MYCOPHENOLATE MOFETIL - mycophenolate mofetil tablet, film coated 
MYCOPHENOLATE MOFETIL - mycophenolate mofetil capsule 
Ascend Laboratories, LLC

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MEDICATION GUIDE

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

 Mycophenolate Mofetil (MYE-koe-FEN-oh-late MOE-fe-til) Tablets USP 500mg


 
Read the Medication Guide that comes with mycophenolate mofetil capsules or tablets 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.

o By phone at 1-800-617-8191 or

o By visiting the REMS website at:www.mycophenolateREMS.com

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:

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:


Call your doctor right away if you have any of the following signs and symptoms of infection:

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

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?

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:


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?

Keep mycophenolate mofetil and all medicines out of the reach of children. 

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?

Active Ingredient: Mycophenolate mofetil

Inactive Ingredients: Mycophenolate mofetil 250 mg capsules: croscarmellose sodium, pregelatinized starch, povidone (K-90), isopropyl alcohol, and magnesium stearate. The capsule shells contain gelatin, sodium lauryl sulphate, FD&C blue 2, red iron oxide, yellow iron oxide, and titanium dioxide. The capsule is printed with edible black ink comprised of shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.

Mycophenolate mofetil 500 mg tablets: croscarmellose sodium, povidone (K-90), isopropyl alcohol, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, red iron oxide, black iron oxide, and yellow iron oxide.

 

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


For more information call at  Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901)   

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

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.


Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

 

Revised: May, 2022

PT1264-09

Revised: 9/2022
Ascend Laboratories, LLC