YEYTUO

What it is

YEYTUO is a medicine containing lenacapavir sodium, available as an injection (463.5 mg/1.5 mL per vial) and tablets (300 mg). The injection is a solution for subcutaneous administration, and the tablets are film-coated. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

— Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents 16 years and older weighing at least 35 kg.

Dosing overview

The dosing schedule consists of a required initiation dosing phase followed by once every 6-months continuation dosing. On day 1, the required dose is 927 mg by subcutaneous injection and 600 mg orally; on day 2, the required dose is 600 mg orally. Continuation dosing is 927 mg administered by subcutaneous injection once every 6 months from the date of the last injection. YEYTUO oral tablets may be taken with or without food. If the scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, YEYTUO tablets may be used for oral bridging on an interim basis, with 300 mg taken orally once every 7 days, initiated within 26 to 28 weeks from the last injection.

Key safety warnings

YEYTUO should only be used to prevent HIV-1 acquisition in individuals confirmed to be HIV-negative, with HIV-1 negative status confirmed prior to initiation and routinely thereafter as clinically appropriate. Drug-resistant HIV-1 variants have been identified with use of YEYTUO by individuals with undiagnosed HIV-1 infection. There is a risk of developing resistance to lenacapavir if an individual acquires HIV-1 either before, when receiving, or following discontinuation of YEYTUO; YEYTUO alone does not constitute a complete regimen for HIV-1 treatment, and individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Residual concentrations of lenacapavir may remain in the systemic circulation for prolonged periods (up to 12 months or longer); if YEYTUO is discontinued and it is clinically appropriate to continue PrEP, alternative forms of PrEP should be considered and initiated within 28 weeks of the last YEYTUO injection. Improper administration (intradermal injection) of lenacapavir has been associated with serious injection site reactions, including necrosis and ulcer; YEYTUO must be administered subcutaneously. The most common adverse reaction reported in both clinical trials was injection site reactions, which may lead to a nodule at the injection site in some individuals.

Contraindications

YEYTUO is contraindicated in individuals with unknown HIV-1 status.

PBS listing

Information on PBS listing, including strength, item count, restriction type and ex-manufacturer price, is not provided in the available source documents.

Regulatory history

YEYTUO lenacapavir (as sodium) was first registered on the Australian Register of Therapeutic Goods on 8 January 2026, with registrations for both the 463.5 mg/1.5 mL solution for injection and the 300 mg tablet formulations. The product is subject to additional monitoring in Australia.