MYCOPHENOLATE MOFETIL - mycophenolate mofetil powder, for suspension 
Ascend Laboratories, LLC

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MEDICATION GUIDE


Mycophenolate Mofetil For Oral Suspension USP 200 mg/ml
(mye" koe fen' oh late moe' fe til)
Read the Medication Guide that comes with mycophenolate mofetil 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?
Mycophenolate mofetil 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 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. 

       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 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

Increased risk of getting serious infections. Mycophenolate mofetil weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil and can lead to hospitalizations and death. These serious infections can include:

What is mycophenolate mofetil?

Who should not take mycophenolate mofetil?
Do not take mycophenolate mofetil if you are allergic to mycophenolate mofetil or any of the ingredients in mycophenolate mofetil.
See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil.
What should I tell my doctor before taking mycophenolate mofetil?
Tell your doctor about all of your medical conditions, including if you:

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 works, and mycophenolate mofetil may affect how some medicines work.
Especially tell your doctor if you take:

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?

o If you accidentally get the powder or oral suspension on the skin, wash the area well with soap and water.

o If you accidentally get the powder or oral suspension in your eyes or other mucous membranes, flush with plain water. 

What should I avoid while taking mycophenolate mofetil? 

What are the possible side effects of mycophenolate mofetil?
Mycophenolate mofetil can cause serious side effects, 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 1 month to 6 months after your transplant.

o 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 and during treatment with mycophenolate mofetil 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?”), including any unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting.

The most common side effects of mycophenolate mofetil include: 

Side effects that can happen more often in children than in adults taking mycophenolate mofetil include: 

These are not all of the possible side effects of mycophenolate mofetil. 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.
How should I store mycophenolate mofetil?

General Information about the safe and effective use of mycophenolate mofetil.
Medicines are sometimes prescribed for purposes other than those listed in a medication guide. Do not use mycophenolate mofetil for a condition for which it was not prescribed. Do not give mycophenolate mofetil 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. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolate mofetil that is written for health professionals.
What are the ingredients in mycophenolate mofetil for oral suspension?
Active Ingredient: Mycophenolate mofetil USP
Inactive Ingredients:
Mycophenolate Mofetil for Oral Solution 200 mg/ml: Sorbitol, sodium citrate dehydrate, citric acid anhydrous, methyl paraben, xanthan gum, aspartame, soybean lecithin and N & A gum fruit flavor.

This Medication Guide has been approved by the US Food and Drug Administration.

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.

Manufactured in India by:
Alkem Laboratories Limited

H.O.: Alkem House, Senapati Bapat Marg,
Lower Parel, Mumbai – 400 013, INDIA

Distributed by:
Ascend Laboratories, LLC
Parsippany, NJ 07054

Revised: January,2020

Revised: 8/2020
Ascend Laboratories, LLC