Mycophenolic acid

Mycophenolic acid is used with other medicines to help stop the body from rejecting a kidney transplant. mycophenolic acid is for adults and children who are at least 5 years old.

Mycophenolic acid may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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. Avoid medication errors by using only the brand, form, and strength of this medicine that your doctor has prescribed.

You will need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

mycophenolic acid can cause a miscarriage or birth defects when used during pregnancy. Both men and women should use effective birth control to prevent pregnancy during and shortly after treatment with mycophenolic acid.

Using mycophenolic acid may increase your risk of cancer, serious infections, or kidney transplant failure.

Call your doctor right away if you have symptoms such as: fever, swollen glands, weight loss, vomiting or diarrhea, painful urination, a new skin lesion, any change in your mental state, weakness on one side of your body, or pain near your transplanted kidney.

You should not use this medicine if you are allergic to mycophenolic acid, mycophenolate mofetil, or mycophenolate sodium.

Talk with your doctor about the risks and benefits of mycophenolic acid. This medicine can affect your immune system, which may increase your risk of cancer, serious or fatal infections, or kidney transplant failure.

Tell your doctor if you have ever had:

• a stomach ulcer or problems with digestion;
• hepatitis B or C or another viral infection (may become active or get worse while you are using mycophenolic acid); 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 can 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.

Sexually active men and their partners should use effective contraception during treatment and for at least 90 days after the last dose.

Mycophenolic acid can make birth control pills less effective. Ask your doctor about using an additional barrier form of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy.

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 unable to use other needed transplant medications.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

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

Mycophenolic acid may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have issues with speech, thought, vision, or muscle movement. These symptoms may start slowly and worsen quickly.

Mycophenolic acid affects your immune system and may increase your risk of cancer or serious infection. Call your doctor right away if you have:

• fever of 100.5 degrees F or higher, 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, problems with thinking, loss of interest in things you usually enjoy;
• pain or burning when you urinate;
• dark urine, jaundice (yellowing of the skin or eyes);
• pain or tenderness around the transplanted kidney;
• tingly or painful blistering rash on one side of your body;
• 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 right away 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.

Common side effects of mycophenolic acid may include:

• upset stomach, nausea, vomiting;
• diarrhea, constipation;
• low blood cell counts, infections;
• sleep problems (insomnia);
• painful urination; 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.

Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis:

720 mg orally 2 times dailyComments:-This drug should be used in combination with cyclosporine and corticosteroids.-Take on an empty stomach 1 hour before or 2 hours after food.-Swallow tablets whole; do not crush, chew, or divide.Use: For prophylaxis of organ rejection in kidney transplant

Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis:

5 years and older:-In conversion (at least 6 months posttransplant): 400 mg/m2 orally 2 times a day (up to a maximum dose of 720 mg 2 times a day)Note: Pediatric patients with a BSA of 1.19 to 1.58 m2 may be dosed either with three of the 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet 2 times a day. Patients with a BSA greater than 1.58 m2 may be dosed either with four of the 180 mg tablets, or two of the 360 mg tablets twice daily. Pediatric doses for patients with BSA less than 1.19 m2 cannot be accurately administered using currently available formulations of this drug.Comments:-This drug should be used in combination with cyclosporine and corticosteroids.-Take on an empty stomach 1 hour before or 2 hours after food.-Swallow tablets whole; do not crush, chew, or divide.Use: For the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking an antacid together with mycophenolic acid.

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.

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, and varicella (chickenpox).

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

You must not donate blood or sperm while using mycophenolic acid, and for at least 6 weeks (for blood) or 90 days (for sperm) after your last dose.

Tell your doctor about all the other medicines you are taking, 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.