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CELLCEPT- mycophenolate mofetil capsule


  1. Patient Information
  2. Cellcept Can Cause Serious Side Effects:
  3. Who Should Not Take Cellcept?
  4. Tell Your Healthcare Provider About All Of Your Medical Conditions, If You:
  5. What Should I Avoid While Taking Cellcept?
  6. Active Ingredient:
  7. Cellcept 250 Mg Capsules:
  8. Cellcept 500 Mg Tablets:
  9. Cellcept Oral Suspension:
  10. Cellcept Intravenous:
  11. Repackaged By:

Patient Information 

CellCept[SEL-sept]
(mycophenolate mofetil capsules)
(mycophenolate mofetil tablets)

CellCeptOral Suspension
(mycophenolate mofetil for oral suspension)

CellCeptIntravenous
(mycophenolate mofetil hydrochloride for injection)

Read the Medication Guide that comes with CellCept before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.

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 notstop 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 (

      CellCept is a prescription medicine to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant. Rejection is when the body's immune system perceives the new organ as a "foreign" threat and attacks it.

      CellCept is used with other medicines called cyclosporine (Sandimmune, Gengraf, Neoral) and corticosteroids. These medicines work together to prevent rejection to your transplanted organ.

      CellCept has been used safely and works in children who received a kidney transplant as it does in adults. It is not known if CellCept is safe and works in children who receive a heart or liver transplant.

Who Should Not Take Cellcept? 

Do not take CellCept if you are allergic to mycophenolate mofetil or any of the ingredients in CellCept.

Tell Your Healthcare Provider 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-

    • Take CellCept exactly as prescribed
    • Do not stop taking CellCept or change the dose unless your healthcare provider 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 healthcare provider 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 healthcare provider 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
    • If you take too much CellCept, call your healthcare provider or the poison control center right away

What Should I Avoid While Taking Cellcept? 

  • Avoid pregnancy.

Active Ingredient: 

mycophenolate mofetil

Cellcept 250 Mg Capsules: 

croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.

Cellcept 500 Mg Tablets: 

black iron oxide, croscarmellose sodium, FD&C blue #2 aluminum lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone (K-90), red iron oxide, talc, and titanium dioxide; may also contain ammonium hydroxide, ethyl alcohol, methyl alcohol, n-butyl alcohol, propylene glycol, and shellac.

Cellcept Oral Suspension: 

aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum.

Cellcept Intravenous: 

polysorbate 80, and citric acid. Sodium hydroxide may have been used in the manufacture of CellCept Intravenous to adjust the pH.

This Medication Guide has been approved by the US Food and Drug Administration.

CELLCEPT, CYTOVENE-IV, and VALCYTE are registered trademarks of Hoffmann-La Roche Inc.
BACTRIM and BACTRIM DS are trademarks of Hoffmann-La Roche Inc.

Distributed by:
Genentech USA, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990

Repackaged By: 

Rebel Distributors Corp

Thousand Oaks, CA 91320

MG Revised: February 2010

For additional copies of this Medication Guide, please call 1-800-617-8191 or visit www.gene.com/gene/products/information/cellcept.

CTCTIO_1061443_PI/MG_AR2010_N(2)
CTCTIO_1061443_PI/MG_AR2010_K(2)

2010 Genentech, Inc. All rights reserved.

Representative sample of labeling (see theHOW SUPPLIEDsection for complete listing):



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