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 therapy 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 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. In certain situations, you and your doctor may decide that taking CellCept 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 you and your baby.

FAQ Quick Links

How long will I need to take CellCept?

Just as you will always need regular medical checkups to monitor your health, most transplant recipients take anti-rejection 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.

FAQ Quick Links

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

CellCept is part of an overall treatment program following kidney, liver or heart transplantation. Follow your transplant team's recommendations regarding all 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.

FAQ Quick Links

How do I know if I'm getting CellCept?

If your doctor decides to prescribe you brand name CellCept, it's important that you Be in the Know About Your Prescription so you can help ensure that you receive CellCept every month.

FAQ Quick Links

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.

    You should have one 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.

    If you are a woman who can get pregnant, you must use acceptable birth control during your entire CellCept therapy, and continue birth control for 6 weeks after you stop taking CellCept, unless you choose to abstain from sexual intercourse with a man completely. Talk to your doctor about other birth control methods that you can use while 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.

    If you become pregnant while taking CellCept, do not stop taking CellCept. Call your doctor right away. In certain situations, you and your doctor may decide that taking CellCept 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 you and your baby.

  • 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. These serious infections can include:

    • Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. These viruses or infections may include:

      • Cytomegalovirus (CMV), shingles, other herpes infections. CMV can cause serious tissue and blood infections.

      • BK virus. This virus can damage the kidney. It can cause the new 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.

    • 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 (such as not caring about things that you usually care about and confusion).

    • Fungal infections. Yeasts and other types of fungal infections can happen with CellCept and 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 Boxed WARNING and Medication Guide, for additional Important Safety Information.