Active Ingredient: Ipilimumab
Ipilimumab in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.
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:
For:
Intravenous, 3 milligrams ipilimumab per kilogram of body weight, once every 3 weeks, 4 doses in total.
In adults and adolescents 12 years of age and older and weighing at least 50 kg, 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 Table 1. For the monotherapy phase, the first dose of nivolumab should be administered:
In adolescents 12 years of age and older and weighing less than 50 kg, 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 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks 4, 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 ipilimumab in combination with nivolumab:
| Combination phase, every 3 weeks for 4 dosing cycles | Monotherapy phase | |
|---|---|---|
| Nivolumab | Adults and adolescents 12 years of age and older: 1 mg/kg over 30 minutes | Adults and adolescents (12 years of age and older weighing at least 50 kg): 240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 60 minutes 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 |
| Ipilimumab | Adults and adolescents 12 years of age and older: 3 mg/kg over 30 minutes | - |
Treatment with ipilimumab in combination with nivolumab, should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient (and up to maximum duration of therapy if specified for an indication).
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 ipilimumab in combination with nivolumab for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Liver function tests (LFTs) and thyroid function tests should be evaluated at baseline and before each dose of ipilimumab. In addition, any signs or symptoms of immune-related adverse reactions, including diarrhoea and colitis, must be assessed during treatment with ipilimumab.
The recommended infusion period is 30 minutes.
Ipilimumab must not be administered as an intravenous push or bolus injection.
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