Active Ingredient: Serplulimab
Serplulimab in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥5.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 3 milligrams serplulimab per kilogram of body weight, once every 2 weeks.
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 Summary of Product Characteristics (SmPC) for the concomitant therapies.
Dose escalation or reduction of serplulimab 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.
No dose adjustment is needed for elderly patients (≥65 years).
When administered in combination with chemotherapy, serplulimab should be given first followed by chemotherapy on the same day. Use separate infusion bags for each infusion.
Serplulimab must not be administered as an intravenous push or bolus injection.
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