Females of reproductive potential who are prescribed mycophenolate must be aware of the following:

• The increased risks of first trimester pregnancy loss and congenital malformations when taking mycophenolate during pregnancy.

• The importance of pregnancy prevention and planning when taking mycophenolate.

Please read the following:  US FDA Patient brochure

Understanding the risks of taking mycophenolate during pregnancy

If you are a girl or woman who can get pregnant, your doctor will talk with you about the risks of mycophenolate during pregnancy.

You need to learn about the risks of mycophenolate in pregnancy:

• Higher risk of losing a pregnancy (miscarriage) during the first 3 months.

• Higher risk that the baby may be born with the birth defects:

1. Defects of the ears

2. Cleft lip or cleft palate

3. Defects of the arms, legs, heart, esophagus, kidney

4. and nervous system

Click here to see complete patient information in the Mycophenolate REMS Patient Brochure: What You Need To Know About Mycophenolate

Do I need to use birth control?

You must always use acceptable birth control:

• During your entire treatment with mycophenolate

• For 6 weeks after you stop taking mycophenolate

Unless you choose not to have sexual intercourse with a man at any time (abstinence), you must always use acceptable forms of birth control.

What are my birth control options?

You may need to use more than one method of birth control at the same time.

If you use an intrauterine device (IUD), had sterilization surgery (had your tubes tied or blocked), or if your partner has had a vasectomy, you do not need to use a second form of birth control.

Mycophenolate could make hormone methods of birth control not work as well.

• Studies show that mycophenolate lowers blood levels of certain hormones in the birth control pill.

• It is possible that birth control pills may not work as well when you take mycophenolate and you could become pregnant.

• It is possible that other hormone methods (like the patch, the ring, the shot, and the implant) may also not work well and you could become pregnant.

• It is important that a barrier method of birth control is also used with any hormone method of birth control.

Do I need a pregnancy test?

You should have one pregnancy test immediately before starting mycophenolate and another pregnancy test 8 to 10 days later to determine if you are pregnant.

• Pregnancy tests should be repeated during routine follow-up visits with your doctor.

• Talk to your doctor about the results of all your pregnancy tests

What if I am thinking about getting pregnant?

If you are thinking about having a baby, talk with your doctor right away. Your doctor will decide if other medicines to prevent rejection may be right for you.

What if I get pregnant?

If you get pregnant while taking mycophenolate or within 6 weeks after you stop, call your doctor right away. Do not stop taking your mycophenolate. Your doctor will talk with you about taking part in the Mycophenolate Pregnancy Registry.

You should report your pregnancy to the Mycophenolate Pregnancy Registry?

There are 2 ways to report a pregnancy:

• By phone: 1-800-617-8191

• Online by clicking this link Report a Pregnancy