mifepristone

mif-e-PRIS-tone

Oral route(Tablet)

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 mifepristone

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.

mifepristone is available only with your doctor's prescription.

Before Using mifepristone

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 mifepristone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to mifepristone 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. When you are taking mifepristone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using mifepristone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clozapine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of mifepristone. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal failure—Mifepristone may not work appropriately

• Bleeding problems—May cause excessive vaginal bleeding

• Diabetes or


• Heart disease or


• High blood pressure or


• Kidney disease or


• Liver disease or


• Lung disease


• Women older than 35 years of age who smoke cigarettes (10 or more a day)—You should use caution if you have any of these chronic conditions and let your doctor know before beginning treatment with mifepristone.

• Ectopic pregnancy (e.g., a pregnancy that develops in fallopian tubes instead of the uterus) or


• Lower abdominal mass—Mifepristone will not terminate an ectopic pregnancy

• An intrauterine device (IUD) that is still in the uterus—Must be removed before mifepristone therapy is started

• Porphyria, inherited

• Anemia, severe or


• Poor blood circulation or


• Inability of blood to clot properly—Mifepristone causes heavy bleeding in a small portion of users, this may be intensified in patients with bleeding disorders

Proper Use of mifepristone

Dosing

The dose of mifepristone 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 mifepristone. 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 mifepristone

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.

mifepristone 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: mifepristone side effects (in more detail)

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More mifepristone resources

• Mifepristone Side Effects (in more detail)
• Mifepristone Dosage
• Mifepristone Use in Pregnancy & Breastfeeding
• Mifepristone Drug Interactions
• Mifepristone Support Group
• 0 Reviews for Mifepristone - Add your own review/rating

• mifepristone Concise Consumer Information (Cerner Multum)


• Mifepristone Professional Patient Advice (Wolters Kluwer)


• Mifepristone Monograph (AHFS DI)


• Mifepristone MedFacts Consumer Leaflet (Wolters Kluwer)

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