MARAVIROC WAYMADE

What it is

Maraviroc Waymade contains maraviroc and is available as 150 mg or 300 mg film-coated tablets. Maraviroc is a CCR5 antagonist that selectively binds to the human chemokine receptor CCR5, preventing CCR5-tropic HIV-1 from entering cells.

Approved indications

— Maraviroc Waymade, in combination with other antiretroviral medicinal products, is indicated for adult patients infected with only CCR5-tropic HIV-1.

Dosing overview

The recommended dose of Maraviroc Waymade for adults is 150 mg, 300 mg or 600 mg twice daily depending on interactions with concomitant antiretroviral therapy and other medicinal products. Maraviroc Waymade can be taken with or without food. CCR5 tropism should be confirmed using a highly sensitive, appropriately validated tropism assay prior to initiation of Maraviroc Waymade therapy. Outgrowth of pre-existing low-level CXCR4 or dual/mixed-tropic HIV-1 not detected by tropism testing at screening has been associated with virologic failure on Maraviroc Waymade.

Key safety warnings

Hypersensitivity reactions including severe and potentially life-threatening events have been reported in patients taking maraviroc, characterised by features including rash, constitutional findings, and sometimes organ dysfunction and hepatic failure. Cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and drug rash with eosinophilia and systemic symptoms have been reported. Maraviroc Waymade and other suspect agents should be discontinued immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as delay in stopping treatment after the onset of rash may result in a life-threatening reaction. Caution should be used in patients at increased risk for cardiovascular events. Eleven patients (1.3%) who received maraviroc had cardiovascular events that may be linked to coronary heart disease including myocardial ischaemia and/or infarction during the Phase 3 studies in CCR5-tropic patients in treatment-experienced studies, while no patients who received placebo had such events. Symptomatic postural hypotension was seen at greater frequency with maraviroc at doses higher than the recommended dose compared with placebo. Caution should be used when administering Maraviroc Waymade in patients on concomitant medicinal products known to lower blood pressure, and in patients with severe renal insufficiency, risk factors for, or a history of postural hypotension. An increase in hepatic adverse reactions with maraviroc was observed during studies of treatment-experienced patients with HIV infection. Hepatotoxicity accompanied by severe rash or systemic allergic reaction including potentially life-threatening events has been reported. Hepatic laboratory parameters including ALT, AST, and bilirubin should be obtained prior to starting Maraviroc Waymade and at other time points during treatment as clinically indicated.

Contraindications

Hypersensitivity to the active substance or to any of the excipients is a contraindication to Maraviroc Waymade.

PBS listing

Maraviroc Waymade is listed on the PBS in two strengths: 150 mg and 300 mg tablets. Both strengths have streamlined restriction status with an ex-manufacturer price of A$588.48.

Regulatory history

Maraviroc Waymade (sponsored by Waymade) was first registered on the ARTG on 25 September 2024, with separate entries for the 150 mg and 300 mg film-coated tablets.