VYXEOS

What it is

Vyxeos is a medicinal product containing daunorubicin (as hydrochloride) 44 mg and cytarabine 100 mg. After reconstitution, the solution contains 2.2 mg/1 mL of daunorubicin and 5.0 mg/1 mL of cytarabine encapsulated in liposomes in a fixed combination in a 1:5 molar ratio. Vyxeos is a purple lyophilised cake presented as powder for injection. This medicinal product is subject to additional monitoring in Australia, which will allow quick identification of new safety information.

Approved indications

— Newly diagnosed therapy-related acute myeloid leukaemia (t-AML) — Acute myeloid leukaemia with myelodysplasia-related changes (AML-MRC)

Dosing overview

Vyxeos dosing is based on the patient's body surface area (BSA). Vyxeos is administered by intravenous infusion over a period of 90 minutes. A subsequent course of induction may be administered in patients who do not show disease progression or unacceptable toxicity. No dose adjustment is required in elderly patients aged 65 years or older.

Key safety warnings

Severe myelosuppression, including fatal infections and haemorrhagic events, has been reported in patients after administration of Vyxeos. Serious or fatal haemorrhagic events, including fatal central nervous system haemorrhages associated with severe thrombocytopenia, have occurred in patients treated with Vyxeos. Baseline assessment of blood counts should be obtained, and patients should be carefully monitored during treatment with Vyxeos for possible clinical complications due to myelosuppression. Cardiotoxicity is a known risk of anthracycline treatment. Prior therapy with anthracyclines, pre-existing cardiac disease, previous radiotherapy of the mediastinum, or concomitant use of cardiotoxic products may increase the risk of daunorubicin-induced cardiac toxicity. A baseline cardiac evaluation with an electrocardiogram (ECG) and a multi-gated radionuclide angiography (MUGA) scan or an echocardiography (ECHO) is recommended, especially in patients with risk factors for increased cardiac toxicity. Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with daunorubicin and cytarabine. Daunorubicin has been associated with local tissue necrosis at the site of medicinal product extravasation. In clinical studies with Vyxeos, one event of extravasation occurred, but no necrosis was observed.

Contraindications

Hypersensitivity to the active substances or to any of the excipients.

PBS listing

No source document contains PBS listing information for Vyxeos.

Regulatory history

Vyxeos was first registered on the ARTG on 3 June 2022. In July 2022, a PBAC submission for acute myeloid leukaemia (therapy-related acute myeloid leukaemia and acute myeloid leukaemia with myelodysplasia-related changes) was withdrawn. In July 2023, a PBAC submission for acute myeloid leukaemia was not recommended. In November 2023, Vyxeos was recommended for PBS listing for treatment of t-AML or AML-MRC, with the PBAC noting it was cost-effective at the proposed price. In March 2024, this item was considered out-of-session and was recommended for listing under the Section 100 HSD Program.