Welcome to Mycophenolate REMS What You Need to Know Your Role Your Birth Control Options Reporting Your Pregnancy...

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3 Table of Contents Welcome to Mycophenolate REMS... 5 What You Need to Know... 6 Your Role... 7 Your Birth Control Options... 8 Reporting Your Pregnancy Important Resources Other Resources Indications and Important Safety Information About Mycophenolate-Containing Medicines

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6 Welcome to Mycophenolate REMS Women who take mycophenolate and can get pregnant should participate in Mycophenolate REMS (Risk Evaluation and Mitigation Strategy). Mycophenolate REMS has been designed to tell you about the risks of taking mycophenolate. Women 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. These medicines contain mycophenolate: CellCept (mycophenolate mofetil) Myfortic (mycophenolic acid) Generic formulations of mycophenolate mofetil This booklet, the Mycophenolate REMS Overview & Your Birth Control Options, tells you what you need to know about Mycophenolate REMS. It explains how it works and what your role is. Please read all of the information in this booklet. Talk with your doctor if you have questions. Program Overview & Your Birth Control Options For complete safety information, please see full Prescribing Information, including Boxed WARNING and Medication Guide, which can be found at 5

7 What You Need to Know If you are a girl or woman who can get pregnant, your doctor will talk with you about the risks of mycophenolate during pregnancy. Talk with your doctor about birth control and pregnancy planning. You must always use acceptable birth control Before starting mycophenolate 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 2 different types of acceptable 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 had a vasectomy, you should not need to use a second form of birth control. It is important to talk with your doctor about the best forms of birth control for you. The table on page 9 lists your options for birth control during treatment with mycophenolate. If you are thinking about having a baby Tell your doctor right away Do not stop taking mycophenolate on your own In some cases, you and your doctor may decide that your medicine is more important to your health than the possible risks to your unborn baby If you get pregnant while you are taking mycophenolate or within 6 weeks after you stop, tell your doctor right away. 6

8 Your Role If you are a woman who can get pregnant, you should take part in Mycophenolate REMS while you are taking mycophenolate. Steps you need to take: 1. Talk with your doctor about mycophenolate use and risk of miscarriage or birth defects. 2. Sign the Patient-Prescriber Acknowledgment Form. 3. Decide with your doctor what birth control methods are right for you. 4. If you are thinking about having a baby, talk with your doctor right away. 5. If you get pregnant while you are taking mycophenolate or within 6 weeks after you stop, tell your doctor right away. 6. If you get pregnant while you are taking mycophenolate, participate in the Mycophenolate Pregnancy Registry. The information you provide helps patients and doctors understand the effects of mycophenolate during pregnancy. 4

9 Your Birth Control Options Choosing birth control is very personal. This booklet gives you information on birth control methods you can use while taking mycophenolate. This information should be used along with your doctor s medical advice. After you read this booklet, talk with your doctor or obstetrician/gynecologist. Then you and your doctor can decide what is best for you. You must always use acceptable birth control Before starting mycophenolate 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 2 different types of acceptable birth control at the same time 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 should not need to use a second form of birth control. Mycophenolate could reduce the effectiveness of hormonal methods of birth control. Hormonal methods of birth control must be used with a barrier method because studies show that mycophenolate decreases blood levels of certain hormones in the oral contraceptive pill. It is possible that mycophenolate could reduce the effectiveness of the oral contraceptive pill The effectiveness of other hormone methods (like the patch, the ring, the shot, and the implant) may also be reduced while you are taking mycophenolate The table on page 9 lists your options for birth control during treatment with mycophenolate. 8

10 Your Birth Control Options (cont d) Acceptable Contraception Methods for Females Potential The table below lists your options for birth control during treatment with mycophenolate. Pick from the following birth control options: 9

11 Option 1 Methods to Use Alone Intrauterine devices (IUDs) Tubal sterilization Patient s partner had a vasectomy OR Hormone Methods choose 1 Barrier Methods choose 1 Option 2 Choose One Hormone Method AND One Barrier Method Estrogen and Progesterone Oral contraceptive pill Transdermal patch Vaginal ring Progesterone-only Injection Implant AND Diaphragm with spermicide Cervical cap with spermicide Contraceptive sponge Male condom Female condom OR Option 3 Choose One Barrier Method from each column (must choose two methods) Barrier Methods choose 1 Diaphragm with spermicide Cervical cap with spermicide Contraceptive sponge AND Barrier Methods choose 1 Male condom Female condom 7

12 Reporting Your Pregnancy 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. Your doctor should report pregnancies to the Registry. If you would like to report a pregnancy to the Registry yourself: Call and choose Mycophenolate Pregnancy Registry from the menu, or Visit 9

13 Important Resources There are many resources to help you get the information you need about Mycophenolate REMS. Mycophenolate REMS Overview & Your Birth Control Options (this booklet) Patient-Prescriber Acknowledgment Form After a discussion with your doctor about mycophenolate use and risk of miscarriage or birth defects, both of you will sign this form. It is included with this booklet. Medication Guide for mycophenolate Gives you important safety information you need to know about your medicine. Your doctor Mycophenolate REMS Web site: Provides access to all Mycophenolate REMS resources and materials. Mycophenolate Pregnancy Registry Collects information about pregnancies that occur during treatment with mycophenolate or within 6 weeks after stopping. You can contact the Registry by calling or by visiting Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients Provides answers to frequently asked questions about the Registry. It is included with this booklet. 9

14 Other Resources For more information about birth control* Association of Reproductive Health Professionals: Planned Parenthood: For emergency birth control* Call your doctor or pharmacy Emergency Contraception Hotline: NOT-2-LATE ( ) For more information about Mycophenolate REMS Read the Mycophenolate REMS Overview & Your Birth Control Options (this booklet) Talk with your doctor Visit the Mycophenolate REMS Web site: Call * Mycophenolate REMS is neither affiliated with nor an endorser of these organizations. The information provided by Mycophenolate REMS or these organizations is meant for informational purposes only, and is not intended to replace your doctor s medical advice. 11

15 Indications and Important Safety Information About Mycophenolate-Containing Medicines WHO ARE MYCOPHENOLATE-CONTAINING MEDICINES FOR? CellCept (mycophenolate mofetil) is a medicine given by prescription to people who had a kidney, heart or liver transplant. Myfortic (mycophenolic acid) is a medicine given by prescription to people who had a kidney transplant. Mycophenolate-containing medicines including CellCept, Myfortic, and generic formulations of mycophenolate mofetil can help prevent rejection of the new organ. Your body's immune system can tell that the organ transplant is different and tries to reject it. Mycophenolate-containing medicines are taken along with other anti-rejection medicines to help control your immune system. They help keep it from rejecting the transplant. Follow your doctor's exact orders for taking mycophenolate-containing medicines, and all other medicines. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT MYCOPHENOLATE- CONTAINING MEDICINES? Females who take mycophenolate-containing medicines 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. If you are a female who can get pregnant, you should have a negative pregnancy test before starting mycophenolate-containing medicines and another pregnancy test 8 to 10 days later. Repeat pregnancy tests should be performed during routine follow-up doctor visits. If you are a female who can get pregnant, you must use two different acceptable methods of birth control before starting and during mycophenolate-containing medicines therapy, and continue birth control for 6 weeks after you stop taking mycophenolate-containing medicines, unless you choose to avoid sexual intercourse completely (abstinence). o Abstinence means that you do not have sexual intercourse with a man at any time. If you use an intrauterine device (IUD), had sterilization surgery (had your tubes tied or blocked), or if your partner had a vasectomy, you should not need to use a second form of birth control. Possible miscarriage and higher risk of birth defects: 12

16 Important Safety Information About Mycophenolate-Containing Medicines (cont d) Mycophenolate-containing medicines decrease 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-containing medicines, and you could become pregnant. If you plan to become pregnant, talk with your doctor or nurse. You and your doctor or nurse can decide if other medicines to prevent rejection may be right for you. If you get pregnant while taking mycophenolatecontaining medicines, do not stop taking the mycophenolate-containing medicines. Call your doctor or nurse right away. You and your doctor or nurse should report your pregnancy to the Mycophenolate Pregnancy Registry at You should not breastfeed while taking mycophenolate-containing medicines without first talking with your doctor or nurse. It is not known if mycophenolate-containing medicines pass into breast milk. You and your doctor or nurse will decide if you will take mycophenolate-containing medicines or breastfeed. Increased risk of getting serious infections: Mycophenolate-containing medicines weaken the body's immune system and affect your ability to fight infections. Serious infections, possibly leading to death, can happen with mycophenolate-containing medicines. Types of infections can include: o Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with mycophenolate-containing medicines include: Shingles, other herpes infections, and cytomegalovirus (CMV). CMV can cause serious tissue and blood infections. BK virus. BK virus can affect how your kidney works and cause your transplanted kidney to fail. o A brain infection called progressive multifocal leukoencephalopathy (PML). In some patients, mycophenolate-containing medicines may cause an infection of the brain that may cause death. You are at risk for this brain infection because you have a weakened immune system. You should tell your doctor or nurse right away if you have any of the following symptoms: Weakness on one side of the body You do not care about things that you usually care about (apathy) You are confused or have problems thinking You cannot control your muscles 13

17 Important Safety Information About Mycophenolate-Containing Medicines (cont d) o Fungal infections. Yeasts and other types of fungal infections can happen with mycophenolatecontaining medicines and can cause serious tissue and blood infections. Call your doctor or nurse right away if you have any of the following signs and symptoms of infection: Temperature of F or greater Cold symptoms, such as a runny nose or sore throat Flu symptoms, such as an upset stomach, stomach pain, vomiting or diarrhea Earache or headache Pain during urination White patches in the mouth or throat Unexpected bruising or bleeding Cuts, scrapes or incisions that are red, warm and oozing pus Increased risk of getting certain cancers. People who take mycophenolate-containing medicines have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor or nurse if you have: Unexplained fever, prolonged tiredness, weight loss or lymph node swelling A brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other A change in the size and color of a mole A new skin lesion or bump Any other changes to your health WHO SHOULD NOT TAKE MYCOPHENOLATE- CONTAINING MEDICINES? Do not take mycophenolate-containing medicines if you are allergic to mycophenolate mofetil, mycophenolic acid, mycophenolate sodium, or any of the ingredients in the mycophenolatecontaining medicines. Please discuss this with your doctor or nurse. WHAT ADDITIONAL INFORMATION SHOULD I KNOW ABOUT MYCOPHENOLATE-CONTAINING MEDICINES? People taking high doses of mycophenolate-containing medicines each day may have a decrease in blood counts, including white blood cells, red blood cells and platelets. Your doctor will do blood 13

18 Important Safety Information About Mycophenolate-Containing Medicines (cont d) tests before you start taking mycophenolatecontaining medicines and during therapy to check your blood cell counts. Tell your doctor or nurse right away if you have any signs of infection, or any unexpected bruising or bleeding, unusual tiredness, lack of energy, dizziness or fainting. Cases of bleeding in the stomach or intestines that required hospitalization have been reported. Early signs of bleeding may include stomach pain, blood in your stool, or dark, sticky stools. Tell your doctor or nurse if you have any digestive problems, such as ulcers. People taking mycophenolate-containing medicines should not take live vaccines. Some vaccines may not work as well during treatment with mycophenolatecontaining medicines. Tell your doctor or nurse about all the medicines you are taking including prescription and nonprescription medicines, vitamins and herbal supplements. Tell your doctor or nurse if you have Lesch-Nyhan or Kelley-Seegmiller syndrome or another rare inherited deficiency hypoxanthine-guanine phosphoribosyltransferase (HGPRT). You should not take mycophenolate-containing medicines if you have one of these disorders. Tell your doctor or nurse if you have phenylketonuria (PKU). Mycophenolate mofetil Oral Suspension contains aspartame (a source of phenylalanine). WHAT ARE THE MOST COMMON SIDE EFFECTS FROM MYCOPHENOLATE-CONTAINING MEDICINES? The most common side effects of mycophenolate mofetil include: diarrhea, vomiting, pain, stomach area pain, swelling of the lower legs, ankles and feet, and high blood pressure. These are not all of the possible side effects of mycophenolate mofetil. Tell your doctor or nurse about any side effect that bothers you or that does not go away. 15

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20 Important Safety Information About Mycophenolate-Containing Medicines (cont d) The most common side effects of mycophenolic acid include: constipation, nausea, diarrhea, vomiting, urinary tract infections, and stomach upset. This important safety information does not take the place of talking with your doctor or nurse about your medical condition or your treatment. Talk with your doctor or nurse if you have any questions about your health problems or treatment. Your pharmacist should give you a Medication Guide each time you fill your mycophenolate-containing medicine prescription. The Medication Guide is a patient handout that describes important information on the medicine, such as specific risks with the medicine, proper use, storage, and dosing. Please ask your pharmacist for a copy of the Medication Guide with every prescription, as new information may be added after you start taking the medicine. For additional safety information, please see full Prescribing Information, including Boxed WARNING and Medication Guide, which can be found at 17

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