Active Ingredient: Paltusotine
Paltusotine is indicated for the medical treatment of adult patients with acromegaly.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A :
Oral, 20 milligrams paltusotine, once daily, over the duration of 2 weeks. Afterwards, oral, 40 milligrams paltusotine, once daily, over the duration of 2 to 4 weeks. Afterwards, oral, between 40 milligrams paltusotine and 60 milligrams paltusotine, once daily.
Regimen B :
Oral, 40 milligrams paltusotine, once daily, over the duration of 2 to 4 weeks. Afterwards, oral, between 40 milligrams paltusotine and 60 milligrams paltusotine, once daily.
For medically naïve patients, the recommended initial dose is 20 mg paltusotine by oral route once daily for 2 weeks and if well tolerated, the dose should be increased to 40 mg once daily. After 2 to 4 weeks on paltusotine 40 mg once daily, if 40 mg is well tolerated, the dose can be increased to 60 mg based on insulin-like growth factor-1 (IGF-1) levels or clinical signs and symptoms.
For non-medically naïve patients, the recommended initial dose is 40 mg paltusotine by oral route once a day. After 2 to 4 weeks on paltusotine 40 mg once daily, based on IGF-1 levels or clinical signs and symptoms, the dose can be increased to 60 mg once daily.
Based on tolerability, the dose may be temporarily reduced by 20 mg. Once adverse reactions have resolved, paltusotine can be resumed at the previous dose.
Monitoring of IGF-1 levels and assessment of symptoms should be made periodically as per the clinician's discretion. Normalisation of IGF-1 levels may require a longer treatment duration in patients with high IGF-1 levels at baseline. In patients with elevated baseline IGF-1 levels (e.g. ≥2.5×upper limit of normal [ULN]), especially in medically naïve patients, a more regular re-evaluation of the benefit risk of the treatment in monotherapy should be considered.
If the daily dose of paltusotine is missed, the patient should be told not to take the missed dose and continue with the next scheduled dose.
Paltusotine should be taken on an empty stomach, at least 6 hours after a meal (e.g. after overnight fast), and at least 1 hour prior to a meal.
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