Mycophenolate Treatment Report

Precautions

Instructions

Side Effects

Interactions

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

Before using mycophenolate mofetil, tell your doctor if you are allergic to any drugs, or if you have:

• a stomach ulcer or other disorders of your stomach or intestines;
• kidney disease;
• a viral, bacterial, or fungal infection; or
• a rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category D. This medication can cause harm to an unborn baby, especially if used during the first trimester of pregnancy. Do not use mycophenolate mofetil without telling your doctor if you are pregnant or if you plan to become pregnant during treatment.

If you are a woman of child-bearing potential, you will be required to receive contraceptive counseling and to start using two forms of birth control 4 weeks before the start of your treatment with mycophenolate mofetil. You will also need to have a negative pregnancy test within 1 week before your treatment begins.

Unless you have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. Adolescent girls who have entered puberty are also considered to be of child-bearing potential, even if not yet sexually active.

Use two non-hormone forms of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy before and during your treatment with mycophenolate mofetil, and for at least 6 weeks after your treatment ends. Tell your doctor right away if you become pregnant.

Mycophenolate mofetil can make birth control pills less effective. Ask your doctor about the most effective non-hormonal forms of birth control and which two are best for you.

Although mycophenolate mofetil can cause harm to an unborn baby, not treating the mother with this medication after a transplant could pose a greater risk to the mother’s health. Mycophenolate mofetil is sometimes given to pregnant women who are unable to take other needed transplant medications. Your doctor will decide whether you should receive this medication.

Your name may need to be listed on a national transplant pregnancy registry if you use mycophenolate mofetil during pregnancy. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether mycophenolate mofetil had any effect on the baby.

It is not known whether mycophenolate mofetil passes into breast milk or if it could harm a nursing baby. Do not use mycophenolate mofetil without telling your doctor if you are breast-feeding a baby.

The oral liquid form of this medication may contain phenylalanine. Talk to your doctor before using this form of mycophenolate mofetil if you have phenylketonuria (PKU).

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live” vaccine while you are being treated with mycophenolate mofetil. The live vaccine may not work as well during your treatment, and may not fully protect you from disease.

Avoid using antacids without your doctor’s advice while using mycophenolate mofetil. Antacids contain different medicines and some types can make it harder for your body to absorb mycophenolate mofetil.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Mycophenolate mofetil can increase your risk of skin cancer. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

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Use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

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

Stop using mycophenolate mofetil and call your doctor at once if you have any of these serious side effects:

• fever, chills, body aches, flu symptoms;
• easy bruising or bleeding, unusual weakness;
• coughing up blood or vomit that looks like coffee grounds;
• bloody, black, or tarry stools;
• painful or difficult urination;
• chest pain;
• feeling like you might pass out;
• problems with vision, speech, balance, or memory; or
• weakness in your legs, lack of coordination.

Less serious side effects may include:

• nausea, vomiting, stomach pain, diarrhea, or constipation;
• headache, mild weakness;
• swelling in your hands or feet;
• numbness or tingly feeling; or
• anxiety, sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Before using mycophenolate mofetil, tell your doctor if you are using any of the following drugs:

• cholestyramine (Questran);
• any type of antibiotic;
• acyclovir (Zovirax), ganciclovir (Cytovene), or valacyclovir (Valtrex); or
• other medicines that weaken the immune system, such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), tacrolimus (Prograf), or daclizumab (Zenapax).

This list is not complete and there may be other drugs that can interact with mycophenolate mofetil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

CellCept and mycophenolate mofetil

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