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mifepristone (cont.)

What should I discuss with my healthcare provider before taking Mifeprex (Mifeprex)?

Mifeprex is used to end an early pregnancy that is not further along than 49 days (7 weeks) after the first day of your last menstrual period. MIFEPREX MUST NOT BE USED IN AN ATTEMPT TO END PREGNANCY BEYOND 7 WEEKS.

Treatment with Mifeprex requires 3 visits to your doctor. Do not use this medication if you cannot attend all required follow-up visits.

You should not take Mifeprex if you are allergic to prostaglandins or medicines that contain misoprostol (Cytotec or Arthrotec), or if you have:

  • an intrauterine device, or IUD (it must be removed before you take Mifeprex);
  • a bleeding or blood clotting disorder, such as hemophilia;
  • problems with your adrenal glands (chronic adrenal failure);
  • a pregnancy outside the uterus (ectopic pregnancy);
  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
  • if you take certain steroid medications or a blood thinner such as warfarin (Coumadin, Jantoven);
  • if it has been more than 49 days (7 weeks) since your last menstrual period began;
  • if you cannot return for the next 2 visits to your doctor; or
  • if you cannot easily get emergency medical help if needed in the 2 weeks after you take Mifeprex.

To make sure you can safely take Mifeprex, tell your doctor if you have any of these other conditions:

  • heart disease, high blood pressure;
  • liver or kidney disease;
  • asthma, bronchitis, or other breathing problems;
  • diabetes (if you use insulin);
  • severe anemia (lack of red blood cells); or
  • if you smoke 10 or more cigarettes per day.

FDA pregnancy category X. Do not use Mifeprex if you do not intend to end your pregnancy. Mifeprex can cause birth defects in an unborn baby if the treatment procedure does not fully terminate the pregnancy. If you are still pregnant after 2 weeks, you may need surgery to end the pregnancy completely.

It is not known whether Mifeprex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is Mifeprex given (Mifeprex)?

Before receiving this medication, you must read a Mifeprex Medication Guide. Then you must sign a Patient Agreement form stating that you understand the risks and benefits of using this medication.

Treatment with Mifeprex requires 3 visits to your doctor.

  • At the first visit (Day 1) you will be take 3 Mifeprex tablets at one time.
  • Two (2) days later at the second visit (Day 3), your doctor will check your uterus to determine if the pregnancy has ended.
  • If you are still pregnant on Day 3, you will take 2 misoprostol tablets at one time. Misoprostol can cause cramps, nausea, diarrhea, and other side effects. Your doctor may give you medication to treat or prevent these side effects.
  • Two (2) weeks later at the third visit (Day 14 after you took Mifeprex), your doctor will again check your uterus to make sure the pregnancy has completely ended.

Treatment with Mifeprex causes cramping and bleeding, which are signs that medication is working properly. But sometimes you can have cramping and bleeding and still be pregnant. Only your doctor can confirm whether your pregnancy has completely ended. Using a home pregnancy test kit is not effective in confirming that your uterus has been completely cleared of the pregnancy. Do not miss your follow-up visits on Day 3 and Day 14.

Call your doctor or seek emergency medical help if you still have any of the following symptoms more than 24 hours after taking Mifeprex: ongoing fever, severe stomach pain, heavy vaginal bleeding, nausea, vomiting, diarrhea, or if you feel like you might pass out.

In an emergency situation, make sure any doctor caring for you knows that you have taken Mifeprex.

If you are still pregnant after 2 weeks, you may need surgery to end the pregnancy completely. Carrying the pregnancy to term after taking Mifeprex may result in birth defects in the baby. Talk with your doctor about your treatment options.

You may continue bleeding for up to 30 days after taking Mifeprex. Bleeding may be heavier than a normal heavy period, and you may also pass blood clots and tissue.

It is possible to get pregnant again right after terminating a pregnancy with Mifeprex. You may begin using birth control after your doctor has confirmed that treatment with Mifeprex has effectively ended your pregnancy.

Report Problems to the Food and Drug Administration

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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