Lanreotide

SPC source: Lanreotide ADVANZ PHARMA 120 mg solution for injection in pre-filled syringe. Acromegaly titration: individualise to response (reduction in symptoms and/or in GH and/or IGF-1). If clinical symptoms and biochemical parameters are not adequately controlled, the dose may be increased to a maximum of 120 mg at 28-day intervals. If complete control is obtained (GH under 1 ng/ml, normalised IGF-1 levels and/or disappearance of symptoms) the dose may be decreased. Patients well controlled on a somatostatin analogue may alternatively be treated with 120 mg every 42-56 days (6 to 8 weeks). Conversion from lanreotide 30 mg: if previously dosed every 14 days start 60 mg every 28 days; if previously dosed every 10 days start 90 mg every 28 days. Long-term monitoring of symptoms, GH and IGF-1 should be routinely carried out in all patients. OTHER INDICATIONS - Grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumours of midgut, pancreatic or unknown origin (hindgut origin excluded) in adults with unresectable locally advanced or metastatic disease: 120 mg every 28 days, continued for as long as needed for tumour control. Symptoms associated with neuroendocrine tumours: starting dose 60 to 120 mg every 28 days, adjusted according to the degree of symptomatic relief obtained. Paediatric population: not recommended for use in children and adolescents due to lack of data on safety and efficacy. US labelling differs and should be reconciled by the reviewing clinician: acromegaly starting dosage 90 mg every 4 weeks for 3 months then adjusted; GEP-NETs and carcinoid syndrome 120 mg every 4 weeks; starting dosage 60 mg every 4 weeks for 3 months in acromegalic patients with moderate or severe renal impairment (CLcr less than 60 mL/min) or moderate or severe hepatic impairment (Child-Pugh B or C).