Obinutuzumab

Other indications from the same label: Follicular lymphoma — each dose is 1,000 mg; for relapsed/refractory FL give with bendamustine over six 28-day cycles, and patients achieving stable disease, complete response or partial response continue GAZYVA 1,000 mg monotherapy for up to two years; for previously untreated FL give with bendamustine (six 28-day cycles), or with CHOP (six 21-day cycles followed by 2 additional 21-day cycles of obinutuzumab alone), or with CVP (eight 21-day cycles), with monotherapy continuation for up to two years in responders. Active lupus nephritis — 1,000 mg at the initial infusion, at Week 2, Week 24, Week 26 and every 6 months thereafter. Infusion rates (CLL): Day 1 at 25 mg/hr over 4 hours, do not increase the rate; Day 2 at 50 mg/hr (25 mg/hr if an infusion-related reaction occurred previously), escalating in increments of up to 50 mg/hr every 30 minutes to a maximum of 400 mg/hr; Days 8 and 15 and subsequent cycles may start at 100 mg/hr and increase by 100 mg/hr every 30 minutes to a maximum of 400 mg/hr if no IRR occurred and the final rate was 100 mg/hr or faster. Infusion rates (FL): Cycle 1 Day 1 at 50 mg/hr escalating in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr; from Cycle 2 onwards a shorter approximately 90-minute infusion (100 mg/hr for 30 minutes then 900 mg/hr for approximately 60 minutes) may be considered in patients who did not experience a Grade 3 or higher IRR in Cycle 1, with continued premedication. Premedicate before each infusion; provide prophylactic hydration and anti-hyperuricaemics to patients at high risk of tumour lysis syndrome. Monitor blood counts at regular intervals. Should only be administered by a healthcare professional with medical support to manage severe infusion-related reactions, which can be fatal. Missed dose: administer as soon as possible and adjust the schedule to maintain the interval between doses; if appropriate, patients who do not complete the Day 1 Cycle 1 dose may proceed to the Day 2 Cycle 1 dose. §5 Warnings also advises avoiding administration of live virus vaccines during treatment (text truncated in the source). No dedicated drug-interactions section was captured in the fetched label — verify against UK SPC §4.5. Paediatric use: the US label states safety and effectiveness in paediatric patients have not been established — no paediatric dose is given; verify any paediatric use against a children's formulary and specialist protocol. No UK SPC (eMC) record was present in the source bundle — this dose is from US prescribing information and must be verified against UK labelling.