Generic Name: mycophenolic acid (MYE koe phe NOLE ik AS id)
Brand Names: Myfortic
Mycophenolic acid lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.
Mycophenolic acid is used to prevent your body from rejecting a kidney transplant. This medication is usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication.
Mycophenolic acid may also be used for other purposes not listed in this medication guide.
If you are a woman of child-bearing potential, you will be required to use two forms of birth control to prevent pregnancy before and during your treatment with mycophenolic acid, and for at least 6 weeks after your treatment ends. You will also need to have a negative pregnancy test within 1 week before you start using this medication.
Tell your doctor right away if you become pregnant while using mycophenolic acid.Although mycophenolic acid can cause harm to an unborn baby, not treating the mother after a transplant could pose a greater risk to the mother's health. Mycophenolic acid 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.
Using mycophenolic acid can make it easier for you to bleed from an injury or get sick from being around others who are ill. You may also have an increased risk of certain forms of cancer. Your blood will need to be tested on a weekly or monthly basis while using this medication. Do not miss any scheduled appointments.
Do not crush, chew, or break an enteric-coated pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating.Before using mycophenolic acid, 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 mycophenolic acid 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 mycophenolic acid. 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 mycophenolic acid, and for at least 6 weeks after your treatment ends. Tell your doctor right away if you become pregnant. Mycophenolic acid 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 mycophenolic acid 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. Mycophenolic acid 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 mycophenolic acid during pregnancy. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether mycophenolic acid had any effect on the baby.
It is not known whether mycophenolic acid passes into breast milk or if it could harm a nursing baby. Do not breast-feed a baby while taking mycophenolic acid and for at least 6 weeks after your treatment ends.Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Mycophenolic acid is usually given twice a day. Follow your doctor's instructions.
Take mycophenolic acid on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not crush, chew, cut, or break an enteric-coated pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating.Mycophenolic acid (Myfortic) tablets and mycophenolate mofetil (CellCept) capsules 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. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.
Mycophenolic acid can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. You may also have an increased risk of certain forms of cancer. To be sure your blood cells do not get too low, your blood will need to be tested on a weekly or monthly basis. Do not miss any scheduled appointments.
Store mycophenolic acid at room temperature away from moisture and heat.Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
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 mycophenolic acid. The live vaccine may not work as well during your treatment, and may not fully protect you from disease. You may still be able to receive a flu shot, but ask your doctor first.Avoid taking an antacid together with mycophenolic acid. Antacids contain different medicines and some types can make it harder for your body to absorb mycophenolic acid.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Mycophenolic acid can increase your risk of skin cancer. Use a sunscreen (minimum SPF 30) and wear protective clothing if you must be out in the sun.fever, chills, body aches, flu symptoms, mouth sores, white patches in your mouth or throat;
pale skin, easy bruising or bleeding, unusual weakness, trouble breathing, fast heart rate;
coughing up blood or vomit that looks like coffee grounds;
bloody, black, or tarry stools;
painful or difficult urination;
thirst, increased urination, hot and dry skin;
chest pain;
feeling like you might pass out;
high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
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, constipation, upset stomach;
headache, dizziness, blurred vision;
swelling in your hands or feet;
joint or muscle pain, back pain;
runny or stuffy nose, cough;
anxiety, sleep problems (insomnia); or
weight gain.
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.
Usual Adult Dose for Rejection Prophylaxis:
Dose: 720 mg twice a day
Doses should be taken on an empty stomach, one hour before or two hours after food intake.
Usual Geriatric Dose for Rejection Prophylaxis:
Dose: 720 mg twice a day
Doses should be taken on an empty stomach, one hour before or two hours after food intake.
The maximum dosage recommended for use in geriatric patients is 720 mg twice a day.
Usual Pediatric Dose for Rejection Prophylaxis:
5 years to 16 years:
Dose: 400 mg/m2 twice a day (up to a maximum of 720 mg twice a day)
Pediatric doses for patients with a body surface area less than 1.19 m2 cannot be accurately administered using currently available formulations of the delayed-release tablets.
Before using mycophenolic acid, tell your doctor if you are using any of the following drugs:
cholestyramine (Questran), colesevelam (Welchol), or colestipol (Colestid);
acyclovir (Zovirax) or ganciclovir (Cytovene); or
other medicines that weaken the immune system, such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), or mycophenolate mofetil (CellCept).
This list is not complete and there may be other drugs that can interact with mycophenolic acid. 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.