PALSONIFY Film-coated tablet Ref.[116079] Active ingredients: Paltusotine

2.1 Important Administration Instructions

• Take PALSONIFY orally once daily with water on an empty stomach, at least 6 hours after a meal (e.g., after overnight fasting) and at least 1 hour before the next meal [see Clinical Pharmacology (12.3)].

2.2 Recommended Dosage, Titration, and Monitoring

• The recommended initial dosage of PALSONIFY is 40 mg once daily.
• During initiation period, PALSONIFY may be temporarily reduced to 20 mg once daily if needed, based on tolerability [see Adverse Reactions (6.1)]. Once adverse reactions have resolved, resume PALSONIFY 40 mg once daily.
• After 2 to 4 weeks on PALSONIFY 40 mg once daily, based on IGF-1 levels, titrate to a PALSONIFY dosage of 60 mg once daily.

2.3 Dosage Modifications for Drug Interactions

Concomitant Use with Strong CYP3A4 Inducers

Patients taking strong CYP3A4 inducers may require an increased dosage of PALSONIFY. Do not exceed three-fold the PALSONIFY dosage prior to concomitant use or 120 mg daily, whichever is less [see Drug Interactions (7.1)].

Concomitant Use with Moderate CYP3A4 Inducers

Patients taking moderate CYP3A4 inducers may require an increased dosage of PALSONIFY. Do not exceed two-fold the PALSONIFY dosage prior to concomitant use or 120 mg daily, whichever is less [see Drug Interactions (7.1)].

Concomitant Use with Proton Pump Inhibitors

Patients taking proton pump inhibitors may require an increased dosage of PALSONIFY. Avoid concomitant use of proton pump inhibitors in patients who are already on PALSONIFY 60 mg [see Drug Interactions (7.1)].

Overdose with somatostatin analogs may result in hyperglycemia or hypoglycemia, bradycardia, arrhythmia, diarrhea, vomiting, and other gastrointestinal symptoms. If overdose is suspected, initiate supportive treatment as dictated by patient's clinical status.

• PALSONIFY tablets are packaged in a child-resistant container; keep out of reach of children.
• Store tablets at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Excursions permitted 15°C to 30°C (59°F to 86°F).
• Store and dispense in original container or USP equivalent tight container.