What is mycophenolate mofetil (oral/injection)?
Mycophenolate mofetil 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.
Mycophenolate mofetil is used to prevent your body from rejecting a kidney, liver, or
heart transplant. This medication is usually given with cyclosporine (Sandimmune, Neoral) and a
steroid medication.
Mycophenolate mofetil may also be used for other purposes not listed in this medication
guide.
What should I discuss with my healthcare provider before taking mycophenolate mofetil (oral/injection)?
You should not use this medication if you are allergic to mycophenolate mofetil,
mycophenolic acid (Myfortic), or to an ingredient called Polysorbate 80.
Before using mycophenolate mofetil, 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 mycophenolate
mofetil 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 mycophenolate mofetil. 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 mycophenolate mofetil, and for at least 6 weeks after your treatment ends. Tell
your doctor right away if you become pregnant.
Mycophenolate mofetil 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 mycophenolate mofetil 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.
Mycophenolate mofetil 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
mycophenolate mofetil during pregnancy. The purpose of this registry is to track the outcome of
the pregnancy and delivery to evaluate whether mycophenolate mofetil had any effect on the
baby.
It is not known whether mycophenolate mofetil passes into breast milk or if it could
harm a nursing baby. Do not use mycophenolate mofetil without telling your doctor if you are
breast-feeding a baby.
The oral liquid form of this medication may contain phenylalanine. Talk to your doctor
before using this form of mycophenolate mofetil if you have phenylketonuria (PKU).
How should I take mycophenolate mofetil (oral/injection)?
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.
Mycophenolate mofetil is usually given twice a day. Follow your doctor's instructions.
The injection form of this medication is given through a needle placed into a vein. The medicine
must be given slowly through an IV infusion, and can take at least 2 hours to complete.
Mycophenolate mofetil injection is usually given within 24 hours after your transplant.
You may be given the injection for up to 14 days before you switch to the oral (pill) form of
mycophenolate mofetil.
Take the pill form of this medicine with a full glass of water.
Take mycophenolate mofetil on an empty stomach, at least 1 hour before or 2 hours
after a meal.
Shake the mycophenolate mofetil oral liquid well just before you measure a dose. To
be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine
cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your
pharmacist for one.
Do not open the mycophenolate mofetil capsule or crush or chew a tablet. Do not use
a pill that has been accidentally broken. The medicine from a crushed or broken pill can be
dangerous if it gets in your eyes, mouth, or nose, or on your skin. If it does come in contact with
these areas, wash your skin with soap and water or rinse your eyes with water. Ask your doctor
or pharmacist how to safely handle and dispose of a broken tablet or capsule.
Mycophenolate mofetil 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.
If you need to have any type of surgery, tell the surgeon ahead of time that you are
using mycophenolate mofetil. You may need to stop using the medicine for a short time.
Store mycophenolate mofetil at room temperature away from moisture and heat. The
oral liquid may be stored at room temperature or in the refrigerator. Keep from freezing. Throw
away any unused liquid medicine that is older than 60 days.
What happens if I miss a dose of mycophenolate mofetil (oral/injection)?
Use the missed dose as soon as you remember. If it is almost time for your next dose,
skip the missed dose and use the medicine at the next regularly scheduled time.
Do not
use extra medicine to make up the missed dose.
Where can I get more information about mycophenolate mofetil (oral/injection)?
Your pharmacist has information about mycophenolate mofetil (oral/injection) written for health professionals that you may read.
What are the possible side effects of mycophenolate mofetil (oral/injection)?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using mycophenolate mofetil and call your doctor at once if you have any of
these serious side effects:
-
fever, chills, body aches, flu symptoms;
-
easy bruising or bleeding, unusual weakness;
-
coughing up blood or vomit that looks like coffee grounds;
-
bloody, black, or tarry stools;
-
painful or difficult urination;
-
chest pain;
-
feeling like you might pass out;
-
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, or constipation;
-
headache, mild weakness;
-
swelling in your hands or feet;
-
numbness or tingly feeling; or
-
anxiety, sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Tell
your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about mycophenolate mofetil (oral/injection)?
This medication can cause harm to an unborn baby, especially if used during the first
trimester of pregnancy.
Do not use mycophenolate mofetil 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 use two forms of
birth control to
prevent pregnancy
before and during your treatment with
mycophenolate mofetil, 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 mycophenolate
mofetil.
Although mycophenolate mofetil can cause harm to an unborn baby, not treating the
mother after a transplant could pose a greater risk to the mother's health. Mycophenolate mofetil
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 mycophenolate mofetil 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 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 open the mycophenolate mofetil capsule or crush or chew a tablet. Do not use
a pill that has been accidentally broken. The medicine from a crushed or broken pill can be
dangerous if it gets in your eyes, mouth, or nose, or on your skin.
What should I avoid while taking mycophenolate mofetil (oral/injection)?
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 mycophenolate
mofetil. The live vaccine may not work as well during your treatment, and may not fully protect
you from disease.
Avoid using antacids without your doctor's advice while using mycophenolate mofetil.
Antacids contain different medicines and some types can make it harder for your body to absorb
mycophenolate mofetil.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds).
Mycophenolate mofetil can increase your risk of skin cancer. Use a sunscreen (minimum SPF
15) and wear protective clothing if you must be out in the sun.
What other drugs will affect mycophenolate mofetil (oral/injection)?
Before using mycophenolate mofetil, tell your doctor if you are using any of the following
drugs:
-
cholestyramine (Questran);
-
any type of antibiotic;
-
acyclovir (Zovirax), ganciclovir (Cytovene), or valacyclovir
(Valtrex); or
-
other medicines that weaken the immune system, such as
azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), tacrolimus (Prograf), or daclizumab
(Zenapax).
This list is not complete and there may be other drugs that can interact
with mycophenolate mofetil. 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.
What happens if I have an overdose of mycophenolate mofetil (oral/injection)?
