MYCOPHENOLATE MOFETIL- mycophenolate mofetil injection, powder, lyophilized, for solution 
Amneal Pharmaceuticals LLC

----------

MEDICATION GUIDE

Mycophenolate Mofetil (mye’’ koe fen’ oh late moe’ fe til) for Injection, USP 

Read the Medication Guide that comes with mycophenolate mofetil for injection 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 for injection?

Mycophenolate mofetil for injection 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 for injection 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.

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:

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 for injection 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 change in the size and color of a mole
  • a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other
  • a new skin lesion or bump

  • any other changes to your health

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

  • weakness on one side of the body
  • you are confused or have problems thinking
  • you do not care about things you usually care about (apathy)
  • you cannot control your muscles

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

  • temperature of 100.5°F or greater
  • pain during urination
  • cold symptoms, such as a runny nose or sore throat
  • white patches in the mouth or throat
  • flu symptoms, such as an upset stomach, stomach pain, vomiting or diarrhea
  • unexpected bruising or bleeding
  • earache or headache
  • cuts, scrapes or incisions that are red, warm and oozing pus

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

What is mycophenolate mofetil for injection?

Who should not take mycophenolate mofetil for injection?

Do not take mycophenolate mofetil for injection if you are allergic to mycophenolate mofetil or any of the ingredients in mycophenolate mofetil for injection.

See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil for injection.

What should I tell my doctor before taking mycophenolate mofetil for injection?

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 for injection works, and mycophenolate mofetil for injection 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 for injection?

What should I avoid while taking mycophenolate mofetil for injection?

What are the possible side effects of mycophenolate mofetil for injection?

Mycophenolate mofetil for injection can cause serious side effects, including:

Your doctor will do blood tests before you start taking mycophenolate mofetil for injection and during treatment with mycophenolate mofetil for injection 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 for injection?”), 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 for injection include:

  • diarrhea
  • changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia)
  • blood problems including low white and red blood cell counts
  • stomach problems including diarrhea, constipation, nausea and vomiting
  • infections
  • rash
  • blood pressure problems
  • nervous system problems such as headache, dizziness and tremor
  • fast heart beat

  • swelling of the lower legs, ankles and feet

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

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

These are not all of the possible side effects of mycophenolate mofetil for injection. 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 Amneal Pharmaceuticals at 1-877-835-5472.

How should I store mycophenolate mofetil for injection?

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

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

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil for injection for a condition for which it was not prescribed. Do not give mycophenolate mofetil for injection 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 for injection. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolate mofetil for injection that is written for health professionals.

What are the ingredients in mycophenolate mofetil for injection?

Active Ingredient: mycophenolate mofetil, USP

Inactive Ingredients: Polysorbate 80, 25 mg; and citric acid anhydrous, 5 mg. Sodium hydroxide and hydrochloric acid may have been used in the manufacture of mycophenolate mofetil for injection to adjust the pH.

For more information, go to www.amneal.com or call toll-free 1-877-835-5472

All trademarks are the property of their respective owner.

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

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Parenteral Unit

Ahmedabad 382213, INDIA

Distributed by:
Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 04-2021-01

Revised: 4/2021
Amneal Pharmaceuticals LLC