Ublituximab

Infusion rates (exact, per Table 1): First infusion 150 mg (6 mL) in 250 mL — start at 10 mL per hour for the first 30 minutes, increase to 20 mL per hour for the next 30 minutes, increase to 35 mL per hour for the next hour, then increase to 100 mL per hour for the remaining 2 hours; total duration 4 hours. Second infusion and all subsequent infusions 450 mg (18 mL) in 250 mL — start at 100 mL per hour for the first 30 minutes, then increase to 400 mL per hour for the remaining 30 minutes; total duration 1 hour. Infusion duration may take longer if the infusion is interrupted or slowed. Premedication before every infusion: 100 mg of methylprednisolone intravenously (or an equivalent oral dosage or equivalent corticosteroid) approximately 30 minutes before each infusion, plus an antihistamine (e.g. diphenhydramine) orally or intravenously approximately 30–60 minutes before each infusion; an antipyretic (e.g. paracetamol/acetaminophen) may also be considered. Before the first dose: screen for hepatitis B virus, test quantitative serum immunoglobulins, and obtain serum aminotransferases (ALT and AST), alkaline phosphatase and bilirubin. Administer all immunizations according to guidelines at least 4 weeks before initiation for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiation for non-live vaccines. Before every infusion determine whether there is an active infection and delay the infusion until it resolves. Observe the patient for at least one hour after completion of the first two infusions; post-infusion monitoring of subsequent infusions is at physician discretion unless an infusion reaction and/or hypersensitivity has been observed. Missed dose: administer as soon as possible, do not wait until the next scheduled infusion, and reset the schedule so the next sequential infusion is 24 weeks after the missed infusion is given. Life-threatening infusion reactions: immediately stop the infusion and permanently discontinue. Paediatric use: safety and effectiveness in paediatric patients have not been established. Source note: no UK SPC posology was available in the fetched bundle — this draft is from US labelling and must be verified against the UK SPC.