Active Ingredient: Tremelimumab
It is indicated in combination with durvalumab 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 ≥ 40 kg, intravenous, 300 milligrams tremelimumab, one dose.
Regimen B: In case that patient weight is ≤ 40 kg, intravenous, 4 milligrams tremelimumab per kilogram of body weight, one dose.
The recommended dose of tremelimumab is presented in the table below. Tremelimumab is administered as an intravenous infusion over 1 hour.
Recommended dose of tremelimumab:
| Indication | Recommended tremelimumab dosage | Duration of Therapy |
|---|---|---|
| Advanced or unresectable HCC | Tremelimumab 300 mga as a single dose administered in combination with durvalumab 1500 mga at Cycle 1/Day 1, followed by durvalumab monotherapy every 4 weeks | Until disease progression or unacceptable toxicity |
a For tremelimumab, HCC patients with a body weight of 40 kg or less must receive weight-based dosing, equivalent to tremelimumab 4 mg/kg until weight is greater than 40 kg. For durvalumab, 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.
Dose escalation or reduction is not recommended during treatment with tremelimumab in combination with durvalumab. Treatment withholding or discontinuation may be required based on individual safety and tolerability.
For suspected immune-mediated adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude alternate aetiologies.
Administer tremelimumab prior to durvalumab on the same day.
Tremelimumab and durvalumab are administered as separate intravenous infusions.
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