MYCOPHENOLATE MOFETIL- mycophenolate mofetil capsule 
MYCOPHENOLATE MOFETIL- mycophenolate mofetil tablet 
Roxane Laboratories, Inc

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MEDICATION GUIDE

Read the Medication Guide that comes with Mycophenolate Mofetil Capsules USP and Tablets USP 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 Mycophenolate Mofetil Capsules USP and Tablets USP?

Mycophenolate Mofetil Capsules USP and Tablets USP can cause serious side effects:

Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take mycophenolate mofetil USP 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 defects.

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 mycophenolate mofetil USP.
Increased risk of getting serious infections. Mycophenolate mofetil USP weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil USP and can lead to death. Types of infections can include:
Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with mycophenolate mofetil USP 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 cause your transplanted kidney to fail.
A brain infection called Progressive Multifocal Leukoencephalopathy (PML). In some patients, mycophenolate mofetil USP 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 healthcare provider 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 (apathy)
You are confused or have problems thinking
You can not control your muscles
Fungal infections. Yeasts and other types of fungal infections can happen with mycophenolate mofetil USP and can cause serious tissue and blood infections (see “What are the possible side effects of Mycophenolate Mofetil Capsules USP and Tablets USP?”)

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, vomiting or diarrhea
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 mycophenolate mofetil USP 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 node swelling
a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other
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 Mycophenolate Mofetil Capsules USP and Tablets USP?” for information about other serious side effects.

What is Mycophenolate Mofetil Capsules USP and Tablets USP?

Mycophenolate Mofetil Capsules USP and Tablets USP 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.

Mycophenolate Mofetil Capsules USP and Tablets USP is used with other medicines called cyclosporine (Sandimmune®, Gengraf®, Neoral®) and corticosteroids.

Mycophenolate mofetil USP has been used safely and works in children who received a kidney transplant as it does in adults. It is not known if mycophenolate mofetil USP is safe and works in children who receive a heart or liver transplant.

Who should not take Mycophenolate Mofetil Capsules USP and Tablets USP?

Do not take mycophenolate mofetil USP if you are allergic to mycophenolate mofetil USP or any of the ingredients in Mycophenolate Mofetil Capsules USP and Tablets USP. See the end of this Medication Guide for a complete list of ingredients in Mycophenolate Mofetil Capsules USP and Tablets USP.

What should I tell my doctor before taking Mycophenolate Mofetil Capsules USP and Tablets USP?

Tell your doctor about all of your medical conditions, if you:

have any digestive problems, such as ulcers
have Phenylketonuria (PKU). Mycophenolate mofetil oral suspension USP contains aspartame (a source of phenylalanine)
have Lesch-Nyhan or Kelley-Seegmiller syndrome or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take mycophenolate mofetil USP if you have one of these disorders
plan to receive any vaccines. People taking mycophenolate mofetil USP should not take live vaccines. Some vaccines may not work as well during treatment with mycophenolate mofetil USP
are pregnant or are planning to become pregnant. See “What is the most important information I should know about Mycophenolate Mofetil Capsules USP and Tablets USP?”
are breastfeeding or plan to breastfeed. It is not known if mycophenolate mofetil USP passes into breast milk. You and your doctor will decide if you will take mycophenolate mofetil USP 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 mycophenolate mofetil USP works, and mycophenolate mofetil USP may affect how some medicines work. Especially tell your healthcare provider if you take:

birth control pills (oral contraceptives). See “What is the most important information I should know about Mycophenolate Mofetil Capsules USP and Tablets USP?”
sevelamer (Renagel®, Renvela™). These products should be taken 2 hours after taking mycophenolate mofetil USP
acyclovir (Zovirax®), valacyclovir (Valtrex®), ganciclovir (Cytovene®-IV, Vitrasert®), valganciclovir (Valcyte®)
rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)
antacids that contain magnesium and aluminum (mycophenolate mofetil USP 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® IV, Metro IV, Helidac®, Pylera™)
ciprofloxacin (Cipro®, Cipro® XR, Ciloxan®, Proquin® XR) and amoxicillin plus clavulanic acid (Augmentin®, Augmentin XR™)
azathioprine (Azasan®, Imuran®)
cholestyramine (Questran Light®, Questran®, Locholest Light, Locholest, Prevalite®)

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 Mycophenolate Mofetil Capsules USP and Tablets USP?

Take mycophenolate mofetil USP exactly as prescribed.
Do not stop taking mycophenolate mofetil USP or change the dose unless your doctor tells you to.
If you miss a dose of mycophenolate mofetil USP, or are not sure when you took your last dose, take the regular amount of mycophenolate mofetil USP 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 mycophenolate mofetil capsules USP, tablets USP and oral suspension USP 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, mycophenolate mofetil USP can be taken with food if necessary.
Most people take mycophenolate mofetil USP by mouth either as caramel opaque/blue opaque capsules or white tablets. Some people may get mycophenolate mofetil USP soon after their transplant surgery as an infusion into a vein.
Do not crush mycophenolate mofetil tablets USP. Do not open or crush mycophenolate mofetil capsules USP.
If you are not able to swallow mycophenolate mofetil tablets USP or capsules USP, your healthcare provider may prescribe mycophenolate mofetil oral suspension. USP. This is a liquid form of mycophenolate mofetil USP. Your pharmacist will mix the medicine before giving it to you.
Do not mix mycophenolate mofetil oral suspension USP with any other medicine.
If you take too much mycophenolate mofetil USP, call your doctor or the poison control center right away.

What should I avoid while taking Mycophenolate Mofetil Capsules USP and Tablets USP?

Avoid pregnancy. See “What is the most important information I should know about Mycophenolate Mofetil Capsules USP and Tablets USP?”
Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take mycophenolate mofetil USP have a higher risk of getting skin cancer. (See “What is the most important information I should know about Mycophenolate Mofetil Capsules USP and Tablets USP?”) 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 Mycophenolate Mofetil Capsules USP and Tablets USP?

Mycophenolate Mofetil Capsules USP and Tablets USP can cause serious side effects:

See “What is the most important information I should know about Mycophenolate Mofetil Capsules USP and Tablets USP?”
Low blood cell counts. People taking high doses of mycophenolate mofetil USP 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. Platelets help with blood clotting.

Your doctor will do blood tests before you start taking mycophenolate mofetil USP and during treatment with mycophenolate mofetil USP 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 Mycophenolate Mofetil Capsules USP and Tablets USP?”), or any unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting.

Stomach problems. Stomach and intestinal bleeding can happen in people who take high doses of mycophenolate mofetil USP. 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 mycophenolate mofetil USP 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 Mycophenolate Mofetil Capsules USP and Tablets USP include:

stomach area pain
sore throat
fever
colds (respiratory tract infections)
infection
high blood pressure
pain
low white blood cell count
blood infection (sepsis)
low red blood cell count
diarrhea
vomiting

These are not all of the possible side effects of mycophenolate mofetil USP. 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 Roxane Laboratories, Inc., at 1-800-962-8364.

How should I store Mycophenolate Mofetil Capsules USP and Tablets USP?

Store Mycophenolate Mofetil Capsules USP and Tablets USP at room temperature, between 59oF to 86oF (15oC to 30oC). Keep the container closed tightly
Store the prepared mycophenolate mofetil oral suspension USP at room temperature, between 59oF to 86oF (15oC to 30oC), for up to 60 days. You can also store mycophenolate mofetil oral suspension USP in the refrigerator at 36oF to 46oF (2oC to 8oC). Do not freeze mycophenolate mofetil oral suspension USP.
Keep Mycophenolate Mofetil Capsules USP and Tablets USP and all medicines out of the reach of children

General Information about Mycophenolate Mofetil Capsules USP and Tablets USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil USP for a condition for which it was not prescribed. Do not give mycophenolate mofetil USP 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 mycophenolate mofetil USP. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolate mofetil USP that is written for healthcare professionals. For more information, call 1-800-962-8364 or visit www.Roxane.com. 

What are the ingredients in Mycophenolate Mofetil Capsules USP and Tablets USP?

Active Ingredient: mycophenolate mofetil USP

Inactive Ingredients: Mycophenolate Mofetil Capsules USP, 250 mg: croscarmellose sodium, magnesium stearate, povidone, and pregelatinized starch. The capsule shells contain FD&C blue #1, FD&C red #3, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide.

Mycophenolate Mofetil Tablets USP, 500 mg: croscarmellose sodium, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, polydextrose, povidone, pregelatinized starch, titanium dioxide, and triacetin.

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.

Any other trademarks in this document are the property of their respective owners.

For additional copies of this Medication Guide, please call 1-800-962-8364 or visit www.Roxane.com.

Roxane Laboratories, Inc.

Columbus, Ohio 43216

 

10004763/06

Revised February 2013

© RLI, 2013

Revised: 02/2013
 
Roxane Laboratories, Inc