Active Ingredient: Nivolumab
Nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥5.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 360 milligrams nivolumab, once every 3 weeks.
Regimen B: Intravenous, 240 milligrams nivolumab, once every 2 weeks.
The recommended dose is 360 mg nivolumab administered intravenously over 30 minutes in combination with fluoropyrimidine- and platinum-based chemotherapy administered every 3 weeks or 240 mg nivolumab administered intravenously over 30 minutes in combination with fluoropyrimidineand platinum-based chemotherapy administered every 2 weeks. Treatment with nivolumab is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
Nivolumab must not be administered as an intravenous push or bolus injection.
Intravenous infusion over a period of 30 minutes.
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