MYCOPHENOLATE MOFETIL- mycophenolate mofetil capsule 
Teva Pharmaceuticals USA, Inc.

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MEDICATION GUIDE

MEDICATION GUIDE

Mycophenolate Mofetil (MYE-koe-FEN-oh-late MOE-fe-til) Capsules, 250 mg

Read the Medication Guide that comes with mycophenolate mofetil capsules 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 treatment.

What is the most important information I should know about mycophenolate mofetil capsules?

Mycophenolate mofetil capsules can cause serious side effects, including:

Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take mycophenolate mofetil capsules 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 capsules. You should have 1 pregnancy test immediately before starting mycophenolate mofetil capsules 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 mycophenolate mofetil capsule treatment and for 6 weeks after stopping mycophenolate mofetil capsules, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. Mycophenolate mofetil capsules decrease 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 mycophenolate mofetil capsules, and you could become pregnant. If you take birth control pills while using mycophenolate mofetil capsules you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking mycophenolate mofetil capsules.

  • If you are a sexually active male whose female partner can become pregnant while you are taking mycophenolate mofetil capsules, use effective contraception during treatment and for at least 90 days after stopping mycophenolate mofetil capsules.
  • 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 mycophenolate mofetil capsules, do not stop taking mycophenolate mofetil capsules. Call your doctor right away.

    You and your doctor may decide that other medicines to prevent rejection may be right for you. You and your doctor should report your pregnancy to the Mycophenolate Pregnancy Registry either:

    • By phone at 1-800-617-8191 or

The purpose of this registry is to gather information about the health of you and your baby.

Increased risk of getting certain cancers. People who take mycophenolate mofetil capsules 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·a change in the size and color of a mole or lymph node swelling·a new skin lesion or bump
  • a brown or black skin lesion with uneven borders,·any other changes to your health or one part of the lesion does not look like the other

Increased risk of getting serious infections. Mycophenolate mofetil capsules weaken the body’s immune system and affect your ability to fight infections. Serious infections can happen with mycophenolate mofetil capsules and can lead to hospitalizations and death. These serious 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 capsules 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.
    • Hepatitis B and C viruses. Hepatitis viruses can affect how your liver works. Talk to your doctor about how hepatitis viruses may affect you.
  • A brain infection called Progressive Multifocal Leukoencephalopathy (PML). In some patients, mycophenolate mofetil capsules 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. Call 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 you usually care about (apathy)
    • you are confused or have problems thinking
    • you cannot control your muscles
  • Fungal infections. Yeasts and other types of fungal infections can happen with mycophenolate mofetil capsules and can cause serious tissue and blood infections (See “What are the possible side effects of mycophenolate mofetil capsules?”).

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

See “What are the possible side effects of mycophenolate mofetil capsules?” for information about other serious side effects.

What are mycophenolate mofetil capsules?

  • Mycophenolate mofetil capsules are 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 are used with other medicines containing cyclosporine and corticosteroids.

Who should not take mycophenolate mofetil capsules?

Do not take mycophenolate mofetil capsules if you are allergic to mycophenolate mofetil or any of the ingredients in mycophenolate mofetil capsules. See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil capsules.

What should I tell my doctor before taking mycophenolate mofetil capsules?

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

  • have any digestive problems, such as ulcers.
  • have Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome, or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take mycophenolate mofetil capsules if you have one of these disorders.
  • plan to receive any vaccines. People taking mycophenolate mofetil capsules should not receive live vaccines. Some vaccines may not work as well during treatment with mycophenolate mofetil capsules.
  • are pregnant or plan to become pregnant. See “What is the most important information I should know about mycophenolate mofetil capsules?”
  • are breastfeeding or plan to breastfeed. It is not known if mycophenolate mofetil passes into breast milk. You and your doctor will decide if you will take mycophenolate mofetil capsules or breastfeed.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines may affect the way mycophenolate mofetil capsules work, and mycophenolate mofetil capsules 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 mycophenolate mofetil capsules?”
  • sevelamer (Renagel®, Renvela). These products should be taken at least 2 hours after taking mycophenolate mofetil capsules.
  • acyclovir (Zovirax®), valacyclovir (Valtrex®), ganciclovir (CYTOVENE®-IV, Vitrasert®), valganciclovir (VALCYTE®).
  • rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®).
  • antacids that contain magnesium and aluminum (mycophenolate mofetil capsules and the antacid should not be taken at the same time).
  • proton pump inhibitors (PPIs) (Prevacid®, Protonix®).
  • sulfamethoxazole/trimethoprim (BACTRIMä, BACTRIM DSä).
  • ·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?

  • Take mycophenolate mofetil capsules exactly as prescribed.
  • Do not stop taking mycophenolate mofetil capsules or change the dose unless your doctor tells you to.
  • If you miss a dose of mycophenolate mofetil capsules, or you are not sure when you took your last dose, take your prescribed dose of mycophenolate mofetil capsules as soon as you remember. If your next dose is less than 2 hours away, 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 on an empty stomach, unless your doctor tells you otherwise.
  • Do not open or crush mycophenolate mofetil capsules.
  • If you are not able to swallow mycophenolate mofetil capsules, your doctor may prescribe mycophenolate mofetil oral suspension. This is a liquid form of mycophenolate mofetil capsules. Your pharmacist will mix the medicine before you pick it up from a pharmacy.
  • Do not breathe in (inhale) or let mycophenolate mofetil capsules powder come in contact with your skin or mucous membranes.
    • If you accidentally get the powder on the skin, wash the area well with soap and water.
    • If you accidentally get the powder in your eyes or other mucous membranes, flush with plain water.

If you take too many mycophenolate mofetil capsules, call your doctor or the poison control center right away.

These are not all of the possible side effects of mycophenolate mofetil capsules. 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 FDA at 1-800-FDA-1088.

You may also report side effects to Teva at 1-888-838-2872.

How should I store mycophenolate mofetil capsules?

  • Store mycophenolate mofetil capsules at room temperature, between 68°F to 77°F (20°C to 25°C). Keep the container closed tightly.
  • Keep mycophenolate mofetil capsules and all medicines out of the reach of children.

General Information about the safe and effective use of mycophenolate mofetil capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil capsules for a condition for which they were not prescribed. Do not give mycophenolate mofetil capsules to other people, even if they have the same symptoms that you have. They may harm them.

This Medication Guide summarizes the most important information about mycophenolate mofetil capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolate mofetil capsules that is written for health professionals.

What are the ingredients in mycophenolate mofetil capsules?

Active Ingredient: mycophenolate mofetil

Inactive Ingredients:

Mycophenolate mofetil capsules, 250 mg: black iron oxide, croscarmellose sodium, D&C red #28, D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, magnesium stearate, povidone, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide.

Manufactured In Czech Republic By:
Teva Czech Industries, s.r.o.
Opava-Komarov, Czech Republic

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.

For more information, call 1-888-838-2872 or visit www.tevagenerics.com.

This Medication Guide has been approved by the U.S. Food and Drug Administration.                                                                                 Rev. J 9/2018


Revised: 9/2018
Teva Pharmaceuticals USA, Inc.