What is Mifeprex?

Mifeprex is a pill that block a hormone necessary to sustain pregnancy. When followed by another medicine, misoprostol, Mifeprex ends the pregnancy. The FDA approved regimen includes use of Mifeprex for ending early pregnancy up to 49 days from a woman's last menstrual period (LMP).

For a more detailed description of Mifeprex you may want to review the Description section in the Prescribing Information.

How does Mifeprex work?

Mifeprex blocks progesterone, a naturally produced hormone that prepares the lining of the uterus for a fertilized egg and helps maintain pregnancy. Without progesterone the pregnancy cannont continue and the lining of the uterus softens, breaks down and bleeding begins. Mifeprex is followed by a prostaglandin, misoprostol, that causes the uterus to contract, which helps to complete the process.

For more detailed information on the clinical pharmacology of Mifeprex you may wish to review that section of the Prescribing Information.

When is Mifeprex appropriate?

Mifeprex is indicated for the medical termination of intrauterine pregnancy through 49 days' pregnancy. The duration of pregnancy may be determined from menstrual history and by clinical examination. Ultrasonographic scan should be used if the duration of pregnancy is uncertain, or if ectopic pregnancy is suspected.

Mifeprex should not be used in cases of confirmed or suspected ectopic pregnancy, as it is not effective for terminating those pregnancies.

For more detailed information on indication and usage for Mifeprex you may want to review that section of the Prescribing Information.

How effective is Mifeprex?

Mifeprex is 92-95% effective for safely ending pregnancy (5-8% of women will need a surgical procedure to end the pregnancy or stop heavy bleeding).

For more information on the efficacy of Mifeprex you may want to review the Clinical Pharmacology section of the Prescribing Information.

What are the advantages of Mifeprex?

Mifeprex expands your services and offers patients a choice. It is taken orally and allows women to avoid surgery and anesthesia in most cases. With Mifeprex, women can act early- up to 49 days from after the beginning of a woman’s last menstrual period. Overall, many women like the privacy of using Mifeprex.

What important safety information should I know about Mifeprex?

Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifeprex use. No causal relationship between the use of Mifeprex and misoprostol and these events has been established. A high index of suspicion is needed to rule out serious and rarely fatal infections (e.g. Clostridium sordellii) and sepsis that can present without fever, bacteremia or significant findings on a pelvic exam, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.

 

Cramping and bleeding are expected; bleeding may continue for 9-16 days. 5-8% of women will need a surgical procedure to end a pregnancy or stop heavy bleeding.

 

Patients should counseled to seek immediate medical attention if they experience sustained fever (100.4°F or higher), severe abdominal pain, prolonged heavy vaginal bleeding, syncope or general malaise more than 24 hours after taking misoprostol.

 

Mifeprex should not be used in cases of confirmed or suspected ectopic pregnancy, as Mifeprex is not effective in terminating these pregnancies. Physicians may need to consider the possibility of a ruptured ectopic pregnancy, even if efforts were made to rule out an ectopic pregnancy, because an ectopic pregnancy may have been missed.

 

For additional safety information, you may want to review the Prescribing Information.

How is Mifeprex provided?

Mifeprex may be administered only in a clinic, medical office, or hospital, by or under the supervision of a physician. Women who choose Mifeprex make three visits to their healthcare provider's office over a 2-week period. The FDA-approved regimen for Mifeprex is:

• Day One: 600 mg of Mifeprex taken in single oral dose.
• Day Three: 400 mcg of misoprostol taken orally.
• About Day 14: Follow-up visit to confirm the pregnancy has been terminated.

For more detailed information on the Mifeprex regimen and administration, you may want to review the Prescribing Information.

Is there important information that I should discuss with patients before administering Mifeprex?

It is important to help your patients understand the benefits and risks of the Mifeprex regimen before administering Mifeprex.

During the first office visit, please give the patient a Medication Guide and Patient Agreement to read and review. If she decides to end her pregnancy with the Mifeprex regimen, ask her to sign the Patient Agreement.

Please advise patients to report abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea), with or without fever, if they experience these symptoms more than 24 hours after taking misoprostol. Also, you should advise your patients to take their Medication Guide with them if they visit an emergency room or another healthcare provider who did not prescribe Mifeprex, so that provider will be aware that the patient is undergoing a medical abortion.

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.

You may want to review the Prescribing Information for more information on counseling patients before administering Mifeprex.

What are the side effects can patients expect?

Bleeding and cramping are an expected part of ending a pregnancy. Patients can expect bleeding or spotting for an average of 9-16 days and may last for up to 30 days. Bleeding may be similar to, or greater than, a normal heavy period.

The most common side effects include nausea, headache, vomiting, diarrhea, dizziness, fatigue, and back pain.

You should ensure that your patient knows whom to call and what to do, including going to an Emergency Room with her Medication Guide if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, syncope, or general malaise more than 24 hours after taking misoprostol.

Side effects lessen after Day 3 and usually gone by Day 14. You should discuss with your patient how to manage any pain or other side effects.

For more detailed information on adverse reactions you may want to review the Prescribing Information.

What kind of follow-up care is necessary?

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. Women should expect to experience vaginal bleeding or spotting for an average of 9-16 days and may last up to 30 days. Persistence of heavy or moderate vaginal bleeding at this visit, however, could indicate 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.

While serious adverse events associated with the use of Mifeprex are rare, you must report any hospitalization, transfusion or other serious event to Danco Laboratories.

For more detailed information on the administration of Mifeprex , you may want to review the Dosage and Administration section of the Prescribing Information.

Who should not take Mifeprex?

Administration of Mifeprex is contraindicated for women with any one of the following conditions:

• Confirmed or suspected ectopic pregnancy- Mifeprex is not effective for terminating these pregnancies;
• IUD in place. It must be taken out before Mifeprex is administered;
• Chronic adrenal failure;
• Concurrent long-term corticosteroid therapy;
• Hemorrhagic disorders or concurrent anticoagulant therapy;
• Not able to return for the next 2 visits;
• Not able to access appropriate medical care if an emergency develops;
• History of allergy to mifepristone, misoprostol, or other prostaglandin

For more information, you may want to review the Contraindications section of the Prescribing Information.

Is Mifeprex covered by insurance?

Insurance coverage of Mifeprex is comparable to that for surgical abortion. Mifeprex is generally covered by private insurance companies and Medicaid in the same way as surgical abortions. Most major payers reimburse for each component of the Mifeprex regimen separately, often using existing E/M codes for office visits and J codes for drug reimbursement at full invoice cost. Medicaid reimbursement for Mifeprex is currently provided in a number of states.

To read more about insurance coverage of Mifeprex, including reimbursement and state payer policies, click here.

What experience has there been with Mifeprex?

In 2005, more than half of all known abortion providers performed early medication abortion using Mifeprex, a nearly 80% increase since 2001¹.

In the years since FDA approval of Mifeprex, more than 1.4 Million women in the United States have chosen Mifeprex for ending early pregnancy. It has been used by about 2 million European women for ending their pregnancies.

For more information on abortion in the United States you may want to visit the Abortion Facts and/or Resources section.

What type of physician can provide Mifeprex?

Mifeprex must be provided by or under the supervision of a physician who meets the following qualifications:

• Ability to assess the duration of pregnancy accurately.
• Ability to diagnose ectopic pregnancies.
• Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and are able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation if necessary.
• Has read and understood the Prescribing Information of Mifeprex.

For more information on becoming a Mifeprex provider you may want to review the Prescriber's Agreement/Account Setup Form.

How can I order Mifeprex for a patient?

You can order Mifeprex by establishing an account:

• Read the Prescriber's Agreement/Account Setup Form
• Complete and sign the Account Setup Form
• Fax it to the number on the bottom of the form

Any information you provide is kept confidential. Once your account is established, you usually will receive your order within 24 hours. This is a one-time only process; future orders can be made over the phone.

For more detailed information on ordering Mifeprex go to Ordering Mifeprex.

You may wish to read Providing Mifeprex prior to ordering.

How can I order additional Mifeprex support materials?

If you would like additional Mifeprex support materials, you may download them by clicking here. You can also order additional materials to be sent directly to your office by downloading the Reimbursement/Additional Materials Order Form and faxing it to the distributor.

1. Facts on Induced Abortion in the United States. Guttmacher Institute. Accessed at http://www.guttmacher.org/pubs/fb_induced_abortion.html on March 17, 2008.

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