Advanced Consumer Information

Mifeprex

Generic Name: mifepristone (Oral route)

mif-e-PRIS-tone

Oral routeTablet

Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following mifepristone use. No causal relationship between the use of mifepristone and misoprostol and these events has been established. Before prescribing mifepristone, inform the patient about the risk of these serious events and discuss the medication guide and the patient agreement. Ensure that the patient knows whom to call and what to do, including going to an emergency room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol.

Atypical Presentation of Infection. Patients with serious bacterial infections (e.g. Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination following an abortion. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis.

Bleeding. Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.

Patients should be advised to take their medication guide with them if they visit an emergency room or another health care provider who did not prescribe mifepristone, so that provider will be aware that the patient is undergoing a medical abortion .

Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following mifepristone use. Advise patients about these serious risks and discuss the medication guide and the patient agreement with them .

Commonly used brand name(s):

In the U.S.

Mifeprex

Available Dosage Forms:

Tablet

Therapeutic Class: Antiprogesterone

Uses For Mifeprex

Mifepristone is used to end a pregnancy that is less than 49 days in duration. It works by stopping the supply of hormones that maintains the interior of the uterus. Without these hormones, the uterus cannot support the pregnancy and the contents of the uterus are expelled.

This medicine is available only with your doctor's prescription.

Before Using Mifeprex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Mifeprex

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

To terminate a pregnancy of 49 days or less duration:
- For oral dosage form (tablets):
  - Adults—600 milligrams (mg) (three 200 mg tablets) as a single oral dose followed two days later by 400 micrograms (mcg) (two 200 mcg tablets) of misoprostol as a single oral dose as needed.

Precautions While Using Mifeprex

You must have 3 visits to your physicians office during the treatment procedure. It is extremely important that you attend all three visits.

Check with your physician if the vaginal bleeding becomes severe or seems to last longer than expected (i.e., soaking through two thick full-size sanitary pads per hour for two consecutive hours).

You may need to have a surgical procedure to stop excessive vaginal bleeding or to terminate a pregnancy that was not terminated with the medical treatment procedure.

You should check with your physician immediately if signs or symptoms of serious infection (i.e., continuing fever ≥ 100.4 °F, severe stomach pain, pelvic tenderness, weakness, nausea, vomiting, diarrhea or abnormally fast heartbeat) occur.

Mifeprex Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Excessively heavy vaginal bleeding
unusual tiredness or weakness

Incidence not known

Chest pain or discomfort
confusion
cough or hoarseness
fast, weak pulse
fever or chills
lower back or side pain
pain or discomfort in arms, jaw, back or neck
painful or difficult urination
pale, cold, clammy skin
shortness of breath
sudden increase in abdominal or shoulder pain
sweating
unusual or large amount of vaginal bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal pain or uterine cramping
back pain
diarrhea
dizziness
headache
nausea or vomiting

Less common

Acid or sour stomach
anxiety
belching
cough
fainting or light-headedness when getting up from a lying or sitting position
fever
flu-like symptoms
headache
heartburn
increased clear or white vaginal discharge
indigestion
itching of the vagina or genital area
lack or loss of strength
pain during sexual intercourse
pain or tenderness around eyes and cheekbones
pale skin
shaking chills
shortness of breath or troubled breathing
sleeplessness or trouble sleeping
stomach discomfort, upset, or pain
tightness of chest or wheezing
troubled breathing, exertional
unusual bleeding or bruising
stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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