Korlym

What is Korlym?

• Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome.

Limitations of Use:

• KORLYM is not for people who have type 2 diabetes mellitus not caused by Cushing's syndrome.
• It is not known if KORLYM is safe and effective in children.

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Mifepristone-3D

What are the uses of this medicine?

• KORLYM is a prescription medicine used to treat high blood sugar (hyperglycemia) caused by high cortisol levels in the blood (hypercortisolism) in adults with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or cannot have surgery.

How does this medicine work?

• Mifepristone is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses.
• Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor.
• In addition, mifepristone appears to have little or no affinity for estrogen, muscarinic, histaminic, or monoamine receptors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are pregnant

• are taking:
• simvastatin (Zocor®, Vytorin®, Simcor®)
• lovastatin (Mevacor®, Altoprev®, Advicor®)
• cyclosporine (Gengraf®, Neoral®, Restasis®, Sandimmune®)
• dihydroergotamine (Migranal®)
• ergotamine (Ergomar®, Migergot®)
• fentanyl (Abstral®, Actiq®, Duragesic®, Fentora®, Lazanda®, Onsolis®, Sublimaze Preservative Free®, Subsys®)
• pimozide (Orap®)
• quinidine (Nuedexta®)
• sirolimus (Rapamune®, Torisel®)
• tacrolimus (Prograf®, Protopic®)

• must take corticosteroid medicines for other serious medical problems

• are a woman who still has her uterus (womb) and have:
• unexplained bleeding from your vagina
• changes in the cells lining your uterus (endometrial hyperplasia) or cancer of the lining of your uterus (endometrial cancer)
• are allergic to mifepristone or any of the ingredients in KORLYM.

What drug interactions can this medicine cause?

• Administer drugs that are metabolized by CYP3A at the lowest dose when used with KORLYM.
• Caution should be used when KORLYM is used with strong CYP3A inhibitors. Limit mifepristone dose to 900 mg per day when used with strong CYP3A inhibitors.
• Do not use KORLYM with CYP3A inducers.
• Use the lowest dose of CYP2C8/2C9 substrates when used with KORLYM.
• Use of KORLYM should be done with caution with bupropion and efavirenz.
• Do not use hormonal contraceptives with KORLYM.

Is this medicine FDA approved?

Initial U.S. Approval :2000

How should this medicine be used?

• Obtain a negative pregnancy test in females of reproductive potential prior to initiating treatment with KORLYM or if treatment is interrupted for more than 14 days.

Recommended dosage:

• The recommended starting dose is 300 mg once daily.
• Based on clinical response and tolerability, the dose may be increased in 300 mg increments to a maximum of 1200 mg once daily.
• Do not exceed 20 mg/kg per day.

Renal impairment:

• No change in initial dose of KORLYM is required in renal impairment. The maximum dose should be limited to 600 mg.

Mild-to-moderate hepatic impairment:

• No change in the initial dose of KORLYM is required in mild to moderate hepatic impairment. The maximum dose should be limited to 600 mg. KORLYM should not be used in severe hepatic impairment.

Administration:

• Take KORLYM exactly as your doctor tells you.
• Your doctor may change your dose if needed.
• KORLYM is usually taken 1 time each day.
• Take KORLYM with food.
• Swallow KORLYM whole. Do not split, crush or chew KORLYM tablets. If you cannot swallow KORLYM tablets whole, tell your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 300 mg

This medicine is available in fallowing brand namesː

• Korlym

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• headache
• pain in your arms and legs (arthralgia)
• swelling of your arms and legs (peripheral edema)
• dizziness
• thickening of the lining of the uterus (endometrial hypertrophy)
• fatigue
• low potassium in your blood
• vomiting
• high blood pressure
• decreased appetite

This medicine can cause serious side effects including:

• Loss of a pregnancy
• reduced effects of adrenal hormones (adrenal insufficiency)
• low blood potassium (hypokalemia)
• bleeding from the vagina
• disruption of menstrual cycle
• problems with the electrical system of your heart (QT interval prolongation).
• worsening of symptoms of other medical problems that are treated with corticosteroids when you take corticosteroids and KORLYM at the same time.

What special precautions should I follow?

• Patients receiving mifepristone may experience adrenal insufficiency. Patients should be closely monitored for signs and symptoms of adrenal insufficiency.
• Hypokalemia can occur at any time during KORLYM treatment. Hypokalemia should be corrected prior to treatment and monitored for during treatment
• Women may experience endometrial thickening or unexpected vaginal bleeding. Use with caution if patient also has a hemorrhagic disorder or is on anti-coagulant therapy.
• Mifepristone and its metabolites block IKr. KORLYM prolongs the QTc interval in a dose-related manner. Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval.
• KORLYM should be used with caution in patients taking ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir, fosamprenavir, clarithromycin, conivaptan, lopinavir/ritonavir, posaconazole, saquinavir, telithromycin, or voriconazole, as these could increase the concentration of mifepristone in the blood. Use only when necessary and limit mifepristone dose to 900 mg .
• KORLYM does not reduce serum cortisol levels. Caution should be used in patients with underlying heart conditions including heart failure and coronary vascular disease.

What to do in case of emergency/overdose?

• There is no experience with overdosage of KORLYM.

Can this medicine be used in pregnancy?

• KORLYM is contraindicated in pregnancy because the use of KORLYM results in pregnancy loss.

Can this medicine be used in children?

• Safety and effectiveness of KORLYM in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• mifepristone

Inactive ingredients:

• silicified microcrystalline cellulose, sodium starch glycolate, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide, triacetin, D&C yellow 10 aluminum lake, polysorbate 80, and FD&C yellow 6 aluminum lake.

Who manufactures and distributes this medicine?

• Manufactured for: Corcept Therapeutics Incorporated, Menlo Park, CA 94025

KORLYM® is a registered trademark of Corcept Therapeutics Incorporated.

What should I know about storage and disposal of this medication?

• Store KORLYM at room temperature, between 68°F to 77°F (20°C to 25°C).
• Keep KORLYM and all medicines out of the reach of children.

• Dailymed label info on Korlym
• FDA Korlym

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