What is the most important information I should know about mycophenolate mofetil?
This medicine can cause a miscarriage or birth defects, especially if used during the first 3 months of pregnancy. If you are a woman of child-bearing potential, you must use specific types of birth control to prevent pregnancy before, during, and shortly after treatment with mycophenolate mofetil.
Mycophenolate mofetil is sometimes given to pregnant women. Although this medicine can affect pregnancy or fertility, it is sometimes given to women who are unable to use other needed transplant medications.
Using mycophenolate mofetil may increase your risk of developing serious infections or other types of cancer, such as lymphoma or skin cancer. You must remain under the care of a doctor while you are using mycophenolate mofetil.
What is mycophenolate mofetil?
Mycophenolate mofetil is an immunosuppressant. Your body may "reject" an organ transplant when the immune system treats the new organ as an invader. An immunosuppressant helps to prevent this rejection.
Mycophenolate mofetil is used to prevent your body from rejecting a kidney, liver, or heart transplant. This medicine is usually given with cyclosporine and a steroid medicine.
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.
Using mycophenolate mofetil may increase your risk of developing serious infections or other types of cancer, such as lymphoma or skin cancer. Ask your doctor about your specific risk.
To make sure mycophenolate mofetil is safe for you, tell your doctor if you have:
- a stomach ulcer or other disorder of your stomach or intestines;
- a viral, bacterial, or fungal infection; or
- a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.
This medicine can cause a miscarriage or birth defects, especially during the first 3 months of pregnancy. You will need to have a negative pregnancy test before and during treatment with mycophenolate mofetil. You must prevent pregnancy before and during your treatment with mycophenolate mofetil, and for at least 6 weeks after your treatment ends.
If you are a woman of child-bearing potential, you will be required to use birth control. You have child-bearing potential (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.
Mycophenolate mofetil can make hormonal birth control (pills, injections, implants, skin patches, or vaginal rings) less effective. If you use hormonal birth control, you must also use a back-up barrier method (such as a cervical sponge, a male or female condom, or a diaphragm or cervical cap used together with spermicide).
You do not need to use additional birth control if you use an intrauterine device (IUD), if you have had a tubal ligation, or if your sexual partner has had a vasectomy.
This medicine comes with patient instructions about the most effective non-hormonal forms of birth control to use. Follow these directions carefully. 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 pregnant or planning to become pregnant. Although this medicine can affect pregnancy or fertility, it is sometimes given to women who are unable to use other needed transplant medications.
It is not known whether mycophenolate mofetil passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
The liquid form may contain phenylalanine. Talk to your doctor before using this form of mycophenolate mofetil if you have phenylketonuria (PKU).
How should I use mycophenolate mofetil?
You must remain under the care of a doctor while you are using mycophenolate mofetil. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
The injection form of mycophenolate mofetil is injected into a vein through an IV. 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.
Do not crush, chew, break, or open a mycophenolate mofetil capsule or tablet. Swallow it whole.
Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
Mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic) are not absorbed equally in the body. If you are switched from one brand to the other, take only the pills your doctor has prescribed. Always check your refills to make sure you have received the correct brand and type of medicine.
You will need regular medical tests to be sure this medicine is not causing harmful effects.
If you have ever had hepatitis B or C, mycophenolate mofetil can cause this condition to come back or get worse. You may need blood tests to check your liver function.
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 missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
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), zoster (shingles), and nasal flu (influenza) vaccine.
Avoid taking an antacid together with mycophenolate mofetil. If you also take sevelamer, take it at least 2 hours after you take oral mycophenolate mofetil.
Avoid exposure to sunlight or tanning beds. Mycophenolate mofetil can increase your risk of developing skin cancer. 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 any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Mycophenolate mofetil can lower blood cells that help your body fight infection. This can lead to serious conditions including herpes, shingles, hepatitis, blood or tissue infections, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure. Call your doctor right away if you have:
- diarrhea, stomach pain, nausea, vomiting, 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;
- fever, night sweats, tiredness, painful mouth sores, flu symptoms;
- runny or stuffy nose, cough, sore throat, ear pain, headache;
- pale skin, feeling light-headed or short of breath, easy bruising or bleeding (nosebleeds, bleeding gums);
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- pain or burning when you urinate;
- swelling, warmth, redness, or oozing around a skin wound; or
- a new bump or lesion on your skin, or a mole that has changed in size or color.
Common side effects may include:
- nausea, vomiting, diarrhea;
- swelling in your ankles or feet; or
- high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, shortness of breath).
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?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with mycophenolate mofetil, especially:
- azathioprine;
- cholestyramine;
- an antiviral medicine--acyclovir, ganciclovir, valacyclovir;
- an antibiotic--amoxicillin, ciprofloxacin, metronidazole, norfloxacin, rifampin;
- stomach acid reducers--lansoprazole (Prevacid), pantoprazole (Protonix), and others; or
- a sulfa drug (Bactrim, Septra, SMX-TMP or SMZ-TMP, and others).
This list is not complete. Other drugs may interact with mycophenolate mofetil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
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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