What is mechanism of action?

mechanism of action is Progestational Hormone Receptor Antagonists [MoA]

Korlym

(Mifepristone)

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Dosage & Administration

* 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. (

2.1 Testing Prior to and During KORLYM Administration

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

[see Contraindications , Warnings and Precautions , Use in Specific Populations ].

)
* Administer once daily orally with a meal (

2.2 Adult Dosage

The recommended starting dose is 300 mg orally once daily. KORLYM must be given as a single daily dose. KORLYM should always be taken with a meal. Patients should swallow the tablet whole. Do not split, crush, or chew tablets.

Dosing and titration

The daily dose of KORLYM may be increased in 300 mg increments. The dose of KORLYM may be increased to a maximum of 1200 mg once daily but should not exceed 20 mg/kg per day. Increases in dose should not occur more frequently than once every 2-4 weeks. Decisions about dose increases should be based on a clinical assessment of tolerability and degree of improvement in Cushing's syndrome manifestations. Changes in glucose control, anti-diabetic medication requirements, insulin levels, and psychiatric symptoms may provide an early assessment of response (within 6 weeks) and may help guide early dose titration. Improvements in cushingoid appearance, acne, hirsutism, striae, and body weight occur over a longer period of time and, along with measures of glucose control, may be used to determine dose changes beyond the first 2 months of therapy. Careful and gradual titration of KORLYM accompanied by monitoring for recognized adverse reactions [

See Warnings and Precautions and

] may reduce the risk of severe adverse reactions. Dose reduction or even dose discontinuation may be needed in some clinical situations. If KORLYM treatment is interrupted, it should be reinitiated at the lowest dose (300 mg). If treatment was interrupted because of adverse reactions, the titration should aim for a dose lower than the one that resulted in treatment interruption.

).
* The recommended starting dose is 300 mg once daily (

2.2 Adult Dosage

Dosing and titration

See Warnings and Precautions and

).
* 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 (

2.2 Adult Dosage

Dosing and titration

See Warnings and Precautions and

).
* Renal impairment: do not exceed 600 mg once daily (

2.3 Dosing in Renal Impairment

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

[See Renal Impairment and Clinical Pharmacology ]

).
* Mild-to-moderate hepatic impairment: do not exceed 600 mg once daily. Do not use in severe hepatic impairment (

2.4 Dosing in 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.

[See Hepatic Impairment and Clinical Pharmacology ]

).
* Concomitant administration with strong CYP3A inhibitors: Do not exceed 900 mg once daily (

2.5 Concomitant Administration with CYP3A Inhibitors

Ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir and fosamprenavir, clarithromycin, conivaptan, lopinavir/ritonavir, posaconazole, saquinavir, telithromycin, or voriconazole may increase exposure to mifepristone. KORLYM should be used in combination with strong CYP3A inhibitors only when necessary.

[See Warnings and Precautions , Drug Interactions ]

Administration of KORLYM to patients already being treated with strong CYP3A inhibitors:

* Start at a dose of 300 mg. If clinically indicated, titrate to a maximum of 900 mg.

Administration of strong CYP3A inhibitors to patients already being treated with KORLYM:

* Adjust the dose of KORLYM according to Table 1.

Table 1. Dose adjustment of KORLYM when strong CYP3A inhibitor is added
Current dose of KORLYM	Adjustment to dose of KORLYM if adding a strong CYP3A inhibitor
300 mg	No change
600 mg	Reduce dose to 300 mg. If clinically indicated, titrate to a maximum of 600 mg
900 mg	Reduce dose to 600 mg. If clinically indicated, titrate to a maximum of 900 mg
1200 mg	Reduce dose to 900 mg

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Korlym Prescribing Information

Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with KORLYM and prevented during treatment and for one month after stopping treatment by the use of a non-hormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential.

Dosage and Administration (

2.5 Concomitant Administration with CYP3A Inhibitors

[See Warnings and Precautions , Drug Interactions ]

Administration of KORLYM to patients already being treated with strong CYP3A inhibitors:

Start at a dose of 300 mg. If clinically indicated, titrate to a maximum of 900 mg.

Administration of strong CYP3A inhibitors to patients already being treated with KORLYM:

Adjust the dose of KORLYM according to Table 1.

Table 1. Dose adjustment of KORLYM when strong CYP3A inhibitor is added
Current dose of KORLYM	Adjustment to dose of KORLYM if adding a strong CYP3A inhibitor
300 mg	No change
600 mg	Reduce dose to 300 mg. If clinically indicated, titrate to a maximum of 600 mg
900 mg	Reduce dose to 600 mg. If clinically indicated, titrate to a maximum of 900 mg
1200 mg	Reduce dose to 900 mg

)

11/2019

KORLYM (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.

LIMITATIONS OF USE:

KORLYM should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing's syndrome.

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. (
2.1 Testing Prior to and During KORLYM Administration
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
[see Contraindications , Warnings and Precautions , Use in Specific Populations ].
)
Administer once daily orally with a meal (
2.2 Adult Dosage
The recommended starting dose is 300 mg orally once daily. KORLYM must be given as a single daily dose. KORLYM should always be taken with a meal. Patients should swallow the tablet whole. Do not split, crush, or chew tablets.
Dosing and titration
The daily dose of KORLYM may be increased in 300 mg increments. The dose of KORLYM may be increased to a maximum of 1200 mg once daily but should not exceed 20 mg/kg per day. Increases in dose should not occur more frequently than once every 2-4 weeks. Decisions about dose increases should be based on a clinical assessment of tolerability and degree of improvement in Cushing's syndrome manifestations. Changes in glucose control, anti-diabetic medication requirements, insulin levels, and psychiatric symptoms may provide an early assessment of response (within 6 weeks) and may help guide early dose titration. Improvements in cushingoid appearance, acne, hirsutism, striae, and body weight occur over a longer period of time and, along with measures of glucose control, may be used to determine dose changes beyond the first 2 months of therapy. Careful and gradual titration of KORLYM accompanied by monitoring for recognized adverse reactions [
See Warnings and Precautions and
] may reduce the risk of severe adverse reactions. Dose reduction or even dose discontinuation may be needed in some clinical situations. If KORLYM treatment is interrupted, it should be reinitiated at the lowest dose (300 mg). If treatment was interrupted because of adverse reactions, the titration should aim for a dose lower than the one that resulted in treatment interruption.
).
The recommended starting dose is 300 mg once daily (
2.2 Adult Dosage
The recommended starting dose is 300 mg orally once daily. KORLYM must be given as a single daily dose. KORLYM should always be taken with a meal. Patients should swallow the tablet whole. Do not split, crush, or chew tablets.
Dosing and titration
The daily dose of KORLYM may be increased in 300 mg increments. The dose of KORLYM may be increased to a maximum of 1200 mg once daily but should not exceed 20 mg/kg per day. Increases in dose should not occur more frequently than once every 2-4 weeks. Decisions about dose increases should be based on a clinical assessment of tolerability and degree of improvement in Cushing's syndrome manifestations. Changes in glucose control, anti-diabetic medication requirements, insulin levels, and psychiatric symptoms may provide an early assessment of response (within 6 weeks) and may help guide early dose titration. Improvements in cushingoid appearance, acne, hirsutism, striae, and body weight occur over a longer period of time and, along with measures of glucose control, may be used to determine dose changes beyond the first 2 months of therapy. Careful and gradual titration of KORLYM accompanied by monitoring for recognized adverse reactions [
See Warnings and Precautions and
] may reduce the risk of severe adverse reactions. Dose reduction or even dose discontinuation may be needed in some clinical situations. If KORLYM treatment is interrupted, it should be reinitiated at the lowest dose (300 mg). If treatment was interrupted because of adverse reactions, the titration should aim for a dose lower than the one that resulted in treatment interruption.
).
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 (
2.2 Adult Dosage
The recommended starting dose is 300 mg orally once daily. KORLYM must be given as a single daily dose. KORLYM should always be taken with a meal. Patients should swallow the tablet whole. Do not split, crush, or chew tablets.
Dosing and titration
The daily dose of KORLYM may be increased in 300 mg increments. The dose of KORLYM may be increased to a maximum of 1200 mg once daily but should not exceed 20 mg/kg per day. Increases in dose should not occur more frequently than once every 2-4 weeks. Decisions about dose increases should be based on a clinical assessment of tolerability and degree of improvement in Cushing's syndrome manifestations. Changes in glucose control, anti-diabetic medication requirements, insulin levels, and psychiatric symptoms may provide an early assessment of response (within 6 weeks) and may help guide early dose titration. Improvements in cushingoid appearance, acne, hirsutism, striae, and body weight occur over a longer period of time and, along with measures of glucose control, may be used to determine dose changes beyond the first 2 months of therapy. Careful and gradual titration of KORLYM accompanied by monitoring for recognized adverse reactions [
See Warnings and Precautions and
] may reduce the risk of severe adverse reactions. Dose reduction or even dose discontinuation may be needed in some clinical situations. If KORLYM treatment is interrupted, it should be reinitiated at the lowest dose (300 mg). If treatment was interrupted because of adverse reactions, the titration should aim for a dose lower than the one that resulted in treatment interruption.
).
Renal impairment: do not exceed 600 mg once daily (
2.3 Dosing in Renal Impairment
No change in initial dose of KORLYM is required in renal impairment. The maximum dose should be limited to 600 mg.
[See Renal Impairment and Clinical Pharmacology ]
).
Mild-to-moderate hepatic impairment: do not exceed 600 mg once daily. Do not use in severe hepatic impairment (
2.4 Dosing in 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.
[See Hepatic Impairment and Clinical Pharmacology ]
).

Concomitant administration with strong CYP3A inhibitors: Do not exceed 900 mg once daily (

2.5 Concomitant Administration with CYP3A Inhibitors

[See Warnings and Precautions , Drug Interactions ]

Administration of KORLYM to patients already being treated with strong CYP3A inhibitors:

Start at a dose of 300 mg. If clinically indicated, titrate to a maximum of 900 mg.

Administration of strong CYP3A inhibitors to patients already being treated with KORLYM:

Adjust the dose of KORLYM according to Table 1.

Table 1. Dose adjustment of KORLYM when strong CYP3A inhibitor is added
Current dose of KORLYM	Adjustment to dose of KORLYM if adding a strong CYP3A inhibitor
300 mg	No change
600 mg	Reduce dose to 300 mg. If clinically indicated, titrate to a maximum of 600 mg
900 mg	Reduce dose to 600 mg. If clinically indicated, titrate to a maximum of 900 mg
1200 mg	Reduce dose to 900 mg

Risk Summary

KORLYM is contraindicated in pregnancy because the use of KORLYM results in pregnancy loss. There are no data that assess the risk of birth defects in women exposed to KORLYM during pregnancy. Available data limited to exposure following a single dose of mifepristone during pregnancy showed a higher rate of major birth defects compared to the general population comparator

(See

Data

Human Data

There are no data on long term exposure to mifepristone in pregnancy. Available data are limited to exposure to a single dose of mifepristone for pregnancy termination. In a prospective study in France of 46 pregnancies exposed to a single dose of mifepristone alone and 59 pregnancies exposed to a single dose of mifepristone and misoprostol, the overall major birth defect rate (4%) was greater than the general population background rate of 2 to 3% (2 birth defects in each group). There was no pattern of birth defects identified.

Animal Data

Reproductive studies were performed in mice, rats and rabbits at doses of 0.25 to 4.0 mg/kg (less than human exposure at the maximum clinical dose, based on body surface area). Because of the anti-progestational activity of mifepristone, fetal losses were much higher than in control animals. Skull deformities were detected in rabbit studies at less than human exposure, although mifepristone did not cause any adverse developmental effects in rats or mice during organogenesis. These deformities were most likely due to the mechanical effects of uterine contractions resulting from antagonism of the progesterone receptor.

)

. Mifepristone administered to pregnant mice, rats, and rabbits during organogenesis caused pregnancy loss in all species at clinically relevant doses based on body surface area comparisons

(See

Data

Human Data

Animal Data

)

. The inhibition of both endogenous and exogenous progesterone by mifepristone at the progesterone receptor results in pregnancy loss. If KORLYM is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

[See Contraindications (

4 CONTRAINDICATIONS

KORLYM is contraindicated in:

Pregnancy
[See Dosage and Administration , Use in Specific Populations ]
Patients taking drugs metabolized by CYP3A such as simvastatin, lovastatin, and CYP3A substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events.
[See Drug Interactions and Clinical Pharmacology ]
Patients receiving systemic corticosteroids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because KORLYM antagonizes the effect of glucocorticoids.
Women with a history of unexplained vaginal bleeding or with endometrial hyperplasia with atypia or endometrial carcinoma.
Patients with known hypersensitivity to mifepristone or to any of the product components.

Pregnancy
Patients taking drugs metabolized by CYP3A such as simvastatin, lovastatin, and CYP3A substrates with narrow therapeutic ranges
Patients receiving systemic corticosteroids for lifesaving purposes
Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma
Patients with known hypersensitivity to mifepristone or to any of the product components

)]

The estimated risk of fetal loss is elevated in patients with active Cushing's syndrome (24-30%), and the risk of major birth defects is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

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