Mifepristone (for Cushing’s Syndrome), Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to control high blood sugar in people who have Cushing’s syndrome and type 2 diabetes or glucose intolerance. Take it exactly as directed.
• DO NOT take this medicine if you are pregnant. It may seriously harm the baby.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause adrenal insufficiency or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: cortisol receptor blocker

Generic and brand names: mifepristone, oral; Korlym

What is this medicine used for?

This medicine is used to control high blood sugar in people who have Cushing’s syndrome and type 2 diabetes or glucose intolerance. This medicine is not for people with type 2 diabetes that is not caused by Cushing’s syndrome.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• An autoimmune disease such as rheumatoid arthritis or lupus
• An organ transplant
• Adrenal gland problems
• Bleeding problems, or if you take blood thinners
• Heart disease
• Liver or kidney disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Low levels of potassium in the blood
• Problems with the lining of the uterus (endometrial hyperplasia or endometrial cancer)
• Unexplained vaginal bleeding

It is very important that you tell your healthcare provider about all the medicines you are taking. You should not take this medicine if you take certain medicines.

Females of childbearing age: DO NOT take this medicine if you are pregnant. It may seriously harm the baby. You will need to have a negative pregnancy test before you start taking this medicine or if you stop taking this for 14 or more days. Use an effective non-hormonal birth control method while you are taking this medicine and for 1 month after stopping it. Talk to your healthcare provider about birth control methods. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Your healthcare provider may adjust your dose based upon your response and how you tolerate the medicine.

Check with your healthcare provider before using this medicine in children under age 18.

Do not stop taking this medicine without your healthcare provider’s approval. If you stop taking the medicine for more than 14 days, females of childbearing age must have a negative pregnancy test before restarting the medicine.

This medicine is usually taken once a day. Take this medicine with a meal. Swallow the tablet whole. Do not split, crush, or chew the tablet.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine stops a hormone made by the adrenal gland from working. This can cause a serious problem called adrenal insufficiency. Tell your healthcare provider right away if you have symptoms such as:

• Unusual tiredness or weakness
• Severe dizziness or fainting
• Signs of low blood sugar such as confusion, shaking, weakness, strong hunger, cold sweats, headache, nausea, vision problems, and feeling faint

It is very important that your healthcare provider check your progress while you are taking this medicine. You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Keep the medication guide with you at all times.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unusual tiredness or weakness; severe dizziness or fainting; symptoms of low blood sugar (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness); irregular heartbeat; unexplained muscle pain; vaginal bleeding; trouble breathing; swelling in the arms or legs; severe nausea or vomiting.

Other: Mild tiredness, mild nausea or vomiting, decreased appetite, mild dizziness, muscle or joint pain, dry mouth, constipation, stuffy nose, diarrhea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), silodosin (Rapaflo), and tamsulosin (Flomax)
• Anagrelide (Agrylin)
• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, diazepam (Valium), and midazolam (Versed)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as diphenhydramine (Benadryl) and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as daclatasvir (Daklinza), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Apomorphine (Apokyn)
• Atomoxetine (Strattera)
• Bromocriptine (Cycloset, Parlodel)
• Buprenorphine (Buprenex, Butrans)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), lenvatinib (Lenvima), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lomitapide (Juxtapid), lovastatin (Altoprev), and simvastatin (Zocor)
• Cinacalcet (Sensipar)
• Colchicine (Colcrys)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Fingolimod (Gilenya)
• Flibanserin (Addyi)
• Heart medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, sotalol (Betapace, Sorine), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Lithium (Lithobid)
• Lumacaftor/ivacaftor (Orkambi)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, primaquine, and quinine
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), budesonide (Entocort, Rhinocort, Uceris), fluticasone (Flonase, Flovent, Veramyst), fluticasone/salmeterol (Advair), formoterol (Perforomist), and salmeterol (Serevent)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol, and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer), sildenafil (Revatio), and tadalafil (Adcirca)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), and ergotamine (Ergomar)
• Naloxegol (Movantik)
• Natural remedies such as alfalfa, bilberry, fenugreek, garlic, ginger, ginseng, and St. John's wort
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), droperidol (Inapsine), netupitant/palonosetron (Akynzeo), ondansetron (Zofran), and promethazine
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Octreotide (Sandostatin)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), methadone (Dolophine, Methadose), and oxycodone (OxyContin, Roxicodone)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Ranolazine (Ranexa)
• Sleeping pills such as eszopiclone (Lunesta), flurazepam, and triazolam (Halcion)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Tetrabenazine (Xenazine)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.