RUKOBIA (fostemsavir)

Rukobia (fostemsavir) is a first-in-class attachment inhibitor for the treatment of HIV-1 infection.

Rukobia was approved by the US Food and Drug Administration (FDA) on 2 July 2020 for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, whose current ARV regimen is failing due to resistance, intolerance or safety considerations.1

Marketing Authorisation was also granted by the European Commission on 5th February 2021 for Rukobia (fostemsavir) 600mg extended-release tablets, for use in combination with other antiretroviral (ARV) therapies for the treatment of adults with multidrug-resistant HIV-1 infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen.2

Rukobia is currently under review by other global regulatory authorities.

[1] Rukobia (fostemsavir) Prescribing Information. US Approval 2020.

[2] Rukobia (fostemsavir) EU Summary of Product Information. February 2021

Prescribing information

United States

Prescribing Information and Patient Information for Rukobia

Europe

European Summary of Product Information

This medicine is subject to additional monitoring. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.