The Mycophenolate REMS has been designed to tell you about the risks of taking mycophenolate during pregnancy. Females taking mycophenolate while they are pregnant have a higher risk of miscarriage in the first 3 months. There is also a higher risk that the baby will have birth defects.

Patients do not register in the Mycophenolate REMS.

If you become pregnant during treatment with mycophenolate or within 6 weeks after stopping treatment with mycophenolate, you should inform your doctor and participate in the Mycophenolate Pregnancy Registry. Participation is voluntary; however, the information you provide is important to the success of the program.

The Mycophenolate Pregnancy Registry collects information about pregnancies that occur during treatment with mycophenolate or within 6 weeks after stopping. The information from the Registry helps doctors and patients understand the effects of mycophenolate on pregnant females and their babies.

You can fill your prescription in any pharmacy.

You should talk with your doctor about what birth control is right for you. You can also get birth control information in the Mycophenolate REMS Patient Brochure: What You Need To Know About Mycophenolate book. This book is available from your doctor or can be viewed on this Web site.

If you are taking mycophenolate, and you are able to get pregnant, 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 birth control.

Talk with your doctor about birth control and what is best for you. You can also get birth control information in the Mycophenolate REMS Patient Brochure: What You Need To Know About Mycophenolate book. This book is available from your doctor and can also be viewed on this Web site.

It is best if you talk with your doctor about your medicines and birth defects.

You can find information on the Registry on this Web site.

The Registry collects information about pregnancies that occur during treatment with mycophenolate or within 6 weeks after stopping. The information from the Registry helps doctors and patients understand the effects of mycophenolate on pregnant females and their babies.

The Registry reports information about an individual female's pregnancy to the maker of the mycophenolate medicine she took. The maker of the drug is required by the law to report the pregnancy to the government.

Summary information (without patient identifiers) may also be shared among makers of mycophenolate medicine who support the Mycophenolate REMS. They may choose to publish it in scientific journals.

For more information about emergency birth control, talk with your doctor or pharmacist. You can also call the Emergency Contraception Hotline at 1-888-NOT-2-LATE (1-888-668-2528).

You can talk with your doctor for more information.

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.

The Registry collects information about pregnancies that occur during treatment with mycophenolate or within 6 weeks after stopping. The information from the Registry helps doctors and patients understand the effects of mycophenolate on pregnant females and their babies.

The information you provide to the Registry will help us better understand the effects of mycophenolate in pregnancy.

When you take part in the Registry, you provide important information that may help you and other females who took mycophenolate during their pregnancies. Females taking mycophenolate while they are pregnant have a higher risk of miscarriage in the first 3 months. There is also a higher risk that the baby will have birth defects.

All females who are pregnant while taking the following medicines and all females who get pregnant within 6 weeks after stopping treatment:

• CellCept® (mycophenolate mofetil)
• Myfortic® (mycophenolic acid)
• Generic formulations of mycophenolate mofetil
• Generic formulations of mycophenolic acid

Tell your doctor right away if you get pregnant. Your doctor must report your pregnancy to the Registry. We encourage you to take part in the Registry. The information you provide to the Registry will help us better understand the effects of mycophenolate in pregnancy. All the information you provide will be kept private.

There are a few simple steps to take.

1. Tell your doctor if you get pregnant
   • The Registry will contact you after speaking with your doctor.
2. Complete an Informed Consent form
   • The Informed Consent form will be mailed to you with a pre-addressed postage-paid return envelope.
   • The form tells you what to expect with the Registry. It tells you what your rights are.
   • By signing, you allow the Registry to ask you questions about your health and your baby’s health. The Registry will also ask for information from your doctors.
3. Answer questions about your health and your baby's health
   • After the first 3 months of pregnancy.
   • 2 more times during the next 6 months of pregnancy.
   • At the time of expected delivery.
   • When your baby is 2 months, 6 months and 1 year.
4. Let the Registry know if your contact information changes
   • The Registry relies on your information to contact you.
   • If your contact information changes, please call 1-800-617-8191.

• You can quit at any time
• Your privacy is protected

• Call 1-800-617-8191 and choose "Mycophenolate Pregnancy Registry" from the menu

For information on side effects, you can talk with your doctor, ask your pharmacist, read the mycophenolate Medication Guide or the Prescribing Information (PI).

• Store your medication at room temperature (59°F to 86°F).
• Make sure the container is tightly closed.
• Keep mycophenolate and all medicines out of the reach of children.

For information on what to avoid when taking mycophenolate, talk with your doctor, ask your pharmacist, read the mycophenolate Medication Guide or the Prescribing Information (PI).

If you are experiencing browser issues, your browser (i.e., Microsoft Internet Explorer, Mozilla Firefox, or Apple Safari) may be blocking the Mycophenolate REMS site, or parts of the Mycophenolate REMS site. You can resolve this by

1. Disabling the pop-up blocker completely every time you need to use the site, or
2. Adding www.MycophenolateREMS.com into your browser's list of allowed sites.

If this does not resolve the issue, it is recommended that you use Internet Explorer 8.0.

• Mycophenolate REMS Patient Brochure: What You Need To Know About Mycophenolate
  This Brochure tells you what you need to know about the Mycophenolate REMS. It explains how the program works and what your role is
• Mycophenolate REMS Patient-Prescriber Acknowledgment Form
  After discussion with your doctor about mycophenolate use and risks of miscarriage or birth defects, both of you will sign this form
• Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients
  Provides answers to frequently asked questions about the Registry

Mycophenolate REMS is designed to help inform prescribers, nurses, pharmacists, and females of reproductive potential of the risks associated with exposure to mycophenolate during pregnancy.

A female patient is considered eligible if she meets either of the following criteria:

• A patient who is or was pregnant and was exposed to at least 1 dose of mycophenolate during pregnancy
• A patient who got pregnant within 6 weeks following discontinuation of treatment

Patients who meet either of these criteria, regardless of indication, can participate. Patients whose pregnancy does not meet these criteria may not participate in the Mycophenolate Pregnancy Registry.

Exposure to mycophenolate during pregnancy is associated with:

• Increased risks of pregnancy loss during the first trimester
• Higher risk of congenital malformations
  • Ear abnormalities such as microtia
  • Facial deformities, including cleft lip and palate
  • Anomalies of the distal limbs, heart, esophagus, kidney, and nervous system

The Mycophenolate Pregnancy Registry will collect data to characterize the risks associated with exposure to mycophenolate during pregnancy or within 6 weeks following discontinuation of treatment, regardless of indication. There is no limit to the number or type of physicians and/or patients who may contribute data to the Mycophenolate Pregnancy Registry. All reports of potential maternal and fetal exposure to mycophenolate will be considered for the Mycophenolate Pregnancy Registry.

The success of the Mycophenolate Pregnancy Registry depends on the participation of both patients and healthcare providers. Healthcare providers should identify patients who are currently pregnant or who may have been exposed to mycophenolate while pregnant, inform them of the Mycophenolate Pregnancy Registry, and encourage them to participate in the Mycophenolate Pregnancy Registry. Healthcare providers should report any pregnancy that may involve exposure to mycophenolate, whether or not the patient chooses to participate. Patients should be informed that you will report any pregnancies of which you become aware to the Mycophenolate Pregnancy Registry.

Instruct patients to tell you if they get pregnant during treatment with mycophenolate or within 6 weeks following discontinuation of treatment. If you learn that a patient is pregnant.

• Report the pregnancy to the Mycophenolate Pregnancy Registry
• Encourage the patient to participate in the Mycophenolate Pregnancy Registry

When you report an eligible pregnancy to the Mycophenolate Pregnancy Registry, you should provide your contact information. Also provide the Mycophenolate Pregnancy Registry with information about the pregnancy and the patient’s contact information so that she can be called for follow-up for this safety study. Provision of patient contact and medical information to the Mycophenolate Pregnancy Registry is covered by an HIPAA waiver.

When patients participate in the Mycophenolate Pregnancy Registry, they agree to provide information about their pregnancy, including information about prenatal drug exposure of any duration, maternal demography and history, and maternal and fetal outcomes of pregnancies exposed to mycophenolate. Patients are encouraged to participate in the Mycophenolate Pregnancy Registry as soon as their pregnancy is known, preferably in the first trimester.

The patient will be asked in telephone interviews to answer questions regarding her health and her baby’s health. These interviews will take place during each trimester of pregnancy; near the expected time of delivery or at pregnancy outcome; and when the infant reaches 2 months, 6 months, and 1 year of age. Since the Mycophenolate Pregnancy Registry relies on being able to contact the patient, it is important for you to advise her to keep the Mycophenolate Pregnancy Registry informed of any changes to her contact information throughout her participation.

You will be asked to provide pregnancy and outcomes data on a paper-based case report form (CRF) and submit it via mail or fax, or enter the data into an electronic data capture (EDC) system. You must keep the Mycophenolate Pregnancy Registry informed of any changes to your contact information throughout your participation.

The Mycophenolate Pregnancy Registry program administrator will report personally identifiable pregnancy data to the appropriate drug manufacturer for purposes of reporting to regulatory agencies as required by law. Aggregated de-identified data may be shared among participating sponsors of Mycophenolate REMS and/or submitted for publication in peer-reviewed scientific journals.

All pregnancies occurring during treatment with mycophenolate or within 6 weeks following discontinuation of treatment should be reported to the Mycophenolate Pregnancy Registry, regardless of indication, for inclusion and follow-up. In addition to reporting exposed pregnancies to the Mycophenolate Pregnancy Registry, you may also report pregnancies to the NTPR.

• Visit www.MycophenolateREMS.com
• Call 1-800-617-8191

The Mycophenolate REMS Pregnancy Registry actively collects information on all pregnancies that occur during treatment or within 6 weeks of stopping treatment with Mycophenolate. For newly reported and ongoing pregnancies, questions are asked at baseline, first, 2^nd and 3^rd trimesters, at time of expected delivery and at infant ages 2,6 and 12 months. Data elements include but are not limited to:

• Demographics
• Mycophenolate exposure including dose and timing of exposure
• Maternal and fetal outcomes
• Root cause analysis (understand the circumstances that led to the fetal exposure)
• Frequency of educational counseling
• Infant development to age 12 months

For completed pregnancies, the available information on the pregnancy outcome will be captured and any infant follow-up

No. Pharmacies do not register in the Mycophenolate REMS. Pharmacies are required to provide patients with the medication guide for a particular mycophenolate product when dispensing the drug.

The only requirement for pharmacies in the Mycophenolate REMS is to provide the patient with a medication guide when dispensing mycophenolate.

Additional medication guides can be ordered over the phone (1-800-617-8191).

No. Patients in the Mycophenolate REMS do not have cards or ID numbers.

Yes. The Mycophenolate REMS does not affect a pharmacy's policy on how a prescription is received. You can accept a mycophenolate prescription by any means you would accept any other prescriptions.

The Mycophenolate REMS Pregnancy Registry actively collects information on all pregnancies that occur during treatment or within 6 weeks of stopping treatment with Mycophenolate. For newly reported and ongoing pregnancies, questions are asked at baseline, first, 2^nd and 3^rd trimesters, at time of expected delivery and at infant ages 2,6 and 12 months. Data elements include but are not limited to:

• Demographics
• Mycophenolate exposure including dose and timing of exposure
• Maternal and fetal outcomes
• Root cause analysis (understand the circumstances that led to the fetal exposure)
• Frequency of educational counseling
• Infant development to age 12 months

For completed pregnancies, the available information on the pregnancy outcome will be captured and any infant follow-up

Listed below are steps to help with receiving emails from Mycophenolate REMS.

Because email clients differ, and spam filters sometimes filter legitimate email, Mycophenolate REMS suggests you add the Mycophenolate REMS domain to your Safe Senders list in your email client. This will minimize the chance that you'll miss Mycophenolate REMS emails.

For Outlook 2000 and Higher

1. Open the email from Mycophenolate REMS.
2. Click on the “Actions” menu on the top of your email window.
3. Choose “Junk Email.”
4. Select“Add Senders Domain...to Safe Senders List” to add Mycophenolate REMS to your safe sender list.

Or Follow These Steps

1. Open the email from Mycophenolate REMS.
2. Right-click Mycophenolate REMS email address.
3. Click “Add to Contacts” in the short-cut menu.
4. Click “Save and Close.”

Outlook Express (6+)

1. Open the email from Mycophenolate REMS.
2. Left-click Mycophenolate REMS icon, or right-click Mycophenolate REMS name.
3. Click “Add to Contacts.”
4. Click “Save and Close.”

AOL 9.0

1. Open the email from Mycophenolate REMS.
2. Click the “Add Address” icon.
3. Verify Mycophenolate REMS contact information.
4. Save it.

AOL WebMail

1. Open the email from Mycophenolate REMS.
2. Click on Mycophenolate REMS name and email address.
3. Click “Add to Address Book” in the window that appears.
4. Enter extra information as needed.
5. Click “Save.”

Earthlink

1. Open the email from Mycophenolate REMS.
2. Click “Add to Address Book” in the email header.
3. Use the “Address Book Editor” to verify Mycophenolate REMS contact details, and click “Save.”

Entourage

1. Open the email from Mycophenolate REMS.
2. Right-click Mycophenolate REMS email address.
3. Select “Add to Address Book” in the short-cut menu.
4. Verify Mycophenolate REMS contact details.
5. Click “Save.”

Gmail

1. Open the email from Mycophenolate REMS.
2. Click “More Options” in the email header.
3. Click “Add Sender to Contacts List.”

Hotmail

1. Open the email from Mycophenolate REMS.
2. Click “Save Address” in the toolbar.
3. Verify Mycophenolate REMS contact details.
4. Click “ok.”

* Users may also white-list Mycophenolate REMS entire domain (everything behind the @ sign) using the “Safe List” feature under Options –> Mail –> Junk Email Protection.

Yahoo!

1. Open the email from Mycophenolate REMS.
2. Click “Add to Address Book” to the right, next to Mycophenolate REMS name.
3. Verify Mycophenolate REMS contact details.
4. Click “Add to Address Book.”

MacMail

1. Open the email from Mycophenolate REMS.
2. Ctr-click Mycophenolate REMS email address and select “Open in Address Book.”
3. Verify Mycophenolate REMS contact details.