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CellCept

MYCOPHENOLATE MOFETIL SUSPENSION

GENERIC NAME(S): MYCOPHENOLATE MOFETIL

WARNINGS:

Mycophenolate decreases the body's ability to protect against illness and infection, and may also increase your risk of developing lymph node tumors (lymphoma) and other types of cancer (especially skin cancer). Therefore, this medication must only be given under close medical supervision. Discuss the risks of taking mycophenolate with your doctor.

Notify your doctor immediately if you develop signs of infection (such as persistent sore throat or fever) or other symptoms such as weight loss, night sweats, enlarged lymph nodes, or skin changes/growths.

Women of childbearing age must use reliable forms of birth control when using mycophenolate, since it may harm an unborn baby. (See also Precautions).

Who should not take CellCept?
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Uses

Mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted organ (e.g., kidney, liver, heart). It belongs to a class of medications called immunosuppressants. This medication works by lowering your body's immune system activity.

How to use CellCept

Read the Medication Guide provided by your pharmacist before you start taking mycophenolate and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth, usually twice daily without food, or take as directed by your doctor. The dosage and length of treatment is based on your medical condition and response to therapy.

Shake the bottle well before each dose. Be careful not to get any of the suspension on your skin or mucous membranes (e.g., eyes, open wounds). If such contact should occur, wash the affected skin area well with soap and water or rinse your eyes with plain water. Consult your pharmacist for details.

Certain drugs may decrease the amount of mycophenolate that your body absorbs if taken at the same time. Do not take this medication at the same time as antacids containing aluminum and/or magnesium, cholestyramine, colestipol, or calcium-free phosphate binders (e.g., aluminum products, lanthanum, sevelamer). For more details, ask your pharmacist.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. Dosage is based on your medical condition and response to therapy.

Take this medication exactly as prescribed by your doctor. Do not skip any doses. It is very important to continue taking this medication even if you feel well. Do not stop taking mycophenolate without first talking to your doctor.

Side Effects

See also Warnings section.

Constipation, nausea, headache, diarrhea, vomiting, stomach upset, loss of appetite, gas, tremor, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Because this medication weakens your immune system, you are more likely to develop infections which may be serious. Tell your doctor immediately if you develop any of the following signs of infection: persistent sore throat/fever, night sweats, flu-like symptoms, painful urination, vision changes, a sore or wound on the skin that feels warm/tender/painful and appears reddened.

This drug increases the risk of a rare and possibly fatal brain infection (PML - progressive multifocal leukoencephalopathy). Tell your doctor right away if you have any of these symptoms: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, difficulty speaking.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, fast/irregular heartbeat, muscle weakness, easy bleeding/bruising, swelling of the feet or ankles, mental/mood changes, weakness on one side of the body, unusual change in the amount of urine.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds, shortness of breath/rapid breathing.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking mycophenolate mofetil, tell your doctor or pharmacist if you are allergic to it; or to mycophenolic acid, or mycophenolate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: any type of cancer, kidney disease, liver disease (e.g., hepatitis B, hepatitis C), current/past infections (e.g., herpes, shingles), stomach/intestinal problems (e.g., ulcers), rare genetic disorders (e.g., Lesch-Nyhan or Kelley-Seegmiller syndromes).

This medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist regarding the safe use of this medicine.

If you had a kidney transplant and the new kidney does not work properly even though you are taking this medication, the amount of mycophenolate in your body may increase, which can result in increased side effects.

Mycophenolate may cause swelling and growth of the gums (gingival hyperplasia). Brush and floss your teeth daily, and see your dentist regularly.

Because this medication may increase your risk of developing skin cancers, it is best to avoid prolonged sun exposure, tanning booths and sunlamps while you are using this medication. Use a sunscreen and wear protective clothing when outdoors.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

Avoid contact with people have the flu or any other infection.

Notify your doctor if you are scheduled for any kind of test or surgery involving your colon (e.g., colonoscopy, abdominal surgery) that requires cleaning out your colon before the procedure. Removing the bacteria in your digestive tract can decrease the amount of mycophenolate in your body.

Caution is advised when using this drug in the elderly because they are less able to remove this drug from their bodies, and therefore may be more sensitive to its effects.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Women of childbearing age should talk to their doctor(s) about the benefits and risks (such as miscarriage). Women of childbearing age should have a pregnancy test before starting this medication, after 8-10 days on treatment, and during routine follow-up visits. Also, use reliable forms of birth control during treatment, and continue for at least 6 weeks after mycophenolate is stopped. Consult your doctor for more details.

It is not known whether this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug and for 6 weeks after stopping mycophenolate. If you must take the drug while you are producing milk, but wish to resume breast-feeding six weeks after treatment is finished, pump your breast milk and discard. Consult your doctor for more details.

Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: antacids containing aluminum and/or magnesium, antivirals (e.g., acyclovir, ganciclovir, valganciclovir), azathioprine, calcium-free phosphate binders (e.g., aluminum products, lanthanum, sevelamer), cholestyramine, colestipol, live vaccines, rifampin, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. If you are using hormonal birth control, you should use an additional non-hormonal form of birth control while using this medication. Discuss your options with your doctor or pharmacist. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood counts, drug levels, kidney function, pregnancy test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Do not change brands or forms of mycophenolate unless directed by your doctor.

Attend a transplant education class or support group. Learn to recognize the signs and symptoms of organ rejection. Seek immediate medical attention if they occur.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store the mixed US product at room temperature or in a refrigerator between 36 and 86 degrees F (2 and 30 degrees C) for no longer than 60 days.

Store the mixed Canadian product at room temperature between 59 and 86 degrees F (15 and 30 degrees C) for no longer than 60 days.

Do not freeze. Discard any unused portion of the bottle. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.

Images

CELLCEPT 500 MG TABLET
CELLCEPT 500 MG TABLET
View Larger Picture
color
lavender
shape
oblong
imprint
CellCept 500, Roche
CELLCEPT 500 MG TABLET
CELLCEPT 500 MG TABLET

Identification

color
lavender
shape
oblong
imprint
CellCept 500, Roche
This medicine is a lavender, oblong, film-coated tablet imprinted with "CellCept 500" and "Roche".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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