- 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 or its approved generic Mifepristone Tablets, 200 mg, 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.
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 8), the approved generic version of Mifeprex is required to use the single, shared system REMS with the brand product, Mifeprex.
- What determination related to the Mifepristone REMS Program did FDA announce on December 16, 2021?
After conducting a review of the single, shared system Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, known as the Mifepristone REMS Program, FDA determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks. The modifications to the Mifepristone REMS Program will consist of:
- Removing the requirement that mifepristone be dispensed only in certain healthcare settings, specifically clinics, medical offices, and hospitals (referred to as the “in-person dispensing requirement”)
- Adding a requirement that pharmacies that dispense the drug be certified
- Where can women get Mifeprex?
Mifeprex (mifepristone) must be prescribed by or under the supervision of a certified healthcare provider who meets certain qualifications. In December 2021, FDA announced that the REMS must be modified by removing the in-person dispensing requirement. Removing the in-person dispensing requirement will allow, for example, dispensing of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals as currently outlined in the Mifepristone Rems Program. Applicants began using a mail order distribution model when the in-person dispensing requirement was not being enforced during the COVID-19 public health emergency (PHE); this distribution model remains in use today.
Mifeprex (mifepristone) can still be dispensed to patients in clinics, medical offices, or hospitals by or under the supervision of a certified prescriber.
The above information also applies 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.
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 the drug. These restrictions were converted to a risk evaluation and mitigation strategy (REMS) in 2011.
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.
Most recently, in December 2021, FDA undertook a full review of the Mifepristone REMS Program, and determined that certain modifications were warranted. See question 5 above.
- 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 FDA to receive reports of serious adverse events for prescription drugs after they are approved. FDA has received reports of serious adverse events in women who took mifepristone. As of June 30, 2021, there were reports of 26 deaths of women associated with mifepristone since the product was approved in September 2000, including two cases of ectopic pregnancy (a pregnancy located outside the womb, such as in the fallopian tubes) 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 June 30, 2021 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.
- How has the in-person dispensing requirement of the risk evaluation and mitigation strategy (REMS) for Mifeprex been handled during the COVID-19 public health emergency?
The Mifepristone REMS Program currently requires that certified prescribers dispense mifepristone directly to the patient in a clinic, medical office, or hospital. The requirement to dispense directly to the patient in one of these settings is referred to as the “in-person dispensing requirement.”
From July 13, 2020 until January 12, 2021, enforcement of the in-person dispensing requirement was barred by an injunction issued in the ACOG v. FDA litigation. More recently, on April 12, 2021, the Agency stated its intent to exercise enforcement discretion with respect to the in-person dispensing requirement, including any in-person requirements that may be related to the Patient Agreement Form, during the COVID-19 public health emergency (PHE), provided all other requirements of the Mifepristone REMS Program are met. Additionally, to the extent all of the other requirements of the Mifepristone REMS Program are met, the Agency intends to exercise enforcement discretion during the COVID-19 PHE with respect to the dispensing of Mifeprex or the approved generic version of Mifeprex, Mifepristone Tablets, 200 mg, through the mail, either by or under the supervision of a certified prescriber, or through a mail-order pharmacy when such dispensing is done under the supervision of a certified prescriber. The PHE is ongoing.