Active Ingredient: Durvalumab
Durvalumab in combination with tremelimumab 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, 20 milligrams durvalumab per kilogram of body weight, once every 4 weeks.
Durvalumab 1,500 mg administered in combination with 300 mg tremelimumab as a single dose at Cycle 1/Day 1, followed by durvalumab as monotherapy every 4 weeks.
HCC patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to durvalumab 20 mg/kg until weight is greater than 30 kg. Patients with a body weight of 40 kg or less must receive weightbased dosing, equivalent to tremelimumab 4 mg/kg until weight is greater than 40 kg.
Until disease progression or unacceptable toxicity.
Dose escalation or reduction is not recommended. Treatment withholding or discontinuation may be required based on individual safety and tolerability.
For uHCC, when durvalumab is administered in combination with tremelimumab, administer tremelimumab prior to durvalumab on the same day. Durvalumab and tremelimumab are administered as separate intravenous infusions. Refer to the SmPC for tremelimumab dosing information.
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