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Yeytuo is a brand name for Lenacapavir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Yeytuo injection 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 (see sections 4.2, 4.4 and 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Yeytuo should be prescribed by a healthcare professional experienced in the management of HIV prevention. Each injection should be administered by a healthcare professional. 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) followed by once every 6-month continuation dosing (subcutaneous injections) (Table 1).
Oral tablets can be taken with or without food (see Yeytuo tablet SmPC). 5 mL injectionsb) 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). c From the date of the last injection. Missed dose 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 (see Table 1).
Missed injections During the continuation period, if more than 28 weeks have elapsed since the last injection and lenacapavir tablets have not been taken for oral bridging, restart the initiation dosing schedule from Day 1 (see Table 1).
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.
Summary of the safety profile The most common adverse reaction in PURPOSE 1 and PURPOSE 2 was injection site reactions (71% and 85% respectively). Tabulated list of adverse reactions Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
1) attributed to lenacapavir (or to the procedure) by the investigator. b Includes injection site nodule, pain, induration, erythema, swelling, pruritus, bruising, warmth, discolouration, oedema, ulcer, haematoma, haemorrhage, and discomfort.
Description of injection-associated adverse reactions Local injection site reactions (ISRs) PURPOSE 1 In PURPOSE 1, 71% of participants receiving lenacapavir experienced ISRs, compared to 38% of participants receiving placebo injections (and emtricitabine/tenofovir alafenamide [FTC/TAF] or emtricitabine/tenofovir disoproxil fumarate [FTC/TDF]).
Most participants who received lenacapavir had mild (Grade 1, 50%) or moderate (Grade 2, 21%) severity ISRs. 2%) participants, and included ulcer and nodule. 2%) participants.
Nodules:
Injection site nodule was reported in 66% of participants who received lenacapavir and resolved more slowly than other ISRs. The median duration of nodules was 274 (180, 407) days. Of the injection site nodule events associated with Day 1 lenacapavir injections, 70% had resolved within a median time of 276 days.
Other ISRs:
The other ISRs reported in more than 2% of participants who received lenacapavir were pain (34%), swelling (5%), induration (4%), and pruritus (3%). The median duration of ISRs, excluding nodules and indurations, was 9 (4 to 30) days.
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. Individuals should be re-tested for HIV-1 prior to each subsequent injection of lenacapavir, and additionally as clinically appropriate.
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.
5 Individuals who are confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen to reduce the risk of developing resistance. Long-acting properties Residual concentrations of lenacapavir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer).
1. 4). Co-administration with strong inducers of CYP3A, P-gp, and UGT1A1, such as: • antimycobacterials: rifampicin • anticonvulsants: carbamazepine, phenytoin • herbal products: St. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 subcutaneous use only. 6). 4). For instructions on preparation and administration, see ‘Instructions for Use’ in the package leaflet.
‘Instructions for Use’ are also available as a card in the injection kit. Following lenacapavir injection, a subcutaneous drug depot forms whereby lenacapavir is slowly released from the site of administration. 2).
PURPOSE 2 In PURPOSE 2, 85% of participants receiving lenacapavir experienced ISRs, compared to 70% of participants receiving placebo injections (and FTC/TDF). Most participants had mild (Grade 1, 66%) or moderate (Grade 2, 18%) severity ISRs.
6%) participants, and included ulcer, pain, erythema, oedema, and dermatitis. 2%) participants.
Nodules:
Injection site nodule was reported in 65% of participants and resolved more slowly than other ISRs. The median duration of nodules was 239 (163, 362) days. Of the injection site nodule events associated with Day 1 lenacapavir injections, 70% had resolved within a median time of 269 days.
Other ISRs:
The other ISRs reported in more than 2% of participants who received lenacapavir were pain (58%), erythema (18%), induration (16%), swelling (7%), pruritus (4%), bruising (3%), and warmth (2%). The median duration of ISRs, excluding nodules and indurations, was 4 (2 to 8) days.
Paediatric population The safety of lenacapavir was evaluated in 59 adolescents aged 16 to <18 years and weighing ≥35 kg in PURPOSE 1 and PURPOSE 2. The adverse reactions in adolescents were consistent with those in adults. 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. Healthcare 12 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
e. 5). If lenacapavir 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 lenacapavir injection. Injection site reactions Injection site reactions with improper administration Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer.
2). Slow or non-resolving injection site nodules and indurations Administration of Yeytuo may result in local injection site reactions (ISRs), including nodules and indurations. 8). The mechanism driving the persistence of injection site nodules in some individuals is not fully understood but may be related to the presence of the subcutaneous drug depot and an associated foreign body response at the injection site.
Non-resolving ISRs should be subject to clinical monitoring. 5). e. 5). Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium-free’.