Mycophenolic Acid

Mycophenolic Acid is a prescription medication used to prevent organ rejection after a kidney transplant.

• Mycophenolic Acid is available under various brand names: Myfortic 

Common side effects of Mycophenolic Acid include:

• upset stomach, nausea, vomiting.
• diarrhea, constipation.
• low blood cell counts and infections.
• sleep problems (insomnia);
• pain after surgery.
• painful urination; or
• sore throat.

Serious side effects of Mycophenolic Acid include:

• hives. 
• difficult breathing. 
• swelling of the face, lips, tongue, or throat.
• fever, swollen glands, painful mouth sores, cold or flu symptoms, headache, and ear pain.
• stomach pain, vomiting, diarrhea, and weight loss.
• weakness on one side of your body, loss of muscle control.
• confusion, thinking problems, and 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; 
• a new skin lesion, or a mole that has changed in size or color.
• bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds.
• signs of shingles--flu-like symptoms, tingly or painful blistering rash on one side of your body; 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.

Rare side effects of Mycophenolic Acid include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule

• 250 mg (generic; MMF)

Tablet

• 500 mg (generic, CellCept; MMF)

Oral suspension

• 200 mg/mL (generic, CellCept; MMF)

Powder for injection

• 500 mg/vial (generic, CellCept; MMF)

Tablet, delayed release (generic, Myfortic, MPA)

• 180 mg
• 360 mg

Kidney Transplant

Adult dosage

• Mycophenolate mofetil (MMF): 1 g orally/Intravenous every 12 hours, infused over above 2 hours
• Mycophenolic Acid (MPA): 720 mg orally every 12 hours

Pediatric dosage

Mycophenolate mofetil (MMR; CellCept)

• Children below 3 months: Safety and efficacy not established
• Children above 3 months
  • Suspension: 600 mg/m2 orally every 12 hours; not to exceed 2 g/day  
  • Capsules; BSA 1.25-1.5 m2: 750 mg capsule orally every 12 hours
  • Capsules or tablets; BSA above 1.5 m2: 1 g capsule/tablet orally every 12 hours

Mycophenolic Acid (MPA; Myfortic)

• Aged children below 5 years: Safety and efficacy not established
• Aged children above 5 years who are at least 6 months post kidney transplant
• Extended-release tablets: 400 mg/m2 orally every 12 hours; not to exceed 720 mg every12hours

Heart Transplant

Adult dosage

• MMF: 1.5 g orally/Intravenous every 12 hours, infused over above 2 hours

Pediatric dosage

CellCept only

• Suspension: 600 mg/m2 orally every 12 hours; if tolerated, may increase the dose to the maintenance of 900 mg/m2 two times a day (not to exceed 3 g/day)
• Capsules; BSA 1.25 to below 1.5 m2: 750 mg capsule orally every12hours initially; may increase maintenance dose, not to exceed 3 g/day
• Capsules or tablets; BSA below 1.5 m2: 1 g capsule/tablet orally every12hours initially; may increase maintenance dose, not to exceed 3 g/day

Liver Transplant

Adult dosage

• MMF (IV): 1 g every12hours; infused over above 2 hours
• MMF (Oral): 1.5 g every 12 hours

Pediatric dosage

CellCept only

• Suspension: 600 mg/m2 orally every12hours; if tolerated, may increase the dose to the maintenance of 900 mg/m2 two times a day (not to exceed 3 g/day)
• Capsules; BSA 1.25 to below 1.5 m2: 750 mg capsule orally every12hours initially; may increase maintenance dose, not to exceed 3 g/day
• Capsules or tablets; BSA above 1.5 m2: 1 g capsule/tablet orally every12hours initially; may increase maintenance dose, not to exceed 3 g/day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Mycophenolic Acid has severe interactions with the following drugs:
• cholestyramine
• colestipol
• Mycophenolic Acid has serious interactions with at least 86 other drugs.
• Mycophenolic Acid has moderate interactions with at least 107 other drugs.
• Mycophenolic Acid has minor interactions with the following drugs:
• bazedoxifene/conjugated estrogens
• conjugated estrogens
• conjugated estrogens, vaginal
• estradiol
• estrogens conjugated synthetic
• estrogens esterified
• estropipate
• mestranol
• phenytoin

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• You should not use this medicine if you are allergic to mycophenolate sodium, Mycophenolic Acid, or mycophenolate mofetil.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Mycophenolic Acid?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Mycophenolic Acid?”

Cautions

• 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 can get pregnant, you must use birth control during and shortly after treatment with Mycophenolic Acid.
• 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.
• 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.
• Mycophenolic Acid can make hormonal birth control (pills, injections, implants, skin patches, or vaginal rings) less effective. You must also use a backup barrier method (such as a cervical sponge, a male or female condom, or a diaphragm or cervical cap used together with spermicide).
• Sexually active men and their partners should use effective contraception during treatment and for at least 90 days after the last dose.
• 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.
• Mycophenolic Acid is not approved for use in kidney transplants by anyone younger than 5 years old.

Pregnancy and Lactation

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