What is mifepristone?
Mifepristone blocks the actions of the naturally occurring hormone progesterone, which is
necessary for pregnancy to continue.
When used together with another medicine called misoprostol, mifepristone is used to end an
early pregnancy.
Mifepristone may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking mifepristone?
Do not take mifepristone if
-
it has been more than 49 days (7 weeks) since your last menstrual
period began;
-
you have an IUD;
-
your healthcare provider has told you that you have a
pregnancy outside the uterus (ectopic pregnancy);
-
you have problems with your adrenal glands (chronic
adrenal failure);
-
you take a medicine such as warfarin (Coumadin) to thin
your blood;
-
you have a bleeding problem;
-
you take certain steroid medicines:
-
you cannot return for the next 2 visits;
-
you cannot easily get emergency medical help in the 2
weeks after you take mifepristone; or
-
you are allergic to medicines that contain misoprostol, such
as Cytotec or Arthrotec.
Before taking mifepristone, tell your healthcare provider about any other
medical conditions that you have and if you smoke 10 or more cigarettes a day. You may not be able to
take mifepristone, or you may require special monitoring during treatment.
Mifepristone is in the FDA pregnancy category X. This means that mifepristone is known to
cause birth defects in an unborn baby. Mifepristone treatment that does not end in termination of
pregnancy may cause birth defects in the unborn baby.
It is not known whether mifepristone passes into breast milk. Do not take mifepristone
without first talking to your doctor if you are breast-feeding a baby.
How should I take mifepristone?
Take mifepristone exactly as directed by your doctor. If you do not understand these directions,
ask your doctor, nurse, or pharmacist to explain them to you.
Mifepristone is used to end an early pregnancy. Early pregnancy means it is 49 days (7
weeks) or less since your last menstrual period. Mifepristone must not be used to attempt to end
pregnancy beyond this time.
Before taking mifepristone, you will need to read and understand the information in the
Medication Guide that will be given to you. Then you will need to sign a statement (Patient Agreement)
that you have decided to end the pregnancy.
On Day 1 at your healthcare provider's office, you will read the Medication Guide for
mifepristone and discuss the benefits and risks of using mifepristone. If you decide that mifepristone is
right for you, you will sign the Patient Agreement then, after getting a physical exam, swallow 3 tablets
of mifepristone.
When you return to your healthcare provider's office on Day 3, your healthcare provider will
check to see if you are still pregnant. If you are still pregnant, you will take 2 misoprostol tablets.
Misoprostol may cause cramps, nausea, diarrhea, and other symptoms. Your healthcare provider may
send you home with medicines for these symptoms.
About Day 14 (2 weeks after you took mifepristone), you will return to your healthcare
provider's office to be sure you are well and that you are not pregnant. Your healthcare provider will
check to see whether the pregnancy has completely ended. If you are still pregnant after mifepristone
therapy, you may need a surgical procedure to end the pregnancy. There is a chance that there may be
birth defects from mifepristone if the pregnancy is not ended. Your healthcare provider will talk with
you about the other choices you have, including a surgical procedure to end the pregnancy.
This treatment causes cramping and bleeding. Usually, these symptoms mean the treatment is
working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you
must return
to your provider on Day 3 and about day 14.
Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30
days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You
may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can
be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about
what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your
healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per
hour for two consecutive hours or if you are concerned about heavy bleeding.
What happens if I miss a dose of mifepristone?
Your doctor will administer mifepristone, so you will not miss a dose.
Where can I get more information about mifepristone?
Your pharmacist has information about mifepristone written for health professionals that you may read.
What are the possible side effects of mifepristone?
Seek emergency medical attention if you experience an allergic reaction (difficulty breathing;
closing of your throat; swelling of your lips, tongue, or face; or hives).
Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30
days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You
may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can
be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about
what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your
healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per
hour for two consecutive hours or if you are concerned about heavy bleeding.
Other less serious side effects may include:
Side effects other than those listed here may also occur. Talk to your doctor
about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about mifepristone?
Mifepristone is used to end an early pregnancy. Early pregnancy means it is 49 days (7
weeks) or less since your last menstrual period. Mifepristone must not be used to attempt to end
pregnancy beyond this time.
Before taking mifepristone, you will need to read and understand the information in the
Medication Guide that will be given to you. Then you will need to sign a statement (Patient Agreement)
that you have decided to end the pregnancy.
If you are still pregnant after mifepristone therapy, you may need a surgical procedure to end
the pregnancy. There is a chance that there may be birth defects from mifepristone if the pregnancy is
not ended. Your healthcare provider will talk with you about the other choices you have, including a
surgical procedure to end the pregnancy.
This treatment causes cramping and bleeding. Usually, these symptoms mean the treatment is
working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you
must return
to your provider on Day 3 and about day 14.
Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30
days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You
may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can
be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about
what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your
healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per
hour for two consecutive hours or if you are concerned about heavy bleeding.
What should I avoid while taking mifepristone?
You should not take certain other medicines because they may interfere with mifepristone
treatment. Ask your healthcare provider about what medicines you can take for pain. Do not take any
other prescription or non-prescription medicines (including herbal medicines and supplements) at any
time during the treatment period without first asking your healthcare provider.
What other drugs will affect mifepristone?
You should not take certain other medicines because they may interfere with mifepristone
treatment. Ask your healthcare provider about what medicines you can take for pain. Do not take any
other prescription or non-prescription medicines (including herbal medicines and supplements) at any
time during the treatment period without first asking your healthcare provider.
What happens if I have an overdose of mifepristone?