(mifepristone) Tablets, for Oral Use
Read this information carefully before taking Mifeprex
and misoprostol. It will help you understand how the treatment works. This
Medication Guide does not take the place of talking with your healthcare
What is the most important information I should know
What symptoms should I be concerned with? Although
cramping and bleeding are an expected part of ending a pregnancy, rarely,
serious and potentially life-threatening bleeding, infections, or other
problems can occur following a miscarriage, surgical abortion, medical
abortion, or childbirth. Seeking medical attention as soon as possible is
needed in these circumstances. Serious infection has resulted in death in a
very small number of cases. There is no information that use of Mifeprex and
misoprostol caused these deaths. If you have any questions, concerns, or
problems, or if you are worried about any side effects or symptoms, you should
contact your healthcare provider. You can write down your healthcare provider's
telephone number here ________________________.
Be sure to contact your healthcare provider promptly
if you have any of the following:
- Heavy 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. In about 1 out of 100 women, bleeding can be so heavy that it
requires a surgical procedure (surgical aspiration or D&C).
- Abdominal Pain or “Feeling Sick.” If you have
abdominal pain or discomfort, or you are “feeling sick,” including weakness,
nausea, vomiting, or diarrhea, with or without fever, more than 24 hours after
taking misoprostol, you should contact your healthcare provider without delay.
These symptoms may be a sign of a serious infection or another problem (including
an ectopic pregnancy, a pregnancy outside the womb).
- Fever. In the days after treatment, if you have a
fever of 100.4°F or higher that lasts for more than 4 hours, you should contact
your healthcare provider right away. Fever may be a symptom of a serious
infection or another problem.
If you cannot reach your healthcare provider, go to
the nearest hospital emergency room. Take this Medication Guide with you.
When you visit an emergency room or a healthcare provider who did not give you
your Mifeprex, you should give them your Medication Guide so that they
understand that you are having a medical abortion with Mifeprex.
What to do if you are still pregnant after Mifeprex
with misoprostol treatment. If you are still pregnant, your healthcare
provider will talk with you about a surgical procedure to end your pregnancy.
In many cases, this surgical procedure can be done in the office/clinic. The
chance of birth defects if the pregnancy is not ended is unknown.
Talk with your healthcare provider. Before you take
Mifeprex, you should read this Medication Guide and you and your healthcare
provider should discuss the benefits and risks of your using Mifeprex.
What is Mifeprex?
Mifeprex is used in a regimen with another
prescription medicine called misoprostol, to end an early pregnancy. Early
pregnancy means it is 70 days (10 weeks) or less since your last menstrual
period began. Mifeprex is not approved for ending pregnancies that are further
along. Mifeprex blocks a hormone needed for your pregnancy to continue. When
you use Mifeprex on Day 1, you also need to take another medicine called
misoprostol 24 to 48 hours after you take Mifeprex, to cause the pregnancy to
be passed from your uterus.
The pregnancy is likely to be passed from your uterus
within 2 to 24 hours after taking Mifeprex and misoprostol. When the pregnancy
is passed from the uterus, you will have bleeding and cramping that will likely
be heavier than your usual period. About 2 to 7 out of 100 women taking
Mifeprex will need a surgical procedure because the pregnancy did not
completely pass from the uterus or to stop bleeding.
Who should not take Mifeprex?
Some women should not take Mifeprex. Do not take Mifeprex
- Have a pregnancy that is more than 70 days (10 weeks).
Your healthcare provider may do a clinical examination, an ultrasound
examination, or other testing to determine how far along you are in pregnancy.
- Are using an IUD (intrauterine device or system). It must
be taken out before you take Mifeprex.
- Have been told by your healthcare provider that you have
a pregnancy outside the uterus (ectopic pregnancy).
- Have problems with your adrenal glands (chronic adrenal
- Take a medicine to thin your blood.
- Have a bleeding problem.
- Have porphyria.
- Take certain steroid medicines.
- Are allergic to mifepristone, misoprostol, or medicines
that contain misoprostol, such as Cytotec or Arthrotec. Ask your healthcare
provider if you are not sure about all your medical conditions before taking
this medicine to find out if you can take Mifeprex.
What should I tell my healthcare provider before
Before you take Mifeprex, tell your healthcare
provider if you:
- cannot follow-up within approximately 7 to 14 days of
your first visit
- are breastfeeding. Mifeprex can pass into your breast
milk. The effect of the Mifeprex and misoprostol regimen on the breastfed
infant or on milk production is unknown.
- are taking medicines, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. Mifeprex and
certain other medicines may affect each other if they are used together. This
can cause side effects.
How should I take Mifeprex?
- Mifeprex will be given to you by a healthcare provider in
a clinic, medical office, or hospital.
- You and your healthcare provider will plan the most
appropriate location for you to take the misoprostol, because it may cause
bleeding, cramps, nausea, diarrhea, and other symptoms that usually begin
within 2 to 24 hours after taking it.
- Most women will pass the pregnancy within 2 to 24 hours
after taking the misoprostol tablets.
Follow the instruction below on how to take Mifeprex
Mifeprex (1 tablet) orally + misoprostol (4 tablets)
- Take 1 Mifeprex tablet by mouth.
- Your healthcare provider will either give you or prescribe
for you 4 misoprostol tablets to take 24 to 48 hours later.
24 to 48 hours after taking Mifeprex:
- Place 2 misoprostol tablets in each cheek pouch (the area
between your teeth and cheek -see Figure A) for 30 minutes and then swallow
anything left over with a drink of water or another liquid.
- The medicines may not work as well if you take
misoprostol sooner than 24 hours after Mifeprex or later than 48 hours after
- Misoprostol often causes cramps, nausea, diarrhea, and
other symptoms. Your healthcare provider may send you home with medicines for
these symptoms. Figure A (2 tablets between your left cheek and gum and 2
tablets between your right cheek and gum).
Figure A (2 tablets between your left cheek and gum
and 2 tablets between your right cheek and gum).
Follow-up Assessment at Day 7 to 14:
- This follow-up assessment is very important. You must
follow-up with your healthcare provider about 7 to 14 days after you have taken
Mifeprex to be sure you are well and that you have had bleeding and the pregnancy
has passed from your uterus.
- Your healthcare provider will assess whether your
pregnancy has passed from your uterus. If your pregnancy continues, the chance
that there may be birth defects is unknown. If you are still pregnant, your
healthcare provider will talk with you about a surgical procedure to end your
- If your pregnancy has ended, but has not yet completely
passed from your uterus, your provider will talk with you about other choices
you have, including waiting, taking another dose of misoprostol, or having a
surgical procedure to empty your uterus.
When should I begin birth control?
You can become pregnant again right after your pregnancy
ends. If you do not want to become pregnant again, start using birth control as
soon as your pregnancy ends or before you start having sexual intercourse
What should I avoid while taking Mifeprex and
Do not take any other prescription or over-the-counter
medicines (including herbal medicines or supplements) at any time during the
treatment period without first asking your healthcare provider about them
because they may interfere with the treatment. Ask your healthcare provider
about what medicines you can take for pain and other side effects.
What are the possible side effects of Mifeprex and
Mifeprex may cause serious side effects. See “What is
the most important information I should know about Mifeprex?” Cramping and
bleeding. Cramping and vaginal bleeding are expected with this treatment.
Usually, these symptoms mean that the treatment is working. But sometimes you
can get cramping and bleeding and still be pregnant. This is why you must
follow-up with your healthcare provider approximately 7 to 14 days after taking
Mifeprex. See “How should I take Mifeprex?” for more information on your
follow-up assessment. If you are not already bleeding after taking Mifeprex,
you probably will begin to bleed once you take misoprostol, the medicine you
take 24 to 48 hours after Mifeprex. Bleeding or spotting can be expected for an
average of 9 to16 days and may last for up to 30 days. Your bleeding may be
similar to, or greater than, a normal heavy period. You may see blood clots and
tissue. This is an expected part of passing the pregnancy. The most common side
effects of Mifeprex treatment include: nausea, weakness, fever/chills,
vomiting, headache, diarrhea and dizziness. Your provider will tell you how to
manage any pain or other side effects.These are not all the possible side
effects of Mifeprex.
Call your healthcare provider for medical advice about
any side effects that bother you or do not go away. You may report side effects
to FDA at 1-800-FDA-1088.
General information about the safe and effective use
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. This Medication Guide summarizes the
most important information about Mifeprex. If you would like more information,
talk with your healthcare provider. You may ask your healthcare provider for
information about Mifeprex that is written for healthcare professionals.
For more information about Mifeprex, go to
www.earlyoptionpill.com or call 1-877-4 Early Option (1-877-432-7596).