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Mifepristone (Mifeprex)



(mi fe' pri stone)

Mifeprex®

RU-486

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 (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.

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.

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

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.

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



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 these symptoms, call your doctor immediately or get emergency medical treatment:



nausea

loss of appetite

dizziness or lightheadedness

unusual tiredness or weakness

nervousness or irritability

shakiness

sweating 

muscle weakness, aches, or cramps

rapid, irregular, or pounding heartbeats

unexpected vaginal bleeding or spotting

shortness of breath
Mifepristone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them.  However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community.  See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking mifepristone.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.