Active Ingredient: Durvalumab
Durvalumab as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient weight is > 30 kg
Intravenous, 1,500 milligrams durvalumab, once every 4 weeks.
Regimen B, in case that patient weight is ≤ 30 kg
Intravenous, 10 milligrams durvalumab per kilogram of body weight, once every 2 weeks.
Regimen C, in case that patient weight is ≤ 30 kg
Intravenous, 20 milligrams durvalumab per kilogram of body weight, once every 4 weeks.
1,500 mg every 4 weeks.
Patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to durvalumab 10 mg/kg every 2 weeks or 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg.
Until disease progression or until unacceptable toxicity.
Dose escalation or reduction is not recommended. Treatment withholding or discontinuation may be required based on individual safety and tolerability.
It is to be administered as an intravenous infusion solution over 1 hour.
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