Viktig sikkerhets- og forskrivningsinformasjon
Opdualag is a Fixed-Dose combination administered as a 30-minute intravenous infusion every 4 weeks1
Opdualag fixed-dose is 480 mg of nivolumab and 160 mg relatlimab.
Opdualag 1 sales unit consists of nivolumab 240 mg and relatlimab
80 mg.
Therefore, Opdualag dosage needs 2 sales units of Opdualag.
Adult patients and pediatric patients*
Single 30-minute infusion of nivolumab 480 mg
and relatlimab 160 mg every 4 weeks
Treat until disease progression or unacceptable toxicity
Dose increases or decreases are not recommended. Depending on individual safety and tolerability, it may be necessary to delay a dose or permanently discontinue treatment.
The patient should be monitored continuously for at least 5 months after the last dose as an adverse reaction may occur at any time during or after discontinuation of treatment.
The patient should be given a patient alert card and informed of the risks of use.
PD-L1 testing
The decision whether a patient should be treated with Opdualag should be based on PD-L1 expression in tumor cells confirmed by a validated test.
*This dose is established for adolescents 12 years of age and older patients weighing at least 30 kg.
Reference:
1425-NO-2500004 February 2025
We refer to the SmPC for full information on Opdualag®