Mifepristone Tablets (Cushing Syndrome)

What is this medication?

MIFEPRISTONE (mi FE pri stone) treats high blood sugar (glucose) in people with Cushing Syndrome, a condition that occurs when the body releases too much of the hormone cortisol. Cortisol helps your body respond to stress in many ways, including by telling your body to release more sugar into the body for energy. This medication works by reducing the effects of cortisol in your body, which decreases your blood sugar.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Korlym

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Cancer
• Depression
• Diabetes that is not related to Cushing's disease
• Heart disease
• High blood pressure
• Liver disease
• Low levels of potassium in the blood
• Organ transplant
• Taking steroids such as dexamethasone or prednisone
• Unexplained vaginal bleeding
• An unusual or allergic reaction to mifepristone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take it with food. Do not take this medication with grapefruit juice. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Certain medications for cholesterol, such as lovastatin or simvastatin
• Certain medications for fungal infections, such as fluconazole, ketoconazole, or posaconazole
• Cisapride
• Cyclosporine
• Dronedarone
• Ergot alkaloids, such as dihydroergotamine or ergotamine
• Fentanyl
• Pimozide
• Quinidine
• Sirolimus
• Tacrolimus
• Thioridazine

This medication may also interact with the following:

• Certain antibiotics, such as clarithromycin, erythromycin, or telithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for seizures, such as carbamazepine, phenytoin, or phenobarbital
• Certain medications that prevent or treat blood clots, such as warfarin
• Conivaptan
• Estrogen or progestin hormones
• Grapefruit juice
• Itraconazole
• Medications for depression or anxiety
• Opioids
• Other medications that cause heart rhythm changes
• Repaglinide
• Rifabutin
• Rifampin
• Rifapentine
• St. John's wort
• Steroid medications, such as prednisone or cortisone
• Thyroid hormones
• Voriconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need blood work done while you are taking this medication.

This medication may affect blood sugar levels. If you have diabetes, check with your care team before you change your diet or the dose of your diabetic medication.

Keep the MedGuide for this medication. If you need emergency medical care, show your care team the MedGuide. Tell the care team that you have taken this medication.

Talk to your care team if you or your partner wish to become pregnant or think either of you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 1 month after stopping treatment. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 1 month after stopping treatment. Talk to your care team about effective forms of contraception.

Estrogen and progestin hormones may not work as well while you are taking medication. A barrier contraceptive, such as a condom or diaphragm, is recommended if you are using these hormones for contraception while taking this medication and for 1 month after stopping this medication. Talk to your care team about effective forms of contraception.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Irregular menstrual cycles or spotting
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Fatigue
• Headache
• Joint pain
• Loss of appetite
• Nausea
• Swelling of the ankles, hands, or feet

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.