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MIFEPREX
MIFEPRISTONE - ORAL

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

MIFEPRISTONE - ORAL

(miff-eh-PRIH-stone)

COMMON BRAND NAME(S): Mifeprex

WARNING: If mifepristone does not cause a complete abortion, surgery may be necessary. Read the Medication Guide and Patient Agreement, and consult with your doctor regarding any questions. You must be given clear instructions regarding whom to call and what to do in case of an emergency (e.g., severe bleeding).

Uses

This medication, also known as RU 486, blocks a hormone (progesterone) which is needed for your pregnancy to continue. When used together with another medicine called misoprostol, mifepristone usually causes an abortion to occur. Use of this treatment must occur within the first 49 days of pregnancy (where day one of pregnancy is defined as the first day of your last menstrual period). Mifepristone is not used if your pregnancy is outside the womb (ectopic pregnancy); it will not cause an abortion in this case. In fact, it may cause an ectopic pregnancy to rupture, resulting in very serious internal or external bleeding.

How To Use

Before taking this medication, you must read and sign the "Patient Agreement" form, and read the Medication Guide. Mifepristone is taken by mouth as a single dose, as directed by your doctor. Two days later, if abortion has not occurred, you take misoprostol by mouth as a single dose. You must visit the doctor's office three times to complete your treatment and important examinations. This treatment is only given under direct MD supervision, in a doctor's office, clinic, or hospital. Be sure to have clear instructions from your doctor regarding whom to call and what to do in case of an emergency. Avoid grapefruit juice while using this medication unless your doctor instructs you otherwise. If this medication treatment fails to work, abortion surgery is generally performed.

Side Effects

Nausea, vomiting, diarrhea, headache, dizziness, and fatigue may occur. If these effects persist or worsen, notify your doctor promptly. Bleeding and cramping are expected during this treatment. Usually, the symptoms mean the drugs are working. However, sometimes you can have cramps and bleeding and still be pregnant. Therefore, you must return for all three of your doctor visits. Bleeding and spotting may last up to 30 days, and may be greater than a normal, heavy period. In a very few cases, this bleeding will need to be stopped by performing a surgical procedure. Tell your doctor immediately if you bleed enough to soak through two thick full-size sanitary pads per hour for two straight hours, or if you are concerned about heavy bleeding. Tell your doctor immediately if you have any of these unlikely but serious side effects: fever, fainting, vaginal discomfort or itching, unusual vaginal discharge, any other sign of infection. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, including: anemia, if you are a smoker 35 years of age or greater. This medication is not recommended for use if you have the following medical conditions: proven or possible pregnancy outside the womb (ectopic pregnancy), an undiagnosed abdominal growth, chronic adrenal gland failure, any allergies (including misoprostol or other prostaglandins), bleeding disorders, certain blood disorders (inherited porphyrias). This drug must be used where there is easy access to adequate emergency medical facitilies in case problems develop. If you are using an IUD (intrauterine birth control device), it should be removed before mifepristone treatment begins. Another pregnancy can occur following this abortion treatment, and before your normal period begins again. Birth control can be started as soon as this treatment is successfully completed. Mifepristone usually causes fetal death. In the unlikely event you have an ongoing pregnancy after treatment, birth defects may result. It is not known whether this drug passes into breast milk. Since the effects of mifepristone on infants are unknown, breast- feeding women should consult their doctor and determine if they should discard their breast milk for a few days following this treatment.

Drug Interactions

This drug is not recommended for use with: "blood thinners" (e.g., anticoagulants such as warfarin, or heparins), long-term corticosteroid therapy (e.g., prednisone). Ask your doctor or pharmacist for more details. Tell your doctor of all prescription and nonprescription medication you may use, especially of: azole antifungals (e.g., ketoconazole, itraconazole), certain macrolide antibiotics (e.g., erythromycin), rifamycins (e.g., rifampin), dexamethasone, St John's wort, certain anti-seizure drugs (e.g., phenytoin, phenobarbital, carbamazepine). Do not eat grapefruit or drink grapefruit juice unless your doctor instructs you otherwise. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe vaginal bleeding.

Notes

Do not share this medication with others. Laboratory and/or medical tests (e.g., ultrasound) may be performed to monitor your progress. Keep all scheduled medical appointments (at least three will be required); vaginal bleeding is not proof that the abortion was successful.

Missed Dose

You must follow the dosing schedule as directed by your doctor. If you miss an appointment, contact your doctor immediately.

Storage

Store at room temperature; 77 degrees F (25 degrees C) away from light and moisture.