Mifepristone

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What is mifepristone

What is mifepristone

Mifepristone also known as RU-486, is used in a regimen together with misoprostol to end a pregnancy (induce medical abortion) that is less than 70 days in duration. Mifepristone works by stopping the supply of hormones that maintains the interior of the uterus. Without these hormones, the uterus cannot support the pregnancy and the contents of the uterus are expelled. Mifepristone alone, without misoprostol, is also used to control high blood sugar (hyperglycemia) in patients with Cushing’s syndrome who also have type 2 diabetes and have failed surgery or are not candidates for surgery, where it is given in a higher dose and for extended periods.

Mifepristone is available only with your doctor’s prescription.

Mifepristone was first approved for use in France in 1988, in Great Britain in 1991, Sweden in 1992, and the United States in 2000. The current indications for mifepristone with misoprostol combination is for medical termination of intrauterine pregnancy through 70 days of gestation. Mifepristone is available in tablets of 200 mg under the brand name Mifeprex. The currently recommended dose of mifepristone for inducing a medical abortion is as a single 200 mg tablet followed 24 to 48 hours later by buccal administration of 800 mcg of misoprostol (a prostaglandin agonist). Mifepristone has been used off-label as a means of emergency contraception, but is not approved for that use.

Mifepristone side effects are common, but generally mild-to-moderate in severity and can include uterine bleeding, nausea, vomiting, abdominal cramps, weakness, fever, headache, diarrhea, and dizziness. Rare, but potentially severe adverse events include serious uterine bleeding and serious bacterial infections, failed abortion and need for hospitalization. Contraindications to use of mifepristone/misoprostol include pregnancy beyond 70 days (10 weeks), ectopic pregnancy, presence of an intrauterine device, adrenal failure, porphyria and use of anticoagulants. Because of the serious nature of these side effects, mifepristone/misoprostol is available only through a Risk Evaluation and Mitigation Strategy program to certified prescribers.

Mifepristone was also approved for use to control high blood sugar (hyperglycemia) in patients with Cushing’s syndrome who also have type 2 diabetes and have failed surgery or are not candidates for surgery in 2012 and is available in 300 mg tablets under the brand name Korlym. The recommended dose is 300 mg once daily initially with subsequent increases based upon efficacy and tolerance to a maximum of 1200 mg daily. Adverse events are not uncommon but generally mild and manageable, including nausea, vomiting, anorexia, fatigue, headache, arthralgia, peripheral edema, hypertension, dizziness, and hypokalemia. Severe adverse reactions include termination of pregnancy, adrenal insufficiency, vaginal bleeding, endometrial changes and QTc interval prolongation. Mifepristone is metabolized by CYP 3A4 and 2C8/2C9 and has many drug-drug interactions.

Abortion pill mifepristone

Mifepristone is used in combination with misoprostol (Cytotec) to end an early pregnancy. Early pregnancy means it has been 70 days or less since your last menstrual period began. Mifepristone is in a class of medications called antiprogestational steroids. It works by blocking the activity of progesterone, a substance your body makes to help continue pregnancy.

Mifepristone is also available as another product (Korlym), which is used to control hyperglycemia (high blood sugar) in people with a certain type of Cushing’s Syndrome in which the body makes too much of the hormone cortisol. This monograph only gives information about mifepristone (Mifeprex), which is used alone or in combination with another medication to end an early pregnancy. If you are using mifepristone to control hyperglycemia caused by Cushing’s syndrome, read the monograph entitled mifepristone (Korlym) that has been written about this product.

Mifepristone comes as a tablet to take by mouth. You will take one tablet of mifepristone once on the first day. Within 24 to 48 hours after taking mifepristone, you will apply four tablets in total of another medication called misoprostol buccally (between the gum and cheek) by placing two tablets in each cheek pouch for 30 minutes, then swallowing the remaining content with water or another liquid. Make sure that you are in an appropriate location when you take misoprostol because vaginal bleeding, cramps, nausea, and diarrhea usually begins within 2 to 24 hours after taking it but could begin within 2 hours. Vaginal bleeding or spotting usually lasts for 9 to 16 days but can last for 30 days or longer. You must go back to your doctor for an exam or ultrasound 7 to 14 days after taking mifepristone to confirm that the pregnancy has ended and to check the amount of bleeding. Take mifepristone exactly as directed.

IMPORTANT WARNING

Serious or life-threatening vaginal bleeding may occur when a pregnancy is ended by miscarriage or by medical or surgical abortion. It is not known if taking mifepristone increases the risk that you will experience very heavy bleeding. Tell your doctor if you have or have ever had bleeding problems, anemia (less than normal number of red blood cells), or if you are taking anticoagulants (‘blood thinners’) such as aspirin, apixaban (Eliquis), dabigatran (Pradaxa), dalteparin (Fragmin), edoxaban (Savaysa). enoxaparin (Lovenox), Fondaparinux (Arixtra), heparin, rivaroxaban (Xarelto), or warfarin (Coumadin, Jantoven). If so, your doctor will probably tell you not to take mifepristone. If you experience very heavy vaginal bleeding, such as soaking through two thick full-size sanitary pads every hour for two continuous hours, call your doctor immediately or seek emergency medical care.

Serious or life threatening infections may occur when a pregnancy is ended by miscarriage or by medical or surgical abortion. A small number of patients died due to infections that they developed after they used mifepristone and misoprostol to end their pregnancies. It is not known if mifepristone and/or misoprostol caused these infections or deaths. If you develop a serious infection, you may not have many symptoms and your symptoms may not be very severe. You should call your doctor immediately or get emergency medical treatment if you experience any of the following symptoms: fever greater than 100.4 °F (38 °C) that lasts for more than 4 hours, severe pain or tenderness in the area below the waist, chills, fast heartbeat, or fainting.

You should also call your doctor immediately or get emergency medical treatment if you have general symptoms of illness such as weakness, nausea, vomiting, diarrhea, or feeling sick for more than 24 hours after taking mifepristone even if you do not have a fever or pain in the area below your waist.

Because of the risks of serious complications, mifepristone is available only through a restricted program. A program under called the Mifeprex Risk Evaluation and Mitigation Strategies (REMS) Program has been set up for all female patients that are prescribed mifepristone. Your doctor will give you the manufacturer’s patient information sheet (Medication Guide) to read before you begin treatment with mifepristone. You will also need to sign a patient agreement before taking mifepristone. Tell your doctor if you have questions about treatment with mifepristone or if you cannot follow the guidelines in the patient agreement. Mifepristone is only available in clinics, medical offices, and hospitals and is not dispensed through retail pharmacies.

Talk to your doctor and decide whom to call and what to do in case of an emergency after taking mifepristone. Tell your doctor if you do not think that you will be able to follow this plan or to get medical treatment quickly in an emergency during the first two weeks after you take mifepristone. Take your medication guide with you if you visit an emergency room or seek emergency medical care so that the doctors who treat you will understand that you are undergoing a medical abortion.

Keep all appointments with your doctor. These appointments are necessary to be sure that your pregnancy has ended and that you have not developed serious complications of medical abortion.

Talk to your doctor about the risks of taking mifepristone.

Mifepristone special precautions

Before taking mifepristone:

tell your doctor if you are allergic to mifepristone (hives, rash, itching, swelling of the face, eyes, mouth, throat, hands; difficulty breathing or swallowing); misoprostol (Cytotec, in Arthrotec); other prostaglandins such as alprostadil (Caverject, Edex, Muse, others), carboprost tromethamine (Hemabate), dinoprostone (Cervidil, Prepidil, Prostin E2), epoprostenol (Flolan, Veletri), latanoprost (Xalatan), treprostinil (Orenitram, Remodulin, Tyvaso);any other medications, or any of the ingredients in mifepristone tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
tell your doctor if you are taking corticosteroids such as beclomethasone (Beconase, QNASL, QVAR), betamethasone (Celestone), budesonide (Entocort, Pulmicort, Uceris), cortisone, dexamethasone, fludrocortisone, flunisolide (Aerospan HFA), fluticasone (Advair, Flovent, Veramyst, others), hydrocortisone (Cortef, Solu-Cortef, U-Cort, others), methylprednisolone (Medrol, Depo-Medrol), prednisolone (Omnipred, Prelone, others), prednisone (Rayos), and triamcinolone (Kenalog, others). Your doctor will probably tell you not to take mifepristone.
tell your doctor what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: benzodiazepines such as alprazolam (Xanax), diazepam (Diastat, Valium), midazolam, or triazolam (Halcion); buspirone; calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Cartia, Diltzac, others), felodipine, nifedipine (Adalat, Afeditab CR, Procardia), nisoldipine (Sular), or verapamil (Calan, Verelan, in Tarka); carbamazepine (Equetro, Tegretol, Teril, others); chlorpheniramine (antihistamine in cough and cold products); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet), lovastatin (Altoprev, in Advicor), or simvastatin (Simcor, Zocor, in Vytorin); clarithromycin (Biaxin, in Prevpac); cyclosporine (Gengraf, Neoral, Sandimmune); erythromycin (E.E.S., Erythrocin, others); haloperidol; furosemide; HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, others), or saquinavir (Invirase); itraconazole (Onmel, Sporanox); ketoconazole (Nizoral); methadone (Dolophine, Methadose); nefazodone; phenobarbital; phenytoin (Dilantin, Phenytek); pimozide (Orap); propranolol (Hemangeol, Inderal, Innopran); quinidine (in Nuedexta); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); rifabutin (Mycobutin); tacrolimus (Astagraf, Prograf, Protopic, others); tamoxifen (Soltamox); trazodone; or vincristine (Marqibo Kit). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor what herbal products you are taking, especially St. John’s wort.
tell your doctor if you have or have ever had an ectopic pregnancy (‘tubal pregnancy’ or pregnancy outside the uterus), adrenal failure (problems with your adrenal glands), or porphyria (an inherited blood disease that may cause skin or nervous system problems). Your doctor will probably tell you not to take mifepristone. Also, tell your doctor if you have had an intrauterine device (IUD) inserted. It must be removed before you take mifepristone.
you should know that it is possible that mifepristone will not end your pregnancy. Your doctor will check to be sure that your pregnancy has ended when you return for your follow-up appointment after you take mifepristone. If you are still pregnant after taking mifepristone, there is a chance that your baby may be born with birth defects. If your pregnancy has not ended completely, your doctor will discuss other options to consider. You may choose to wait, take another dose of misoprostol or have surgery to end the pregnancy. If you take a repeat dose of misoprostol, you must have a follow-up visit with your doctor in 7 days after that dose to be sure that your pregnancy has ended.
tell your doctor if you are breastfeeding.
if you are having surgery, including dental surgery, tell the doctor or dentist that you have taken mifepristone.
you should know that after ending a pregnancy with mifepristone, you can become pregnant again right away, even before your period returns. If you do not want to become pregnant again, you should begin using birth control as soon as this pregnancy ends or before you start having sexual intercourse again.

Pregnancy

Pregnancy Category X: Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Special dietary instructions

Do not take mifepristone with grapefruit juice. Talk to your doctor about drinking grapefruit juice after taking mifepristone.

What should I do if I forget a dose?

You will only take mifepristone in your doctor’s office or clinic, so you do not have to worry about forgetting to take a dose at home.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking mifepristone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using mifepristone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amisulpride
Bepridil
Cisapride
Cyclosporine
Dihydroergotamine
Dronedarone
Ergotamine
Fentanyl
Fluconazole
Ketoconazole
Lovastatin
Mesoridazine
Pimozide
Piperaquine
Posaconazole
Quinidine
Saquinavir
Simvastatin
Sirolimus
Sparfloxacin
Tacrolimus
Terfenadine
Thioridazine

Using mifepristone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfentanil
Amiodarone
Anagrelide
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Astemizole
Azithromycin
Benzhydrocodone
Boceprevir
Buprenorphine
Buserelin
Carbamazepine
Ceritinib
Chloroquine
Chlorpromazine
Cilostazol
Ciprofloxacin
Citalopram
Clarithromycin
Clofazimine
Clomipramine
Clozapine
Cobicistat
Codeine
Colchicine
Conivaptan
Crizotinib
Dabrafenib
Dasabuvir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Deutetrabenazine
Digoxin
Dihydrocodeine
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxorubicin
Doxorubicin Hydrochloride Liposome
Droperidol
Efavirenz
Encorafenib
Erythromycin
Escitalopram
Fingolimod
Flecainide
Fluoxetine
Foscarnet
Fosphenytoin
Gemifloxacin
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydrocodone
Hydroxychloroquine
Hydroxyzine
Ibutilide
Idelalisib
Ifosfamide
Iloperidone
Imipramine
Indinavir
Inotuzumab Ozogamicin
Itraconazole
Ivabradine
Ivosidenib
Lapatinib
Leuprolide
Levofloxacin
Lofexidine
Lopinavir
Lumefantrine
Macimorelin
Mefloquine
Meperidine
Methadone
Metronidazole
Moxifloxacin
Nafarelin
Naloxegol
Nefazodone
Nelfinavir
Nilotinib
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olaparib
Ondansetron
Osimertinib
Oxycodone
Paliperidone
Panobinostat
Pasireotide
Pazopanib
Pentazocine
Phenobarbital
Phenytoin
Pimavanserin
Pitolisant
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinine
Ranolazine
Ribociclib
Rifabutin
Rifampin
Rifapentine
Ritonavir
Salmeterol
Sertraline
Sevoflurane
Simeprevir
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
St John’s Wort
Sufentanil
Sulpiride
Sunitinib
Telaprevir
Telavancin
Telithromycin
Tetrabenazine
Toremifene
Tramadol
Trazodone
Triclabendazole
Trifluoperazine
Trimipramine
Triptorelin
Vandetanib
Vardenafil
Vemurafenib
Vinflunine
Voriconazole
Ziprasidone
Zuclopenthixol

Using mifepristone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alprazolam
Fluvastatin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Mifepristone for high blood sugar in Cushing’s syndrome

Mifepristone (Korlym) is used to treat hyperglycemia (high blood sugar) in people with a certain type of Cushing’s syndrome in which the body makes too much cortisol (a hormone) and who have failed surgery or cannot have surgery to treat this condition. Mifepristone is in a class of medications called cortisol receptor blockers. It works by blocking the activity of cortisol.

Mifepristone is also available as another product (Mifeprex) that is used alone or in combination with another medication to end an early pregnancy. This monograph only gives information about mifepristone (Korlym) used to control hyperglycemia in people with a certain type of Cushing’s syndrome. If you are using mifepristone to terminate a pregnancy, read the monograph entitled mifepristone (Mifeprex), which has been written about this product.

Mifepristone comes as a tablet to take by mouth. It is usually taken once a day with a meal. Take mifepristone at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mifepristone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them. Tell your doctor or pharmacist if you are not able to swallow the tablets whole.

Your doctor will start you on a low dose of mifepristone and gradually increase your dose, not more often than once every 2 to 4 weeks. If you stop taking mifepristone, call your doctor. Your doctor may have to start you again on the lowest dose of mifepristone and gradually increase your dose.

Mifepristone can control your condition but does not cure it. It may take 6 weeks or longer before you feel the full benefit of mifepristone. Continue to take mifepristone even if you feel well.

IMPORTANT WARNING

For female patients:

Do not take mifepristone if you are pregnant or plan to become pregnant. Mifepristone can cause loss of the pregnancy. You must have a negative pregnancy test before starting treatment with mifepristone and before beginning treatment again if you stop taking it for more than 14 days. If you can become pregnant, you will need to avoid becoming pregnant during your treatment with mifepristone. You must use acceptable forms of birth control during your treatment and for at least 1 month after your treatment is completed. Your doctor will tell you which forms of birth control are acceptable. If you think you are pregnant, you miss a menstrual period, or you have sex without using birth control while taking mifepristone or within 1 month after your treatment, call your doctor immediately.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body’s response to mifepristone.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with mifepristone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risk(s) of taking mifepristone.

Mifepristone special precautions

Before taking mifepristone:

tell your doctor if you are allergic to mifepristone, any other medications, or any of the ingredients in mifepristone tablets. Ask your pharmacist or check the manufacturer’s patient information for a list of the ingredients.
tell your doctor if you are taking any of the following medications or have taken them in the last two weeks: corticosteroids such as betamethasone (Celestone), budesonide (Entocort), cortisone (Cortone), dexamethasone (Decadron, Dexpak, Dexasone, others), fludrocortisone (Floriner), hydrocortisone (Cortef, Hydrocortone), methylprednisolone (Medrol, Meprolone, others), prednisolone (Prelone, others), prednisone (Deltasone, Meticorten, Sterapred, others), and triamcinolone (Aristocort, Azmacort); medications that suppress the immune system such as cyclosporine (Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); dihydroergotamine (D.H.E. 45, Migranal); ergotamine (Ergomar, in Cafergot, in Migergot); fentanyl (Duragesic); lovastatin (Mevacor); pimozide (Orap); quinidine (Quinidex); and simvastatin (Zocor). Your doctor will probably tell you not to take mifepristone if you are taking one or more of these medications.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or have taken in the last two weeks. Be sure to mention any of the following: anticoagulants (‘blood thinners’) such as warfarin (Coumadin); antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), or voriconazole (Vfend); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); bupropion (Wellbutrin); ciprofloxacin (Cipro); clarithromycin (Biaxin); conivaptan (Vaprisol); diltiazem (Cardizem); erythromycin (E.E.S., E-Mycin, Erythrocin); fluvastatin (Lescol); hormonal contraceptives such as birth control pills, implants, patches, rings, or injections; medications for hepatitis C such as boceprevir (Victrelis) and telaprevir (Incivek); medications for HIV or AIDS such as amprenavir (Agenerase), atazanavir (Reyataz), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir and ritonavir combination (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Fortovase, Invirase); medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin); medications for tuberculosis such as rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater) and rifapentine (Priftin); nefazodone (Serzone); repaglinide (Prandin); telithromycin (Ketek); and verapamil (Calan, Isoptin, others). Many other medications may also interact with mifepristone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor what herbal products you are taking, especially St. John’s Wort.
tell your doctor if you have ever had an organ transplant or if you have or ever had thyroid disease. If you are a woman and have not had surgery to remove your uterus, tell your doctor if you have or have ever had unexplained vaginal bleeding, endometrial hyperplasia (overgrowth of the lining of the uterus), or endometrial cancer (cancer of the lining of your uterus). Your doctor will probably tell you not to take mifepristone.
tell your doctor if you have or have ever had heart failure, a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), low potassium in your blood, adrenal insufficiency(condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions), a bleeding disorder, or liver, kidney, or heart disease.
tell your doctor if you are breast-feeding.

Special dietary instructions

Do not eat grapefruit or drink grapefruit juice while you are taking mifepristone.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

How does mifepristone work?

Mifepristone is a potent synthetic steroidal antiprogesterone which is used as a single dose in combination with misoprostol, a prostaglandin analogue, to induce medical abortion. Mifepristone antagonizes the action of progesterone by competing with its binding to its receptor. The sudden loss of progesterone activity during pregnancy causes a series of intrauterine and cervical changes that result in termination of pregnancy. Misoprostol is a prostaglandin analogue that causes uterine contraction which completes the medical abortion. In multiple large prospective studies, the administration of a single dose of mifepristone followed within 24 to 48 hours by a prostaglandin agonist safely terminated early pregnancy in more than 90% of women.

Mifepristone (without misoprostol) is also approved for use in Cushing syndrome caused by excessive production of glucocorticoids. Mifepristone also blocks the actions of a hormone called cortisol, which can reduce certain side effects caused by excess cortisol in the body. Mifepristone has antiglucocorticoid receptor activity and has been found to alleviate high blood sugar (hyperglycemia) in adults with hypercortisolism (Cushing’s syndrome) who also have type 2 diabetes mellitus and glucose intolerance or type 2 diabetes who have failed to respond or are not candidates for surgical therapy.

Mifepristone uses

Mifepristone is also sometimes used to end pregnancies when more than 70 days have passed since the woman’s last menstrual period; as an emergency contraceptive after unprotected sexual intercourse (‘morning-after pill’); to treat tumors of the brain, endometriosis (growth of uterus tissue outside the uterus), or fibroids (noncancerous tumors in the uterus); or to induce labor (to help start the birth process in a pregnant woman). Talk to your doctor about the possible risks of using this drug for your condition.

Mifepristone dosage

Adult Dose for Abortion

Use: Medical termination of intrauterine pregnancy through 70 days gestation

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.

Adult Dose for Cushing’s Syndrome

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

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.

Pediatric Dose for Abortion

Use: Medical termination of intrauterine pregnancy through 70 days gestation

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.

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 KORYLM 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.

Mifepristone side effects

Mifepristone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

vaginal bleeding or spotting
cramps
pelvic pain
vaginal burning, itching, or discharge headache
vomiting
dry mouth
diarrhea
constipation
joint or muscle pain
swelling of the hands, feet, ankles, or lower legs
rash
itching

Some side effects can be serious. If you experience any of the symptoms mentioned below including in the IMPORTANT WARNING sections, call your doctor immediately or get emergency medical treatment: