Mifepristone (By mouth)
Ends a pregnancy that is less than 7 weeks along (49 days or less since the start of your last menstrual period). Also used to control high blood sugar in patients with Cushing syndrome who also have type 2 diabetes and have failed surgery or are not candidates for surgery.
MifeprexThere may be other brand names for this medicine.
When This Medicine Should Not Be Used:Do not use this medicine if you have had an allergic reaction to mifepristone, misoprostol, Arthrotec, Cytotec, or any type of prostaglandin. You should not use this medicine if you are pregnant, or have a tubal (ectopic) pregnancy, abnormal vaginal bleeding, endometrial cancer, problems with your adrenal glands, bleeding disorders, or porphyria. Do not use this medicine if you are also taking blood thinners (Coumadin), cyclosporine (Gengraf, Neoral, Sandimmune), dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Ergostat), fentanyl (Sublimaze), lovastatin (Altocor, Mevacor), pimozide (Orap), quinidine (Quinora), simvastatin (Zocor), sirolimus (Rapamune), tacrolimus (Prograf), or steroid medicine such as dexamethasone, prednisone, or Medrol. Tell your doctor is you have an IUD. It will need to be removed before you take this medicine. Do not use this medicine if you cannot get emergency medical care during your treatment.
How to Use This Medicine:
- Mifeprex tablets:
- The entire treatment requires 3 visits to your doctor.
- At the first visit, you will be given 3 mifepristone tablets. Two days later at the second visit, you will be given 2 tablets of another medicine called misoprostol. Two weeks later at the third visit, your doctor will check to make sure you are no longer pregnant. This may include an ultrasound exam.
- This medicine will cause you to bleed and have cramps for about 2 to 4 weeks. Call your doctor if you have little or no vaginal bleeding after receiving the medicine.
- It is sometimes necessary to have a surgical abortion to completely end the pregnancy. You may also need to have surgery if there is any tissue left in your uterus after treatment with mifepristone.
- Korlym? tablets:
- Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
- It is best to take this medicine with food or milk.
- Swallow the tablet whole. Do not break, crush, or chew it.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
If a dose is missed:
- It is very important for you to go to all of your appointments during your Mifeprex treatment. Call your doctor if you are not able to keep one of your appointments.
- If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
How to Store and Dispose of This Medicine:
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are using St. John's wort, medicine to treat an infection (such as ciprofloxacin, clarithromycin, erythromycin, telithromycin, Biaxin, Ery-Tab, or Ketek), medicine to treat a fungal infection (such as fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole, Nizoral, Sporanox, or Vfend), medicine to treat tuberculosis (such as rifabutin, rifampin, rifapentine, Mycobutin, Rifadin, or Rimactane), medicine to treat HIV/AIDS (such as amprenavir, atazanavir, darunavir/ritonavir, efavirenz, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, Crixivan, Fortovase, Invirase, Kaletra, Norvir, or Viracept), medicine for seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin, or Tegretol), or a blood thinner (such as warfarin, Coumadin).
- Tell your doctor if you are also using aprepitant (Emend), boceprevir (Victrelis), bupropion (Wellbutrin), conivaptan (Vaprisol), fluvastatin (Lescol), imatinib (Gleevec), mibefradil (Posicor), nefazodone (Serzone), repaglinide (Prandin), telaprevir (Incivek), or certain heart rhythm medicines (such as diltiazem, verapamil, Cardizem, or Verelan), pain or arthritis medicine called NSAIDs (such as ibuprofen, naproxen, Aleve, Celebrex, Motrin, Vioxx, or Voltaren), or birth control pills.
- Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Warnings While Using This Medicine:
- Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment and for 1 month after the last dose of this medicine. After treatment it is possible for you to get pregnant again, even before you have your next period. If you think you have become pregnant while using the medicine, tell your doctor right away.
- Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease, adrenal problems, autoimmune disorders, bleeding problems, low potassium in the blood, lung disease, heart failure, or a history of cardiovascular disease or high blood pressure.
- Your doctor will give you instructions on what to do if you have a medical emergency, such as severe bleeding. Keep all emergency phone numbers with you during your treatment.
- Call your doctor right away if you have a fever (100.4F or higher), severe abdominal pain, heavy vaginal bleeding, weakness, nausea, vomiting, diarrhea, or you feel dizzy or faint after you receive this medicine. These could be symptoms of a serious infection. If you cannot reach your doctor, go to a hospital or other medical facility right away.
- Make sure you tell any other doctor who treats you that you are using this medicine. Keep your medication guide with you at all times so you can show the doctor.
- Only your doctor can tell whether your pregnancy has been completely ended. During your 2-week follow-up visit, you will be examined to make sure you are no longer pregnant. It is extremely important for you to have this examination. If the treatment has not worked, your pregnancy may continue and the baby could be born with birth defects.
- This medicine may cause adrenal gland problems. Stop using this medicine and check with your doctor if you have unusual tiredness or weakness, lightheadedness, dizziness, or fainting, nausea or changes in your appetite, or darkening of the skin.
- Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
- Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Dry mouth, increased thirst, muscle cramps, nausea, or vomiting
- Fast, pounding, or uneven heartbeat
- Increased hunger or thirst
- Lightheadedness, dizziness, or fainting
- Heavy vaginal bleeding or severe cramping
- Severe abdominal pain
- Shortness of breath or trouble breathing
- Swelling in your hands, ankles, or feet
- Unusual tiredness or weakness
If you notice these less serious side effects, talk with your doctor:
- Anxiety, sleepiness or unusual drowsiness
- Back, joint, or muscle pain
- Cramps or stomach pain (may be worse after you receive misoprostol at the second visit)
- Decreased appetite
- Diarrhea or constipation
- Nausea or vomiting
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
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