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SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS › PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES › HYPOTHALAMIC HORMONES › Somatostatin and analogues
paltusotine
H01CB06
Forms & Strengths
- Oral capsules: 20 mg
- Oral capsules: 40 mg
- Oral capsules: 60 mg
Adult Dosing
- Acromegaly: Initial dose 40 mg orally once daily
- Titration: Adjust in 20 mg increments based on IGF-1 levels and tolerability
- Maximum dose: 60 mg orally once daily
- Administration: Take on an empty stomach at least 1 hour before or 2 hours after a meal
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
Indications
- Treatment of acromegaly in adult patients who have had an inadequate response to surgery and/or radiation, or for whom surgery and/or radiation is not an option
Mechanism of Action
- Selective, non-peptide somatostatin receptor type 2 (SSTR2) agonist
- Binds to SSTR2 on anterior pituitary cells, inhibiting growth hormone (GH) secretion
- Reduces circulating levels of GH and insulin-like growth factor 1 (IGF-1)
Contraindications
- Hypersensitivity to paltusotine or any of its excipients
Adverse Reactions
- Headache
- Arthralgia
- Fatigue
- Nausea
- Diarrhea
- Abdominal pain
- Peripheral edema
- Sinus bradycardia
- Cholelithiasis
Drug Interactions
- CYP3A4 inducers: May decrease paltusotine exposure; avoid coadministration or monitor efficacy closely
- CYP3A4 inhibitors: May increase paltusotine exposure
- Drugs that prolong the QT interval: Coadministration may increase the risk of ventricular arrhythmias
- Bradycardia-inducing drugs: May potentiate the risk of symptomatic bradycardia
Curated Content: Needs Vetting Before Put to Clinical Use