Mifeprex

Mifepristone (Mifeprex)



(mi fe' pri stone)

Mifeprex®

RU-486

Serious or life-threatening vaginal bleeding may occur when a pregnancy is ended by miscarriage or by medical or surgical abortion. It is not known if taking mifepristone increases the risk that you will experience very heavy bleeding. Tell your doctor if you have or have ever had bleeding problems, anemia (less than normal number of red blood cells), or if you are taking anticoagulants ('blood thinners') such as aspirin, apixaban (Eliquis), dabigatran (Pradaxa), dalteparin (Fragmin), edoxaban (Savaysa). enoxaparin (Lovenox), Fondaparinux (Arixtra), heparin, rivaroxaban (Xarelto), or warfarin (Coumadin, Jantoven). If so, your doctor will probably tell you not to take mifepristone. If you experience very heavy vaginal bleeding, such as soaking through two thick full-size sanitary pads every hour for two continuous hours, call your doctor immediately or seek emergency medical care.
Serious or life threatening infections may occur when a pregnancy is ended by miscarriage or by medical or surgical abortion. A small number of patients died due to infections that they developed after they used mifepristone and misoprostol to end their pregnancies. It is not known if mifepristone and/or misoprostol caused these infections or deaths. If you develop a serious infection, you may not have many symptoms and your symptoms may not be very severe. You should call your doctor immediately or get emergency medical treatment if you experience any of the following symptoms: fever greater than 100.4 °F (38 °C) that lasts for more than 4 hours, severe pain or tenderness in the area below the waist, chills, fast heartbeat, or fainting.
You should also call your doctor immediately or get emergency medical treatment if you have general symptoms of illness such as weakness, nausea, vomiting, diarrhea, or feeling sick for more than 24 hours after taking mifepristone even if you do not have a fever or pain in the area below your waist.
Because of the risks of serious complications, mifepristone is available only through a restricted program. A program under called the Mifeprex Risk Evaluation and Mitigation Strategies (REMS) Program has been set up for all female patients that are prescribed mifepristone. Your doctor will give you the manufacturer's patient information sheet (Medication Guide) to read before you begin treatment with mifepristone. You will also need to sign a patient agreement before taking mifepristone. Tell your doctor if you have questions about treatment with mifepristone or if you cannot follow the guidelines in the patient agreement. Mifepristone is only available in clinics, medical offices, and hospitals and is not dispensed through retail pharmacies.
Talk to your doctor and decide whom to call and what to do in case of an emergency after taking mifepristone. Tell your doctor if you do not think that you will be able to follow this plan or to get medical treatment quickly in an emergency during the first two weeks after you take mifepristone. Take your medication guide with you if you visit an emergency room or seek emergency medical care so that the doctors who treat you will understand that you are undergoing a medical abortion.
Keep all appointments with your doctor. These appointments are necessary to be sure that your pregnancy has ended and that you have not developed serious complications of medical abortion.
Talk to your doctor about the risks of taking mifepristone.

Mifepristone is used in combination with misoprostol (Cytotec) to end an early pregnancy. Early pregnancy means it has been 70 days or less since your last menstrual period began. Mifepristone is in a class of medications called antiprogestational steroids. It works by blocking the activity of progesterone, a substance your body makes to help continue pregnancy.
Mifepristone is also available as another product (Korlym), which is used to control hyperglycemia (high blood sugar) in people with a certain type of Cushing's Syndrome in which the body makes too much of the hormone cortisol. This monograph only gives information about mifepristone (Mifeprex), which is used alone or in combination with another medication to end an early pregnancy. If you are using mifepristone to control hyperglycemia caused by Cushing's syndrome, read the monograph entitled mifepristone (Korlym) that has been written about this product.

Mifepristone comes as a tablet to take by mouth. You will take one tablet of mifepristone once on the first day. Within 24 to 48 hours after taking mifepristone, you will apply four tablets in total of another medication called misoprostol buccally (between the gum and cheek) by placing two tablets in each cheek pouch for 30 minutes, then swallowing the remaining content with water or another liquid. Make sure that you are in an appropriate location when you take misoprostol because vaginal bleeding, cramps, nausea, and diarrhea usually begins within 2 to 24 hours after taking it but could begin within 2 hours. Vaginal bleeding or spotting usually lasts for 9 to 16 days but can last for 30 days or longer. You must go back to your doctor for an exam or ultrasound 7 to 14 days after taking mifepristone to confirm that the pregnancy has ended and to check the amount of bleeding. Take mifepristone exactly as directed.

Before taking mifepristone,

tell your doctor if you are allergic to mifepristone, any other medications, or any of the ingredients in mifepristone tablets. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.

tell your doctor if you are taking any of the following medications or have taken them in the last two weeks: corticosteroids such as betamethasone (Celestone), budesonide (Entocort), cortisone (Cortone), dexamethasone (Decadron, Dexpak, Dexasone, others), fludrocortisone (Floriner), hydrocortisone (Cortef, Hydrocortone), methylprednisolone (Medrol, Meprolone, others), prednisolone (Prelone, others), prednisone (Deltasone, Meticorten, Sterapred, others), and triamcinolone (Aristocort, Azmacort); medications that suppress the immune system such as cyclosporine (Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); dihydroergotamine (D.H.E. 45, Migranal); ergotamine (Ergomar, in Cafergot, in Migergot); fentanyl (Duragesic); lovastatin (Mevacor); pimozide (Orap); quinidine (Quinidex); and simvastatin (Zocor). Your doctor will probably tell you not to take mifepristone if you are taking one or more of these medications.

tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or have taken in the last two weeks. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), or voriconazole (Vfend); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); bupropion (Wellbutrin); ciprofloxacin (Cipro); clarithromycin (Biaxin); conivaptan (Vaprisol); diltiazem (Cardizem); erythromycin (E.E.S., E-Mycin, Erythrocin); fluvastatin (Lescol); hormonal contraceptives such as birth control pills, implants, patches, rings, or injections; medications for hepatitis C such as boceprevir (Victrelis) and telaprevir (Incivek); medications for HIV or AIDS such as amprenavir (Agenerase), atazanavir (Reyataz), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir and ritonavir combination (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Fortovase, Invirase); medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin); medications for tuberculosis such as rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater) and rifapentine (Priftin); nefazodone (Serzone); repaglinide (Prandin); telithromycin (Ketek); and verapamil (Calan, Isoptin, others). Many other medications may also interact with mifepristone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

tell your doctor what herbal products you are taking, especially St. John's Wort.

tell your doctor if you have ever had an organ transplant or if you have or ever had thyroid disease. If you are a woman and have not had surgery to remove your uterus, tell your doctor if you have or have ever had unexplained vaginal bleeding, endometrial hyperplasia (overgrowth of the lining of the uterus), or endometrial cancer (cancer of the lining of your uterus). Your doctor will probably tell you not to take mifepristone.

tell your doctor if you have or have ever had heart failure, a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), low potassium in your blood, adrenal insufficiency(condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions), a bleeding disorder, or liver, kidney, or heart disease.

tell your doctor if you are breast-feeding.

Do not eat grapefruit or drink grapefruit juice while you are taking this medication.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Mifepristone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:



headache

vomiting

dry mouth

diarrhea

constipation

joint or muscle pain

swelling of the hands, feet, ankles, or lower legs

rash

itching

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:



nausea

loss of appetite

dizziness or lightheadedness

unusual tiredness or weakness

nervousness or irritability

shakiness

sweating 

muscle weakness, aches, or cramps

rapid, irregular, or pounding heartbeats

unexpected vaginal bleeding or spotting

shortness of breath
Mifepristone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Your doctor will store the medication in his or her office.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking mifepristone.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.