Korlym

This medication guide provides information about the Korlym brand of mifepristone. Mifeprex is another brand of mifepristone that is not covered in this medication guide.

Korlym is used to treat high blood sugar (hyperglycemia) in adults with Cushing's syndrome who also have type 2 diabetes mellitus or glucose intolerance.

Korlym should not be used to treat type 2 diabetes that is not related to Cushing's syndrome.

Korlym may also be used for purposes not listed in this medication guide.

You should not take Korlym if you are allergic to mifepristone.

You should not take Korlym if you are a woman who still has her uterus and you have:

• endometrial hyperplasia (changes in the cells lining your uterus);
• endometrial cancer (cancer of the cells lining your uterus); or
• unusual or unexplained vaginal bleeding.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with mifepristone. Your doctor may change your treatment plan if you also use:

• cyclosporine;
• dihydroergotamine, ergotamine;
• fentanyl;
• lovastatin, simvastatin;
• pimozide;
• quinidine;
• sirolimus, tacrolimus; or
• steroid medicine (dexamethasone, prednisone, methylprednisolone, and others).

Tell your doctor if you have ever had:

• low levels of potassium in your blood;
• heart disease;
• a bleeding or blood-clotting disorder;
• liver or kidney disease;
• an organ transplant; or
• a problem with your adrenal glands.

You will need to have a negative pregnancy test before you start taking Korlym, or if you restart the medicine after not taking it for longer than 2 weeks.

Do not use mifepristone if you are pregnant. It could harm the unborn baby or cause a miscarriage. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose.

Mifepristone can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using mifepristone, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

Do not breastfeed while using this medicine, and for at least 21 days after your last dose. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Mifepristone is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Always take this medicine with food.

Swallow the tablet whole and do not crush, chew, or break it.

Store at room temperature away from moisture and heat.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with mifepristone and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Korlym and call your doctor at once if you have:

• nausea;
• unusual weakness or tiredness;
• a light-headed feeling, like you might pass out;
• abnormal vaginal bleeding;
• worsening of any medical problems for which you use steroid medicine;
• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or
• low potassium--leg cramps, irregular heartbeats, fluttering in your chest, muscle weakness or limp feeling.

Common side effects may include:

• nausea, vomiting, loss of appetite;
• low potassium;
• tired feeling;
• headache, dizziness;
• pain in your arms and legs;
• thickened lining of your uterus;
• swelling in your arms and legs; or
• high blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Mifepristone can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your current medicines. Many drugs can affect mifepristone, especially:

• antifungal medicine (ketoconazole, and others);
• an antibiotic;
• an antidepressant;
• antiviral medicine to treat HIV/AIDS or hepatitis C;
• blood pressure medications;
• a blood thinner--warfarin, Coumadin, Jantoven;
• steroid medicine (dexamethasone, prednisone, methylprednisolone, and others); or
• thyroid medication.

This list is not complete and many other drugs may affect mifepristone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Your doctor or pharmacist can provide more information about mifepristone (Korlym).