Mifepristone (By mouth)

Introduction

Mifepristone (mif-e-PRIS-tone)

Ends a pregnancy that is less than 7 weeks along (49 days or less since the start of your last menstrual period).

Brand Name(s)

Mifeprex

There may be other brand names for this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are breast feeding, if you have anemia, or if you smoke. Tell your doctor if you have liver disease, kidney disease, or lung disease. Make sure your doctor knows if you have a history of heart problems or high blood pressure.
• Your doctor will give you instructions on what to do if you have a medical emergency, such as severe bleeding. Keep all emergency phone numbers with you during your treatment.
• Some people might have serious side effects such as bleeding or infection after using this medicine. Call your doctor right away if you have a fever (100.4°F or higher), severe stomach pain, heavy vaginal bleeding, weakness, nausea, vomiting, diarrhea, or if you feel dizzy or faint after you receive this medicine. If you cannot reach your doctor, go to a hospital or other medical facility right away.
• Make sure you tell any other doctor who treats you that you are using this medicine. Keep your medication guide with you at all times so you can show the doctor.
• Only your doctor can tell whether your pregnancy has been completely ended. During your 2-week follow-up visit, you will be examined to make sure you are no longer pregnant. It is extremely important for you to have this examination. If the treatment has not worked, your pregnancy may continue and the baby could be born with birth defects.
• After treatment it is possible for you to get pregnant again, even before you have your next period. Start using an effective form of birth control right away after your pregnancy has been ended.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fainting or unusual weakness.
• Fast heartbeat.
• Feeling sick including nausea, vomiting or diarrhea.
• Fever.
• Heavy vaginal bleeding or severe cramping.
• Severe stomach pain.

If you notice these less serious side effects, talk with your doctor:

• Back pain.
• Cramps or stomach pain (may be worse after you receive misoprostol at the second visit).
• Headache.
• Mild dizziness.
• Unusual tiredness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to mifepristone, misoprostol, Cytotec®, Arthrotec®, or any type of prostaglandin. You should not receive mifepristone if you have a tubal (ectopic) pregnancy, problems with your adrenal glands, bleeding disorders, or porphyria. You should not use this medicine if you use blood thinners (Coumadin®) or have used steroids for a long time. Tell your doctor is you have an intrauterine device (IUD). It will need to be removed before taking this medicine. You should not receive this medicine if you can not get emergency medical care if needed during your treatment.

How to Use This Medicine

Tablet

• 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.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• At the first visit, you will be given three mifepristone tablets. Two days later at the second visit, you will be given two 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.

If a dose is missed:

• It is very important for you to go to all of your appointments during your treatment. Call your doctor if you are not able to keep one of your appointments.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using ketoconazole (Nizoral®), itraconazole (Sporanox®), or erythromycin. Tell your doctor if you are using rifampin (Rifadin®), dexamethasone (Decadron®), St. John's Wort, or a seizure medicine such as phenobarbital, (Dilantin®), or carbemazepine, (Tegretol®).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.