CELLCEPT- mycophenolate mofetil capsule 
Cardinal Health

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MEDICATION GUIDE

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

CellCept® Oral Suspension
(mycophenolate mofetil for oral suspension)

CellCept® Intravenous
(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 doctor about your medical condition or your treatment.

What is the most important information I should know about CellCept?

CellCept can cause serious side effects:

Call your doctor right away if you have any of the following signs and symptoms of infection:

See the section "What are the possible side effects of CellCept?" for information about other serious side effects.

What is CellCept?

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.

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. See the end of this Medication Guide for a complete list of ingredients in CellCept.

What should I tell my doctor before taking CellCept?

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

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:

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.

How should I take CellCept?

What should I avoid while taking CellCept?

What are the possible side effects of CellCept?

CellCept can cause serious side effects:

Common side effects include:

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. Tell your doctor about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or to Genentech at 1-888-835-2555.

How should I store CellCept?

General Information about CellCept

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CellCept for a condition for which it was not prescribed. Do not give CellCept to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about CellCept. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about CellCept that is written for healthcare professionals. For more information, call 1-888-835-2555 or visit www.gene.com/gene/products/information/cellcept.

What are the ingredients in CellCept?

Active Ingredient: mycophenolate mofetil

Inactive Ingredients:

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

MG Revised: June 2012

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_2011_02_K

© 2012 Genentech, Inc. All rights reserved.

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

Cellcept 250 mg capsules are available from Cardinal Health in unit dose packages of 100.

250 mg, unit dose package of 100 capsules, NDC 55154-3122-4

Cardinal Health

Zanesville OH 43701
IU37362040613

Revised: 11/2013
 
Cardinal Health