Active Ingredient: Nivolumab
Nivolumab in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 3 milligrams nivolumab per kilogram of body weight, once every 3 weeks, 4 doses in total, over the duration of 15 weeks. Afterwards, intravenous, 240 milligrams nivolumab, once every 2 weeks.
Regimen B: Intravenous, 3 milligrams nivolumab per kilogram of body weight, once every 3 weeks, 4 doses in total, over the duration of 18 weeks. Afterwards, intravenous, 480 milligrams nivolumab, once every 4 weeks.
The recommended dose is 3 mg/kg nivolumab in combination with 1 mg/kg ipilimumab administered intravenously every 3 weeks for the first 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 the table below. For the monotherapy phase, the first dose of nivolumab should be administered;
Recommended doses and infusion times for intravenous administration of nivolumab in combination with ipilimumab for RCC:
| Combination phase, every 3 weeks for 4 dosing cycles | Monotherapy phase | |
|---|---|---|
| Nivolumab | 3 mg/kg over 30 minutes | 240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 60 minutes |
| Ipilimumab | 1 mg/kg over 30 minutes | - |
Nivolumab must not be administered as an intravenous push or bolus injection.
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