What does cellcept do?

New guidance on how and when to stop immunosuppressants in lupus patients

Lupus is a chronic inflammatory disease that can affect any organ system, but mainly involves the joints, kidneys and skin.2 It typically follows a relapsing and remitting course; during a relapse, patients feel fatigue, and may develop rashes, arthritis (painful and swollen joints) and fever.2 Being able to stop long-term immunosuppressant therapy in a lupus patient without inducing a relapse is an important treatment goal because of the potential side effects of these drugs, including the increased risk of infection and cancer.

In the USA, the average incidence of SLE has been estimated to range between 1.8 and 7.6 cases per 100,000 person-years.3 Incidence rates in Europe are similar, ranging from 3.3 to 4.8 per 100,000 person-years. The incidence of SLE is greater in Afro-Americans compared with Caucasians.4 SLE affects 10 times as many women as men.2

Lupus patients who develop serious or life-threatening problems such as kidney inflammation, lung or heart involvement, and central nervous system symptoms need more aggressive treatment, including high-dose corticosteroids such as prednisone, and immunosuppressants such as azathioprine (AZA), methotrexate (MTX) and mycophenolate mofetil (MMF).

“Until now, information on whether and how immunosuppressant therapy might be stopped in lupus patients after achieving low disease activity or remission has been limited,” said lead author Dr Zahi Touma, Assistant Professor of Medicine, Clinician-Scientist, Division Of Rheumatology, University of Toronto, Canada.

“The results from our study provide useful guidance on how best to stop the immunosuppressant without triggering a flare. For example, patients who discontinued their immunosuppressant more slowly were less likely to flare within two years,” Dr Touma explained. “Those lupus patients who were serologically active at the time the immunosuppressant was stopped were much more likely to flare on follow-up visits,” he added.

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Out of a total population of 1,678 patients registered at the Toronto Lupus Clinic, 973 had been prescribed an immunosuppressant; and 99 had stopped taking it, of which 56 had been on AZA, 25 on MTX, and 18 on MMF. Of the 99 patients who stopped their immunosuppressant, 25 flared within two years (16 on AZA; 7 on MTX and 2 on MMF; p=0.31); 17 patients experienced a flared after year two.

Comparing patients who flared within two years to those who did not, the percentage of patients with positive serology† at the time their immunosuppressant was stopped was greater in those who flared, 68% vs. 42% (p=0.04).

In the no flare group, the length of time from the start of tapering to stopping the immunosuppressant was 1.8±1.8 years, significantly slower than the 0.9±0.9 years in the group who did experience a flare (p=0.002).

At the start of tapering, the mean age of the patients was 40.4±13.1 and mean disease duration was 11.4±9.4 years. 46 of the patients had follow-up available beyond two years; 32 were followed beyond three years, 26 beyond four years and 24 beyond five years. Using a Kaplan-Meier curve for the time to flare, at one, two, three, four and five years, the percentage of patients who flared was 17%, 30%, 46%, 49% and 51% respectively.

The analysis for this study was conducted on all patients seen in the Toronto Lupus Clinic in whom an immunosuppressant was tapered and then stopped. To be included, the lupus patient had to be in clinical remission: defined as no activity in the clinical SLE Disease Activity Index-2000 (SLEDAI-2K) descriptors‡ and an absence of proteinuria or lupus-related thrombocytopenia and leukopenia, and also to be taking ≤7.5mg of prednisone per day.

Three time points were identified for each patient:

  • the start of tapering defined as the first visit with a decrease of at least 25% in the dose of immunosuppressant
  • the day the immunosuppressant was completely stopped
  • the end of the study — defined as the date of flare, or last clinic visit after the immunosuppressant was stopped.

Flare was defined as the introduction of a new immunosuppressant, or any increase of prednisone dosage in the context of clinically active lupus.

Flare was evaluated within the first two years from the immunosuppressant being stopped, and also at any time after the immunosuppressant was stopped.

Cellcept

CellCept is the brand name of the prescription drug mycophenolate mofetil, used to prevent organ rejection in people who’ve had a kidney, heart, or liver transplant.

The medicine is usually given along with other drugs.

It’s sometimes also used to treat Crohn’s disease (a condition in which the body’s immune system attacks the lining of the digestive tract).

CellCept is an immunosuppressant. It works by weakening the body’s immune system so that it won’t attack a transplanted organ.

The U.S. Food and Drug Administration (FDA) approved CellCept in 1995. It’s manufactured by Genentech, Inc.

CellCept Warnings

CellCept contains a black box warning because it may increase your risk of developing an infection, or reduce your body’s ability to fight serious infections.

Alert your doctor before taking CellCept if you have any type of infection. Avoid being around people who are sick while you’re taking CellCept, and wash your hands often.

Tell your doctor immediately if you experience any of the following symptoms while taking CellCept:

  • Fever, sore throat, chills, or cough
  • Unusual bruising or bleeding
  • Pain or burning while urinating
  • Frequent urination
  • Drainage from a skin wound
  • A wound that won’t heal
  • Weakness or extreme fatigue
  • Feeling like you have the flu or a cold
  • White patches in the mouth or throat
  • Cold sores
  • Blisters
  • Headache or earache

CellCept may cause you to develop a number of infections, including shingles, cytomegalovirus (CMV), herpes, blood infections, BK virus, hepatitis B or C, and others.

It can also increase your risk of developing a serious and sometimes life-threatening infection of the brain known as progressive multifocal leukoencephalopathy (PML).

Before taking CellCept, tell your doctor if you have, or have ever had:

  • PML
  • Human immunodeficiency virus (HIV)
  • Acquired immunodeficiency syndrome (AIDS)
  • Sarcoidosis (a condition that causes inflammation and swelling of the lungs and other parts of the body)
  • Leukemia or lymphoma
  • Any other condition that affects your immune system

Call your doctor immediately if you experience any of the following symptoms while taking CellCept:

  • Weakness on one side of the body or legs
  • Confusion or difficulty thinking clearly
  • Difficulty controlling your muscles
  • Loss of balance
  • Memory loss
  • Difficulty speaking or understanding others
  • Lack of interest in activities you usually care about

CellCept also contains a black-box warning because it may increase your risk of developing lymphoma or skin cancer.

Tell your healthcare provider if you or anyone in your family has ever had skin cancer. Avoid unnecessary exposure to the sun while taking this medicine.

Let your doctor know immediately if you experience any of the following symptoms:

  • Swelling or pain in the neck, groin, or armpits
  • A new skin bump or sore
  • Change in the size or color of a mole
  • A brown or black skin lesion that isn’t symmetrical or has uneven edges
  • Skin changes
  • Sores that don’t heal
  • Weight loss
  • Extreme tiredness
  • Unexplained fever

Don’t have any vaccinations while taking CellCept without first talking to your healthcare provider.

Also, let your doctor know if you have any of the following medical conditions before taking CellCept:

  • Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome (inherited diseases)
  • Anemia (low red blood cell count)
  • Neutropenia (low white blood cell count)
  • Stomach ulcers
  • Any disease that affects the stomach, intestines, or digestive system
  • Any type of cancer
  • Kidney disease
  • Liver disease
  • Hepatitis B or hepatitis C
  • Allergies to medications

If you have phenylketonuria (PKU) and follow a special diet, you should know that the liquid form of CellCept contains aspartame.

Your doctor will want to monitor your body’s response to CellCept. Be sure to keep all appointments with your doctor’s office and laboratory while taking this medicine.

Pregnancy and CellCept

CellCept contains a black-box warning because it may increase the risk of birth defects or miscarriage in pregnant women.

Women who are pregnant or may become pregnant shouldn’t take this medicine.

If you’re a woman of childbearing age, you must use two forms of effective birth control for four weeks before starting on CellCept, as well as throughout the duration of your treatment, and for six weeks after you stop taking the medicine.

CellCept may reduce the effectiveness of hormonal contraceptives, which is why it’s important to use two forms of birth control.

Tell your doctor immediately if you miss your menstrual period while taking CellCept.

It’s not known whether CellCept passes into breast milk or could harm a breastfeeding baby. Don’t breastfeed while taking this drug without first talking to your doctor.

CellCept

Generic Name: mycophenolate mofetil (oral/injection) (MYE koe FEN oh late MOE fe til)
Brand Names: CellCept, Myfortic, MMF

Medically reviewed by Kaci Durbin, MD Last updated on Feb 18, 2019.

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What is CellCept?

CellCept (mycophenolate mofetil) weakens your body’s immune system, to help keep it from “rejecting” a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

CellCept is used with other medicines to prevent organ rejection after a kidney, liver, or heart transplant.

CellCept is usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication. It can be given by mouth or as an injection.

Important Information

CellCept can cause a miscarriage or birth defects when used during pregnancy. Women using mycophenolate mofetil should use effective birth control to prevent pregnancy. However, if no safer options are available, CellCept is sometimes given to pregnant women.

CellCept may cause your body to overproduce white blood cells. This can lead to cancer or a severe brain infection causing disability or death. CellCept can also make you more likely to develop severe bacterial, viral, fungal, or protozoal infections.

Call your doctor right away if you have symptoms such as: fever, swollen glands, night sweats, weight loss, vomiting or diarrhea, burning when you urinate, a new skin lesion, any change in your mental state, weakness on one side of your body, problems with speech or vision, or tenderness near your transplanted kidney.

Do not open the CellCept capsule or crush or chew a tablet. Do not use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin.

Before taking this medicine

You should not use CellCept if you are allergic to mycophenolate mofetil, mycophenolic acid (Myfortic), or to an ingredient called Polysorbate 80.

Talk with your doctor about the risks and benefits of using this medicine. Mycophenolate mofetil can affect your immune system, and may cause overproduction of certain white blood cells. This can lead to cancer, severe brain infection causing disability or death, viral infections causing kidney transplant failure, or other serious infections.

To make sure CellCept is safe for you, tell your doctor if you have ever had:

  • a stomach ulcer or problems with digestion;

  • hepatitis B or C;

  • liver or kidney disease;

  • phenylketonuria or PKU (the liquid form of this medicine may contain phenylalanine); or

  • a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

CellCept can cause a miscarriage or birth defects when used during pregnancy. You will need to have a negative pregnancy test before and during treatment with this medicine. If you are able to get pregnant, you must use specific forms of birth control to prevent pregnancy while using mycophenolate mofetil, and for at least 6 weeks after your last dose. Do not use birth control pills alone as this medicine can make birth control pills less effective. Follow all patient instructions about using effective non-hormonal forms of birth control. Ask your doctor if you have any questions.

You are considered able to get pregnant (even if you are not sexually active) from the age of puberty until you have been in menopause for at least 12 months in a row.

If you are a man, use effective birth control if your sex partner is able to get pregnant. CellCept is present in semen and can also harm an unborn baby if the father is using this medicine. Keep using birth control for at least 90 days after your last dose.

If a pregnancy occurs during treatment, do not stop using CellCept. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191).

You should not breast-feed while using CellCept.

How should I use CellCept?

Use CellCept exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You must remain under the care of a doctor while you are using this medicine.

CellCept injection is given as an infusion into a vein. A healthcare provider will give you this injection.

Take the oral medication on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the tablet or capsule whole and do not crush, chew, break, or open it.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic) are not absorbed equally in the body. Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

While using CellCept, you may need frequent blood tests.

If you’ve ever had hepatitis B or C, using CellCept can cause this virus to become active or get worse. You may need frequent liver function tests while using CellCept and for several months after you stop.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Throw away any unused liquid that is older than 60 days.

CellCept liquid medicine may also be stored in the refrigerator. Do not freeze.

Follow all handling and disposal procedures given to you. Avoid inhaling or direct contact of the skin and mucus membranes (mouth, nose) with the powder in CellCept capsules.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using CellCept? An overdose can lead to dangerously low white blood cell levels or cause stomach pain, diarrhea, nausea, and vomiting.

You must not donate blood or sperm while using CellCept, and for at least 6 weeks (for blood) or 90 days (for sperm) after your last dose.

Do not receive a “live” vaccine while using mycophenolate mofetil. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

CellCept can make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

CellCept side effects

Get emergency medical help if you have signs of an allergic reaction to CellCept: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

CellCept can affect your immune system, and may cause certain white blood cells to grow out of control. Call your doctor right away if you have:

  • fever, swollen glands, painful mouth sores, cold or flu symptoms, headache, ear pain;

  • stomach pain, vomiting, diarrhea, weight loss;

  • weakness on one side of your body, loss of muscle control;

  • confusion, thinking problems, loss of interest in things that normally interest you;

  • pain or burning when you urinate;

  • tenderness around the transplanted kidney;

  • swelling, warmth, redness, or oozing around a skin wound; or

  • a new skin lesion, or a mole that has changed in size or color.

Also call your doctor at once if you have:

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • easy bruising, nosebleeds, gum bleeding or other unusual bleeding;

  • signs of increased blood pressure such as severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or

  • signs of low blood cell counts including fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common CellCept side effects may include:

  • stomach discomfort, nausea, vomiting, diarrhea, constipation;

  • swelling in your ankles or feet;

  • rash;

  • headache, dizziness, tremors;

  • fever, sore throat, or other signs of infections;

  • low blood cell counts; or

  • increased blood pressure or heart rate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect CellCept?

Avoid taking an antacid at the same time. If you also take sevelamer, take it at least 2 hours after you take oral CellCept.

Tell your doctor about all your current medicines. Many drugs can interact with CellCept, especially:

  • azathioprine;

  • cholestyramine;

  • cyclosporine;

  • antiviral medicine – acyclovir, ganciclovir, valacyclovir, valganciclovir;

  • an antibiotic – amoxicillin, ciprofloxacin, metronidazole, norfloxacin, rifampin, sulfa drugs (SMX-TMP or SMZ-TMP, and others); or

  • stomach acid reducers including esomeprazole, lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, Protonix, and others; or

  • birth control pills;

This list is not complete and many other drugs may affect CellCept. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use CellCept only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 8.01.

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Related treatment guides

  • Nephrotic Syndrome
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CellCept®
(mycophenolate mofetil)

Contact Support & Other Resources

  • Report side effects for your Cellcept prescription

    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.

    Get help paying for your Cellcept prescription

    SUPPORT

    Genentech Access To Care Foundation
    This service offers coverage support and patient assistance. Please call 888-754-7651 for more information.

    RESOURCES

    CellCept.com
    Provides additional resources and information.

    Get answers to your questions about your Cellcept prescription

    Medicine Information Support
    Ask about possible side effects and any other medical questions related to your prescribed Genentech medicine.

    Call a nurse at (800) 821-8590, Monday-Friday, 5am-5pm PT.
    Chat with a nurse using our live chat feature, Monday-Friday, 5am-5pm PT.
    Email a nurse by filling out this form.

    CellCept.com
    Provides additional resources and information.

What it Treats

  • 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 containing cyclosporine and corticosteroids.

Important Safety Information

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

CELLCEPT can cause serious side effects, including:

Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take CELLCEPT during pregnancy have a higher risk of 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 who can become pregnant, your doctor must talk with you about acceptable birth control methods (contraceptive counseling) to use while taking CELLCEPT. You should have 1 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 your doctor. Talk to your doctor about the results of all of your pregnancy tests. You must use acceptable birth control during your entire CELLCEPT treatment and for 6 weeks after stopping CELLCEPT, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. 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 take birth control pills while using CELLCEPT you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking CELLCEPT.
  • If you are a sexually active male whose female partner can become pregnant while you are taking CELLCEPT, use effective contraception during treatment and for at least 90 days after stopping CELLCEPT.
  • If you plan to become pregnant, talk with your doctor. Your doctor will decide if other medicines to prevent rejection may be right for you.
  • If you become pregnant while taking CELLCEPT, do not stop taking Call your doctor right away. You and your doctor may decide that other medicines to prevent rejection may be right for you. You and your doctor should report your pregnancy to the Mycophenolate Pregnancy Registry either:
    • by phone at 1-800-617-8191 or
    • by visiting the Risk Evaluation and Mitigation Strategy (REMS) website at mycophenolateREMS.com

The purpose of this registry is to gather information about the health of you and your baby.

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 doctor 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

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 hospitalizations and death. These serious 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
    • hepatitis B and C viruses. Hepatitis viruses can affect how your liver works. Talk to your doctor about how hepatitis viruses may affect you
  • 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 aweakened immune system. Call your doctor 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 (See “What are the possible side effects of CELLCEPT?”).

Call your doctor 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

See “What are the possible side effects of CELLCEPT?” for information about other serious side effects.

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

What should I tell my doctor before taking CELLCEPT?

Tell your doctor about all of your medical conditions, including 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 receive live vaccines. Some vaccines may not work as well during treatment with CELLCEPT.
  • are pregnant or plan to become pregnant. See “What is the most important information I should know about CELLCEPT?”
  • are breastfeeding or plan to breastfeed. It is not known if CELLCEPT passes into breast milk. You and your doctor will decide if you will take CELLCEPT or breastfeed.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter 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). See “What is the most important information I should know about CELLCEPT?”
  • sevelamer (Renagel®, Renvela™). These products should be taken at least 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).
  • proton pump inhibitors (PPIs) (Prevacid®, Protonix®).
  • 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 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?

  • Take CELLCEPT exactly as prescribed.
  • Do not stop taking CELLCEPT or change the dose unless your doctor tells you to.
  • If you miss a dose of CELLCEPT, or you are not sure when you took your last dose, take your prescribed dose of CELLCEPT as soon as you remember. If your next dose is less than 2 hours away, skip the missed dose and take your next dose at your normal scheduled time. Do not take 2 doses at the same time. Call your doctor if you are not sure what to do. capsules, tablets and oral suspension on an empty stomach, unless your doctor tells you otherwise.
  • Take CELLCEPT capsules, tablets and oral suspension on an empty stomach, unless your doctor tells you otherwise.
  • 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 you pick it up from a pharmacy.
  • Do not mix CELLCEPT Oral Suspension with any other medicine. CELLCEPT Oral Suspension should not be mixed with any type of liquids before taking the dose.
  • Do not breathe in (inhale) or let CELLCEPT powder or oral suspension come in contact with your skin or mucous membranes.
    • If you accidentally get the powder or oral suspension on the skin, wash the area well with soap and water.
    • If you accidentally get the powder or oral suspension in your eyes or other mucous membranes, flush with plain water.
  • If you take too much CELLCEPT, call your doctor or the poison control center right away.

What should I avoid while taking CELLCEPT?

  • Avoid becoming pregnant. See “What is the most important information I should know about CELLCEPT?”
  • Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take CELLCEPT have a higher risk of getting skin cancer. (See “What is the most important information I should know about CELLCEPT?”) Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen with a high protection factor. This is especially important if your skin is very fair or if you have a family history of skin cancer.
  • You should not donate blood while taking CELLCEPT and for at least 6 weeks after stopping CELLCEPT.
  • You should not donate sperm while taking CELLCEPT and for 90 days after stopping CELLCEPT.

CELLCEPT may influence your ability to drive and use machines (See “What are the possible side effects of CELLCEPT?”). If you experience drowsiness, confusion, dizziness, tremor, or low blood pressure during treatment with CELLCEPT, you should be cautious about driving or using heavy machines.

What are the possible side effects of CELLCEPT?

CELLCEPT can cause serious side effects, including:

  • See “What is the most important information I should know about CELLCEPT?”
  • 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. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 1 month to 6 months after your transplant
    • red blood cells. Red blood cells carry oxygen to your body tissues. You have a higher chance of getting severe anemia when your red blood cell count is low
    • platelets. 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 (see “What is the most important information I should know about CELLCEPT?”), including any unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting.

Stomach problems. Stomach problems including intestinal bleeding, a tear in your intestinal wall (perforation) or stomach ulcers can happen in people who take CELLCEPT. Bleeding can be severe and you may have to be hospitalized for treatment. Call your doctor right away if you have sudden or severe stomach-area pain or stomach-area pain that does not go away, or if you have diarrhea.

The most common side effects of CELLCEPT include:

  • diarrhea
  • blood problems including low white and red blood cell counts
  • infections
  • blood pressure problems
  • fast heart beat
  • swelling of the lower legs, ankles and feet
  • changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia)
  • stomach problems including diarrhea, constipation, nausea and vomiting
  • rash
  • nervous system problems such as headache, dizziness and tremor

Side effects that can 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 FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

CellCept (mycophenolate mofetil) is a medication marketed by Genentech and approved to prevent organ rejection in transplant patients (liver, kidneys and heart) by working to suppress the immune system.

As an immunosuppressive, CellCept is also prescribed to treat such autoimmune and inflammatory diseases as rheumatoid arthritis and lupus nephritis (lupus that affects the kidneys). It has also been investigated as a potential alternative to prednisone, a glucocorticoid, for the treatment of sarcoidosis.

Glucocorticoids like prednisone are often used as a first-line treatment for active sarcoidosis, and prednisone is FDA-approved to treat pulmonary sarcoidosis. However, such corticosteroid treatments can have severe side effects, especially with long-term use, and many patients either do not tolerate or respond to them.

Mycophenolate mofetil, the main ingredient of CellCept, is one among the non-steroid medications being considered as an alternative to prednisone in treating sarcoidosis.

How CellCept works

CellCept is a precursor of mycophenolic acid (MPA), an inhibitor of a protein called inosine monophosphate dehydrogenase (IMPDH) 2, which is involved in the production of guanosine nucleotides. Guanosine nucleotides have various functions in the cell, but mainly act as signaling molecules. Lymphocytes, a type of immune cell, are most affected by CellCept because other cell types use a slightly different protein to produce guanosine nucleotides called IMPDH 1 and are less sensitive to CellCept.

CellCept in clinical trials

CellCept has not been tested in randomized clinical trials as a sarcoidosis treatment. But several small studies suggest it may be beneficial to patients with this disease.

One study retrospectively looked at 37 pulmonary sarcoidosis patients who either did not respond to or tolerate other immunosuppressive agents. It reported that mycophenolate mofetil treatment enabled these patients to reduce the dose of prednisone required to control their disease symptoms of the disease, but overall did not show signs of improving lung function. In a subgroup analysis, however, patients intolerant of other immunosuppressives showed “some improvement” in forced vital capacity (FVC) and diffusing capacity for carbon monoxide (DLCO), parameters of lung function, when treated with mycophenolate mofetil. Mycophenolate mofetil “appears to have potential as a second line agent for some pulmonary sarcoidosis subjects,” the researchers wrote. CellCept provided no benefit in patients who had not responded to a prior agent that suppresses the immune system.

Another retrospective study suggested that mycophenolate mofetil is beneficial in combination with prednisone (or other corticosteroids) in patients with chronic pulmonary sarcoidosis. Its data showed a mean FVC improvement of 8.5 percent in 10 treated patients, who were also able to significantly lower to less than 10 mg/day corticosteroid doses used to maintain stable disease or improve lung symptoms.

A case study found mycophenolate mofetil treatment to be beneficial to an array of patients with cutaneous, central nervous system, and renal sarcoidosis.

Another case study of a 41-year-old man with cutaneous and bone marrow sarcoidosis found he responded to a corticosteroid-sparing treatment combination of mycophenolate mofetil and methotrexate.

Additional information

CellCept is toxic at high doses and has to be dosed carefully. Neutropenia, or abnormally low levels of white blood cells called neutrophils, is a known side effect but one less pronounced than with other agents that suppress the immune system. Other side effects include diarrhea and nausea, which can be dose limiting.

***

Sarcoidosis News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

CellCept Side Effects

Generic Name: mycophenolate mofetil

Medically reviewed by Drugs.com. Last updated on Jan 22, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Note: This document contains side effect information about mycophenolate mofetil. Some of the dosage forms listed on this page may not apply to the brand name CellCept.

In Summary

Common side effects of CellCept include: asthma, herpes simplex infection, infection, metabolic acidosis, oral candidiasis, pleural effusion, respiratory tract infection, systemic cytomegalovirus disease, urinary tract infection, viremia, abdominal pain, acne vulgaris, anemia, anxiety, asthenia, back pain, cardiovascular disorder, chest pain, constipation, cough, depression, diarrhea, disorder of integument, drowsiness, dyspepsia, dyspnea, edema, fever, headache, hypercholesterolemia, hyperlipidemia, hypertension, hypertonia, hyperuricemia, hypervolemia, hypokalemia, hypotension, increased lactate dehydrogenase, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum creatinine, leukopenia, lower limb cramp, myalgia, myasthenia, nausea, pain, paresthesia, peripheral edema, pulmonary disease, rhinitis, sinusitis, tachycardia, thrombocytopenia, tremor, vomiting, weight gain, chills, and flatulence. Other side effects include: malignant neoplasm of skin, dizziness, and insomnia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to mycophenolate mofetil: oral capsule, oral powder for suspension, oral tablet

Other dosage forms:

  • intravenous powder for solution

Warning

Oral route (Capsule; Tablet; Powder for Suspension)

Provide information on pregnancy prevention and planning to female patients of childbearing potential, as this drug is associated with increased risk of first-trimester pregnancy loss and congenital malformations. In addition, use may increase susceptibility to infection. Lymphoma may develop as a result of immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe this drug, and they should have complete information needed for patient followup.

Along with its needed effects, mycophenolate mofetil (the active ingredient contained in CellCept) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking mycophenolate mofetil:

More common

  • Abdominal or stomach cramps or pain
  • black, tarry stools
  • bladder pain
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine or stools
  • bloody or cloudy urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • chest pain
  • confusion
  • convulsions
  • cough or hoarseness
  • decreased urine
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • dry mouth
  • fainting
  • fast, slow, pounding, or irregular heartbeat or pulse
  • fever or chills
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • irregular heartbeats
  • irregular pulse
  • irritability
  • lightheadedness
  • loss of appetite
  • lower back or side pain
  • muscle cramps in the hands, arms, feet, legs, or face
  • muscle pain or cramps
  • muscle spasms (tetany) or twitching
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • rapid weight gain
  • rapid, shallow breathing
  • seizures
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain and bloating
  • sweating
  • swollen glands
  • tightness in the chest
  • tingling of the hands or feet
  • trembling
  • tremor
  • troubled breathing with exertion
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weakness or heaviness of the legs

Incidence not known

  • Back pain
  • constipation
  • coughing or spitting up blood
  • darkened urine
  • general feeling of illness
  • indigestion
  • night sweats
  • pain
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • severe headache
  • sudden high fever or low-grade fever for months
  • tenderness
  • watery or bloody diarrhea
  • yellow eyes or skin

Some side effects of mycophenolate mofetil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Acid or sour stomach
  • belching
  • fear
  • heartburn
  • lack or loss of strength
  • rash
  • trouble sleeping
  • weight loss

For Healthcare Professionals

Applies to mycophenolate mofetil: intravenous powder for injection, oral capsule, oral powder for reconstitution, oral tablet

Gastrointestinal

Very common (10% or more): Diarrhea (36%), nausea (20%), vomiting (13%), abdominal pain

Common (1% to 10%): GI infection, gastroenteritis

Rare (less than 0.1%): Gingival hyperplasia, colitis including cytomegalovirus colitis, pancreatitis intestinal villous atrophy

Frequency not reported: Ischemic colitis

Hematologic

Very common (10% or more): Leukopenia (11% to 35%), anemia (35%)

Common (1% to 10%): Blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, thrombocytopenia, neutropenia

Very rare (less than 0.01%): Deep venous thrombosis

Postmarketing reports: Pure red cell aplasia (PRCA), abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly

Immunologic

Very common (10% or more): Sepsis (primarily cytomegalovirus viremia) (20%), gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster

Common (1% to 10%): Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis

Postmarketing reports: Hypogammaglobulinemia Serious life-threatening infections including meningitis, endocarditis, tuberculosis, atypical mycobacterial infection

Oncologic

Common (1% to 10%): Lymphoma, lymphoproliferative disease, non-melanoma skin carcinoma

Renal

Very common (10% or more): Hematuria (13%), kidney tubular necrosis (up to 10%)

Common (1% to 10%): Renal impairment

Frequency not reported: BK virus-associated nephropathy

Metabolic

Very common (10% or more): Edema (12% to 28%), hyperphosphatemia (13%), hypokalemia (10%), hyperglycemia (10%)

Common (1% to 10%): Weight loss, hyperkalemia

Respiratory

Very common (10% or more): Respiratory tract infection (23%), dyspnea (16%), increased cough (16%)

Common (1% to 10%): Pneumonia, respiratory moniliasis, bronchitis, pharyngitis, sinusitis, rhinitis, pleural effusion

Dermatologic

Common (1% to 10%): Fungal skin infection, skin hypertrophy, rash, acne, alopecia

Very rare (less than 0.01%): Dyshidrotic eczema, papulosquamous psoriatic-like skin eruption

Musculoskeletal

Common (1% to 10%): Arthralgia

Very rare (less than 0.01%): Myopathy

Other

Common (1% to 10%): Edema, pyrexia, chills, pain, malaise, asthenia

Frequency not reported: Congenital malformations, increased incidence of first trimester pregnancy loss

Hepatic

Common (1% to 10%): Hepatitis, jaundice, hyperbilirubinemia, hepatic enzyme increased

Very rare (less than 0.01%): Sodium-induced hepatotoxicity

Cardiovascular

Common (1% to 10%): Tachycardia, hypotension, hypertension, vasodilatation

Postmarketing reports: Endocarditis

Genitourinary

Common (1% to 10%): Urinary tract infection (up to 45%), vaginal candidiasis

Hypersensitivity

Postmarketing reports: Angioneurotic edema, anaphylactic reaction

2. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

3. “Product Information. CellCept (mycophenolate mofetil).” Roche Laboratories, Nutley, NJ.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

Mycophenolate Mofetil MMF (Brand names CellCept, Myfortic)

Mycophenolate is a medicine that lowers the body’s natural immunity. The immune system response is thought to be involved in Nephrotic Syndrome. This medicine is prescribed if there are too many relapses of Nephrotic Syndrome.

Why is Mycophenolate Mofetil needed for Nephrotic Syndrome patients?
A doctor may recommend Mycophenolate if Nephrotic Syndrome doesn’t get better with steroid treatment or if it keeps coming back. This medicine has shown to reduce relapse rate and steroid dose in people with steroid-dependent Nephrotic Syndrome. It may take several weeks for Mycophenolate to make a difference in your condition.

How should I take Mycophenolate Mofetil? How is Mycophenolate Mofetil administered?
Mycophenolate comes in a capsule, tablet, or liquid form.

If the liquid form is taken you should measure the correct amount using an oral syringe or medicine spoon. (You can get these from your pharmacist.) Do not use a kitchen teaspoon because you will not be able to measure out the correct amount.

Take Mycophenolate at the same time every day. Doses should be at least 12 hours apart. Pick times that are easy for you so that you do not miss a dose.

You should consult your doctor before you stop taking this medicine or before you change the amount for any reason. You may become ill if you stop taking this medicine suddenly.

Taking Mycophenolate with food may help to lessen stomach cramping and diarrhea. Food affects how the body absorbs Mycophenolate. To keep the blood levels of Mycophenolate the same, you should always take Mycophenolate the same way, either with food, or without food.

What are the possible side effects of Mycophenolate Mofetil?
You may experience some of these side effects while on Mycophenolate. Check with your doctor if you continue to have any of these side effects and they do not go away:

  • Constipation
  • Diarrhea
  • Vomiting (throwing up)
  • Nausea (upset stomach)
  • Stomach pain
  • Headache
  • Loss of energy or weakness
  • Dizziness
  • Trouble sleeping
  • Most of the following side effects are not common, but they may be a sign of a serious problem. Call your doctor right away or go to the Emergency Department if you have any of these side effects:
  • Fever, chills, and sore throat
  • Unusual bleeding or bruising
  • Black tarry stools
  • Shortness of breath or trouble breathing
  • Cough or hoarseness
  • Chest pain
  • Trembling or shaking of hands and feet

What are precautionary measures I should take while taking Mycophenolate Mofetil?
Mycophenolate lowers the body’s immunity, which increases chances of getting an infection. Watch closely for signs of infection such as a fever, chills, cough, and sore throat. Contact your doctor right away if you notice any signs of infection.

You should not receive any immunizations (vaccines) without your doctor’s approval.

Taking Mycophenolate with food may help to lessen stomach cramping and diarrhea. Food affects how the body absorbs Mycophenolate. To keep the blood levels of Mycophenolate the same, you or your child should always take Mycophenolate the same way, either with food, or always without food.

If you throw up in:

  • less than 30 minutes: repeat the full Mycophenolate dose (repeat the dose only once)
  • greater than 30 minutes: do not repeat the dose

If you miss a dose, you should make up for it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses to make up for the missed dose.
Avoid taking antacids or iron supplements with Mycophenolate because this will decrease its absorption. If you need an antacid or iron, wait at least one hour before taking Mycophenolate or one hour after taking Mycophenolate.
Many other medications may change the blood levels of Mycophenolate in your body. Check with your doctor before taking any other medicines (prescription, non-prescription, herbal, or natural products).

*Note: The decision to prescribe a medication is the responsibility of your physician/primary care provider based on his/her evaluation of your condition. The above is meant for informational purposes only. Discuss this information and all information about drugs/medications with your physician before starting or stopping any medication.

Abstract

Autoimmune hepatitis (AIH) is a chronic inflammatory disease of the liver of unknown cause. Typically, immune suppressive therapy is used initially for treatment, either in the form of steroids or Azathioprime. In a small proportion of patients, steroids resistance or steroid intolerance develops. When patients are unresponsive to steroids, or develop severe significant side effects to their use, alternative treatments must be used. Mycophenolate mofetil (Cellcept) is a potent immune suppressive medication that is used in a wide variety of autoimmune diseases as well as post solid organ transplantation. Data is emerging to suggest that this medication may be used in selected patients with steroid resistance or steroid intolerance. This data is summarized in this review.

How to cite this article:
Abdo AA. Mycophenolate mofetil (CellCept) in patients with autoimmune hepatitis. Saudi J Gastroenterol 2006;12:38

Autoimmune hepatitis (AIH) is a chronic inflammatory disorder of the liver of unknown etiology. Corticosteroids with or without azathioprine have been shown to be effective in inducing and maintaining remission and are currently the standard method of care. Remission occurs in 65% of those affected after 18 months of therapy, and in 80% after three years of therapy. A minority of patients will either be intolerant of, or fail, conventional therapy. A number of other therapies have been studied with mostly disappointing results.
Mycophenolic acid (MMF) is an ester pro-drug of mycophenolic acid which acts as a noncompetitive inhibitor of inosine monophosphate dehydrogenase, the rate-limiting enzyme involved in the de novo syntheses of purines.
For this reason, MMF is used extensively in the setting of solid organ transplantation, other autoimmune conditions such as Crohn disease and for rheumatoid arthritis. The toxicity profile of MMF includes: diarrhea, nausea, vomiting, leucopenia and anemia. The use of MMF in AIH has been the subject of three small studies so far. In the first report successful treatment of one patient with MMF was described. In the second paper, Richardson evaluated the use of MMF in 7 patients with type 1 AIH. Of the seven patients included, three patients were intolerant of azathioprine and had elevated liver enzymes with a liver biopsy showing active inflammation despite prednisone therapy, while four have been on high dose azathiprine without complete normalization of ALT, and had liver biopsies showing active disease.
All patients were treated with MMF 1 g twice daily and were followed for a median of 46 months. Five of the seven patientsentered clinical remission within 3 months of treatment. Thesteroid dose fell from 20 mg per day to 2 mg per day within9 months and the hepatic activity index fell from a medianof 11 to 3 after 7 months of therapy. One patient requireddose reduction because of a fall in the white count. No otheradverse effects were seen.
More recently, Devlin and collegues reported experiencewith 5 patients with classical type 1 AIH who were eitherintolerant of or resistant to steroid therapy. All patientsachieved clinical and biochemical response. There was noliver biopsy follow up in this study except in one patientwho had a significant improvement in inflammation on MMFalone without any steroids.
From the above preliminary data, we feel that MMF is a promising drug in AIH, and should be considered inpatients who are either resistant to, or intolerant of, standard therapy, including steroids and azathioprine. Before MMF isconsidered, every effort should be exhausted to reconfirm thediagnosis, confirm the compliance of the patient to standardtherapy, optimize medical management with medical therapy,and give enough time for standard immunosuppressantmedications to work. In addition, patients should be informedthat MMF therapy for AIH is not a standard approved therapyand all potential side effects should be explained to thepatient in detail.

1. Czaja A, Freese K. Diagnosis and treatment of autoimmune hepatitis. Hepatology 2002; 36:479-497.
2. Czaja AJ, Bianchi FB, Carpenter HA, Krawitt EL, Lohse AW, Manns MP et al. Treatment challenges and investigational opportunities in autoimmune hepatitis. Hepatology 2005; 41(1):207-215.
3. Heneghan M, McFarlane I. Current and noval immunosuppressive therapy for autoimmune hepatitis. Hepatology 2002; 35:7-13.
4. Schuppan D, Herold C, Strobel D, Schneider H, Hahn E. Succesful treatment of therapy-refractory autoimmune hepatitis with mycopheno;ate mofetil. Hepatology 1998; 28:A1960.
5. Richardson PD, James PD, Ryder SD. Mycophenolate mofetil for maintenance of remission in autoimmune hepatitis in patients resistant to or intolerant of azathioprine. J Hepatol 2000; 33:371-375.
6. Devlin S, Swain M, Urbanski S, Burrak K. Mycophenolate mofetil for the treatment of autoimmune hepatitis in patients refractory to standard therapy. Can J Gastroenterol 2004; 18:321-326.

Correspondence Address:
Ayman A Abdo
P.O.Box 2925(59) College of Medicine, King Saud University , Riyadh 11461
Saudi Arabia

Source of Support: None, Conflict of Interest: None

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PMID: 19858585

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