Information for Healthcare Providers / Patients

CellCept® (mycophenolate mofetil)

Alert

Drug Recall Notice (PDF) - June 27, 2011
Voluntary drug recall of select lots of CellCept® Oral Suspension (mycophenolate mofetil for oral suspension) 200mg/mL 225mL Bottle (NDC # 0004-0261-29)

Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

What it Treats

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.

The 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 the immune system. They help keep it from "rejecting” the transplant. Patients must follow their doctor's exact orders for taking CellCept and all other medicines.

Important Safety Information

  • 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.

Patients 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 the patient’s doctor. Patients must talk to their doctor about the results of all of their pregnancy tests.

If the patient is a woman who can get pregnant, the patient must use acceptable birth control during her entire CellCept therapy, and continue birth control for 6 weeks after she stops taking CellCept, unless the patient chooses to abstain from sexual intercourse with a man completely. Patients must talk to their doctor about other birth control methods that they can use while taking CellCept.

If a patient plans to become pregnant, she must talk with her doctor. The patient and her doctor can decide if other medicines to prevent rejection may be right for the patient.

If a patient becomes pregnant while taking CellCept, she must not stop taking CellCept. The patient must call her doctor right away. In certain situations, the patient and her doctor may decide that taking CellCept is more important to the patient’s health than the possible risks to the patient’s unborn baby.

  • The patient and her doctor should report the patient’s pregnancy to
    • Mycophenolate Pregnancy Registry (1-800-617-8191)

The purpose of this registry is to gather information about the health of the patient and the patient’s baby.

  • Taking CellCept with other anti-rejection medicines may raise the patient’s chance of getting an infection. It may raise the patient’s chance of getting cancer of the immune system (lymphoma) or other cancers, such as skin cancer.

Patients must talk with their doctor right away if they have any signs of infection such as fever, tiredness, headache, redness of skin/wound or swollen lymph glands. Patients must tell their doctor about any changes in their skin.

  • CellCept weakens the body's immune system and affects the body’s 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 the body and cause active infections when a patient’s 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 the liver works. Patients must talk to their doctor about how hepatitis viruses may affect them.
    • 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 the patient usually cares about and confusion).
    • Fungal infections. Yeasts and other types of fungal infections can happen with CellCept and can cause serious tissue and blood infections.

DO NOT TAKE CELLCEPT IF:

  • Patients should not use CellCept if they have ever had an allergic reaction to CellCept or any of its ingredients. Patients should discuss this with their doctor.

ADDITIONAL INFORMATION ABOUT CELLCEPT:

  • Patients taking high doses of CellCept each day may have a decrease in blood counts, including white blood cells, red blood cells and platelets.
  • A patient’s doctor will do blood tests before the patient starts taking CellCept and during therapy with CellCept to check the patient’s blood cell counts.
  • Patients must tell their doctor right away if they 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 the stool, or dark, sticky stools. Patients must tell their doctor if they 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.
  • Patients must tell their doctor about all the medicines they are taking including prescription and nonprescription medicines, vitamins and herbal supplements.
  • Patients must tell their doctor if they have phenylketonuria (PKU). CellCept Oral Suspension contains aspartame (a source of phenylalanine).

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. Patients must tell their doctor about any side effect that bothers them or that does not go away.

This important safety information does not take the place of the patient talking with their doctor about their medical condition or treatment. Patients must talk with their doctor if they have any questions about their health problems or treatment.

Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

Please see the full Prescribing Information and the Medication Guide for serious side effects and additional important safety information at www.cellcept.com.

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