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Osilodrostat Dosage

Medically reviewed by Drugs.com. Last updated on May 7, 2020.

Applies to the following strengths: 1 mg; 5 mg; 10 mg

Usual Adult Dose for Cushing's Syndrome

INITIAL DOSE: 2 mg orally 2 times a day
TITRATION: Initially, titrate the dose by 1 to 2 mg 2 times a day, no more frequently than every 2 weeks based on the rate of cortisol changes, individual tolerability and patient improvement. If a patient tolerates 10 mg 2 times a day and continues to have elevated 24-hour urine free cortisol (UFC) levels above upper normal limit, the dose can be titrated further by 5 mg 2 times a day every 2 weeks. Monitor cortisol levels from at least two 24-hour urine free cortisol collections every 1 to 2 weeks until adequate response is maintained.
MAINTENANCE DOSE: Should be individualized and determined by titration based on cortisol levels and patient's symptoms. Maintenance dose varies between 2 and 7 mg 2 times a day.
Maximum maintenance dose: 30 mg orally 2 times a day; when maintenance dose is achieved, monitor cortisol levels at least every 1 to 2 months or as indicated.

Use: For the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative

Renal Dose Adjustments

No adjustment recommended. In patients with moderate to severe renal impairment urine free cortisol (UFC) levels should be interpreted with caution due to reduced UFC excretion.

Liver Dose Adjustments

More frequent monitoring of adrenal function may be required during dose titration in all patients with hepatic impairment:
-Mild (Child-Pugh A) hepatic impairment: No adjustment recommended.
-Moderate (Child-Pugh B) hepatic impairment: Starting dose is 1 ng orally 2 times a day
-Severe (Child-Pugh C) hepatic impairment: Starting dose is 1 mg orally once a day in the evening.

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Correct hypokalemia and hypomagnesemia prior to starting therapy with this drug.
-Obtain baseline electrocardiogram (ECG); repeat ECG within one week after therapy initiation, and as clinically indicated thereafter.
-This drug may be taken with or without food.
-If a dose is missed, it should be taken at the regularly scheduled time.

Storage requirements:
-Store at room temperature between 68F to 77F (20C to 25C); excursions permitted 15C to 30C (59F to 86F); protect from moisture.

Patient advice:
-Read the approved patient labeling (Patient Information).
-It is important that you keep your appointments for laboratory monitoring.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.