Viktig sikkerhets- og forskrivningsinformasjon
Special populations1
Fertility, pregnancy, and lactation1:
Women of childbearing potential/Contraception: Opdualag is not recommended for women of childbearing potential who are not using effective contraception unless the clinical benefit outweighs the potential risk. Effective contraception should be used for at least 5 months after the last dose.
Pregnancy: There is limited data on the use of Opdualag during pregnancy. Based on its mechanism and animal studies, Opdualag can cause harm to the foetus and is not recommended during pregnancy unless the clinical benefit outweighs the risk.
Breast-feeding: It is unknown if nivolumab or relatlimab are excreted in human milk. As IgG4 antibodies can pass into breast milk, a risk to the infant cannot be excluded. Opdualag may be used during breastfeeding if clinically needed after the first few days post-birth.
Fertility: No studies have been conducted on the effects of Opdualag on fertility, so its impact on male or 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.
Elderly: No dose adjustment is required for elderly patients (≥ 65 years).
Renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment. 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. Data from patients with severe hepatic impairment are too limited to draw conclusions on this population.
See the SmPC for full information
Reference:
1425-NO-2500004 February 2025
We refer to the SmPC for full information on Opdualag®