Active Ingredient: Pembrolizumab
Pembrolizumab as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
200 mg
200 mg once every 21 day(s)
The recommended dose of pembrolizumab as monotherapy is 200 mg every 3 weeks as an intravenous infusion over 30 minutes.
Patients should be treated with pembrolizumab until disease progression or unacceptable toxicity. 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 for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
For the adjuvant treatment of melanoma, pembrolizumab should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year.
Intravenous infusion over 30 minutes.
Intravenous
400 mg
400 mg once every 42 day(s)
The recommended dose of pembrolizumab as monotherapy is 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes.
Patients should be treated with pembrolizumab until disease progression or unacceptable toxicity. 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 for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
For the adjuvant treatment of melanoma, pembrolizumab should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year.
Intravenous infusion over 30 minutes.
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