Cellcept

Cellcept is a prescription medicine used to prevent organ rejection in people who have received kidney, heart, and liver transplants. Rejection is when the body's immune system perceives the new organ as a "foreign" threat and attacks it. Cellcept belongs to a group of drugs called immunosuppressive agents. It works by weakening the body's immune system so it doesn't attack the new organ. 

Cellcept is a prescription medicine to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant. Cellcept is used in combination with other medicines called cyclosporine (Sandimmune, Gengraf, Neoral) and corticosteroids.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Genentech, Inc.

Cellcept can cause serious side effects. See "Drug Precautions".

• Low blood cell counts. People taking high doses of Cellcept each day may have a decrease in blood counts, including white blood cells, especially neutrophils. Neutrophils fight against bacterial infections. Cellcept can cause low red blood cell counts. Red blood cells carry oxygen to your body tissues. Cellcept can decrease the number of platelets in your blood. Platelets help with blood clotting. Your doctor will do blood tests before you start taking Cellcept and during treatment 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. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting.
• Stomach problems. Stomach and intestinal bleeding can happen in people who take high doses of Cellcept. Bleeding can be severe and you may have to be hospitalized for treatment.

Common side effects include:

• diarrhea. Call your healthcare provider right away if you have diarrhea. Do not stop taking Cellcept without first talking with your healthcare provider.
• vomiting
• pain
• stomach area pain
• swelling of the lower legs, ankles and feet
• high blood pressure

Side effects that happen more often in children than in adults taking Cellcept include:

• stomach area pain
• fever
• infection
• pain
• blood infection (sepsis)
• diarrhea
• vomiting
• sore throat
• colds (respiratory tract infections)
• high blood pressure
• low white blood cell count
• low red blood cell count

These are not all of the possible side effects of Cellcept. Ask your doctor for more information.

Tell your doctor 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)
• 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)
• 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 and pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.

Cellcept can cause serious side effects:

• Possible loss of a pregnancy and higher risk of birth defects. Women who take Cellcept during pregnancy have a higher risk of losing a pregnancy (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 and are able to become pregnant
  • your healthcare provider must talk with you about effective birth control methods (contraceptive counseling)
  • you should have a negative pregnancy test within 1 week before you start to take Cellcept
  • you must use 2 different types of effective birth control at the same time, for 4 weeks before you start taking Cellcept, during your entire Cellcept therapy and for 6 weeks after stopping Cellcept, unless you choose to avoid sexual intercourse completely (abstinence). 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 plan to become pregnant, talk with your healthcare provider. Your healthcare provider will decide if other medicines to prevent rejection may be right for you. In certain situations, you and your healthcare provider may decide that taking Cellcept is more important to your health than the possible risks to your unborn baby.

• If you get pregnant while taking Cellcept, do not stop taking Cellcept. Call your healthcare provider right away. You and your healthcare provider should report any cases of pregnancies to:
  • FDA MedWatch at 1-800-FDA-1088
  • Genentech at 1-888-835-2555

  Talk to your healthcare provider about joining the National Transplantation Pregnancy Registry at 1-877-955-6877.

• 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 death. Types of 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.
  • 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. You should tell your healthcare provider 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 

Call your healthcare provider 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

• 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 healthcare provider 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

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cellcept there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor about all of your medical conditions, if you:

• have any digestive problems, such as ulcers
• have Phenylketonuria (PKU). Cellcept oral suspension contains aspartame (a source of phenylalanine)
• have Lesch-Nyhan or Kelley-Seegmiller syndrome or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take Cellcept if you have one of these disorders
• plan to receive any vaccines. People taking Cellcept should not take live vaccines. Some vaccines may not work as well during treatment with Cellcept.
• are pregnant or are planning to become pregnant.
• are breastfeeding. It is not known if Cellcept passes into breast milk. You and your doctor will decide if you will take Cellcept or breastfeed. You should not do both without first talking with your doctor 

Tell your doctor about all of the medicines you are taking including prescription and nonprescription medicines, vitamins and herbal supplements.

Women who take Cellcept during pregnancy have a higher risk of losing a pregnancy (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 and are able to become pregnant your healthcare provider must talk with you about effective birth control methods (contraceptive counseling):

1. you should have a negative pregnancy test within 1 week before you start to take Cellcept
2. you must use 2 different types of effective birth control at the same time, for 4 weeks before you start taking Cellcept, during your entire Cellcept therapy and for 6 weeks after stopping Cellcept, unless you choose to avoid sexual intercourse completely (abstinence).
3. 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.
4. 
If you plan to become pregnant, talk with your healthcare provider. Your healthcare provider will decide if other medicines to prevent rejection may be right for you. In certain situations, you and your healthcare provider may decide that taking Cellcept is more important to your health than the possible risks to your unborn baby.

• If you get pregnant while taking Cellcept, do not stop taking Cellcept. Call your healthcare provider right away. You and your healthcare provider should report any cases of pregnancies.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Cellcept is excreted in human breast milk or if it will harm your nursing baby. 

• Take Cellcept exactly as prescribed by your doctor.
• 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. 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 doctor tells you otherwise. With the approval of your doctor, in stable kidney transplant patients, Cellcept can be taken with food if necessary.
• 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 liquid form of Cellcept. Your pharmacist will mix the medicine before giving it to you.
• Do not mix Cellcept oral suspension with any other medicine.
• Do not change (substitute) between using Myfortic (mycophenolate mofetil) delayed-release tablets and Cellcept (mycophenolate mofetil) tablets, capsules, or oral suspension for one another unless your healthcare provider tells you to. These medicines are absorbed differently. This may affect the amount of medicine in your blood.
• Be sure to keep all appointments at your transplant clinic. During these visits, your doctor may perform regular blood tests.

Take Cellcept exactly as your doctor prescribes it. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

The recommended adult dose with kidney transplant is 1 g taken by mouth twice a day.

The recommended adult dose with heart or liver transplant is 1.5 g taken by mouth twice daily.  

If you take too much Cellcept call your doctor or your local Poison Control Center or seek emergency medical attention right away.

• 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.

WARNING

Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use Cellcept . Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Female users of childbearing potential must use contraception. Use of Cellcept during pregnancy is associated with increased risk of pregnancy loss and congenital malformations.