Summary of the safety profile1
The safety of Opdualag has been studied in 355 patients with advanced (unresectable or metastatic) melanoma (study CA224047). The adverse reactions reported in the dataset for patients treated with nivolumab in combination with relatlimab, with a median follow-up of 19.94 months, are described below:
The most common adverse reactions are fatigue (41%), musculoskeletal pain (32%), rash (29%), arthralgia (26%), diarrhoea (26%), pruritus (26%), headache (20%), nausea (19%), cough (16%), decreased appetite (16%), hypothyroidism (16%), abdominal pain (14%), vitiligo (13%), pyrexia (12%), constipation (11%), urinary tract infection (11%), dyspnoea (10%), and vomiting (10%).
The most common serious adverse reactions are adrenal insufficiency (1.4%), anaemia (1.4%), back pain (1.1%), colitis (1.1%), diarrhoea (1.1%), myocarditis (1.1%), pneumonia (1.1%), and urinary tract infection (1.1%).
The incidence of Grade 3-5 adverse reactions in patients with advanced (unresectable or metastatic) melanoma was 43% for Opdualag.
Immune-Related Adverse Reactions Opdualag is associated with immune-related adverse reactions that can affect multiple body systems simultaneously. Fatal cases have occurred. Early diagnosis and appropriate treatment are necessary to minimize life-threatening complications. Depending on the severity of the adverse reaction, Opdualag treatment should be paused, and corticosteroids should be administered. Patients should be continuously monitored, as adverse reactions can occur at any time during or after treatment.
Other Important Warnings and Precautions May increase the risk of organ transplant rejection. May increase the risk of severe graft-versus-host disease (GVHD) in patients who have undergone allogeneic hematopoietic stem cell transplantation. Serious infusion reactions have been reported.
Reference:
1425-SE-2500009 February 2025
We refer to the SmPC for full information on Opdualag®