Mifepristone (RU 486), Oral

What are other names for this medicine?

Type of medicine: abortifacient

Generic and brand names: mifepristone, oral; Mifeprex; RU 486

What is this medicine used for?

This medicine is used to end a pregnancy (cause an abortion). The pregnancy must be in the uterus. This medicine, also called Mifeprex (or RU 486 in Europe), is taken by mouth in 1 dose. Another medicine, misoprostol, is taken by mouth 2 days later. The treatment must be started within the first 49 days of the pregnancy.

It may be used for other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Do not have this treatment if:

• You have anemia or other bleeding problems.
• You are taking blood thinners, such as warfarin (Coumadin).
• You have adrenal gland problems.
• It has been more than 49 days since your last menstrual period.
• You have an ectopic pregnancy.
• You have an IUD in place.
• You have been taking steroids for a long time.

Tell your provider if you:

• are allergic to any medicine
• are breast-feeding
• smoke cigarettes.

How do I use it?

You will be required to read the medication guide and sign an agreement before you can have this treatment. You will have the chance to ask questions about the treatment. You can get this treatment only from healthcare providers who have been approved to give it.

On your first day of treatment, your healthcare provider will give you 3 tablets of this medicine (mifepristone) to take by mouth in a single dose in the presence of your provider.

On the third day, you will return to the healthcare provider. You will have a physical exam or ultrasound scan to see if you have had a complete abortion. If you have not, you will take 2 tablets of another medicine, misoprostol, by mouth in a single dose. Your provider may also prescribe other medicine for cramps or stomach or intestinal problems.

Mifepristone (Mifeprex) may be less effective if the misoprostol (the second medicine) is taken more than 2 days after the mifepristone. Be sure that you take your medicines exactly on schedule.

Your healthcare provider may adjust the dose and the time you take it for either medicine. Be sure to ask your provider any questions you have about the doses.

Fourteen days after you begin the treatment, you will need to return to your healthcare provider for a physical exam or ultrasound scan to see if the abortion has been complete. If it has not, you may need a surgical abortion.

What should I watch out for?

If this treatment does not cause a complete abortion and the pregnancy continues, the baby may have serious birth defects. This is why it is very important for you to return to your healthcare provider to find out if the abortion has been complete.

Contact your healthcare provider right away if you have any symptoms of infection such as fever 100.4°F or higher that lasts more than 4 hours, severe pain or tenderness in your abdomen, weakness, nausea, vomiting, diarrhea, or a fast heartbeat. If you feel sick more than 24 hours after taking this medicine, contact your healthcare provider.

Your provider will tell you what to do if you have a lot of discomfort or bleeding, or other major side effects. You should also have a phone number to call if you have questions and the name and phone number of a healthcare provider near you who will handle emergencies.

If you have an IUD in your uterus, it must be removed before you start this treatment.

If you are over 35 years old or smoke more than 10 cigarettes a day, you may have a greater risk of problems. Discuss this with your healthcare provider.

Bleeding or spotting for 9 to 16 days is normal. You may have some bleeding for 30 days or longer.

Vaginal bleeding does not always mean that the pregnancy has ended. Your healthcare provider must give you a physical exam or ultrasound scan to see for sure if the pregnancy is over. If you do not have any bleeding after this treatment, an abortion probably did not occur. In this case you will likely need a surgical abortion.

In some cases, heavy bleeding may need to be treated with drugs, curettage (cauterizing), IV infusions (slow drip of saline solution through a needle into a large vein), or blood transfusions. Be sure that you know when and how to contact a healthcare provider to get medical help if you need it.

You can get pregnant after an abortion but before your menstrual periods start again. Talk to your healthcare provider if you need birth control. Birth control can be started as soon as the abortion has been confirmed.

Do not breast-feed after taking this medicine without your healthcare provider's approval.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Serious (report these to your healthcare provider or get emergency medical treatment right away): Heavy vaginal bleeding, severe pelvic cramps, fever, unusual tiredness or weakness, fainting.

Other: Nausea, vomiting, diarrhea, pelvic pain, back pain, itching, headache, dizziness, weakness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antifungal medicines such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• anti-HIV medicines such as indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), delavirdine (Rescriptor), ritonavir (Norvir), and saquinavir (Fortovase, Invirase)
• antiseizure medicines such as carbamazepine (Tegretol) and phenytoin (Dilantin)
• aspirin or other salicylates
• cyclosporine (Sandimmune, Gengraf, Neoral)
• dexamethasone
• erythromycin (Erythrocin, E.E.S., Ery-Tab, EryPed)
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Motrin IB, Advil, Nuprin), naproxen (Naprosyn, Anaprox, Aleve, Naprelan), ketoprofen (Orudis, Orudis KT, Oruvail), nabumetone (Relafen), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), piroxicam (Feldene), diclofenac (Voltaren, Cataflam), and oxaprozin (Daypro)
• phenobarbital
• rifampin (Rifadin, Rimactane)
• St. John's wort
• warfarin (Coumadin).

The effects of this medicine may be increased if you take it with grapefruit juice. Discuss this with your healthcare provider.

Keep a list of all your medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) with you. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.