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MIFEPREX® (mifepristone) Tablets, 200 mg
For Oral Administration Only
DOSAGE AND ADMINISTRATION
Treatment with Mifeprex and misoprostol for the termination of pregnancy requires three office visits by the
patient. Mifeprex should be prescribed only by physicians who have read and understood the prescribing
information. Mifeprex may be administered only in a clinic, medical office, or hospital, by or under the
supervision of a physician, able to assess the gestational age of an embryo and to diagnose ectopic
pregnancies. Physicians must also be able to provide surgical intervention in cases of incomplete abortion or
severe bleeding, or have made plans to provide such care through others, and be able to assure patient
access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
Day One: Mifeprex Administration
Patients must read the MEDICATION GUIDE and read and sign the PATIENT AGREEMENT before
Mifeprex is administered.
Three 200 mg tablets (600 mg) of Mifeprex are taken in a single oral dose.
Day Three: Misoprostol Administration
The patient returns to the health care provider two days after ingesting Mifeprex. Unless abortion has
occurred and has been confirmed by clinical examination or ultrasonographic scan, the patient takes two
200 μg tablets (400 μg) of misoprostol oral y.
During the period immediately following the administration of misoprostol, the patient may need medication
for cramps or gastrointestinal symptoms (see ADVERSE REACTIONS). The patient should be given
instructions on what to do if significant discomfort, excessive vaginal bleeding or other adverse reactions
occur and should be given a phone number to call if she has questions following the administration of the
misoprostol. In addition, the name and phone number of the physician who will be handling emergencies
should be provided to the patient.
Day 14: Post-Treatment Examination
Patients will return for a follow-up visit approximately 14 days after the administration of Mifeprex. This visit
is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of
pregnancy has occurred.
According to data from the U.S. and French studies, women should expect to experience vaginal bleeding or
spotting for an average of nine to 16 days. Up to 8% of women may experience some type of bleeding for
more than 30 days. Persistence of heavy or moderate vaginal bleeding at this visit, however, could indicate
an incomplete abortion.
Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the
treatment. Surgical termination is recommended to manage medical abortion treatment failures (see
Adverse events, such as hospitalization, blood transfusion, ongoing pregnancy, or other major complications
following the use of Mifeprex and misoprostol must be reported to Danco Laboratories. Please provide a
brief clinical and administrative synopsis of any such adverse events in writing to:
Danco Laboratories, LLC
P.O. Box 4816
New York, NY 10185
1-877-4-Early Option (1-877-432-7596)
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