Active Ingredient: Pasireotide
Treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
10 - 10 mg
From 10 To 10 mg once every 28 day(s)
The recommended initial dose for the treatment of Cushing’s disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks. The patient should be evaluated for clinical benefit after the first month of treatment and periodically thereafter. The dose may be titrated every 2 to 4 months based on response and tolerability. The maximum dose of pasireotide in Cushing’s disease is 40 mg every 4 weeks. If no clinical benefit is observed, the patient should be considered for discontinuation.
Management of suspected adverse reactions or over-response to treatment (cortisol levels < lower limit of normal) may require dose reduction, interruption or discontinuation of pasireotide.
There are no clinical data available on switching from the subcutaneous to the intramuscular pasireotide formulation. If such a switch should be required, the recommended initial dose for the treatment of Cushing’s disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks. The patient should be monitored for response and tolerability and further dose adjustments may be needed.
If a dose of pasireotide is missed the missed injection should be administered as soon as possible. The next dose should then be planned for 4 weeks after the injection is administered in order to resume the normal schedule of one dose every 4 weeks.
The site of repeat intramuscular injections should be alternated between the left and right gluteal muscle.
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