Active Ingredient: Nivolumab
Nivolumab as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
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.
Nivolumab as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
240 - 240 mg
From 240 To 240 mg once every 14 day(s)
240 mg
As monotherapy: 240 mg every 2 weeks.
If melanoma patients need to be switched from the 240 mg every 2 weeks schedule to the 480 mg every 4 weeks schedule, the first 480 mg dose should be administered two weeks after the last 240 mg dose. Conversely, if patients need to be switched from the 480 mg every 4 weeks schedule to the 240 mg every 2 weeks schedule, the first 240 mg dose should be administered four weeks after the last 480 mg dose.
Infusion time over 30 minutes.
Intravenous
480 - 480 mg
From 480 To 480 mg once every 28 day(s)
480 mg
As monotherapy: 480 mg every 4 weeks.
If melanoma patients need to be switched from the 240 mg every 2 weeks schedule to the 480 mg every 4 weeks schedule, the first 480 mg dose should be administered two weeks after the last 240 mg dose. Conversely, if patients need to be switched from the 480 mg every 4 weeks schedule to the 240 mg every 2 weeks schedule, the first 240 mg dose should be administered four weeks after the last 480 mg dose.
Infusion time over 60 minutes.
Intravenous
3 - 3 mg per kg of body weight
From 3 To 3 mg per kg of body weight once every 14 day(s) for 365 day(s)
3 mg per kg of body weight
Adjuvant treatment of melanoma: The recommended dose is 3 mg/kg nivolumab administered intravenously over 60 minutes every 2 weeks.
For adjuvant therapy, the maximum treatment duration with nivolumab is 12 months.
Infusion time over 60 minutes.
Intravenous
1 - 1 mg per kg of body weight
From 1 To 1 mg per kg of body weight once every 21 day(s)
1 mg per kg of body weight
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 following table. 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:
| 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 90 minutes | - |
Infusion time over 30 minutes.
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