YEYTUO

Yeytuo should be prescribed by a healthcare professional experienced in the management of HIV prevention. 4). A combined antigen/antibody test as well as an HIV-RNA-based test should be negative. Prescribers are advised to perform both tests, even if the result of the HIV- RNA-based test will become available after initiation of lenacapavir.

If a combined testing strategy including both tests is not available, testing should follow local guidelines. 4). Posology The dosing schedule in adults and adolescents weighing at least 35 kg consists of a required initiation dosing (subcutaneous injections and oral tablets) (Table 1), followed by once every 6-month continuation dosing (subcutaneous injections).

Initiation On Day 1, the required dose is 927 mg of lenacapavir administered by subcutaneous injection and 600 mg taken orally. On Day 2, the required dose is 600 mg taken orally. 5 mL injectionsb) 600 mg orally (2 x 300 mg tablets) Day 2 600 mg orally (2 x 300 mg tablets) a The complete initiation dosing schedule, consisting of subcutaneous injections and oral tablets, is required; the efficacy of lenacapavir has only been established with this dosing schedule.

b Two injections, with the second injection at least 5 centimetres from the first injection (see Method of Administration in the Yeytuo solution for injection SmPC). Missed initiation dose If the Day 1 or Day 2 oral initiation dose (600 mg) is missed, it should be taken as soon as possible.

Day 1 and Day 2 doses should not be taken on the same day. Anticipated delayed injections During continuation dosing, if the scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, lenacapavir tablets may be used for oral bridging on an interim basis (for up to 6 months if needed) until injections resume.

Oral bridging should be initiated within 26 to 28 weeks from the last injection. The dosing schedule is 300 mg (1 tablet) taken orally once every 7 days. Resume the continuation injection dosage within 7 days after the last oral dose.

Vomiting If the individual vomits within 3 hours of taking an oral dose of lenacapavir, another oral dose should be taken. If the individual vomits more than 3 hours after taking an oral dose of lenacapavir there is no need to take another oral dose of lenacapavir, and the scheduled dosing regimen should continue.

Special populations Elderly No dose adjustment of lenacapavir is required for elderly individuals. 2). Renal impairment No dose adjustment of lenacapavir is required in individuals with mild, moderate, or severe renal impairment (creatinine clearance [CrCl] ≥ 15 mL/min).

2), therefore lenacapavir should be used with caution in these individuals. Hepatic impairment No dose adjustment of lenacapavir is required in individuals with mild or moderate hepatic impairment (Child-Pugh Class A or B). 2), therefore lenacapavir should be used with caution in these individuals.

Paediatric population Safety and efficacy of lenacapavir in children and adolescents weighing less than 35 kg have not been established. No data are available. Method of administration For oral use. 2). The film-coated tablet should not be chewed, or crushed, because the effects on lenacapavir absorption have not been studied.

For individuals who are unable to swallow the tablet whole, the tablet may be split in half and both halves taken one after the other, ensuring that the full dose is taken immediately.

No adverse reactions to lenacapavir taken orally were identified in adults or adolescents in PURPOSE 1 and PURPOSE 2. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Prevention strategy Yeytuo should only be used to prevent HIV-1 acquisition in individuals confirmed to be HIV-negative. HIV-1 negative status should be confirmed prior to initiation of lenacapavir, and additionally as clinically appropriate in individuals receiving lenacapavir.

If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, HIV-1 status should be reconfirmed. Yeytuo should be used to prevent HIV-1 acquisition as part of a strategy to reduce the risk of sexually transmitted infections (STIs).

Individuals should be identified for whom the required initiation and every 6-month continuation injection dosing schedule is appropriate. 2) may lead to HIV- 1 acquisition. Individuals should be counselled and supported on adhering to the lenacapavir administration schedule, on the use of other measures to prevent STIs, and on the importance of testing for HIV-1 and other STIs.

2). The exact time from initiation of lenacapavir for HIV-1 PrEP to maximal protection against HIV 1 infection is unknown. 1). There is a risk of developing resistance to lenacapavir if an individual acquires HIV-1 either before or when receiving Yeytuo, or following discontinuation of Yeytuo.

To minimise this risk, it is essential to confirm HIV-1 negative status before each subsequent injection, and additionally as clinically appropriate. Yeytuo alone does not constitute a complete regimen for HIV-1 treatment and mutations have emerged in some individuals with undetected HIV-1 infection who were only taking Yeytuo.

Individuals who are confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen to reduce the risk of developing resistance. 5). e. 5). Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. 4). Co-administration with strong inducers of CYP3A, P-gp, and UGT1A1, such as: • antimycobacterials: rifampicin • anticonvulsants: carbamazepine, phenytoin • herbal products: St. 5).