Pasireotide

SCOPE: the fetched SPC is for Signifor 0.3 mg solution for injection — the SUBCUTANEOUS formulation. The long-acting intramuscular formulation (used in acromegaly) has a separate SPC that was NOT in the bundle; do not apply these figures to the intramuscular product. Evaluate patients for clinical benefit two months after starting; those with a significant reduction in urinary free cortisol should continue for as long as benefit is derived, and those who have not responded after two months should be considered for discontinuation. Management of suspected adverse reactions may require temporary dose reduction, suggested in decrements of 0.3 mg twice a day. Missed dose: give the next injection at the scheduled time; do not double doses. Switching from the intramuscular to the subcutaneous formulation: no clinical data are available; if required, maintain an interval of at least 28 days between the last intramuscular injection and the first subcutaneous injection, and start subcutaneous dosing at 0.6 mg twice a day, monitoring response and tolerability. Hepatic impairment: no adjustment in mild impairment (Child-Pugh A); moderate impairment (Child-Pugh B) initial dose 0.3 mg twice a day with a maximum of 0.6 mg twice a day; severe impairment (Child-Pugh C) is contraindicated. Elderly (65 years and over): data limited but no evidence that dose adjustment is required. Paediatric: safety and efficacy in children and adolescents aged 0 to 18 years have not been established; no data available. Administration: do not use the same injection site for two consecutive injections, and avoid sites showing inflammation or irritation. Monitoring: assess fasting plasma glucose/HbA1c before starting; self-monitor blood glucose and/or fasting plasma glucose weekly for the first two to three months and periodically thereafter, plus over the first two to four weeks after any dose increase; monitor liver function before treatment and after 1, 2, 4, 8 and 12 weeks.