Active Ingredient: Nivolumab
Nivolumab as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. 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:
Intravenous
240 mg
240 mg once every 14 day(s)
As monotherapy: 240 mg every 2 weeks.
If RCC 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 mg
480 mg once every 28 day(s)
As monotherapy: 480 mg every 4 weeks.
If RCC 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 21 day(s)
3 mg per kg of body weight
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 Table 1. For the monotherapy phase, the first dose of nivolumab should be administered;
Table 1. 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 | 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 | - |
Treatment with nivolumab, either as a monotherapy or in combination with ipilimumab, should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Atypical responses (i.e. an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. It is recommended to continue treatment with nivolumab or nivolumab in combination with ipilimumab for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Dose escalation or reduction is not recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability. Guidelines for permanent discontinuation or withholding of doses are described in Table 2.
Table 2. Recommended treatment modifications for nivolumab or nivolumab in combination with ipilimumab:
Nivolumab or nivolumab in combination with ipilimumab should be permanently discontinued for:
Patients treated with nivolumab must be given the patient alert card and be informed about the risks of nivolumab.
When nivolumab is administered in combination with ipilimumab, if either agent is withheld, the other agent should also be withheld. If dosing is resumed after a delay, either the combination treatment or nivolumab monotherapy could be resumed based on the evaluation of the individual patient.
Infusion time over 30 minutes.
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