Mifepristone oral tablets

What is this medicine?

MIFEPRISTONE (mi FE pri stone) is a hormone-like drug. This medicine is available in products that are used for different purposes.

Mifeprex is used in combination with other medicines to end an early pregnancy (usually during the first 10 weeks). This medicine is only available in a doctor's office, health clinic, or hospital.

Korlym is used to treat Cushing's disease.

How should I use this medicine?

Mifeprex: Take this medicine by mouth with a glass of water. It will only be given to you by a health care professional while you are in the hospital, medical office, or clinic. Before you take this medicine, read the information your doctor or health care provider gives you. Talk to your doctor about any questions you have.

Korlym: Take this medicine by mouth with a glass of water. Take at about the same time each day. Swallow the tablets whole. Do not cut, crush, or chew this medicine. Take it with food. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

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 pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• fast, irregular heartbeat

• feeling faint, lightheaded

• fever or chills

• stomach pain

• unusually weak or tired

• vaginal discharge with bad smell

• vomiting

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

• back pain

• mild diarrhea

• dizziness

• headache

• loss of appetite

• nausea

• stomach cramps

• vaginal bleeding

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• certain medicines that treat or prevent blood clots like enoxaparin, warfarin

• cerivastatin

• cisapride

• dofetilide

• dronedarone

• naloxegol

• pimozide

• ranolazine

• steroid medicines like prednisone or cortisone

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• certain medicines for seizures like carbamazepine, phenytoin, phenobarbital

• certain medicines used in surgery for anesthesia

• erythromycin

• grapefruit juice

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• rifampin

• St. John's wort or other herbal products

• thyroid hormones

What if I miss a dose?

Mifeprex: This does not apply.

Korlym: 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.

Where should I keep my medicine?

Mifeprex: This drug is given in a hospital or clinic and will not be stored at home.

Korlym: Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

For use of Mifeprex:

• adrenal gland problems

• bleeding disorders

• cannot easily get emergency medical help in the 2 weeks after you take this medicine

• cannot return for follow up appointments in 1 to 2 weeks after you take this medicine

• have an intrauterine device (IUD)

• it has been more than 70 days (10 weeks) since your last menstrual period began

• porphyria

• take medicines that treat or prevent blood clots like enoxaparin, warfarin

• take steroid medicines like prednisone or cortisone

• tubal or ectopic pregnancy

• an unusual or allergic reaction to mifepristone, misoprostol, prostaglandins, or other medicines, foods, dyes, or preservatives

• breast-feeding

For use of Korlym:

• bleeding disorders

• diabetes not related to Cushing's disease

• heart problems

• organ transplant

• porphyria

• take medicines that treat or prevent blood clots

• take steroid medicines like prednisone or cortisone

• unexplained vaginal bleeding

• uterine cancer or cancer of the uterine lining

• an unusual or allergic reaction to mifepristone, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Mifeprex:

For your safety, you must visit your doctor as directed after taking this medicine. Report any unusual effects to your doctor. This medicine can cause birth defects. You will need surgery if this medicine fails to cause a full abortion.

After you take this medicine, some vaginal bleeding is normal. Heavy bleeding may be a sign that something is wrong. If you soak through 2 thick full-size sanitary pads each hour for 2 hours, get medical help right away. Call your doctor if you have a fever, stomach pain or tenderness, nausea, vomiting, diarrhea, or feel weak. This may be a sign that something is wrong. You may have a serious infection or complication and need medical help.

Keep the MedGuide for this medicine. If you need emergency medical care, show your healthcare provider the MedGuide. Tell the health care provider that you have taken this medicine.

Korlym:

Visit your doctor or health care professional for regular checks on your progress. You will need blood work done while you are taking this medicine.

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

Keep the MedGuide for this medicine. If you need emergency medical care, show your healthcare provider the MedGuide. Tell the health care provider that you have taken this medicine.

Women will need a pregnancy test prior to starting this medicine. Do not become pregnant while taking this medicine or for 1 month after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

Women must use effective birth control with this medicine. Use a non-hormonal form of birth control while taking this medicine and for 1 month after stopping it. Talk to your health care professional about how to prevent pregnancy. Tell your doctor right away if you think you may be pregnant.

Do not breast-feed an infant while taking this medicine.