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What is mycophenolate mofetil?Mycophenolate Mofetil

Mycophenolate mofetil is used with other medicines to prevent organ rejection after a kidney, liver, or heart transplant. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Mycophenolate mofetil may also be used for purposes not listed in this medication guide.

Important Information

mycophenolate mofetil can cause a miscarriage or birth defects when used during pregnancy. Both men and women using mycophenolate mofetil should use effective birth control to prevent pregnancy.

Mycophenolate mofetil 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 symptoms such as: fever, swollen glands, night sweats, weight loss, vomiting or diarrhea, burning when you urinate, a new skin lesion, any change in your mental state, weakness on one side of your body, problems with speech or vision, or tenderness near your transplanted kidney.

Before taking this medicine

You should not use mycophenolate mofetil if you are allergic to it, mycophenolic acid (Myfortic), or to an ingredient called Polysorbate 80.

Talk with your doctor about the risks and benefits of mycophenolate mofetil. This medicine can affect your immune system, and may cause overproduction of certain white blood cells. This can lead to cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure.

Tell your doctor if you have ever had:

  • a stomach ulcer or problems with digestion;
  • diabetes;
  • hepatitis B or C;
  • phenylketonuria, or PKU (the liquid form of this medicine may contain phenylalanine); or
  • a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

Mycophenolate mofetil can cause a miscarriage or birth defects if the mother or the father is using this medicine.

  • If you are a woman, do not use mycophenolate mofetil if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 weeks after your last dose.
  • If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 90 days after your last dose.
  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using mycophenolate mofetil.

You may need to have a negative pregnancy test before starting this treatment.

Mycophenolate mofetil can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy.

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).

You should not breastfeed while using mycophenolate mofetil.

Mycophenolate mofetil is not approved for use for heart or liver transplants by anyone younger than 18 years old. This medicine is not approved for use for kidney transplants by anyone younger than 3 months old.

How should I use mycophenolate mofetil?

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 mycophenolate mofetil.

Mycophenolate mofetil injection is given as an infusion into a vein. 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.

Swallow the capsule whole and do not crush, chew, break, or open it. Tell your doctor if you have trouble swallowing a tablet or capsule.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Your dose needs may change if you switch to a different brand, strength, or form of mycophenolate mofetil. Avoid medication errors by using only the form and strength your doctor prescribes.

You will need frequent medical tests.

If you’ve ever had hepatitis B or C, using mycophenolate mofetil 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. 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 medicine as soon as you can, but skip the missed dose if it is less than 2 hours away for your next dose. Do not use 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 using mycophenolate mofetil?

Avoid driving or hazardous activity until you know how mycophenolate mofetil will affect you. Your reactions could be impaired.

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

Do not receive a “live” vaccine while using mycophenolate mofetil. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Mycophenolate mofetil 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.

Mycophenolate mofetil side effects

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

Mycophenolate mofetil 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;
  • a blood infection (sepsis)–fever, flu symptoms, mouth and throat ulcers, rapid heart rate, shallow breathing; or
  • low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

  • stomach pain, nausea, vomiting, diarrhea, constipation;
  • swelling in your ankles or feet;
  • rash;
  • headache, dizziness, tremors;
  • fever, sore throat, cold symptoms, or other signs of infections;
  • high blood sugar;
  • abnormal blood tests;
  • pain anywhere in your body;
  • low blood cell counts; or
  • increased blood pressure or heart rate.

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.

Mycophenolate mofetil dosing information

Usual Adult Dose for Organ Transplant — Rejection Prophylaxis:

-RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day); [in clinical trials, 1.5 g orally or IV 2 times a day (3 gm per day) was used effectively, however, the safety profile for 3 gm a day was lower]
-CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day)
-HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV)

Comments:
-This drug should be used concomitantly with cyclosporine and corticosteroids.
-The IV formulation should be administered over no less than 2 hours.
-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Usual Geriatric Dose for Organ Transplant — Rejection Prophylaxis:

-RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day)
-CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day)
-HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV)

Comments:
-This drug should be used concomitantly with cyclosporine and corticosteroids.
-The IV formulation should be administered over no less than 2 hours.
-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Usual Pediatric Dose for Organ Transplant — Rejection Prophylaxis:

-RENAL TRANSPLANTATION:
3 months to 18 years of age:
Oral Suspension: 600 mg/m2 orally 2 times a day up to a maximum of 2 grams per day
-Pediatric patients with a body surface area of 1.25 to 1.5 m2 may be dosed with the oral capsules at 750 mg orally 2 times a day (1.5 g per day)
-Pediatric patients with a body surface area greater than 1.5 m2 may be dosed with the oral capsules at 1 g orally 2 times a day (2 g per day)

Comments:
-This drug should be used concomitantly with cyclosporine and corticosteroids.
-The IV formulation should be administered over no less than 2 hours.-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

What other drugs will affect mycophenolate mofetil?

If you take sevelamer or an antacid, take your oral mycophenolate mofetil dose 2 hours before you take these other medicines.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

  • azathioprine;
  • birth control pills or hormone replacement therapy;
  • cholestyramine;
  • antiviral medicine–acyclovir, ganciclovir, valacyclovir, valganciclovir;
  • an antibiotic–amoxicillin, ciprofloxacin, metronidazole, norfloxacin, rifampin, sulfa drugs (SMX-TMP or SMZ-TMP, and others); or
  • a stomach acid reducer–esomeprazole, lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

This list is not complete. Other drugs may affect mycophenolate mofetil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer:

Information on this page is provided for general information purposes. You should not make a clinical treatment decision based on information contained in this page without consulting other references including the package insert of the drug, textbooks and where relevant, expert opinion. We cannot be held responsible for any errors you make in administering drugs mentioned on this page, nor for use of any erroneous information contained on this page.

External Link

Mycophenolate mofetil (oral/injection). (n.d.). Drugs.Com. https://www.drugs.com/mtm/mycophenolate-mofetil-oral-injection.html