Osilodrostat Application Scope

Osilodrostat, marketed under the brand name Isturisa, is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

osilodrostat

Osilodrostat Characteristics

Ingredients: Isturisa, a New Hope For Cushing’s Syndrome Treatment is the active ingredient in Isturisa.
Properties: Osilodrostat inhibits 11β-hydroxylase, an enzyme involved in cortisol synthesis, thereby reducing cortisol production.
Specification: Available in tablet form with strengths of 1 mg, 5 mg, and 10 mg.
Packaging Specification: Supplied in blister packs containing 60 tablets.
Storage: Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from moisture.
Expiry Date: Refer to the expiration date printed on the packaging.
Executive Standard: Approved by the FDA for the treatment of Cushing’s disease in adults.
Approval Number: NDA #212801.
Date of Revision: March 2020.
Manufacturer: Recordati Rare Diseases Inc.

Guidelines for the Use of Osilodrostat

Dosage and Administration:

Initial Dose: 2 mg orally twice daily, with or without food.
Dose Titration: Adjust dosage based on cortisol levels, individual tolerability, and improvement in signs and symptoms. Titrate by 1 to 2 mg twice daily, no more frequently than every 2 weeks.
Maximum Dose: 30 mg twice daily.

Adverse Reactions:

Common adverse reactions (≥20%) include adrenal insufficiency, fatigue, nausea, headache, and edema.

Contraindications:

None.

Precautions:

Hypocortisolism: Monitor patients for signs and symptoms; adjust dosage as necessary.
QTc Prolongation: Obtain baseline and periodic electrocardiograms; correct hypokalemia and hypomagnesemia prior to treatment.
Elevations in Adrenal Hormone Precursors and Androgens: May lead to hypokalemia, worsening of hypertension, edema, and hirsutism; monitor and manage appropriately.

Osilodrostat Interactions

Drug Interactions:

CYP3A4 Inhibitors: Concomitant use may increase osilodrostat exposure; reduce Isturisa dosage by half.
CYP3A4 and CYP2B6 Inducers: Concomitant use may decrease osilodrostat exposure; consider increasing Isturisa dosage.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from HongKong DengYue Medicine. It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.