What is the most important information I should know about mycophenolate mofetil?
This medicine 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.
What is mycophenolate mofetil?
Mycophenolate mofetil 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.
Mycophenolate mofetil is used with other medicines to prevent organ rejection after a kidney, liver, or heart transplant.
Mycophenolate mofetil may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using mycophenolate mofetil?
You should not use this medicine if you are allergic to mycophenolate mofetil, 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;
- 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 when used during 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 mycophenolate mofetil, 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.
If you are a man, use effective birth control if your sex partner is able to get pregnant. Mycophenolate mofetil can also harm an unborn baby if the father is using this medicine. Keep using birth control for at least 90 days after your last dose.
This medicine can make birth control pills less effective. Follow all patient instructions about using effective non-hormonal forms of birth control.
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).
Mycophenolate mofetil 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 mycophenolate mofetil.
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 pill whole and do not crush, chew, break, or open it.
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.
Mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic) 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'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 almost time 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?
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 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).
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.
What are the possible side effects of mycophenolate mofetil?
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;
-
increased blood pressure --severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; 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 may include:
- stomach discomfort, nausea, vomiting, diarrhea, constipation;
- swelling in your ankles or feet;
- rash;
- headache, dizziness, tremors;
- fever, sore throat, or other signs of infections;
- 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.
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.
Tell your doctor about all your current medicines. Many drugs can interact with mycophenolate mofetil, especially:
- azathioprine;
- cholestyramine;
-
antiviral medicine --acyclovir, ganciclovir, valacyclovir, valganciclovir;
-
an antibiotic --amoxicillin, ciprofloxacin, metronidazole, norfloxacin, rifampin, sulfa drugs (SMX-TMP or SMZ-TMP, and others); or
-
stomach acid reducers --esomeprazole, lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.
This list is not complete and many other drugs may affect mycophenolate mofetil. This includes 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 mycophenolate mofetil.
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.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2020 Cerner Multum, Inc. Version: 8.01. Revision date: 8/30/2018.
