Ocrelizumab

eMC §4.2 (OCREVUS 300 mg concentrate for solution for infusion). Treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions with access to appropriate medical support for severe reactions such as serious infusion-related reactions (IRRs). MANDATORY PREMEDICATION before EVERY infusion: 100 mg intravenous methylprednisolone (or equivalent) approximately 30 minutes before, plus an antihistamine approximately 30-60 minutes before; an antipyretic (e.g. paracetamol) approximately 30-60 minutes before may also be considered. INFUSION RATES (eMC §4.2 Table 1): each 300 mg infusion is given in 250 mL - start at 30 mL/hour for 30 minutes, increase in 30 mL/hour increments every 30 minutes to a maximum of 180 mL/hour, over approximately 2.5 hours. Subsequent 600 mg doses are given in 500 mL by either Option 1 (approximately 3.5 hours - start at 40 mL/hour for 30 minutes, increase in 40 mL/hour increments every 30 minutes to a maximum of 200 mL/hour) or, if the patient has had no serious IRR with any previous infusion, Option 2 (approximately 2 hours - start at 100 mL/hour for the first 15 minutes, then increase; the remainder of the Option 2 rate schedule was truncated in the fetched SPC text and must be read from the full SPC). The US label gives Option 2 as 100 mL/hour for 15 minutes, then 200 mL/hour for 15 minutes, then 250 mL/hour for 30 minutes, then 300 mL/hour for the remaining 60 minutes. IRR MANAGEMENT: life-threatening or disabling IRR (e.g. acute hypersensitivity, acute respiratory distress syndrome) - stop the infusion immediately, treat, and permanently discontinue. Severe IRR (e.g. dyspnoea, or a complex of flushing, fever and throat pain) - interrupt immediately and treat symptomatically; restart only after all symptoms have resolved, at half the infusion rate at the time of onset. Mild to moderate IRR (e.g. headache) - reduce the infusion rate to half the rate at onset and maintain for at least 30 minutes, then increase if tolerated. These adjustments change the infusion rate and total duration but NOT the total dose; no dose reductions are recommended. Patients should be observed for at least one hour after completion of the infusion, and warned that an IRR can occur within 24 hours. Withholding antihypertensive treatment for 12 hours prior to and throughout each infusion should be considered because hypotension may occur as a symptom of IRR (eMC §4.4). MISSED DOSE: administer as soon as possible - do not wait until the next planned dose; then maintain the 6-month (minimum 5-month) interval. ADULTS OVER 55 YEARS: no posology adjustment needed based on the limited data available. HEPATIC IMPAIRMENT: not formally studied; patients with mild hepatic impairment were included in trials, no experience in moderate or severe impairment; as a monoclonal antibody cleared by catabolism rather than hepatic metabolism, dose adjustment is not expected to be required. PAEDIATRIC (eMC): safety and efficacy in children and adolescents aged 0 to 18 years has not yet been established and no data are available. US LABELLING DIFFERENCE (openFDA, OCREVUS, Genentech, label date 2026-05-14): the US label DOES include paediatric dosing for relapsing-remitting MS in patients 10 years and older by weight band - 35 kg or more: 300 mg then a second 300 mg two weeks later, then 600 mg every 6 months (same as adults); 25 kg to less than 35 kg: 150 mg then a second 150 mg two weeks later, then 300 mg every 6 months. US premedication for paediatric patients weighing less than 40 kg is methylprednisolone 2 mg/kg (100 mg for 40 kg or more). These weight-band doses are NOT in the UK SPC text fetched here - clinician to confirm local licensing and verify any under-18 use against a children's formulary. The US label also requires hepatitis B screening, quantitative serum immunoglobulins and liver function tests before the first dose.