What is the most important information I should know about mycophenolic acid?
Mycophenolic acid 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, vomiting, diarrhea, painful urination, easy bruising or bleeding, mouth sores, a new skin lesion, skin sores that are red or oozing, any change in your mental state, weakness on one side of your body, or tenderness near your transplanted kidney.
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 mycophenolic acid.
What is mycophenolic acid?
Mycophenolic acid 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.
Mycophenolic acid is used with other medicines to prevent organ rejection after a kidney transplant.
Mycophenolic acid may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking mycophenolic acid?
You should not use this medicine if you are allergic to mycophenolic acid or mycophenolate mofetil (CellCept).
Mycophenolic acid affects your immune system, and may cause certain white blood cells to grow out of control. This can lead to cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure. Talk with your doctor about the risks of using this medicine.
Tell your doctor if you have ever had:
- a stomach ulcer or problems with digestion;
- hepatitis B or C;
- 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 this medicine. If you are able to get pregnant, you must use specific forms of birth control to prevent pregnancy while using mycophenolic acid, 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.
Mycophenolic acid can make hormonal birth control (pills, injections, implants, skin patches, or vaginal rings) less effective. 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 taking mycophenolic acid. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191).
Mycophenolic acid 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 mycophenolic acid.
How should I take mycophenolic acid?
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 mycophenolic acid.
Take mycophenolic acid on an empty stomach, at least 1 hour before or 2 hours after a meal.
Swallow the tablet whole and do not crush, chew, or break it.
Mycophenolic acid (Myfortic) and mycophenolate mofetil (CellCept) 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.
You will need frequent medical tests.
If you have ever had hepatitis B or C, mycophenolic acid 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.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take 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 taking mycophenolic acid?
Avoid taking an antacid together with mycophenolic acid.
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 mycophenolic acid. 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).
Mycophenolic acid 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 mycophenolic acid?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Mycophenolic acid 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; 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.
Side effects may be more likely in older adults.
Common side effects may include:
- indigestion, nausea, vomiting;
- diarrhea, constipation;
- low blood cell counts;
- sleep problems (insomnia); or
- pain after surgery.
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 mycophenolic acid?
Tell your doctor about all your other medicines, especially:
- azathioprine;
- cholestyramine; or
-
antiviral medicine --acyclovir, ganciclovir.
This list is not complete. Other drugs may affect mycophenolic acid, including 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 mycophenolic acid.
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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