Mifepristone

By Medically reviewed by hellodoktor

Generic Name: Mifepristone Brand Name(s): Mifepristone.

Uses

What is Mifepristone used for?

Mifepristone (also known as RU 486) is used to cause an abortion during the early part of a pregnancy. It is used up to week 10 of pregnancy (up to 70 days after the first day of your last menstrual period). Mifepristone blocks a natural substance (progesterone) that is needed for your pregnancy to continue. It is usually used together with another medicine called misoprostol.

Mifepristone must not be used if you have a rare abnormal pregnancy that is outside the womb (ectopic pregnancy). It will not cause an abortion in this case. It may cause an ectopic pregnancy to rupture, resulting in very serious bleeding.

How should I take Mifepristone?

You must visit the doctor’s office at least 2 times to complete your treatment and important examinations. This treatment is only given under direct medical supervision in a doctor’s office, clinic, or hospital. Be sure to have clear instructions from your doctor regarding whom to call and what to do in case of an emergency.

Your doctor may want to do an ultrasound to make sure your pregnancy is less than 10 weeks and is not outside the womb (ectopic).

Take mifepristone by mouth as directed by your doctor, usually as a single dose. After taking mifepristone, your doctor should direct you to wait 24 to 48 hours before taking another medication (misoprostol) by mouth as a single dose. The medications may not work as well if you take misoprostol sooner than 24 hours after taking mifepristone or later than 48 hours after taking mifepristone. Follow your doctor’s instructions carefully. Heavy vaginal bleeding does not mean that an abortion is complete.

Avoid grapefruit juice while using this medication unless your doctor instructs you otherwise.

It is important that you return for a follow-up visit within 7 to 14 days after taking mifepristone, even if you are not having any problems.

If abortion does not occur or is not complete, or there are serious medical problems, surgery may be needed. If the treatment fails and the pregnancy continues until birth, there is a risk of birth defects.

How do I store Mifepristone?

Mifepristone is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Mifepristone in the bathroom or the freezer. There may be different brands of Mifepristone that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Mifepristone down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Mifepristone?

Before taking mifepristone, tell your doctor if you are allergic to it; or to misoprostol; or to other progestins (e.g., norethindrone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions or other problems. Before using this medicine, consult your doctor if you have any of the following: undiagnosed abdominal growth (adnexal mass), certain adrenal gland problem (chronic adrenal failure), bleeding problem (e.g., coagulopathy), certain blood disorder (inherited porphyrias), IUD (intrauterine birth control device) in place, pregnancy longer than 10 weeks, proven or possible abnormal pregnancy outside the womb (ectopic pregnancy), unable to return for a doctor’s visit in 7 to 14 days, unable to easily get emergency help in the 2 weeks after taking mifepristone.

If you are using an IUD (intrauterine birth control device), it should be removed before mifepristone treatment begins.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood count (anemia), smoking more than 10 cigarettes a day.

This drug must be used only if you can easily reach adequate emergency medical services in case you have a serious medical problem.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Mifepristone usually causes fetal death. In the unlikely event you have an ongoing pregnancy after treatment, birth defects may result.

Another pregnancy can occur after this abortion treatment and before your normal period begins again. Birth control can be started as soon as this treatment is successfully completed. Consult your doctor for more information.

This medication passes into breast milk. Since the effects of mifepristone on infants are unknown, breast-feeding women should consult their doctors on whether they should discard their breast milk for a few days following this treatment.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Mifepristone during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Mifepristone. Mifepristone is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Mifepristone?

Nausea, vomiting, diarrhea, weakness, or dizziness may occur. If these effects persist longer than the first 24 hours after taking the second drug (misoprostol), seek immediate medical attention because they can be signs of a serious medical problem.

Bleeding and cramping are expected during this treatment. Usually, the symptoms mean the drugs are working. However, sometimes you can have cramps and bleeding and still be pregnant. Therefore, you must return for all of your follow-up visits with your doctor. Nausea and cramping may worsen in the 24 hours after you take the second drug (misoprostol). Your doctor may direct you to take other medication to help with these symptoms. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Bleeding and spotting may last up to 30 days and may be much heavier than a normal period. In very few cases, this bleeding will need to be stopped by surgery. Seek immediate medical attention if you bleed enough to soak through 2 thick, full-size sanitary pads each hour for 2 hours in a row, or if you are concerned about heavy bleeding.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if you have any of these unlikely but very serious side effects: fever of 100.4 degrees F (38 degrees C) or higher, fainting, fast heartbeat, stomach/abdominal pain or tenderness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Mifepristone?

Some products that may interact with this drug include: long-term corticosteroid therapy (e.g., prednisone), drugs affecting liver enzymes that remove mifepristone from your body (e.g., azole antifungals such as itraconazole/ketoconazole, macrolide antibiotics including erythromycin, dexamethasone, rifamycins including rifabutin, St. John’s wort, certain anti-seizure medicines including carbamazepine/phenytoin/phenobarbital), other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, “blood thinners” such as warfarin/dabigatran).

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Mifepristone can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cyclosporine, ergot alkaloids (such as dihydroergotamine, ergotamine), fentanyl, pimozide, quinidine, some statin drugs (such as fluvastatin, lovastatin, simvastatin), sirolimus, tacrolimus, warfarin, among others.

Mifepristone may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Mifepristone?

Mifepristone may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Mifepristone?

Mifepristone may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Mifepristone.

What is the dose of Mifepristone for an adult?

Usual Adult Dose for Abortion

Brand MIFEPREX:

-Day One: 200 mg mifepristone (MIFEPREX) orally as a single dose

-Day Two or Three: 800 mcg misoprostol buccally 24 to 48 hours after the first dose of mifepristone (Two 200 mcg misoprostol tablets should be placed in each cheek pouch [the area between the cheek and gums] for 30 minutes and then swallow any remnants with water or another liquid).

Post-treatment Assessment Day 7 to 14:

-A follow-up visit approximately 7 to 14 days after the administration of mifepristone is necessary to confirm complete termination of pregnancy and to evaluate the degree of bleeding.

-Termination of pregnancy can be confirmed by medical history, clinical examination, human Chorionic Gonadotropin (hCG) testing, or ultrasonographic scan. Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete abortion.

-The existence of debris in the uterus (e.g., if seen on ultrasonography) following the treatment procedure will not necessarily require surgery for its removal.

-Patients should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Heavy bleeding for a median duration of 2 days has been reported. Some women may experience some type of bleeding for more than 30 days. Persistence of heavy or moderate vaginal bleeding at the time of follow-up, however, could indicate an incomplete abortion.

-If complete expulsion has not occurred, but the pregnancy is not ongoing, another dose of misoprostol 800 mcg buccally may be administered. A follow-up visit in approximately 7 days to assess for complete termination is recommended.

-Surgical evacuation is recommended to manage ongoing pregnancies after medical abortion.

Comments.

-Medication for cramps or gastrointestinal symptoms may be needed during the period immediately following the administration of misoprostol.

-The effectiveness of the regimen may be lower if misoprostol is administered less than 24 hours or more than 48 hours after mifepristone (MIFEPREX) administration.

-Most women will expel the pregnancy within 2 to 24 hours of taking misoprostol; select appropriate location for the patient to be when misoprostol is administered, taking into account that expulsion could begin within 2 hours of administration.

-For purposes of this treatment (pregnancy termination), pregnancy is dated from the first day of the last menstrual period.

-The 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 beginning treatment with this drug.

Use: Medical termination of intrauterine pregnancy through 70 days gestation

Usual Adult Dose for Cushing’s Syndrome

Brand KORLYM:

Initial dose: 300 mg orally once a day

Maximum dose: 1200 mg or 20 mg/kg once a day

Comments:

-Dose increases should occur once every 2 to 4 weeks. For additional information of dose titration refer to the Dose Adjustment section.

Use: Control of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery

Renal Dose Adjustments

Brand KORLYM: The maximum dose should not exceed 600 mg per day in renally impaired patients.

Brand MIFEPREX: Data not available

Liver Dose Adjustments

Brand KORLYM:

-Mild to moderate liver dysfunction: The maximum dose should not exceed 600 mg per day.

-Severe liver dysfunction: Not recommended

Brand MIFEPREX: Data not available

Dose Adjustments

Brand KORLYM:

-Dose increases should be based on tolerability and degree of improvement in Cushing’s syndrome manifestations.

-Changes in glucose control, anti-diabetic medication requirements, insulin levels, and psychiatric symptoms may provide an early assessment of response (within 6 weeks) and may help guide early dose titration.

-Improvements in cushingoid appearance, acne, hirsutism, striae, and body weight occur over a longer period of time and, along with measures of glucose control, may be used to determine dose changes beyond the first 2 months of therapy.

-Careful and gradual titration of KORYLIM accompanied by monitoring for recognized adverse reactions may reduce the risk of severe adverse reactions.

-Dose reduction or even dose discontinuation may be needed in some clinical situations. If treatment is interrupted, it should be reinitiated at the lowest dose (300 mg). If treatment was interrupted because of adverse reactions, the titration should aim for a dose lower than the one that resulted in treatment interruption.

-If combination with strong CYP450 3A inhibitors is necessary, the dose should be limited to 300 mg per day.

Precautions

Brand MIFEPREX:

Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following the use of this drug. No causal relationship between the use of this drug and misoprostol and these events has been established.

-Atypical Presentation of Infection: Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia, or significant findings on pelvic examination following an abortion. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.

-Bleeding: Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy

vaginal bleeding. Before prescribing , inform the patient about the risk of these serious events. Ensure that the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea) for more than 24 hours after taking

misoprostol. Advise the patient to take the Medication Guide with her if she visits an emergency room or a healthcare provider who did not prescribe MIFEPREX, so that the provider knows that she is undergoing a medical abortion.

Brand KORLYM:

Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with KORLYM and prevented during treatment and for one month after stopping treatment by the use of a non-hormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14

days in females of reproductive potential.

Other Comments

Administration advice:

Brand KORLYM:

-Tablets should be taken with a meal and should be swallowed whole. Do not split, crush, or chew tablets.

Brand MIFEPREX:

-Provide instructions to patients on what to do if significant discomfort, excessive vaginal bleeding or other adverse reactions occur.

-Advise the patient whether you will provide such care or will refer her to another provider as part of counseling prior to prescribing MIFEPREX.

Limitation of Use:

Brand KORLYM should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing’s syndrome.

Monitoring:

Brand KORLYM:

-Endocrine: Adrenal insufficiency

-Metabolic: Hypokalemia

Brand MIFEPREX:

-Genitourinary: Persistent vaginal bleeding

-Immunologic: Infection

Patient advice:

-Brand MIFEPREX: Patients should seek immediate medical attention if they experience prolonged heavy vaginal bleeding.

What is the dose of Mifepristone for a child?

Usual Pediatric Dose for Abortion

Brand MIFEPREX:

-Day One: 200 mg mifepristone (MIFEPREX) orally as a single dose

-Day Two or Three: 800 mcg misoprostol buccally 24 to 48 hours after the first dose of mifepristone (Two 200 mcg misoprostol tablets should be placed in each cheek pouch [the area between the cheek and gums] for 30 minutes and then swallow any remnants with water or another liquid).

Post-treatment Assessment Day 7 to 14:

-A follow-up visit approximately 7 to 14 days after the administration of mifepristone is necessary to confirm complete termination of pregnancy and to evaluate the degree of bleeding.

-Termination of pregnancy can be confirmed by medical history, clinical examination, human Chorionic Gonadotropin (hCG) testing, or ultrasonographic scan. Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete abortion.

-The existence of debris in the uterus (e.g., if seen on ultrasonography) following the treatment procedure will not necessarily require surgery for its removal.

-Patients should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Heavy bleeding for a median duration of 2 days has been reported. Some women may experience some type of bleeding for more than 30 days. Persistence of heavy or moderate vaginal bleeding at the time of follow-up, however, could indicate an incomplete abortion.

-If complete expulsion has not occurred, but the pregnancy is not ongoing, another dose of misoprostol 800 mcg buccally may be administered. A follow-up visit in approximately 7 days to assess for complete termination is recommended.

-Surgical evacuation is recommended to manage ongoing pregnancies after medical abortion.

Comments.

-Medication for cramps or gastrointestinal symptoms may be needed during the period immediately following the administration of misoprostol.

-The effectiveness of the regimen may be lower if misoprostol is administered less than 24 hours or more than 48 hours after mifepristone (MIFEPREX) administration.

-Most women will expel the pregnancy within 2 to 24 hours of taking misoprostol; select appropriate location for the patient to be when misoprostol is administered, taking into account that expulsion could begin within 2 hours of administration.

-For purposes of this treatment (pregnancy termination), pregnancy is dated from the first day of the last menstrual period.

-The 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 beginning treatment with this drug.

Use: Medical termination of intrauterine pregnancy through 70 days gestation

Precautions

Brand KORLYM: Safety and efficacy have not been established in patients younger than 18 years.

Brand MIFEPREX: Safety and efficacy in females patients younger than 17 years is similar to that observed in adults.

How is Mifepristone available?

Mifepristone is available in the following dosage forms and strengths:

  • Oral Tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Mifepristone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: March 29, 2018 | Last Modified: September 12, 2019

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