MIFEPRISTONE

Other

Brand names: Korlym

Oral

Mechanism of Action

12.1 Mechanism of Action 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.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS KORLYM is contraindicated in: Pregnancy [See Dosage and Administration ( 2.1 )
• Use in Specific Populations ( 8.1
• 8.3 )] Patients taking drugs metabolized by CYP3A such as simvastatin
• lovastatin
• and CYP3A substrates with narrow therapeutic ranges

FDA Warnings

5 WARNINGS AND PRECAUTIONS Adrenal insufficiency : Patients should be closely monitored for signs and symptoms of adrenal insufficiency ( 5
[See Warnings & Precautions ( 5
6 )] To minimize risk, the lowest effective dose should always be used
, immunosuppression in organ transplantation), KORLYM is contraindicated

Known Side Effects

8 documented side effects by frequency

Nausea

>10%

Fatigue

>10%

Vomiting

1-10%

Dizziness

1-10%

Headache

1-10%

High Blood Pressure

1-10%

Weakness

0.1-1%

Decreased Appetite

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral