What is Korlym?

Korlym (TM): Mifepristone has potent antiprogestational effects and will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment or if treatment is interrupted for more than 14 days in females of reproductive potential. Pregnancy should be prevented during treatment and for one month after stopping treatment by the use of a nonhormonal medically acceptable method of contraception unless the patient has had a surgical sterilization .

Mifeprex (R): Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following mifepristone use. Atypical Presentation of Infection: Patients with serious bacterial infections and sepsis can present without fever, bacteremia or significant findings on pelvic examination; use a high index of suspicion 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. Mifepristone is only available through a restricted program called the MIFEPREX REMS Program. Before prescribing mifepristone, advise the patient about these serious risks, ensure that she knows what to do if she experiences symptoms of these events, and discuss the medication guide and the patient agreement with her .

Mifepristone is used in a regimen together with misoprostol to end a pregnancy that is less than 70 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 also used to control high blood sugar (hyperglycemia) in patients with Cushing's syndrome who also have type 2 diabetes and have failed surgery or are not candidates for surgery.

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

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

For patients using Mifeprex® tablets:

• This medicine is given only by your doctor. You will not be allowed to take it at home. The entire treatment requires three visits to your doctor.
• At the first visit, you will be given one mifepristone tablet. Two days later at the second visit, you will be given four 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 (sonogram).
• 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.
• Tell your doctor if you are using an intrauterine device (IUD). It must be removed first before using this medicine.

For patients using 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.
• Swallow the tablet whole. Do not break, crush, or chew it. Take this medicine with a meal.

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.

• For oral dosage form (tablets):
  • For termination of pregnancy (70 days or less) taken together with misoprostol:
    • Adults—200 milligrams (mg) as a single dose on Day 1. This is followed 2 days later by 800 micrograms (mcg) (four-200 mcg tablets) of misoprostol as a single dose placed in the cheeks.
    • Children—Use is not recommended.
  • For treatment of hyperglycemia in patients with Cushing's syndrome:
    • Adults—At first, 300 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1200 mg per day.
    • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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:

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.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Mifeprex® tablets in pregnant women younger than 17 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of Korlym™ tablets in the pediatric population. Safety and efficacy have not been established.

No information is available on the relationship of age to the effects of Mifeprex® tablets in geriatric patients.

Although appropriate studies on the relationship of age to the effects of Korlym™ tablets have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

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.

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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Cyclosporine
• Dihydroergotamine
• Dronedarone
• Ergotamine
• Fentanyl
• Fluconazole
• Ketoconazole
• Lovastatin
• Mesoridazine
• Pimozide
• Piperaquine
• Posaconazole
• Quinidine
• Saquinavir
• Simvastatin
• Sirolimus
• Sparfloxacin
• Tacrolimus
• Terfenadine
• Thioridazine

Using this medicine 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.

• Alfentanil
• Amiodarone
• Anagrelide
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Azithromycin
• Benzhydrocodone
• Boceprevir
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Dabrafenib
• Dasabuvir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Digoxin
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Efavirenz
• Encorafenib
• Erythromycin
• Escitalopram
• Fingolimod
• Flecainide
• Fluoxetine
• Foscarnet
• Fosphenytoin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Ifosfamide
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Lapatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lopinavir
• Lumefantrine
• Macimorelin
• Mefloquine
• Meperidine
• Methadone
• Metronidazole
• Moxifloxacin
• Nafarelin
• Naloxegol
• Nefazodone
• Nelfinavir
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olaparib
• Ondansetron
• Osimertinib
• Oxycodone
• Paliperidone
• Panobinostat
• Pasireotide
• Pazopanib
• Pentazocine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pitolisant
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinine
• Ranolazine
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Salmeterol
• Sertraline
• Sevoflurane
• Simeprevir
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sufentanil
• Sulpiride
• Sunitinib
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Toremifene
• Tramadol
• Trazodone
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vinflunine
• Voriconazole
• Ziprasidone
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam
• Fluvastatin

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.

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

• Abnormal vaginal bleeding, history of or
• Adrenal failure, chronic or
• Bleeding problems or
• Ectopic pregnancy (eg, a pregnancy that develops in fallopian tubes instead of the uterus) or
• Endometrial hyperplasia or cancer or
• Lower abdominal mass that is undiagnosed or
• Porphyria (an enzyme problem)—Should not be used in patients with these conditions.

• Adrenal problems or
• Autoimmune disorders or
• Diabetes or
• Heart failure or
• Heart or blood vessel disease (eg, coronary vascular disease) or
• Heart rhythm problem (eg, QT prolongation) or
• Hypertension (high blood pressure) or
• Lung disease—Use with caution. May make these conditions worse.

• Anemia, severe or
• Inability of blood to clot properly or
• Poor blood circulation—Mifeprex® causes heavy bleeding in a small portion of users, this may be intensified in patients with bleeding disorders.

• Hypokalemia (low potassium in the blood)—Should be corrected first before using this medicine.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

You must have 3 visits to your doctor's office during treatment with Mifeprex®. It is extremely important that you attend all 3 visits.

Using Korlym™ while you are pregnant can harm your unborn baby. Use an effective form of birth control (eg, a condom, a diaphragm, or a cervical cap) to keep from getting pregnant during therapy and for 1 month after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not use this medicine if you are also using 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 a steroid medicine (such as dexamethasone, hydrocortisone, methylprednisolone, prednisone, Medrol®). Using these medicines together may cause serious problems.

Check with your doctor if the vaginal bleeding becomes severe or seems to last longer than expected (eg, soaking through two thick full-size sanitary pads per hour for 2 consecutive hours) while using this medicine.

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

You should check with your physician immediately if symptoms of serious infection (such as continuing fever ≥ 100.4 °F, severe stomach pain, pelvic tenderness, weakness, nausea, vomiting, diarrhea, non-productive cough shortness of breath, weight loss, or abnormally fast heartbeat) occur.

This medicine may cause adrenal gland problems. Check with your doctor if you have darkening of the skin, diarrhea, lightheadedness, dizziness, or fainting, increased hunger, mental depression, nausea or vomiting, skin rash, or unusual tiredness or weakness.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.