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. This medication is available only through a restricted program called the MIFEPREX REMS Program. Only doctors enrolled in the program may prescribe or give this medication. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
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.Who should not take Mifeprex?
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 10 of pregnancy (up to 70 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.
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 at least 2 times 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.
Take mifepristone by mouth as directed by your doctor, usually as a single dose. After taking mifepristone, your doctor should direct you to wait 24 to 48 hours before taking another medication (misoprostol) by mouth as a single dose. The medications may not work as well if you take misoprostol sooner than 24 hours after taking mifepristone or later than 48 hours after taking mifepristone. Follow your doctor's instructions carefully. 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 within 7 to 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.
See also Warning section.
Nausea, vomiting, diarrhea, weakness, or dizziness may occur. If these effects persist longer than the first 24 hours after taking the second drug (misoprostol), seek immediate medical attention because they can be signs of a serious medical problem.
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 of your follow-up visits with your doctor. Nausea and cramping may worsen in the 24 hours after you take the second drug (misoprostol). Your doctor may direct you to take other medication to help with these symptoms. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Bleeding and spotting may last up to 30 days and may be much heavier than a normal period. In very few cases, this bleeding will need to be stopped by surgery. Seek immediate medical attention if you bleed enough to soak through 2 thick, full-size sanitary pads each hour for 2 hours in a row, or if you are concerned about heavy bleeding.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Seek immediate medical attention if you have any of these unlikely but very serious side effects: fever of 100.4 degrees F (38 degrees C) or higher, fainting, fast heartbeat, stomach/abdominal pain or tenderness.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking mifepristone, tell your doctor if you are allergic to it; or to misoprostol; or to other progestins (e.g., norethindrone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions or other problems. Before using this medicine, consult your doctor if you have any of the following: undiagnosed abdominal growth (adnexal mass), certain adrenal gland problem (chronic adrenal failure), bleeding problem (e.g., coagulopathy), certain blood disorder (inherited porphyrias), IUD (intrauterine birth control device) in place, pregnancy longer than 10 weeks, proven or possible abnormal pregnancy outside the womb (ectopic pregnancy), unable to return for a doctor's visit in 7 to 14 days, unable to easily get emergency help in the 2 weeks after taking mifepristone.
If you are using an IUD (intrauterine birth control device), it should be removed before mifepristone treatment begins.
This drug must be used only if you can easily reach adequate emergency medical services in case you have a serious medical problem.
Mifepristone usually causes fetal death. In the unlikely event you have an ongoing pregnancy after treatment, birth defects may result.
Another pregnancy can occur after this abortion treatment and before your normal period begins again. Birth control can be started as soon as this treatment is successfully completed. Consult your doctor for more information.
This medication passes into breast milk. Since the effects of mifepristone on infants are unknown, breast-feeding women should consult their doctors on whether they should discard their breast milk for a few days following this treatment.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: long-term corticosteroid therapy (e.g., prednisone), drugs affecting liver enzymes that remove mifepristone from your body (e.g., azole antifungals such as itraconazole/ketoconazole, macrolide antibiotics including erythromycin, dexamethasone, rifamycins including rifabutin, St. John's wort, certain anti-seizure medicines including carbamazepine/phenytoin/phenobarbital), other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran).
Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
Mifepristone can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cyclosporine, ergot alkaloids (such as dihydroergotamine, ergotamine), fentanyl, pimozide, quinidine, some statin drugs (such as fluvastatin, lovastatin, simvastatin), sirolimus, tacrolimus, warfarin, among others.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe vaginal bleeding.
Laboratory and/or medical tests (e.g., ultrasound) may be performed to monitor your progress. Keep all scheduled medical appointments (at least 2 will be required).
You must follow the dosing and appointment schedule as directed by your doctor. If you miss an appointment, contact your doctor right away.
This drug is available only from your doctor. Mifepristone is stored at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.
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