- What is the Mycophenolate
REMS ?
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.
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Do I have to register in the Mycophenolate REMS as a patient?
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.
-
Do I have to go to a certain pharmacy to get my prescription filled in the Mycophenolate
REMS?
You can fill your prescription in any pharmacy.
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What forms of birth control should I use while taking mycophenolate?
-
Where can I find more information about birth control options?
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Where can I find more information about drugs and birth defects?
It is best if you talk with your doctor about your medicines and birth defects.
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What type of data is collected by the Mycophenolate Pregnancy Registry and who will
see the data?
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.
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Where can I find more information about emergency contraception?
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).
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How do I get more information about the Mycophenolate REMS?
You can talk with your doctor for more information.
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What if I become pregnant while on a mycophenolate containing medicine or after
I stop taking a mycophenolate containing medicine?
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.
-
What is 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.
-
Why should I take part in the Mycophenolate Pregnancy Registry?
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.
-
Who can take part in the Mycophenolate Pregnancy Registry?
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.
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What will I need to do if I participate in the Mycophenolate Pregnancy Registry?
There are a few simple steps to take.
- Tell your doctor if you get pregnant
- The Registry will contact you after speaking with your doctor.
- 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.
- 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.
- 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.
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What are my rights as a participant in the Mycophenolate Pregnancy Registry?
- You can quit at any time
- Your privacy is protected
- Whom can
I contact for more information?
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Are there other side effects that I should know about with a mycophenolate containing
medicine?
For information on side effects, you can talk with your doctor, ask your pharmacist,
read the mycophenolate Medication Guide or the Prescribing Information (PI).
-
How should I store a mycophenolate containing medicine?
- 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.
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In addition to pregnancy, what should I avoid while taking mycophenolate?
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).
- How do
I handle internet browser issues?
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
- Disabling the pop-up blocker completely every time you need to use the site, or
- 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.
- What
materials will I receive from my doctor?