Active Ingredient: Nivolumab
Nivolumab in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.
Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 1 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, 1 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 1 mg/kg nivolumab in combination with 3 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 Table 2. 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 melanoma:
| 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 60 minutes |
| Ipilimumab | 3 mg/kg over 30 minutes | - |
Nivolumab must not be administered as an intravenous push or bolus injection.
For:
Regimen A: In case that patient weight is ≥ 50 kg, intravenous, 1 milligrams nivolumab per kilogram of body weight, once every 3 weeks, 4 doses in total, over the duration of 15 weeks. Afterwards, in case that patient weight is ≥ 50 kg, intravenous, 240 milligrams nivolumab, once every 2 weeks.
Regimen B: In case that patient weight is ≥ 50 kg, intravenous, 1 milligrams nivolumab per kilogram of body weight, once every 3 weeks, 4 doses in total, over the duration of 18 weeks. Afterwards, in case that patient weight is ≥ 50 kg, intravenous, 480 milligrams nivolumab, once every 4 weeks.
Regimen C: In case that patient weight is ≤ 50 kg, intravenous, 1 milligrams nivolumab per kilogram of body weight, once every 3 weeks, 4 doses in total, over the duration of 15 weeks. Afterwards, in case that patient weight is ≤ 50 kg, intravenous, 3 milligrams nivolumab per kilogram of body weight, once every 2 weeks.
Regimen D: In case that patient weight is ≤ 50 kg, intravenous, 1 milligrams nivolumab per kilogram of body weight, once every 3 weeks, 4 doses in total, over the duration of 18 weeks. Afterwards, in case that patient weight is ≤ 50 kg, intravenous, 6 milligrams nivolumab per kilogram of body weight, once every 4 weeks.
In adolescents 12 years of age and older and weighing at least 50 kg, the recommended dose is 1 mg/kg nivolumab in combination with 3 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:
In adolescents 12 years of age and older and weighing less than 50 kg, the recommended dose is 1 mg/kg nivolumab in combination with 3 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 3 mg/kg every 2 weeks or 6 mg/kg 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 melanoma:
| Combination phase, every 3 weeks for 4 dosing cycles | Monotherapy phase | |
|---|---|---|
| Nivolumab | Adolescents 12 years of age and older: 1 mg/kg over 30 minutes | Adolescents (12 years of age and older and weighing at least 50 kg): 240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 60 minutes Adolescents (12 years of age and older and weighing less than 50 kg): 3 mg/kg every 2 weeks over 30 minutes or 6 mg/kg every 4 weeks over 60 minutes |
| Ipilimumab | Adolescents 12 years of age and older: 3 mg/kg over 30 minutes | - |
Nivolumab must not be administered as an intravenous push or bolus injection.
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