Active Ingredient: Nivolumab
Nivolumab as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 240 milligrams nivolumab, once every 2 weeks, over the duration of 16 weeks. Afterwards, intravenous, 480 milligrams nivolumab, once every 4 weeks.
Regimen B: Intravenous, 480 milligrams nivolumab, once every 4 weeks, over the duration of 16 weeks. Afterwards, intravenous, 480 milligrams nivolumab, once every 4 weeks.
240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 30 minutes for the first 16 weeks, followed by 480 mg every 4 weeks over 30 minutes.
If patients need to be switched from the 240 mg every 2 weeks schedule to the 480 mg every 4 weeks schedule, the first 480 mg dose should be administered two weeks after the last 240 mg dose. Conversely, if patients need to be switched from the 480 mg every 4 weeks schedule to the 240 mg every 2 weeks schedule, the first 240 mg dose should be administered four weeks after the last 480 mg dose.
Nivolumab must not be administered as an intravenous push or bolus injection.
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