Serplulimab (Specialist drug)

Product: UK SPC via MHRA Products - HETRONIFLY 10MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION (PL200751559), Accord Healthcare Limited. SPC §2: 'Each ml of concentrate for solution for infusion contains 10 mg of serplulimab. One vial of 10 ml of concentrate contains 100 mg of serplulimab.' SPC §4.1 (first-line, adults): ES-SCLC with carboplatin and etoposide; non-squamous NSCLC (no EGFR, ALK or ROS1 positive mutations; locally advanced not candidates for surgery or radiotherapy, or metastatic) with carboplatin and pemetrexed; squamous NSCLC (unresectable, locally advanced or metastatic) with carboplatin and nab-paclitaxel; OSCC (unresectable, locally advanced, recurrent or metastatic, tumours expressing PD-L1 with a CPS >= 5) with fluoropyrimidine and platinum-based chemotherapy. The page names no tumour type beyond its pearl (ES-SCLC), so all licensed indications are recorded. SPC §4.2 (verbatim): 'Treatment must be initiated and supervised by a physician experienced in the treatment of cancer.' SCLC: 'The recommended dose in both the induction and maintenance phases is 4.5 mg/kg bodyweight serplulimab every 3 weeks until disease progression or unacceptable toxicity. During the induction phase (4 cycles), carboplatin is administered on day 1, and etoposide on days 1, 2 and 3 of each 3-week cycle.' Non-squamous NSCLC: same 4.5 mg/kg every 3 weeks; 'During the induction phase (4 cycles), carboplatin and pemetrexed are administered on day 1 of each 3-week cycle. During the maintenance phase, the administration of pemetrexed is continued at the discretion of the physician.' Squamous NSCLC: same 4.5 mg/kg every 3 weeks; 'During the induction phase (4 - 6 cycles), carboplatin is administered on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 3-week cycle.' OSCC: 'The recommended dose in both the induction and maintenance phases is 3.0 mg/kg bodyweight serplulimab every 2 weeks until disease progression or unacceptable toxicity. During the induction phase, cisplatin is administered on day 1 of each 2-week cycle for up to 8 cycles, and 5-fluorouracil on day 1 of each 2-week cycle for up to 12 cycles.' For use in combination, see the SmPC for the concomitant therapies. DOSE MODIFICATION: 'Dose escalation or reduction of HETRONIFLY is not recommended. Dose withholding or discontinuation may be required based on individual safety and tolerability. Dose withholding for up to 12 weeks for tolerability is acceptable.' Grade-based withhold / permanently-discontinue rules for immune-mediated adverse reactions are in SPC §4.2 Table 1 (not reproduced here); infusion-related reactions: Grade 2 - reduce infusion rate to half rate or interrupt, treatment may be resumed when resolved; Grade 3 or 4 - permanently discontinue. ADMINISTRATION (§4.2): 'The initial infusion rate should be set up to 100 ml per hour. If the first infusion is well tolerated, all subsequent infusions may be shortened to 30 minutes (± 10 minutes). When administered in combination with chemotherapy, HETRONIFLY should be given first followed by chemotherapy on the same day. Use separate infusion bags for each infusion. HETRONIFLY must not be administered as an intravenous push or bolus injection. The total dose of HETRONIFLY required should be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection (see section 6.6).' The dilution volume / final concentration is in §6.6, which was NOT retrieved and is not stated here. PD-L1 testing: where specified in the indication (OSCC), by a CE-marked IVD or a validated test. Elderly: 'No dose adjustment is needed for elderly patients (≥ 65 years)'. Paediatric: 'There is no relevant use of serplulimab in the paediatric population.' The SPC prints no maximum dose. Some sections of the product information we used were incomplete — check the full SPC.