Microsoft word - cellcept pi mg.doc
(mycophenolate mofetil capsules)
(mycophenolate mofetil tablets)
(mycophenolate mofetil for oral suspension)
(mycophenolate mofetil hydrochloride for injection)
Read the Medication Guide that comes with CellCept before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about
CellCept can cause serious side effects:
Increased risk of loss of a pregnancy (miscarriage) and higher
risk of birth defects.
Females who take CellCept during pregnancy
have a higher risk of miscarriage
during the first 3 months (first
trimester), and a higher risk that their baby will be born with birth
If you are a female who can become pregnant
your doctor must talk with you about acceptable birth control
methods (contraceptive counseling) to use while taking CellCept.
you should have one pregnancy test immediately before starting
CellCept and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests.
you must use acceptable birth control during your entire CellCept
therapy and for 6 weeks after stopping CellCept, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely.
CellCept decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take CellCept, and you could become pregnant. If you take birth control pills while using CellCept you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking CellCept.
If you plan to become pregnant, talk with your doctor. Your doctor will decide if other medicines to prevent rejection may be right for you.
If you become pregnant while taking CellCept, do not stop
taking CellCept. Call your doctor right away.
situations, you and your doctor may decide that taking CellCept is
more important to your health than the possible risks to your
You and your doctor should report your pregnancy to
Mycophenolate Pregnancy Registry (1-800-617-8191)
The purpose of this registry is to gather information about the
health of you and your baby.
Increased risk of getting serious infections.
CellCept weakens the
body’s immune system and affects your ability to fight infections. Serious infections can happen with CellCept and can lead to death. Types of infections can include:
Certain viruses can live in your body and
cause active infections when your immune system is weak. Viral infections that can happen with CellCept include:
Shingles, other herpes infections, and cytomegalovirus
(CMV). CMV can cause serious tissue and blood infections.
BK virus. BK virus can affect how your kidney works and
A brain infection called Progressive Multifocal
In some patients, CellCept may
cause an infection of the brain that may cause death. You are at
risk for this brain infection because you have a weakened
immune system. You should tell your doctor right away if you
have any of the following symptoms:
Weakness on one side of the body
You do not care about things that you usually care about
You are confused or have problems thinking You can not control your muscles
Yeasts and other types of fungal infections
can happen with CellCept and can cause serious tissue and
blood infections (see “What are the possible side effects of
Call your doctor right away if you have any of the following signs and
symptoms of infection:
Temperature of 100.5°F or greater Cold symptoms, such as a runny nose or sore throat Flu symptoms, such as an upset stomach, stomach pain,
Earache or headache Pain during urination White patches in the mouth or throat Unexpected bruising or bleeding Cuts, scrapes or incisions that are red, warm and oozing pus
Increased risk of getting certain cancers.
People who take
CellCept have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have:
unexplained fever, prolonged tiredness, weight loss or lymph
a brown or black skin lesion with uneven borders, or one part of
a change in the size and color of a mole a new skin lesion or bump any other changes to your health
See the section “What are the possible side effects of CellCept?” for
information about other serious side effects.
What is CellCept?
CellCept is a prescription medicine to prevent rejection (antirejection
medicine) in people who have received a kidney, heart or liver transplant.
Rejection is when the body’s immune system perceives the new organ as a
“foreign” threat and attacks it.
CellCept is used with other medicines called cyclosporine (Sandimmune, Gengraf, Neoral) and corticosteroids.
CellCept has been used safely and works in children who received a kidney transplant as it does in adults. It is not known if CellCept is safe and works in children who receive a heart or liver transplant.
Who should not take CellCept?
Do not take CellCept if you are allergic to mycophenolate mofetil or
any of the ingredients in CellCept.
See the end of this Medication Guide
for a complete list of ingredients in CellCept.
What should I tell my doctor before taking CellCept?
Tell your doctor about all of your medical conditions, if you:
have any digestive problems,
such as ulcers.
have Phenylketonuria (PKU).
CellCept oral suspension contains
have Lesch-Nyhan or Kelley-Seegmiller syndrome or another
rare inherited deficiency hypoxanthine-guanine
You should not take
CellCept if you have one of these disorders.
plan to receive any vaccines. People taking CellCept should not
take live vaccines.
Some vaccines may not work as well during
treatment with CellCept.
are pregnant or are planning to become pregnant.
See “What is
the most important information I should know about CellCept?”
are breastfeeding or plan to breastfeed.
It is not known if CellCept
passes into breast milk. You and your doctor will decide if you will take CellCept or breastfeed.
Tell your healthcare provider about all of the medicines you are
taking including prescription and nonprescription medicines,
vitamins and herbal supplements.
Some medicines may affect the way
CellCept works, and CellCept may affect how some medicines work.
Especially tell your doctor if you take:
birth control pills (oral contraceptives). See “What is the most
important information I should know about CellCept?”
sevelamer (Renagel, Renvela). These products should be taken 2
acyclovir (Zovirax), valacyclovir (Valtrex), ganciclovir (CYTOVENE-
IV, Vitrasert), valganciclovir (VALCYTE)
rifampin (Rifater, Rifamate, Rimactane, Rifadin) antacids that contain magnesium and aluminum (CellCept and the
antacid should not be taken at the same time)
proton pump inhibitors (PPIs) (Prevacid, Protonix) sulfamethoxazole/trimethoprim (BACTRIM, BACTRIM DS) norfloxacin (Noroxin) and metronidazole (Flagyl, Flagyl ER, Flagyl
ciprofloxacin (Cipro, Cipro XR, Ciloxan, Proquin XR) and amoxicillin
plus clavulanic acid (Augmentin, Augmentin XR)
azathioprine (Azasan, Imuran) cholestyramine (Questran Light, Questran, Locholest Light,
Know the medicines you take. Keep a list of them to show to your doctor or nurse and pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.
How should I take CellCept?
Take CellCept exactly as prescribed.
Do not stop taking CellCept or change the dose unless your doctor tells
If you miss a dose of CellCept, or are not sure when you took your last
dose, take the regular amount of CellCept prescribed as soon as you remember. If it is time for your next dose, skip the missed dose and take your next dose at your normal scheduled time. Do not take 2 doses at the same time. Call your doctor if you are not sure what to do.
Take CellCept capsules, tablets and oral suspension on an empty
stomach, either 1 hour before or 2 hours after a meal, unless your healthcare provider tells you otherwise. With the approval of your healthcare provider, in stable kidney transplant patients, CellCept can be taken with food if necessary.
Most people take CellCept by mouth either as blue and brown capsules
or lavender tablets. Some people may get CellCept soon after their transplant surgery as an infusion into a vein.
Do not crush CellCept tablets. Do not open or crush CellCept capsules.
If you are not able to swallow CellCept tablets or capsules, your doctor
may prescribe CellCept Oral Suspension. This is a liquid form of CellCept. Your pharmacist will mix the medicine before giving it to you.
Do not mix CellCept Oral Suspension with any other medicine.
If you take too much CellCept, call your doctor or the poison control
What should I avoid while taking CellCept?
See “What is the most important information I
should know about CellCept?”
Limit the amount of time you spend in sunlight.
Avoid using tanning
beds or sunlamps. People who take CellCept have a higher risk of getting
skin cancer. (See “What is the most important information I should
know about CellCept?”
) Wear protective clothing when you are in the
sun and use a sunscreen with a high protection factor (SPF 30 and
above). This is especially important if your skin is very fair or if you have
a family history of skin cancer.
What are the possible side effects of CellCept?
CellCept can cause serious side effects:
See “What is the most important information I should know about
Low blood cell counts.
People taking high doses of CellCept each day
may have a decrease in blood counts, including
white blood cells, especially neutrophils.
Neutrophils fight against
bacterial infections. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 3 months to 6 months after your transplant.
red blood cells.
Red blood cells carry oxygen to your body tissues.
You have a higher chance of getting severe anemia when your red blood cell count is low.
. Platelets help with blood clotting.
Your doctor will do blood tests before you start taking CellCept and during treatment with CellCept to check your blood cell counts.
Tell your doctor right away if you have any signs of infection (see “What
is the most important information I should know about
), or any unexpected bruising or bleeding. Also, tell your
doctor if you have unusual tiredness, lack of energy, dizziness or fainting.
Stomach and intestinal bleeding can happen in
people who take high doses of CellCept. Bleeding can be severe and you may have to be hospitalized for treatment.
Common side effects include:
diarrhea. Call your doctor right away if you have diarrhea. Do not stop
taking CellCept without first talking with your doctor.
vomiting pain stomach area pain swelling of the lower legs, ankles and feet high blood pressure
Side effects that happen more often in children than in adults taking CellCept include:
colds (respiratory tract infections)
infection high blood pressure pain
blood infection (sepsis) low red blood cell count diarrhea
These are not all of the possible side effects of CellCept. Tell your doctor about any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or to Genentech at 1-888-835-2555.
How should I store CellCept?
Store CellCept capsules and tablets at room temperature, between 59oF
to 86oF (15oC to 30oC). Keep the container closed tightly.
Store the prepared CellCept Oral Suspension at room temperature,
between 59oF to 86oF (15oC to 30oC), for up to 60 days. You can also
store CellCept Oral Suspension in the refrigerator at 36oF to 46oF (2oC to
8oC). Do not freeze CellCept Oral Suspension.
Keep CellCept and all medicines out of the reach of children
General Information about CellCept
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CellCept for a condition for which it was not prescribed. Do not give CellCept to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about CellCept. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about CellCept that is written for healthcare professionals. For more information, call 1-888-835-2555 or visit www.gene.com/gene/products/information/cellcept.
What are the ingredients in CellCept?
CellCept 250 mg capsules: croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.
CellCept 500 mg tablets: black iron oxide, croscarmellose sodium, FD&C blue #2 aluminum lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone (K-90), red iron oxide, talc, and titanium dioxide; may also contain ammonium hydroxide, ethyl alcohol, methyl alcohol, n-butyl alcohol, propylene glycol, and shellac.
CellCept Oral Suspension: aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum.
CellCept Intravenous: polysorbate 80, and citric acid. Sodium hydroxide may have been used in the manufacture of CellCept Intravenous to adjust the pH.
This Medication Guide has been approved by the US Food and Drug Administration.
CELLCEPT, CYTOVENE-IV, and VALCYTE are registered trademarks of Hoffmann-La Roche Inc. BACTRIM and BACTRIM DS are trademarks of Hoffmann-La Roche Inc.
For additional copies of this Medication Guide, please call 1-800-617-8191 or visit www.gene.com/gene/products/information/cellcept.
2012 Genentech, Inc. All rights reserved.
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