Active Ingredient: Ipilimumab
Ipilimumab as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older.
Ipilimumab in combination with nivolumab 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.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
3 - 3 mg per kg of body weight
From 3 To 3 mg per kg of body weight once every 21 day(s) for 84 day(s)
The recommended induction regimen of ipilimumab is 3 mg/kg administered intravenously over a 90-minute period every 3 weeks for a total of 4 doses. Patients should receive the entire induction regimen (4 doses) as tolerated, regardless of the appearance of new lesions or growth of existing lesions. Assessments of tumour response should be conducted only after completion of induction therapy.
The recommended dose is 3 mg/kg ipilimumab in combination with 1 mg/kg nivolumab 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 ipilimumab in combination with nivolumab:
| 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 | - |
The recommended infusion period is 30 or 90 minutes, depending on the dose.
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