Satralizumab

SOURCE CAVEAT: no UK SPC was retrieved in this bundle. Dose is from the US FDA prescribing information for ENSPRYNG (Genentech) section 2.2: 'The recommended loading dosage of ENSPRYNG for the first three administrations is 120 mg by subcutaneous injection at Weeks 0, 2, and 4, followed by a maintenance dosage of 120 mg every 4 weeks.' Verify against the UK SPC before use. Before the first dose (section 2.1) the label requires hepatitis B virus screening, evaluation for active tuberculosis plus testing for latent infection, and measurement of liver transaminases and serum bilirubin; caution is advised if AST or ALT is greater than 1.5 times the upper limit of normal. Give live or live-attenuated vaccines at least 4 weeks, and non-live vaccines wherever possible at least 2 weeks, before initiation. Prior to every use, determine whether there is an active infection and delay dosing until it has resolved. Rotate injection sites, each at least 1 inch (2.5 cm) from the most recent site; do not inject within the 2-inch (5 cm) area around the navel. Delayed or missed doses (section 2.2, Table 1): if the last dose was less than 8 weeks ago during maintenance, or a loading dose was missed, give 120 mg subcutaneously as soon as possible; if 8 weeks to less than 12 weeks, give 120 mg at 0 and 2 weeks then 120 mg every 4 weeks; if 12 weeks or longer, give 120 mg at 0, 2 and 4 weeks then 120 mg every 4 weeks. Monitor ALT and AST every 4 weeks for the first 3 months (section 2.4). Paediatrics: section 8.4 states 'Safety and effectiveness in pediatric patients have not been established' — no paediatric dose is given; verify paediatric use against a children's formulary. Elderly: section 8.5 notes that clinical studies did not include sufficient numbers of patients aged 65 years and older, and advises caution when dosing the elderly.