Loading…
Palsonify is a brand name for Paltusotine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Palsonify is indicated for the medical treatment of adult patients with acromegaly.
Verbatim from this product's EMA label. Tap a section to expand.
Posology For medically naïve patients, the recommended initial dose is 20 mg Palsonify 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 Palsonify 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.
3 For non-medically naïve patients, the recommended initial dose is 40 mg Palsonify by oral route once a day. After 2 to 4 weeks on Palsonify 40 mg once daily, based on IGF-1 levels or clinical signs and symptoms, the dose can be increased to 60 mg once daily.
8), 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. g. 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.
Missed dose If the daily dose of Palsonify is missed, the patient should be told not to take the missed dose and continue with the next scheduled dose. g. 5). g. g. 5). g. 5). 2). 2). 2). Paediatric population The safety and efficacy of Palsonify in children aged below 18 years have not been established.
No data are available. Method of administration Oral use. g. after overnight fast), and at least 1 hour prior to a meal. 4
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.
g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable. Women of childbearing potential The therapeutic benefits of a reduction in GH levels and normalisation of IGF-1 concentration in female acromegalic patients could potentially restore fertility.
6). 8). These ECG changes may occur in patients with acromegaly. g. 5). Gallbladder-related events Palsonify may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder stones or sludge. 8). If complications of cholelithiasis are suspected, evaluation and appropriate treatment should be initiated, and benefit-risk should be considered in determining whether or not to continue treatment with paltusotine.
Glucose metabolism Because of its effect on GH, glucagon, and insulin, paltusotine may affect glucose regulation. 8). 5). Thyroid function abnormalities Somatostatin analogues may suppress the secretion of thyroid-stimulating hormone (TSH), which may result in hypothyroidism.
5). Nutrition Somatostatin analogues may alter absorption of dietary fats in some patients. Vitamin B12 deficiency Decreased vitamin B12 levels have been observed in patients treated with somatostatin analogues. Vitamin B12 levels during treatment with Palsonify should be monitored if clinically indicated.
5
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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.