Generic Name: mifepristone (MIF-e-PRIS-tone)
Brand Name: Korlym
Mifepristone tablets may cause loss of pregnancy if you take it while you are pregnant. Women who are pregnant should not take mifepristone tablets. You must have a negative pregnancy test before you start treatment with mifepristone tablets, and if treatment is stopped for more than 14 days. If you are able to become pregnant, you must prevent pregnancy by using a nonhormonal form of birth control (eg, condoms) while taking mifepristone tablets and for 1 month after you stop taking it. Do not use hormonal birth control (eg, birth control pills) to prevent pregnancy while taking mifepristone tablets. Talk to your doctor about how to prevent pregnancy while taking mifepristone tablets.
Mifepristone tablets are used for:
Controlling high blood sugar in certain patients who have type 2 diabetes or glucose intolerance caused by Cushing syndrome.
Mifepristone tablets are a cortisol receptor blocker. It prevents the effects of excess blood cortisol levels, such as high blood sugar.
Do NOT use mifepristone tablets if:
- you are allergic to any ingredient in mifepristone tablets
- you are pregnant
- you have type 2 diabetes that is not caused by Cushing syndrome
- you have undiagnosed vaginal bleeding, changes in the cells lining your uterus (endometrial hyperplasia), or cancer of the lining of your uterus (endometrial cancer)
- you have severe liver problems
- you take corticosteroids (eg, dexamethasone, prednisone) for serious medical problems (eg, to suppress the immune system after organ transplant)
- you are taking alfentanil, cabazitaxel, carbamazepine, crizotinib, cyclosporine, dihydroergotamine, ergotamine, fentanyl, a hydantoin (eg, phenytoin), lovastatin, lurasidone, phenobarbital, pimozide, primidone, quinidine, a rifamycin (eg, rifampin), simvastatin, sirolimus, St. John's wort, tacrolimus, or ticagrelor
Contact your doctor or health care provider right away if any of these apply to you.
Before using mifepristone tablets:
Some medical conditions may interact with mifepristone tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of bleeding problems, irregular heartbeat (eg, QT prolongation), or other heart problems (eg, heart blood vessel problems, heart failure)
- if you have an infection, a recent injury, thyroid problems, or kidney or liver problems
- if you have low blood potassium levels or have had an organ transplant
- if you have been taking corticosteroids (eg, dexamethasone, prednisone)
Some MEDICINES MAY INTERACT with mifepristone tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because the risk of side effects, including excessive bleeding, may be increased
- Aprepitant, azole antifungals (eg, itraconazole, ketoconazole), ciprofloxacin, conivaptan, diltiazem, imatinib, macrolide antibiotics (eg, clarithromycin, erythromycin), mibefradil, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), telithromycin, or verapamil because they may increase the risk of mifepristone tablets's side effects
- Carbamazepine, hydantoins (eg, phenytoin), phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease mifepristone tablets's effectiveness
- Alfentanil, atorvastatin, axitinib, brentuximab, bupropion, cabazitaxel, cilostazol, crizotinib, cyclosporine, dihydroergotamine, docetaxel, domperidone, efavirenz, ergotamine, fentanyl, fluvastatin, ivacaftor, lovastatin , lurasidone, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), oxycodone, pimozide, quinidine, repaglinide, romidepsin, ruxolitinib, saxagliptin, simvastatin, sirolimus, tacrolimus, ticagrelor, toremifene, or vilazodone because the risk of their side effects may be increased by mifepristone tablets
- Corticosteroids (eg, dexamethasone, prednisone) or hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by mifepristone tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if mifepristone tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use mifepristone tablets:
Use mifepristone tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Mifepristone tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get mifepristone tablets refilled.
- Take mifepristone tablets by mouth daily with food.
- Swallow mifepristone tablets whole. Do not break, split, crush, or chew before swallowing. If you cannot swallow mifepristone tablets whole, contact your doctor.
- Do not eat grapefruit or drink grapefruit juice while taking mifepristone tablets.
- Take mifepristone tablets on a regular schedule to get the most benefit from it.
- Continue to take mifepristone tablets even if you feel well. Do not miss any doses.
- If you miss a dose of mifepristone tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss taking mifepristone tablets for several days in a row, contact your doctor for instructions.
Ask your health care provider any questions you may have about how to use mifepristone tablets.
Important safety information:
- Mifepristone tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use mifepristone tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose without checking with your doctor.
- Patients with Cushing syndrome may be at risk for certain infections, such as a certain type of pneumonia (Pneumocystis jiroveci pneumonia) while taking mifepristone tablets. Contact your doctor right away if you experience shortness of breath or other breathing problems.
- Patients taking mifepristone tablets may experience adrenal gland problems. Contact your doctor right away if you experience nausea, symptoms of low blood pressure (eg, fainting, severe or persistent dizziness or light-headedness), or symptoms of low blood sugar (eg, chills; dizziness; fainting; fast heartbeat; increased hunger; tremors; unusual drowsiness, sweating, or weakness; vision changes), or unusual tiredness or weakness.
- Women who are able to become pregnant must have a negative pregnancy test before they start to take mifepristone tablets, and monthly while they are taking it. Talk with your doctor for more information.
- Women who are able to become pregnant must use a nonhormonal form of birth control (eg, condoms) while they take mifepristone tablets and for at least 1 month after they stop taking it. Do not use hormonal birth control (eg, birth control pills) to prevent pregnancy while taking mifepristone tablets. Talk to your doctor about how to prevent pregnancy while taking mifepristone tablets. Tell your doctor right away if you miss a menstrual period or think you may be pregnant.
- Tell your doctor or dentist that you take mifepristone tablets before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including blood potassium levels, may be performed while you use mifepristone tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Mifepristone tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not take mifepristone tablets if you are pregnant. It has been shown to cause loss of a pregnancy. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Mifepristone tablets are found in breast milk. Do not breast-feed while taking mifepristone tablets.
Possible side effects of mifepristone tablets:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; decreased appetite; diarrhea; dizziness; drowsiness; dry mouth; headache; heartburn; joint pain; mild muscle pain; nausea; sinus pain; sore throat; stomach pain; stuffy nose; tiredness; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; back or flank pain; chest pain; fainting; irregular heartbeat; muscle aches, cramps, or weakness; severe or persistent dizziness or headache; shortness of breath; swelling of the hands, ankles, or feet; symptoms of low blood sugar (eg, chills; dizziness; fainting; fast heartbeat; increased hunger; tremors; unusual drowsiness, sweating, or weakness; vision changes); trouble sleeping; unusual tiredness or weakness ; vaginal bleeding or discharge.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of mifepristone tablets:
Store mifepristone tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep mifepristone tablets out of the reach of children and away from pets.
- If you have any questions about mifepristone tablets, please talk with your doctor, pharmacist, or other health care provider.
- Mifepristone tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take mifepristone tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about mifepristone tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to mifepristone tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using mifepristone tablets.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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