OPDUALAG

What it is

OPDUALAG is a medicine containing nivolumab and relatlimab . Relatlimab and nivolumab are human immunoglobulin G4 (IgG4) monoclonal antibodies produced in Chinese hamster ovary cells by recombinant DNA technology . OPDUALAG is supplied as a concentrate for solution for infusion . This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information .

Approved indications

— Unresectable or metastatic melanoma in patients who are at least 12 years old .

Dosing overview

The recommended dose of OPDUALAG for adult patients, or for paediatric patients who are 12 years or older and weigh at least 40 kg, is 480 mg nivolumab and 160 mg relatlimab administered as a 30-minute intravenous infusion once every 4 weeks, until disease progression or unacceptable toxicity . Dose escalation or reduction is not recommended .

Key safety warnings

OPDUALAG can cause immune-related adverse reactions, which can be severe or fatal, and can occur in any organ system or tissue . Most immune-related adverse reactions manifest during treatment, however, patients should continue to be monitored for a minimum of 5 months after the last dose, as an immune-related adverse reaction to OPDUALAG may occur at any time during or after discontinuation of therapy . OPDUALAG can cause immune-related pneumonitis (interstitial lung disease), and a fatal case occurred in clinical studies . OPDUALAG can cause immune-related colitis, defined as requiring use of corticosteroids and with no clear alternate aetiology . OPDUALAG can cause immune-related hepatitis, defined as requiring use of corticosteroids and with no clear alternate aetiology . OPDUALAG can cause immune-related nephritis with renal dysfunction, defined as requiring use of corticosteroids and with no clear alternate aetiology . OPDUALAG can cause immune-related endocrinopathies including thyroiditis, hypothyroidism, hyperthyroidism, adrenal insufficiency (primary or secondary), hypophysitis with or without hypopituitarism, and diabetes mellitus with the potential for diabetic ketoacidosis . OPDUALAG can cause immune-related myocarditis . Cases of myocarditis-myositis-myasthenia gravis overlap syndrome, some with fatal outcome, have been reported with nivolumab in combination with relatlimab . Cases of exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have occurred with the use of other therapeutic goods containing an anti-PD-(L)1 antibody such as nivolumab. These are rare, but can be fatal .

Contraindications

Hypersensitivity to the active substances or any of the excipients .

PBS listing

Information on PBS listing is not available in the provided source documents.

Regulatory history

OPDUALAG nivolumab 240 mg and relatlimab 80 mg in 20 mL concentrate solution for intravenous infusion was first registered on the ARTG on 7 October 2022 . An Australian Public Assessment Report was approved on 2 October 2022 . The Pharmaceutical Benefits Advisory Committee initially recommended against listing in July 2022 for treatment of Stage III or IV metastatic melanoma, but recommended listing in March 2023 for unresectable Stage III or IV malignant melanoma .