Active Ingredient: Nivolumab
Nivolumab as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 240 milligrams nivolumab, once every 2 weeks.
Regimen B: Intravenous, 480 milligrams nivolumab, once every 4 weeks.
240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 60 minutes or over 30 minutes.
If 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.
Nivolumab must not be administered as an intravenous push or bolus injection.
For:
Regimen A: 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, 480 milligrams nivolumab, once every 4 weeks.
Regimen C: 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, 6 milligrams nivolumab per kilogram of body weight, once every 4 weeks.
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 or over 30 minutes.
If 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.
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.
Nivolumab must not be administered as an intravenous push or bolus injection.
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