Mifeprex

Disclaimer

Mifeprex

Mifeprex Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

MIFEPRISTONE - ORAL

(MIF-e-PRIS-tone)

COMMON BRAND NAME(S): Mifeprex

WARNING: Rarely, serious medical problems can occur when a pregnancy ends (e.g., due to medical abortion with medications including mifepristone, surgical abortion, miscarriage), including sometimes fatal infections and bleeding. Read the Medication Guide, read and sign the Patient Agreement, and consult your doctor if you have any questions.

Your doctor must give you clear instructions regarding whom to call and what to do in case of an emergency (e.g., severe bleeding, infection). If you go to the emergency room or visit another health care professional, show them the Medication Guide so they know you are having a medical abortion.

Seek immediate medical attention if you experience symptoms such as severe abdominal pain, fainting, fast heartbeat, fever lasting more than 4 hours. You may have a very serious infection even if you do not have a fever. Therefore, seek immediate medical attention if you have abdominal pain or feel sick (e.g., nausea, vomiting, diarrhea, weakness) more than 24 hours after taking the second drug (misoprostol), even if you do not have a fever. Also seek immediate medical attention if you have continued heavy bleeding, which may be a sign of an incomplete abortion or other serious medical problem. You may need surgery or other medical care. See also Side Effects section.

USES: Mifepristone (also known as RU 486) is used to cause an abortion during the early part of a pregnancy. It is used up to week 7 of pregnancy (up to 49 days after the first day of your last menstrual period). Mifepristone blocks a natural substance (progesterone) that is needed for your pregnancy to continue. It is usually used together with another medicine called misoprostol.

Mifepristone must not be used if you have a rare abnormal pregnancy that is outside the womb (ectopic pregnancy). It will not cause an abortion in this case. It may cause an ectopic pregnancy to rupture, resulting in very serious bleeding.

HOW TO USE: Read the Medication Guide provided by your doctor before you start using mifepristone. Keep the guide to reread if needed. If you have any questions, consult your doctor or pharmacist. Read and sign the Patient Agreement form provided by your doctor. Tell your doctor if you do not understand how to use this medication or cannot follow the instructions. Mifepristone is available only from your doctor. It is not available from store pharmacies.

You must visit the doctor's office 3 times (days 1, 3, and 14) to complete your treatment and important examinations. This treatment is only given under direct medical 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.

Your doctor may want to do an ultrasound to make sure your pregnancy is less than 7 weeks and is not outside the womb (ectopic).

Mifepristone is taken by mouth as a single dose or as directed by your doctor. Return to your doctor's office 2 days later. At that time, if a complete abortion is not confirmed by exam or ultrasound, you will take another medication (misoprostol) by mouth as a single dose. It is very important that you take the misoprostol no more than 48 hours after you take the mifepristone. Heavy vaginal bleeding does not mean that an abortion is complete.

Avoid grapefruit juice while using this medication unless your doctor instructs you otherwise.

It is important that you return for a follow-up visit 14 days after taking mifepristone, even if you are not having any problems.

If abortion does not occur or is not complete, or there are serious medical problems, surgery may be needed. If the treatment fails and the pregnancy continues until birth, there is a risk of birth defects.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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