Mifeprex* Administration

Mifeprex* is the only FDA-approved medication for early abortion. Because it can be taken up to 49 days after the beginning of a woman's last menstrual period, it allows women to act early when deciding to end a pregnancy. Mifeprex is 92-95% effective for safely ending early pregnancy (5-8% of women will need a surgical procedure (surgical abortion/D&C) to end a pregnancy or stop heavy bleeding).

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. For more information on provider qualifications and guidelines, visit Providing Mifeprex

The FDA-approved regimen for Mifeprex requires that a woman make three visits to her healthcare provider over a two-week period.

Day One: Mifeprex Administration and Patient Counseling

Before administering Mifeprex, it is important to help your patients understand the benefits and risks of the Mifeprex regimen. During the first office visit, you should discuss the Medication Guide and Patient Agreement with your patient and provide her with an opportunity to read and review. If she decides to end her pregnancy with Mifeprex, she signs the Patient Agreement.

Three 200 mg tablets (600 mg) of Mifeprex are taken in a single oral dose.

Before administering Mifeprex, each patient must understand:

the necessity of completing the treatment schedule, including a follow-up visit approximately 14 days after taking Mifeprex;
that vaginal bleeding and uterine cramping probably will occur;
that prolonged heavy vaginal bleeding is not proof of a complete abortion;
that if the treatment fails, there is a risk of fetal malformation;
that medical abortion treatment failures are managed by surgical termination; and
the steps to take in an emergency situation, including precise instructions and a telephone number that she can call if she has any problems or concerns.

Another pregnancy can occur following termination of pregnancy and before resumption of normal menses. Contraception can be initiated as soon as the termination of the pregnancy has been confirmed, or before the woman resumes sexual intercourse.

Day Three: Misoprostol Administration

Two days after the administration of Mifeprex, the patient returns and takes two 200 µg tablets (400 µg) of misoprostol orally. 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.

You can review the “How Much Am I Bleeding”¹ guide for information on differences between scant, light, moderate and heavy bleeding. This guide provides basic information and does not replace medical advice or guidance from the healthcare provider.

Day 14: Post-Treatment Examination

Patients should return for a follow-up visit approximately 14 days after the administration of Mifeprex to confirm that the pregnancy has been terminated. Termination can be confirmed by clinical examination or ultrasonographic scan. Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete 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 medication abortion treatment failures. You should discuss with your patients whether you will provide such care or will refer her to another provider as part of counseling prior to prescribing Mifeprex.

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:

Medical Director
Danco Laboratories, LLC
P.O. Box 4816
New York, NY 10185 1-877-4-Early Option (1-877-432-7596)

For more information about Mifeprex you may call the 24-hour hotline, tollfree at 1-877-4 Early Option (1-877-432-7596). If you have an emergent question, a physician will usually return your call within the hour. For general questions, our Medical Director typically returns calls within 24 hours.

For additional information on providing Mifeprex please also review the letters below.

1. Developed by Planned Parenthood of Western Washington.