MYCOPHENOLATE MOFETIL- mycophenolate mofetil capsule 
Lupin Pharmaceuticals, Inc.



Mycophenolate mofetil capsules, USP 250 mg


Mycophenolate mofetil tablets, USP 500 mg

(MYE koe FEN oh late MOE fe til)

Read the Medication Guide that comes with Mycophenolate mofetil capsules and 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.

You must use acceptable birth control during your entire Mycophenolate mofetil treatment and for 6 weeks after stopping Mycophenolate mofetil, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. Mycophenolate mofetil decreases 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, and you could become pregnant. If you take birth control pills while using Mycophenolate mofetil 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.

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 capsules and tablets. See the end of this Medication Guide for a complete list of ingredients in Mycophenolate mofetil capsules and tablets.

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 may cause serious side effects, including:

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.

You may also report side effects to Concord Biotech Limited, at Telephone : 1-855-407-0586.

How should I store Mycophenolate mofetil capsules and tablets?

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 about Mycophenolate mofetil that is written for health professionals.

What are the ingredients in Mycophenolate mofetil capsules and tablets?

Active ingredient: mycophenolate mofetil

Inactive ingredients:

Mycophenolate mofetil capsules, 250 mg: Microcrystalline cellulose, hydroxypropyl cellulose, povidone (K-90), croscarmellose sodium, talc and magnesium stearate.

The capsule shells contain FD&C blue #2, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, iron oxide black and potassium hydroxide.

Mycophenolate mofetil tablets, 500 mg: Microcrystalline cellulose, Povidone, Croscarmellose sodium and Magnesium stearate.

The film coating contains Hypromellose, Titanium dioxide, Polyethylene glycol, Iron oxide red, FD&C blue#2 aluminium lake and black iron oxide.

Manufactured By:

Concord Biotech Limited,

297-298/2P, At Valthera Ta. Dholka,

Ahmedabad – 382225, Gujarat, India.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Any trademarks in this document are property of their respective owner.

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

Revised: December 2022

Revised: 10/2023
Lupin Pharmaceuticals, Inc.