Mifeprex

Your doctor or pharmacist can provide more information about Mifeprex.

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.

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Do not take mifepristone if you are taking:

• simvastatin (Zocor, Vytorin, Juvisync, Simcor)
• lovastatin (Mevacor, Altoprev, Advicor)
• cyclosporine (Gengraf, Neoral, Restasis, Sandimmune)
• dihydroergotamine (Migranal)
• ergotamine (Ergomar, Migerot)
• fentanyl (Abstral, Actiq, Duragesic, Fentora, Lazanda, Onsolis, Sublimaze Preservative Free, Sunsys)
• pimozide (Orap)
• quinidine (Neudexta)
• sirolimus (Rapamune, Torisel)
• tacrolimus (Prograf, Protopic)

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins,  and herbal supplements. Especially tell your doctor if you take:

• cortisone
• dexamethasone
• methylprednisolone
• prednisolone
• prednisone
• warfarin (Coumadin, Jantoven)

This is not a complete list of mifepristone drug interactions. Ask your doctor or pharmacist for more information.

You should not drink grapefruit juice while you take mifepristone. Grapefruit juice may increase the amount of mifepristone in your blood and increase your chance of having side effects.

Do not take mifepristone during pregnancy. See "Black Box Warning".

Mifepristone can cause serious side effects, including:

• Loss of a pregnancy. Women who can become pregnant must:
  • have a negative pregnancy test before starting mifepristone
  • have a negative pregnancy test before restarting mifepristone if you stop taking it for more than 14 days
  • use a non-hormonal form of birth control while taking mifepristone and for 1 month after stopping mifepristone. Talk to your doctor about how to prevent pregnancy. Tell your doctor right away if you think you may be pregnant.

If you take too much mifepristone, call your local Poison Control Center or seek emergency medical attention right away.

WARNING: TERMINATION OF PREGNANCY

Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with mifepristone and prevented during treatment and for one month after stopping treatment by the use of a non-hormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential.

• Binds to progesterone receptor, antagonizing endometrial and myometrial effects of progesterone, resulting in down-regulation of progesterone-dependent genes.1 2 3 4 5 6 7 8 27 Inhibition of progesterone in pregnancy results in detachment of conception product and pregnancy termination.1 2 3 5 6 8 9 Also promotes uterine contractions and softening of cervix.1 2 3 4 5 6 7 9 27

• Sensitizes myometrium to effects of prostaglandins (e.g., misoprostol) that stimulate uterine contraction and expulsion of the products of conception.1 2 3 4 5 6 7 9 27

• At higher doses, exhibits antiglucocorticoid activity.1 3 5 6 7 8 9

In the U.S.

• Korlym
• Mifeprex

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiprogesterone

Mifepristone is used in a regimen together with misoprostol to end a pregnancy that is less than 70 days in duration. It works by stopping the supply of hormones that maintains the interior of the uterus. Without these hormones, the uterus cannot support the pregnancy and the contents of the uterus are expelled.

Mifepristone is also used to control high blood sugar (hyperglycemia) in patients with Cushing's syndrome who also have type 2 diabetes and have failed surgery or are not candidates for surgery.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain mifepristone. It may not be specific to Mifeprex. Please read with care.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

For patients using Mifeprex® tablets:

• This medicine is given only by your doctor. You will not be allowed to take it at home. The entire treatment requires three visits to your doctor.
• At the first visit, you will be given one mifepristone tablet. Two days later at the second visit, you will be given four tablets of another medicine called misoprostol. Two weeks later at the third visit, your doctor will check to make sure you are no longer pregnant. This may include an ultrasound exam (sonogram).
• This medicine will cause you to bleed and have cramps for about 2 to 4 weeks. Call your doctor if you have little or no vaginal bleeding after receiving the medicine.
• It is sometimes necessary to have a surgical abortion to completely end the pregnancy. You may also need to have surgery if there is any tissue left in your uterus after treatment with mifepristone.
• Tell your doctor if you are using an intrauterine device (IUD). It must be removed first before using this medicine.

For patients using Korlym™ tablets:

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Swallow the tablet whole. Do not break, crush, or chew it. Take this medicine with a meal.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For termination of pregnancy (70 days or less) taken together with misoprostol:
    • Adults—200 milligrams (mg) as a single dose on Day 1. This is followed 2 days later by 800 micrograms (mcg) (four-200 mcg tablets) of misoprostol as a single dose placed in the cheeks.
    • Children—Use is not recommended.
  • For treatment of hyperglycemia in patients with Cushing's syndrome:
    • Adults—At first, 300 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1200 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to take Mifeprex as you have been told by your doctor. Do not use more than you were told to use.
• You will need to take this medicine with another drug called misoprostol to pass the pregnancy. Be sure you know when and how to take misoprostol after taking Mifeprex (mifepristone tablets). Check with you doctor or pharmacist if you have questions.
• Most women will pass the pregnancy within 2 to 24 hours after taking misoprostol. During this time, you will have bleeding and cramping that will most likely be heavier than your normal period. Be sure that you take the misoprostol in a proper place so you are ready. Talk with your doctor.
• Follow up with the doctor as you have been told.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Feeling tired or weak.
• Belly pain.
• Loose stools (diarrhea).
• Upset stomach or throwing up.
• Back pain.
• Stomach cramps.
• Vaginal discharge.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Brand KORLYM:
-Mild to moderate liver dysfunction: The maximum dose should not exceed 600 mg per day.
-Severe liver dysfunction: Not recommended

Brand MIFEPREX: Data not available