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Mifepristone (Korlym)



(mi fe' pri stone)

Korlym®

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 (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. 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.

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:



vaginal bleeding or spotting

cramps

pelvic pain

vaginal burning, itching, or discharge

headache

Some side effects can be serious. If you experience any of the symptoms mentioned in the IMPORTANT WARNING section, call your doctor immediately.
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).

Your doctor will store the medication in his or her office.
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

You should get mifepristone only from a certified doctor and use this medication only while under the care of a doctor. You should not buy mifepristone from other sources, such as the Internet, because you would bypass important safeguards to protect your health.
Do not let anyone else take your medication.
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.