RADICAVA

What it is

RADICAVA is a concentrated solution for injection containing 30 mg of edaravone in 20 mL . It must be diluted before use and is for intravenous infusion only . Edaravone is a free radical scavenger to reduce oxidative stress .

Approved indications

— Adults with a diagnosis of amyotrophic lateral sclerosis who are independent in activities of daily living with normal respiratory function and where treatment is initiated within two years of disease onset .

Dosing overview

The recommended dosage is 60 mg of edaravone (two ampoules) diluted with 100 mL of 0.9% sodium chloride for infusion and administered as an intravenous infusion over a 60-minute period. An initial treatment cycle involves daily dosing for 14 days, followed by a 14-day drug-free period. Subsequent treatment cycles involve daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods .

Key safety warnings

Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure and dyspnoea) have been reported in spontaneous postmarketing reports with edaravone . Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA, treat per standard of care, and monitor until the condition resolves . RADICAVA contains sodium bisulfite, a sulfite that may cause allergic type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people . Sulfite sensitivity occurs more frequently in asthmatic people . Women should avoid pregnancy while taking edaravone. If edaravone is used during pregnancy or if the patient becomes pregnant while taking edaravone, the patient should be apprised of the potential hazard to the fetus .

Contraindications

RADICAVA is contraindicated in patients with a history of hypersensitivity to edaravone or any of the excipients .

PBS listing

The 30 mg in 20 mL solution concentrate for intravenous infusion is listed on the PBS with 4 items under authority required restriction at an ex-manufacturer price of A$2200.00 .

Regulatory history

RADICAVA was first listed on the ARTG on 15 February 2023 . In November 2023, the PBAC did not recommend RADICAVA for treatment of amyotrophic lateral sclerosis, noting that benefit in terms of overall survival was uncertain and that it was not cost-effective at the proposed price . In March 2024, the PBAC recommended RADICAVA for amyotrophic lateral sclerosis .