korlym

Korlym (mifepristone) blocks the actions of a hormone called cortisol, which can reduce certain side effects caused by excess cortisol in the body.

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

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

Important information

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 can harm an unborn baby or cause a miscarriage. Do not use if you are pregnant. You will need to have a negative pregnancy test before you start taking mifepristone, or if you restart the medication after not taking it for longer than 2 weeks.

You should not take Korlym if you have unexplained vaginal bleeding, endometrial hyperplasia or a certain type of uterine cancer, if you are pregnant, or if you take steroid medications because of a serious illness or condition (such as an organ transplant).

There are many other drugs that should not be used together with mifepristone. Tell your doctor about all other medicines you use.

Before you take this medicine, tell your doctor if you have liver or kidney disease, heart disease, heart failure, coronary artery disease, high blood pressure, endometriosis, a problem with your thyroid or adrenal glands, or an autoimmune disorder.

Before taking this medicine

You should not take Korlym if you are allergic to mifepristone, or if you have:

• endometrial hyperplasia or a certain type of uterine cancer;

• unusual or unexplained vaginal bleeding;

• if you are pregnant; or

• if you take steroid medications because of a serious illness or condition (such as an organ transplant).

The following drugs should not be used while you are taking Korlym:

• cyclosporine (Gengraf, Neoral, Restasis, Sandimmune);

• ergotamine (Ergomar, Migergot) or dihydroergotamine (Migranal);

• fentanyl (Abstral, Actiq, Fentora, Duragesic, Lazanda, Onsolis, Sublimaze, Subsys);

• pimozide (Orap);

• quinidine (Neudexta);

• lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin, Juvisync); or

• sirolimus (Rapamune, Torisel) or tacrolimus (Prograf, Protopic).

To make sure Korlym is safe for you, tell your doctor if you have:

• low levels of potassium in your blood;

• heart disease;

• liver or kidney disease;

• endometriosis;

• a problem with your thyroid or adrenal glands; or

• an autoimmune disorder such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or psoriasis.

FDA pregnancy category X. Korlym can harm an unborn baby or cause a miscarriage. Do not use if you are pregnant. Stop taking Korlym and tell your doctor right away if you become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

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.

Korlym can make birth control pills less effective. Use a non-hormone method of birth control (such as a condom with spermicide or diaphragm with spermicide) while you are using this medicine and for at least 1 month after your treatment ends.

It is not known whether Korlym passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Korlym?

Take Korlym exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Korlym is usually taken once per day with a meal. Follow your doctor"s instructions.

While using Korlym, you may need frequent blood tests.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Korlym?

Follow your doctor"s instructions about any restrictions on food, beverages, or activity.

Korlym side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Korlym: 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, tired feeling;

• abnormal vaginal bleeding;

• a light-headed feeling, like you might pass out;

• new or worsening medical problems;

• low blood sugar - headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or

• low potassium - confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Common Korlym side effects may include:

• nausea, vomiting, loss of appetite;

• low potassium;

• tired feeling;

• headache, dizziness;

• joint pain;

• changes in your menstrual periods;

• swelling in your hands or feet;

• sleep problems (insomnia); or

• high blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, shortness of breath.

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.

See also: Side effects (in more detail)

What other drugs will affect Korlym?

Many drugs can interact with mifepristone. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Korlym, especially:

• antifungal medicine (ketoconazole, and others);

• an antibiotic;

• an antidepressant;

• antiviral medicine to treat HIV/AIDS or hepatitis C;

• a blood thinner such as warfarin (Coumadin, Jantoven); or

• steroid medicine (dexamethasone, prednisone, methylprednisolone, and others).

This list is not complete and many other drugs can interact with Korlym. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.