This medication guide provides information about the Mifeprex brand of mifepristone. Korlym is another brand of mifepristone that is not covered in this medication guide.
Mifeprex is used together with misoprostol to end an early pregnancy. MIFEPREX MUST NOT BE USED IN AN ATTEMPT TO END PREGNANCY BEYOND 10 WEEKS.
Do not use Mifeprex or misoprostol if you do not intend to end your pregnancy.
Call your doctor right away if you have heavy vaginal bleeding or a general ill feeling after taking this medicine.
Seek emergency medical help if you still have any of the following symptoms more than 24 hours after taking Mifeprex or misoprostol: fever, severe stomach pain, heavy or prolonged vaginal bleeding, nausea, vomiting, diarrhea, or feeling like you might pass out.
Mifeprex blocks the actions of a hormone needed to maintain a pregnancy.
Mifeprex is used to end an early pregnancy that is not further along than 70 days (10 weeks) after the first day of your last menstrual period. Mifeprex is used together with another medicine called misoprostol (Cytotec).
Mifeprex is available only from a certified healthcare provider under a special program. You must be registered in the program and understand the risks of taking this medicine.
MIFEPREX MUST NOT BE USED IN AN ATTEMPT TO END PREGNANCY BEYOND 10 WEEKS.
This medication guide provides information about the Mifeprex brand of mifepristone. Korlym is another brand of mifepristone that is not covered in this medication guide.
Mifeprex may also be used for purposes not listed in this medication guide.
Do not use Mifeprex or misoprostol if you do not intend to end your pregnancy. Mifeprex may cause birth defects in an unborn baby if the treatment procedure does not fully terminate the pregnancy. You may need surgery to end the pregnancy completely.
Treatment with Mifeprex and misoprostol requires at least 2 visits to your doctor. Do not use this medicine if you cannot attend all required follow-up visits.
You should not take Mifeprex or misoprostol if you are allergic to either medicine, or if:
To make sure Mifeprex is safe for you, tell your doctor if you have:
Mifeprex can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Before receiving this medicine, 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 medicine.
Complete treatment to end the pregnancy will require at least 2 visits to your doctor.
Cramping and bleeding are signs that this medicine 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 any of your follow-up visits.
You may need surgery to end the pregnancy completely. Carrying a pregnancy to term after taking Mifeprex or misoprostol may cause birth defects or death of the baby. Talk with your doctor about your treatment options.
Bleeding and spotting are normal side effects of Mifeprex and misoprostol. It is possible to continue bleeding for up to 30 days. Bleeding may be heavier than a normal heavy period, and you may also pass blood clots and tissue.
Call your doctor if you bleed enough to soak through 2 full-size sanitary pads per hour for 2 hours in a row. In rare cases, serious and sometimes fatal bleeding or infection may occur after termination of a pregnancy. Call your doctor if you have heavy vaginal bleeding or a general ill feeling. You may also have a fever, stomach pain, or fast heartbeats.
Go to an emergency room if you still have any of the following symptoms more than 24 hours after taking misoprostol: fever, severe stomach pain, heavy or prolonged vaginal bleeding, nausea, vomiting, diarrhea, or feeling like you might pass out. Be sure to tell your caregivers when you last took misoprostol.
It is possible to get pregnant again right after terminating a pregnancy. You may begin using birth control after your doctor has confirmed that treatment with Mifeprex has effectively ended your pregnancy.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all your current medicines, especially:
This list is not complete. Other drugs may interact with Mifeprex, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2022 Cerner Multum, Inc. Version: 6.01. Revision date: 4/28/2016.
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