Active Ingredient: Osilodrostat
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 2 milligrams osilodrostat, 2 times daily, over the duration of 1 to 2 weeks. Afterwards, oral, between 2 milligrams osilodrostat and 7 milligrams osilodrostat, 2 times daily. The maximum allowed total dose is 30 milligrams osilodrostat daily.
The recommended starting dose is 2 mg osilodrostat twice daily. For patients of Asian ancestry, a reduced starting dose of 1 mg twice daily is recommended.
The dose can be gradually titrated (initially by dose increments of 1 or 2 mg) based on individual response and tolerability, with the aim to achieve normal cortisol levels. It is recommended that cortisol levels (e.g. 24-hour urinary free cortisol, serum/plasma cortisol) be monitored every 1-2 weeks until adequate clinical response is maintained. Thereafter, less frequent monitoring may be considered as clinically indicated, unless there are reasons for additional monitoring. Increases in dose should not occur more frequently than once every 1-2 weeks and should be guided by the results of cortisol assessments and by the individual clinical response.
The dose of osilodrostat should be decreased or treatment temporarily interrupted if cortisol levels are below the lower limit of normal, or if there is a rapid decrease in cortisol levels to the lower part of the normal range, or if the patient has signs or symptoms suggestive of hypocortisolism. Osilodrostat may be resumed after resolution of symptoms at a lower dose, provided that cortisol levels are above the lower limit of normal in the absence of glucocorticoid substitution. Management of other suspected adverse reactions at any time during treatment may also require a temporary dose reduction or temporary interruption of treatment.
The usual maintenance dose in clinical studies varied between 2 and 7 mg twice daily.
The maximum recommended dose of osilodrostat is 30 mg twice daily.
If a dose is missed, the patient should take the prescribed dose at the next scheduled time; the next dose should not be doubled.
There is no evidence to suggest that dose adjustment is required in patients aged 65 years or above. However, data on the use of osilodrostat in this population are limited and osilodrostat should therefore be used with caution in this age group.
It can be taken with or without food.
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