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Important Safety Information
 

Know Your Medicine

If your doctor decides that brand name CellCept is right for you, you can take an active role to help ensure you receive CellCept, not a generic substitute, every month.

First, you should be able to recognize CellCept. Your CellCept capsules or tablets should have “CellCept” written on them.

Pills are not actual size.

Carefully check each refill at the pharmacy to ensure it is the same as the medicine you have been taking. It should have the same:

  • Color
  • Shape
  • Size

Know your prescription

Ask your doctor about the phrase that must be written on your prescription to ensure that you receive CellCept. The law may require your doctor to write “Dispense As Written,” “Brand Medically Necessary” or some other phrase on the prescription to ensure you receive the medicine your doctor intended and that it is not substituted.

Know your insurance

Check with your doctor or pharmacist. Your insurance company may require a prior authorization to get a brand-name drug when a generic is available.

If you have questions about your insurance drug coverage, help is available through Genentech® Transplant Access Services at 1-888-754-7651. You may also be eligible to receive up to $100 toward out-of-pocket expenses on every CellCept prescription and refill through December 31, 2011 with the CellCept Coupon Card.

“Know”-tify your pharmacist

Let your pharmacist know if your doctor does not want your medicine to be substituted. To help ensure that you continue to receive CellCept, a DAW 1 code must be entered into the computer system at the pharmacy.

If you think your prescription has been switched, make sure to check with your pharmacist before leaving the pharmacy.

Because formularies change and many health plans offer more than one formulary, please check with your health plan directly to confirm individual coverage. This information is not a guarantee of coverage in any individual case.
   

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.