mycophenolate mofetil (oral/injection)

Pronunciation: MYE koe FEN oh late MOE fe til

Brand: CellCept

Cellcept 250 mg

slide 1 of 4, Cellcept 250 mg,

capsule, blue/brown, imprinted with CellCept 250, Roche

Image of Cellcept 250 mg
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CellCept 500 mg

slide 2 of 4, CellCept 500 mg,

oval, purple, imprinted with CellCept 500, Roche

Image of CellCept 500 mg
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Mycophenolate 250 mg-APO

slide 3 of 4, Mycophenolate 250 mg-APO,

capsule, blue/pink, imprinted with APO, M250

Image of Mycophenolate 250 mg-APO
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Mycophenolate 500 mg-APO

slide 4 of 4, Mycophenolate 500 mg-APO,

oval, purple, imprinted with APO, MYC500

Image of Mycophenolate 500 mg-APO
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What is the most important information I should know about mycophenolate mofetil?

Mycophenolate mofetil may cause your body to overproduce white blood cells. This can lead to cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure.

Call your doctor right away if you have: fever, swollen glands, flu symptoms, night sweats, weight loss, vomiting, diarrhea, painful urination, a new skin lesion, any change in your mental state, weakness on one side of your body, or loss of muscle control.

This medicine can cause a miscarriage or birth defects when used during the first 3 months of pregnancy. If you are able to get pregnant, you must use birth control during and shortly after treatment with mycophenolate mofetil.

What is mycophenolate mofetil?

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.

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

Mycophenolate mofetil may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using mycophenolate mofetil?

You should not use this medicine 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, or a viral infection causing kidney transplant failure.

Tell your doctor if you have ever had:

  • a stomach ulcer or problems with digestion;
  • hepatitis B or C;
  • phenylketonuria (the liquid form of this medicine may contain phenylalanine); or
  • a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

Mycophenolate mofetil can cause a miscarriage or birth defects when used during the first 3 months of 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.

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.

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.

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

Mycophenolate mofetil is sometimes given to pregnant women. Your doctor will decide whether you should use this medicine if you are are unable to use other needed transplant medications.

You should not breast-feed while using mycophenolate mofetil.

How should I use mycophenolate mofetil?

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 mycophenolate mofetil.

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

Take oral mycophenolate mofetil on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the pill 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 mycophenolate mofetil, you may need frequent blood tests.

If you've ever had hepatitis B or C, using mycophenolate mofetil can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine 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.

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

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 mycophenolate mofetil?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

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).

Mycophenolate mofetil 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.

What are the possible side effects of mycophenolate mofetil?

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

Mycophenolate mofetil 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;
  • increased blood pressure --severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
  • low blood cell counts --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 side effects may include:

  • stomach pain, nausea, vomiting, diarrhea;
  • swelling in your ankles or feet;
  • fever, sore throat, or other signs of infections;
  • low blood cell counts; or
  • increased blood pressure.

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 mycophenolate mofetil?

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

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

  • azathioprine;
  • cholestyramine;
  • 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 --esomeprazole, lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

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

Where can I get more information?

Your doctor or pharmacist can provide more information about mycophenolate mofetil.

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

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