Summary of the safety profile Gastrointestinal symptoms of diarrhoea (18%), abdominal pain (7%), nausea (5%) and abdominal discomfort (3%) were the most frequently reported adverse reactions with paltusotine. Tabulated list of adverse reactions The safety of paltusotine was evaluated in 169 adults with acromegaly in two randomised, double- blind, placebo-controlled studies.
A total of 233 patients were exposed to paltusotine in all phase 2 and 3 and open label extension (OLE) acromegaly studies. 3 weeks). Adverse reactions are listed by MedDRA system organ class (SOC) and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
Adverse reactions System organ class Adverse reaction Frequency Metabolism and nutrition disorders Hyperglycaemia Common Decreased appetite Common Nervous system disorders Headache Common Dizziness Uncommon Cardiac disorders Sinus bradycardiaa Common Gastrointestinal disorders Diarrhoea Very common Abdominal pain Common Nausea Common Abdominal discomfort Common Abdominal distension Common Vomiting Common Hepatobiliary disorders Cholelithiasis Common Bile duct stone Uncommon Skin and subcutaneous tissue disorders Alopecia Common General disorders and administration site conditions Fatigue Common a Sinus bradycardia includes preferred terms: sinus bradycardia and bradycardia.
Description of selected adverse reactions Bradycardia Events of bradycardia occurred in 6% of patients treated with paltusotine, were asymptomatic and did not lead to the discontinuation of the medicinal product. The events occurred in patients with and without a history of bradycardia, occurred in the first three months of treatment and there was no clear dose association.
4). 8 Gallbladder-related adverse reactions In randomised studies, cholelithiasis occurred between 6 and 9 months after the start of paltusotine. 4%. 3% (2/24) of patients. 4). Gastrointestinal disorders Most gastrointestinal adverse reactions occurred within the first two months of paltusotine initiation, all were non serious and had a median duration ranging between 4 to 12 days.
The majority of the adverse reaction were mild, none were severe and improved with continued treatment. There were no discontinuations due to gastrointestinal adverse reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.