MEKTOVI

What it is

MEKTOVI (binimetinib) is supplied as film-coated tablets containing binimetinib 15 mg or 45 mg . The 15 mg tablets are yellow/dark yellow, and the 45 mg tablets are white to off-white .

Approved indications —

Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation in adult patients, used in combination with encorafenib . — Metastatic non-small cell lung cancer with a BRAF V600E mutation in adult patients, used in combination with encorafenib .

Dosing overview

The recommended dose of binimetinib is 45 mg twice daily (corresponding to a total dose of 90 mg), approximately 12 hours apart, when used in combination with encorafenib . Binimetinib tablets should be swallowed whole with water, with or without food . The recommended reduced dose is 30 mg twice daily, and dose reduction below 30 mg twice daily is not recommended .

Key safety warnings

Left ventricular dysfunction, defined as symptomatic or asymptomatic decreases in ejection fraction, can occur with binimetinib. It is recommended that left ventricular ejection fraction is assessed by echocardiogram or multi-gated acquisition scan before initiation, 1 month after initiation and then at approximately 3-month intervals or more frequently as clinically indicated while on treatment . Venous thromboembolism can occur with the use of binimetinib . Binimetinib should be used with caution in patients who are at risk of, or with a history of venous thromboembolism . Ocular toxicities including retinal epithelial detachment and retinal vein occlusion can occur when binimetinib is administered. Uveitis, including iridocyclitis and iritis, was reported in patients treated with binimetinib in combination with encorafenib . Binimetinib is not recommended in patients with a history of retinal vein occlusion . Pneumonitis or interstitial lung disease can occur with binimetinib. Treatment should be withheld in patients with suspected pneumonitis or interstitial lung disease, including patients presenting new or progressive pulmonary symptoms or findings such as cough, dyspnoea, hypoxia, reticular opacities or pulmonary infiltrates . New primary malignancies, cutaneous and non-cutaneous, have been observed in patients treated with BRAF inhibitors and can occur when binimetinib is administered in combination with encorafenib. Cutaneous malignancies such as cutaneous squamous cell carcinoma including kerathoacanthoma have been observed in patients treated with binimetinib when used in combination with encorafenib .

Contraindications

Hypersensitivity to binimetinib or to any of the excipients is a contraindication .

PBS listing

MEKTOVI 15 mg tablets are listed on the PBS with a streamlined restriction and an ex-manufacturer price of A$3526.68 .

Regulatory history

MEKTOVI binimetinib 15 mg film-coated tablets were first registered on the ARTG on 3 January 2019 . MEKTOVI binimetinib 45 mg film-coated tablets were registered on the ARTG on 28 November 2025 .