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Produktresumé för Opdualag på FASS
Special populations1
Fertility, pregnancy, and lactation1:
Women of childbearing potential/Contraception:Opdualag is not recommended in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk. Effective contraception should be used for at least 5 months following the last dose of Opdualag.
Pregnancy: There is a limited amount of data from the use of nivolumab in combination with relatlimab in pregnant women. Based on its mechanism of action and data from animal studies, nivolumab in combination with relatlimab can cause foetal harm when administered to a pregnant woman. Studies in animals receiving nivolumab have shown embryofoetal toxicity (see section 5.3). Human IgG4 is known to cross the placental barrier and nivolumab and relatlimab are an IgG4; therefore, nivolumab and relatlimab have the potential to be transmitted from the mother to the developing foetus. Opdualag is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk.
Breast-feeding: It is unknown whether nivolumab and/or relatlimab are excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. Afterwards, Opdualag could be used during breast-feeding if clinically needed.
Fertility: Studies to evaluate the effect of nivolumab and/or relatlimab on fertility have not been performed. Thus, the effect of nivolumab and/or relatlimab on male and female fertility is unknown.
Paediatric population: The safety and efficacy of Opdualag in children below 12 years of age have not been established. No data are available (see section 5.2).
Elderly: No dose adjustment is required for elderly patients (≥ 65 years) (see section 5.2).
Renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2). Data from patients with severe renal impairment are too limited to draw conclusions on this population.
Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment (see section 5.2). Data from patients with severe hepatic impairment are too limited to draw conclusions on this population.
Reference:
1425-SE-2500023 July 2025
We refer to the SmPC for full information on Opdualag®