Questions and Answers on Mifeprex
- What is Mifeprex and how does it work?
Mifeprex (mifepristone) is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. Mifeprex, when used together with another medicine called misoprostol, is used to end an early pregnancy (70 days or less since the first day of the last menstrual period).
- Is there a generic version of Mifeprex?
The FDA approved GenBioPro, Inc.’s abbreviated new drug application (ANDA) for generic Mifeprex on April 11, 2019. This approval reflects FDA’s determination that GenBioPro’s product, Mifepristone Tablets, 200 mg, is therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. Like Mifeprex, the approved generic product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation.
- Who should not take Mifeprex?
Some women should not take Mifeprex. A woman should not take Mifeprex if it has been more than 70 days since the first day of her last menstrual period, or if she:
- has an ectopic pregnancy (a pregnancy outside of the uterus)
- has problems with the adrenal glands (the glands near the kidneys)
- is currently being treated with long-term corticosteroid therapy (medications)
- has had an allergic reaction to mifepristone, misoprostol or similar drugs
- has bleeding problems or is taking anticoagulant (blood thinning) drug products
- has inherited porphyria
- has an intrauterine device (IUD) in place (it must be removed before taking Mifeprex).
This information applies equally to the approved generic version of Mifeprex.
- What changes to the Mifeprex application did the FDA approve on March 29, 2016?
The FDA first approved Mifeprex in 2000. In 2016, the agency approved a supplemental application submitted by the drug company that markets Mifeprex. This approval included changes in the dose of Mifeprex and the dosing regimen for taking Mifeprex and misoprostol (including the dose of misoprostol and a change in the route of misoprostol administration from oral to buccal (in the cheek pouch), the interval between taking Mifeprex and misoprostol, and the location at which the woman may take misoprostol). The approval also modified the gestational age up to which Mifeprex has been shown to be safe and effective, as well as the process for follow-up after administration of the drug. In addition, the labeling was revised to meet the current labeling requirements in the FDA’s regulations. The FDA also approved changes to the existing Risk Evaluation and Mitigation Strategy (REMS) to reflect the changes approved in the supplemental application, and to make the Mifeprex REMS consistent with more recently approved REMS.
Of note, on April 11, 2019, FDA approved a supplemental application for Mifeprex, approving modifications to the existing approved REMS for Mifeprex to establish a single, shared system REMS for mifepristone products (including Mifeprex as well as the approved generic version of Mifeprex) for the medical termination of intrauterine pregnancy through 70 days gestation. In establishing the single, shared system REMS, no changes were made to the substantive elements of the REMS. This single, shared system REMS is known as the Mifepristone REMS Program.
Find approval information for this 2019 supplement here.
The approved generic version of Mifeprex generally has the same labeling as Mifeprex. As discussed below (see question 7), the approved generic version of Mifeprex is required to use the single, shared system REMS with the brand product, Mifeprex.
- Where can women get Mifeprex?
Mifeprex is supplied directly to healthcare providers who meet certain qualifications. It is only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber. It is not available in retail pharmacies, and it is not legally available over the Internet. These requirements also apply to the approved generic version of Mifeprex.
- What qualifications must healthcare providers have to obtain and dispense Mifeprex?
Healthcare providers who would like to become certified to prescribe Mifeprex must have the ability to date pregnancies accurately and to diagnose ectopic pregnancies. Healthcare providers must also be able to provide any necessary surgical intervention, or have made arrangements for others to provide for such care. Healthcare providers must be able to ensure that women have access to medical facilities for emergency care, and must agree to other responsibilities, including reviewing and signing the Patient Agreement Form with the patient and providing each patient with a copy of the signed Patient Agreement Form and the Medication Guide.
Healthcare providers who prescribe and who meet certain qualifications are authorized to order and dispense Mifeprex. Some states allow healthcare providers other than physicians to prescribe medications. Healthcare providers should check their individual state laws.
These requirements also apply to the approved generic version of Mifeprex.
- Are there restrictions on the distribution of Mifeprex?
When the agency reviewed and approved the original new drug application for Mifeprex in 2000, it concluded that certain distribution restrictions were necessary to ensure the safe use of that drug. These restrictions were converted to a risk evaluation and mitigation strategy (REMS) in 2011. In 2016, after reviewing the additional data and information submitted by the sponsor of Mifeprex, and after taking into consideration the safety data that had become available since the initial approval of Mifeprex, the FDA concluded that certain restrictions continue to be necessary to ensure the safe use of Mifeprex.
These restrictions also apply to the approved generic version of Mifeprex. Under the law, the approved generic version of Mifeprex is required to use a single, shared system REMS with the brand product, Mifeprex. This single, shared system REMS, known as the Mifepristone REMS Program, sets forth the distribution requirements that must be followed for both Mifeprex and the approved generic version of Mifeprex.
Under the Mifepristone REMS Program, Mifeprex and the approved generic version of Mifeprex may only be supplied directly to healthcare providers who are certified to prescribe the drug product and who meet certain qualifications. Under this REMS, the products are only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber. They are not available in retail pharmacies and are not legally available over the Internet. The FDA warns consumers they should not buy Mifeprex or GenBioPro, Inc.’s approved generic version of Mifeprex, Mifepristone Tablets, 200 mg., over the Internet because they will bypass important safeguards designed to protect their health.
- What are the possible side effects of using Mifeprex?
Cramping and vaginal bleeding are expected effects of the treatment regimen. In some cases very heavy vaginal bleeding will need to be stopped by a surgical procedure, which can often be performed in a healthcare provider’s office. Other common side effects of the treatment regimen include nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness in the first day or two after taking the two medicines.
The possible side effects are described in the Adverse Reactions section of the labeling and in the Medication Guide for Mifeprex.
This information applies equally to the approved generic version of Mifeprex, which generally has the same labeling as Mifeprex.
- What serious adverse events have been reported after Mifeprex use?
It is not uncommon for the FDA to receive reports of serious adverse events for prescription drugs after they are approved. The FDA has received reports of serious adverse events in women who took Mifeprex. As of December 31, 2018, there were reports of 24 deaths of women associated with Mifeprex since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal. The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient. A summary report of adverse events that reflects data through December 31, 2018 is here. The FDA has reviewed this information and did not identify any new safety signals. The FDA intends to update this summary report on an annual basis or as appropriate.
As with all approved drugs, when the FDA receives new information regarding adverse events, the agency reviews the new information and, as appropriate, takes necessary action, including providing updates to healthcare providers and their patients so that they have information on how to use the drug safely.
- What should healthcare providers watch for in women who have taken Mifeprex?
All providers of medical abortion and emergency room healthcare practitioners should investigate the possibility of sepsis in women who are undergoing medical abortion and present with nausea, vomiting, or diarrhea and weakness with or without abdominal pain. These symptoms, even without a fever, may indicate a serious infection. Strong consideration should be given to obtaining a complete blood count in these patients. Significant leukocytosis with a marked left shift and hemoconcentration may be indicative of sepsis. This information applies equally to Mifeprex and the approved generic version of Mifeprex.
- Is it possible for a woman to become pregnant again if she takes Mifeprex?
It is possible for a woman to become pregnant again soon after a pregnancy ends. If a woman who has terminated a pregnancy does not want to become pregnant again, she should start taking appropriate precautions after the pregnancy ends. A woman should consult with her healthcare provider regarding any specific questions she may have. This information applies equally to Mifeprex and the approved generic version of Mifeprex.
- Is Mifeprex approved in any other countries?
Mifepristone for termination of pregnancy has been approved in France since 1988, and also is approved in the United Kingdom, Sweden, and approximately 60 other countries.
- How much does Mifeprex cost?
The FDA does not have the authority to regulate the prices of drug products in the United States. Manufacturers, distributors, and retailers establish the prices. Additionally, the FDA has no input into or legal control over whether an insurance company does or does not cover the cost of a drug. Insurance coverage is a decision made by an insurance provider. This information applies equally to Mifeprex and the approved generic version of Mifeprex.