Active Ingredient: Ipilimumab
Ipilimumab in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥1%.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1 milligrams ipilimumab per kilogram of body weight, once every 6 weeks.
The recommended dose is 1 mg/kg ipilimumab administered intravenously over 30 minutes every 6 weeks in combination with either 3 mg/kg nivolumab every 2 weeks or 360 mg nivolumab every 3 weeks administered intravenously over 30 minutes. Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. It is recommended to continue treatment with ipilimumab in combination with nivolumab for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Liver function tests (LFTs) and thyroid function tests should be evaluated at baseline and before each dose of ipilimumab. In addition, any signs or symptoms of immune-related adverse reactions, including diarrhoea and colitis, must be assessed during treatment with ipilimumab.
The recommended infusion period is 30 minutes.
Ipilimumab must not be administered as an intravenous push or bolus injection.
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