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Generic Name: mifepristone (Korlym) (MIF e PRIS tone)
Brand Name: Korlym

What is mifepristone (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 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.

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

What is the most important information I should know about 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 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 Korlym, 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 Korlym. Tell your doctor about all other medicines you use.

What should I discuss with my healthcare provider before taking Korlym?

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. Mifepristone 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.

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?

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: 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 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)

Mifepristone dosing information

Usual Adult Dose for Abortion:

Day 1: three 200 mg tablets (600 mg total) orally administered as a single, one time dose.

Day 3: the patient returns to the health care provider 2 days after mifepristone ingestion. Unless termination of pregnancy has been confirmed via clinical examination or ultrasonographic scan upon follow-up visit, the patient is given two 200 mcg tablets (400 mcg total) of MISOPROSTOL orally, administered as a single dose one time. The patient then returns 14 days after administration of mifepristone to confirm complete termination of early pregnancy.

Usual Adult Dose for Cushing's Syndrome:

To control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery:

The recommended starting dose is 300 mg orally once daily with a meal.
The daily dose may be increased in 300 mg increments not more frequently than once every 2 to 4 weeks. The dose may be increased to a maximum of 1200 mg once daily but should not exceed 20 mg/kg per day.
If treatment is interrupted, it should be reinitiated at the lowest dose (300 mg).

What other drugs will affect Korlym?

Many drugs can interact with Korlym. 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.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about mifepristone (Korlym).
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.02. Revision Date: 2014-11-12, 3:27:27 PM.