What is RU 486

RU-486 also known as mifepristone, is a potent synthetic steroidal antiprogesterone (drug that blocks a hormone called progesterone) which is used as a single dose in combination with another medicine called misoprostol to end an early pregnancy (70 days or less since the first day of the last menstrual period) ¹. Ultrasound should be carried out first to determine the viability of the pregnancy, whether it is uterine or ectopic. After that, the dating of pregnancy should be determined with the help of an ultrasonogram.

RU-486 (mifepristone) is supplied directly to healthcare providers who meet certain qualifications. RU-486 (mifepristone) is only available to be dispensed in certain healthcare settings, specifically, abortion 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 RU 486.

Healthcare providers who would like to become certified to prescribe RU 486 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 RU 486. 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 RU 486.

When the US Food and Drug Administration (FDA) agency reviewed and approved the original new drug application for RU 486 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 RU 486, and after taking into consideration the safety data that had become available since the initial approval of RU 486, the FDA concluded that certain restrictions continue to be necessary to ensure the safe use of RU 486.

These restrictions also apply to the approved generic version of RU 486. Under the law, the approved generic version of RU 486 is required to use a single, shared system risk evaluation and mitigation strategy (REMS) with the brand product, RU 486. This single, shared system risk evaluation and mitigation strategy (REMS), known as the Mifepristone REMS Program, sets forth the distribution requirements that must be followed for both RU 486 and the approved generic version of RU 486.

Under the Mifepristone REMS Program, RU 486 and the approved generic version of RU 486 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 RU 486 or GenBioPro, Inc.’s approved generic version of RU 486, Mifepristone Tablets, 200 mg., over the Internet because they will bypass important safeguards designed to protect their health.

Is it possible for a woman to become pregnant again if she takes RU 486?

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 RU 486 and the approved generic version of RU 486.

Is RU 486 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.

Who should not take RU 486?

Some women should not take RU 486. A woman should not take RU 486 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 RU 486).

RU 486 abortion pill how it works

RU-486 (mifepristone) is given orally during the first visit to an abortion clinic. RU-486 (mifepristone) blocks progesterone synthesis in the female body required to continue the pregnancy. Misoprostol can be taken orally or vaginally about 36 to 72 hours after administration of RU-486 (mifepristone). Misoprostol prompts the uterus to contract and expel the fetus, which may take a few hours to a few days. A physical examination is carried out after 1 to 2 weeks for the assessment of completion of termination of pregnancy or any other complication related to the abortion ².

Medical abortion

RU 486 is indicated for the medical termination of intrauterine pregnancy through 70 days gestation in combination with misoprostol

• Day 1: 200 mg of RU 486 (mifepristone) oral as a single dose under physician supervision
• Days 2-3: 800 mcg of misoprostol buccally once as a single dose; must be administered a minimum of 24-hr and a maximum of 48-hr following mifeprostone dose on day 1
• Days 7-14: Must return for follow-up visit to confirm complete termination has occurred by medical history, clinical examination, hCG testing, or ultrasonographic scan.
  • If complete expulsion has not occurred, but the pregnancy is not ongoing, women may be treated with another dose of misoprostol 800 mcg buccally with follow-up in ~7 days.
  • Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete abortion
  • Surgical evacuation is recommended to manage ongoing pregnancies after medical abortion

Dosing considerations

• Pregnancy is dated from the first day of the last menstrual period
• Duration of pregnancy may be determined from menstrual history and clinical examination
• Assess the pregnancy by ultrasonographic scan if the duration of pregnancy is uncertain or if ectopic pregnancy is suspected
• Remove any intrauterine device (IUD) before treatment
• Because most women will expel the pregnancy within 2-24 hr of taking misoprostol, discuss with the patient an appropriate location for her to be when she takes the misoprostol, taking into account that expulsion could begin within 2 hr of administration

RU 486 pill side effects

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. 10% to 12% of medical abortions remain unsuccessful and need an additional surgical procedure for the complete termination of pregnancy.

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 RU 486 and the approved generic version of RU 486.

As of December 31, 2018 ³, 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 ³.

The possible side effects are described in the Adverse Reactions section of the labeling and in the Medication Guide for RU 486.

This information applies equally to the approved generic version of RU 486, which generally has the same labeling as RU 486.

References

1. Questions and Answers on Mifeprex. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex
2. Macisaac L, Darney P. Early surgical abortion: an alternative to and backup for medical abortion. Am. J. Obstet. Gynecol. 2000 Aug;183(2 Suppl):S76-83.
3. Mifepri st one U.S. Post-Marketing Adverse Events Summary through 12/31/2018. https://www.fda.gov/media/112118/download