Active Ingredient: Ipilimumab
Ipilimumab in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) unresectable or metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1 milligrams ipilimumab per kilogram of body weight, once every 3 weeks, 4 doses in total.
The recommended dose in patients who received prior fluoropyrimidine-based combination chemotherapy for dMMR or MSI-H CRC is 1 mg/kg ipilimumab in combination with 3 mg/kg nivolumab administered intravenously every 3 weeks for the first 4 doses, followed by nivolumab monotherapy administered intravenously 240 mg every 2 weeks, as presented in Table 1. For the monotherapy phase, the first dose of nivolumab should be administered 3 weeks after the last dose of the combination of ipilimumab and nivolumab.
| Combination phase, every 3 weeks for 4 dosing cycles | Monotherapy phase | ||
|---|---|---|---|
| Nivolumab | After prior fluoropyrimidine-based combination chemotherapy | 3 mg/kg over 30 minutes | 240 mg every 2 weeks over 30 minutes |
| Ipilimumab | 1 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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