Mifepristone (RU 486), Oral

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KEY POINTS

• This medicine is taken by mouth to end a pregnancy. Take it exactly as directed.
• It is very important for you to return to your healthcare provider to find out if the abortion has been complete.
• This medicine may cause serious or life-threatening bleeding or infections, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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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 is taken by mouth in 1 dose. Another medicine, misoprostol, is taken by mouth 24 to 48 hours later. The treatment must be started within the first 70 days of the pregnancy.

This medicine may be used to treat 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 medicine that reduces the chance of blood clots forming, such as warfarin (Coumadin).
• You have adrenal gland problems or porphyria.
• It has been more than 70 days since your last menstrual period started.
• 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
• Have heart or lung disease
• Have high or low blood pressure
• Have liver or kidney disease
• Have diabetes
• Have porphyria (nerve pain or sensitivity to sunlight)
• Have Long QT syndrome (problems with electrical activity in the heart muscle)
• 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.

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

On your first day of treatment, your healthcare provider will give you 1 tablet of this medicine (mifepristone) to take by mouth in a single dose in the presence of your provider.

Your provider will prescribe 4 tablets of misoprostol to place between your cheek and gum 24 to 48 hours after you take this medicine. Your provider may also prescribe other medicine for cramps or stomach problems.

Mifepristone (Mifeprex) may be less effective if the misoprostol (the second medicine) is taken less than 24 hours or more than 48 hours 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.

Seven to 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 if I overdose?

Symptoms of an acute overdose have not been reported.

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.

Rarely, serious and sometimes fatal bleeding or infections may happen after an abortion. Contact your healthcare provider right away if you have any symptoms of infection such as fever 100.4°F, or 38°C or higher that lasts more than 4 hours; severe pain or tenderness in your abdomen; weakness; nausea; vomiting; diarrhea; fainting; prolonged heavy bleeding; 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.

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, the abortion may not be complete. 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.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Keep the medication guide with you at all times.

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

Bleeding or spotting for 9 to 16 days is normal. You may have some bleeding for 30 days or longer. Talk with your healthcare provider about this.

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.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Heavy vaginal bleeding, severe pelvic cramps, severe belly pain, fever, unusual tiredness or weakness, fainting, ongoing nausea or vomiting, severe or continued diarrhea, fast heartbeat.

Other: Nausea, vomiting, heartburn, diarrhea, pelvic pain, back pain, itching, headache, trouble sleeping, 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:

• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), and nefazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Oravig), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), pimozide (Orap), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Bosentan (Tracleer)
• Cancer medicines such as arsenic trioxide (Trisenox), enzalutamide (Xtandi), mitotane (Lysodren), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Altoprev), and simvastatin (Zocor)
• Conivaptan (Vaprisol)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dronedarone (Multaq), flecainide, nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, sotalol (Betapace, Sorine), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine (Ergomar)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze) and methadone (Dolophine, Methadose)
• Quinine
• St. John's wort
• Tetrabenazine (Xenazine)
• Warfarin (Coumadin)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, or tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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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.