Evolocumab

Product REPATHA (US labelling). Adults at increased risk for CV events or with hypercholesterolaemia: 140 mg every 2 weeks OR 420 mg once monthly. Adults and paediatric patients aged 10 years and older with HeFH: same regimen (140 mg every 2 weeks OR 420 mg once monthly) — flat dose, not per kg. Adults and paediatric patients aged 10 years and older with HoFH: initial 420 mg once monthly, may be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks; patients on lipid apheresis may initiate 420 mg every 2 weeks to correspond with their apheresis schedule, given after the apheresis session is complete. If switching dosage regimens, give the first dose of the new regimen on the next scheduled date of the prior regimen. The 420 mg dose is administered either over 5 minutes using the single-dose on-body infusor with prefilled cartridge, or as 3 injections given consecutively within 30 minutes using the prefilled single-dose autoinjector or syringe. Missed dose: within 7 days, administer and resume the original schedule; more than 7 days after a missed every-2-week dose, wait until the next scheduled dose; more than 7 days after a missed once-monthly dose, administer and start a new schedule from that date. Assess LDL-C when clinically appropriate — the LDL-lowering effect may be measured as early as 4 weeks after initiation; for the 420 mg monthly regimen measure LDL-C just prior to the next scheduled dose. Safety and effectiveness are not established in paediatric patients with HeFH or HoFH younger than 10 years old, or in paediatric patients with other types of hyperlipidaemia — verify paediatric use against a children's formulary. Prefilled autoinjector/syringe presentations may contain dry natural rubber (latex derivative) in the needle cover; consider a latex-free presentation for latex-sensitive individuals. Allow to reach room temperature before use (at least 30 minutes for autoinjector/syringe, at least 45 minutes for the on-body infusor).