Active Ingredient: Ipilimumab
Ipilimumab in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 3 milligrams ipilimumab per kilogram of body weight, once every 3 weeks, up to 4 doses in total.
The recommended dose is 3 mg/kg ipilimumab in combination with 1 mg/kg nivolumab administered intravenously every 3 weeks for up to 4 doses. This is then followed by a second phase in which nivolumab monotherapy is administered intravenously at either 240 mg every 2 weeks or at 480 mg every 4 weeks, as presented in Table 1. Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months. For the monotherapy phase, the first dose of nivolumab should be administered:
Table 1. Recommended doses and infusion times for intravenous administration of ipilimumab in combination with nivolumab for HCC:
| Combination phase, every 3 weeks for 4 dosing cycles | Monotherapy phase | |
|---|---|---|
| Nivolumab | 1 mg/kg over 30 minutes | 240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 30 minutes |
| Ipilimumab | 3 mg/kg over 30 minutes | - |
The recommended infusion period is 30 minutes.
Ipilimumab must not be administered as an intravenous push or bolus injection.
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