CELSENTRI

What it is

CELSENTRI contains maraviroc and is supplied in two strengths: 150 mg and 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

— CELSENTRI, 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 CELSENTRI is 150 mg, 300 mg or 600 mg twice daily depending on interactions with concomitant antiretroviral therapy and other medicinal products. CELSENTRI can be taken with or without food. Dosing varies by concomitant medication. For patients receiving potent CYP3A inhibitors (with or without a CYP3A inducer), the recommended dose is 150 mg twice daily. For patients receiving other concomitant medications that are not potent CYP3A inhibitors or inducers, the dose is 300 mg twice daily. For patients receiving potent CYP3A inducers without a potent CYP3A inhibitor, the dose is 600 mg twice daily. The safety and efficacy of CELSENTRI have not been established in children younger than 18 years of age.

Key safety warnings

Hypersensitivity reactions including severe and potentially life-threatening events have been reported in patients taking CELSENTRI. These reactions were 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. Discontinue maraviroc immediately if signs or symptoms of severe skin or hypersensitivity reactions develop. Delay in stopping maraviroc after the onset of rash may result in a life-threatening reaction. Use with caution in patients at increased risk for cardiovascular events. Eleven patients (1.3%) who received CELSENTRI had cardiovascular events that may be linked to coronary heart diseases including myocardial ischemia and/or infarction during Phase 3 studies in CCR5-tropic patients in treatment-experienced studies, while no patients who received placebo had such events. When CELSENTRI was administered in studies with healthy volunteers at doses higher than the recommended dose, cases of symptomatic postural hypotension were seen at a greater frequency than with placebo. Caution should be used when administering CELSENTRI in patients on concomitant medicinal products known to lower blood pressure, and in patients with severe renal insufficiency or a history of postural hypotension. CELSENTRI antagonises the CCR5 co-receptor located on some immune cells and could potentially increase the risk of developing infections. The overall incidence and severity of infections was comparable in treatment groups during Phase 3 studies. Patients should be monitored closely for evidence of infections while receiving CELSENTRI.

Contraindications

CELSENTRI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

PBS listing

PBS listing information is not provided in the available source documents.

Regulatory history

CELSENTRI maraviroc 150 mg and 300 mg tablets were first listed on the ARTG on 4 February 2008. The TGA approved a major variation submission for CELSENTRI on 22 August 2012, which extended the approved therapeutic use to include adult patients infected with only CCR5-tropic HIV-1, in combination with other antiretroviral medicinal products.