Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Yeytuo tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV-1 acquisition risk, weighing at least 35 kg for:
(see sections 4.2, 4.4 and 5.1)
Yeytuo should be prescribed by a healthcare professional experienced in the management of HIV prevention.
All individuals must be screened for HIV-1 prior to initiating lenacapavir and additionally as clinically appropriate (see sections 4.3 and 4.4). 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.
Prior to starting Yeytuo, healthcare professionals should identify individuals for whom the required initiation and every 6-month continuation injection dosing schedule is appropriate, and counsel individuals about the importance of adherence to scheduled dosing visits (see section 4.4).
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).
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.
Table 1. Dosing schedule for lenacapavir initiation:
| Time | |
| Dose of lenacapavir: Initiationa | |
| Day 1 | 927 mg subcutaneous injection (2 × 1.5 mL injectionsb) 600 mg orally (2 × 300 mg tablets) |
| Day 2 | 600 mg orally (2 × 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).
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.
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.
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.
No dose adjustment of lenacapavir is required for elderly individuals. There are limited data available on the use of lenacapavir in individuals aged 65 years and above (see section 5.2).
No dose adjustment of lenacapavir is required in individuals with mild, moderate, or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min). Lenacapavir has not been studied in individuals with end stage renal disease (CrCl <15 mL/min or on renal replacement therapy) (see section 5.2), therefore lenacapavir should be used with caution in these individuals.
No dose adjustment of lenacapavir is required in individuals with mild or moderate hepatic impairment (Child-Pugh Class A or B). Lenacapavir has not been studied in individuals with severe hepatic impairment (Child-Pugh Class C) (see section 5.2), therefore lenacapavir should be used with caution in these individuals.
Safety and efficacy of lenacapavir in children and adolescents weighing less than 35 kg have not been established. No data are available.
For oral use.
Lenacapavir tablets should be taken orally with or without food (see section 5.2). 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.
If overdose occurs the individual must be monitored for signs or symptoms of adverse reactions. Treatment of overdose with Yeytuo consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the individual. As lenacapavir is highly protein bound, it is unlikely to be significantly removed by dialysis.
3 years.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Yeytuo tablets are packaged in white high-density polyethylene (HDPE) bottle containing polyester coil and silica gel desiccant. Each bottle is capped using a white, continuous thread, child-resistant polypropylene screw cap with an induction sealed, aluminium-faced liner. Pack size of 4 tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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