Lenacapavir: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 27, 2026🚩 Report this page

Lenacapavir

Other Antivirals

Sold as YEYTUO · SUNLENCA

CA Health CanadaGB MHRAEU EMA

Drug class: Other Antivirals
Availability: See label
Routes: Oral, Subcutaneous
Markets covered: 3
Products on record: 10

Overview

Lenacapavir is an active pharmaceutical ingredient in the Other Antivirals group (J05AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	4	May 27, 2026
GB United Kingdom	MHRA	4	February 10, 2026
EU European Union	EMA	2	May 4, 2026

CACanada· Health Canada

4 products

Uses

CAOfficial regulatory label· revised December 22, 2025[1]

SUNLENCA (lenacapavir), in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance or safety considerations.
2 Geriatrics Clinical studies of SUNLENCA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from adult patients < 65 years of age.

How to take

GBUnited Kingdom· MHRA

4 products

Uses

GBOfficial regulatory label· revised February 10, 2026[2]

1).

How to take

GBOfficial regulatory label· revised February 10, 2026

EUEuropean Union· EMA

2 products

Uses

EUOfficial regulatory label· revised May 4, 2026[3]

1).

How to take

EUOfficial regulatory label· revised May 4, 2026

Sources & citations

[1]Health Canada (DPD) · 02532468 · revised December 22, 2025
[2]MHRA (UK) · PL119720067 · revised February 10, 2026
[3]European Medicines Agency · EMEA/H/C/006658 · revised May 4, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

CAOfficial regulatory label· revised December 22, 2025[1]

1 Dosing Considerations • Initiation of treatment requires SUNLENCA injection to be given with SUNLENCA tablets. • Prior to starting SUNLENCA, health professionals should counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression, reduce the risk of viral rebound and potential development of resistance with missed doses (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment The recommended SUNLENCA treatment regimen in adults consists of an initiation dosing period (oral tablets and subcutaneous injections) and twice yearly (once every 6-months) maintenance dosing (subcutaneous injections).
SUNLENCA oral tablets may be taken with or Product Monograph Page 5 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium without food. • Initiation: On treatment Day 1 and Day 2, the recommended dose of SUNLENCA is 600 mg per day (2 x 300 mg tablets) taken orally.
On treatment Day 8, the recommended dose is 300 mg taken orally. 5 mL injections) administered by subcutaneous injection. 5 mL injections) of SUNLENCA administered by subcutaneous injection every 6 months (26 weeks) from the date of last injection (+/- 2 weeks) (see Table 1).
Table 1. 5 mL injections)a a. Two injections, each at a separate site in the abdomen b. From the date of last injection. If a patient vomits within 3 hours after taking SUNLENCA tablets, the patient should take an extra oral dose, and the scheduled dosing regimen should continue.
If a patient vomits more than 3 hours after taking SUNLENCA tablets, the patient should not take an extra oral dose of SUNLENCA tablets, and the scheduled dosing regimen should continue. 1 Pediatrics). Geriatrics (> 65 years of age) No dose adjustment of SUNLENCA is required for elderly patients.
Clinical studies of SUNLENCA did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from adult patients < 65 years of age. Renal Impairment No dose adjustment of SUNLENCA is required in patients with mild, moderate, or severe renal impairment (CrCl ≥15 mL/min).
SUNLENCA has not been studied in patients with end stage renal disease (ESRD), therefore it should be administered with caution in these patients. Product Monograph Page 6 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium Hepatic Impairment No dose adjustment of SUNLENCA is required in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B).
SUNLENCA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), therefore it should be administered with caution in these patients. 3 Administration SUNLENCA injection is only for subcutaneous administration into the abdomen by a health professional.
Do NOT administer intradermally (see 7 WARNINGS AND PRECAUTIONS). Use aseptic technique. No reconstitution of the injectable solution is required prior to administration. Visually inspect the solution in the vials for particulate matter and discoloration prior to administration.
SUNLENCA injection is yellow to brown solution. Do not use SUNLENCA injection if the solution is discolored or if it contains particulate matter. Once the solution is withdrawn from the vials, the subcutaneous injections should be administered as soon as possible (see 11 STORAGE, STABILITY AND DISPOSAL).
Refer to Figure 1 to identify the components for use in the administration steps. The administration steps are provided in Figure 2. The injection kit components are for single use only. Use of vial access device is required. 5 mL injections are required for a complete dose.
Product Monograph Page 7 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium Figure 1. SUNLENCA Injection Kit Components Figure 2. , 26 weeks + 2 weeks window) have elapsed since the last injection and if clinically appropriate to continue SUNLENCA treatment, restart the initiation dosage regimen from Day 1 (see Table 1).
, Day 1), the entire dosing regimen shifts by the number of days delayed. Recommendations for missed Day 2 and Day 8 oral tablet doses are provided in Table 2. Product Monograph Page 8 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium Table 2.
Recommendations for Missed Day 2 and Day 8 Oral Doses Days Elapsed Since Missed Dose Recommendations If the Day 2 (600 mg) oral dose is missed by: less than 6 days Take 600 mg as soon as possible, and 300 mg on Day 8. 6 days or more Take 600 mg as soon as possible, and 300 mg on Day 15.
If the Day 8 (300 mg) oral dose is missed by: less than 6 days Take 300 mg soon as possible. 6 days or more Take 300 mg on Day 15. Regardless of when the Day 2 or Day 8 oral dose is being taken, subcutaneous injection should be administered on Day 15 as described in Table 1.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised December 22, 2025[1]

1 Adverse Reaction Overview The following adverse drug reactions are discussed in WARNINGS AND PRECAUTIONS: • Immune Reconstitution Inflammatory Syndrome (see 7 WARNINGS AND PRECAUTIONS) The overall safety population reflects exposure to SUNLENCA in 229 patients with HIV.
The primary safety analysis is based on the pivotal study (GS-US-200-4625 [CAPELLA]; N=72), which was conducted in heavily treatment experienced adult patients with HIV who received SUNLENCA in a Phase 2/3 trial through Week 26 (median duration on study of 32 weeks) and Week 52 (median duration on study of 54 weeks) (see 14 CLINICAL TRIALS).
Supportive data was provided in treatment-naïve adult patients with HIV who received SUNLENCA in a Phase 2 trial (GS-US-200-4334 [CALIBRATE]; N=157) through Week 28 (median duration of exposure of 43 weeks) and Week 54 (median duration on study of 66 weeks).
In CAPELLA, a treatment-emergent adverse event (TEAE) was reported in 93% of patients. Excluding injection site reactions (ISR), the most common TEAEs reported in ≥5% of patients were diarrhea, nausea, COVID-19, abdominal distension, constipation, cough, arthralgia, back pain, headache, pyrexia, urinary tract infection, rash, dizziness, fatigue, oral candidiasis and vomiting.
The majority of these events were Grade 1 or Grade 2 and resolved without discontinuation or interruption of study medication. 7%, 48 patients. 2%) had Grade 3 or higher AEs. 8%, 2 patients each). Four patients experienced Grade 3 or higher AEs that were considered related to study drug by the study investigator: rash and abdominal abscess, injection site swelling and injection site erythema, injection site pain, and Product Monograph Page 12 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium immune reconstitution inflammatory syndrome (1 participant each).
1%). None were considered related to the study drug. 4%) discontinued study drug due to an AE of an ISR beyond Week 52. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The most common adverse reactions (all Grades) reported in at least 3% of patients in CAPELLA were nausea and injection site reactions.
Table 4 displays the frequency of adverse reactions (all Grades) ≥3% in the SUNLENCA group. Table 4. Adverse Reactions (All Grades) Reported in ≥3%a of Heavily Treatment Experienced Adults with HIV-1 Receiving SUNLENCA in CAPELLA (Week 26 and 52 Analysis) Week 26 Week 52 Adverse Reactions SUNLENCA + Background Regimen (N=72) SUNLENCA + Background Regimen (N=72) GASTROINTESTINAL DISORDERS Nausea 4% 4% GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection Site Reactions 56% 63%b a.
Frequencies of adverse reactions are based on all treatment-emergent adverse events attributed to study drug by the investigator, based on all patients (cohorts 1 and 2) in CAPELLA. b. Includes injection site swelling, erythema, pain, nodule, induration, pruritus, discomfort, mass, extravasation, hematoma, edema and ulcer.
Median (Q1, Q3) duration of injection site reactions (ISR) was 8 (3, 67) days. Of the 45 patients who experienced a study drug related ISR, majority [67% (30/45)] had Grade 1 ISRs. Most (97%) of the adverse events associated with SUNLENCA were mild or moderate in severity.
No patients who received SUNLENCA in CAPELLA experienced serious adverse events related to study drug. 3 Less Common Clinical Trial Adverse Reactions Adverse reactions occurring in 2 or more patients administered SUNLENCA beyond those included in Table 4 are presented below.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings The frequency of selected laboratory abnormalities (Grades 3 to 4) occurring in at least 3% of patients in CAPELLA are presented in Table 5.
A causal association between SUNLENCA and these laboratory abnormalities has not been established. Table 5. 9 mmol/L) 5% 6% Glycosuria (>2+) 6% 6% ULN = upper limit of normal a. Frequencies are based on treatment-emergent laboratory abnormalities in all patients (cohorts 1 and 2) in CAPELLA.
Percentages were calculated based on the number of patients with post-baseline toxicity grades for each laboratory parameter (n=72 for all parameters except hyperglycemia fasting n=55).

CAOfficial regulatory label· Warnings and precautions· revised December 22, 2025[1]

). 2 Recommended Dose and Dosage Adjustment The recommended SUNLENCA treatment regimen in adults consists of an initiation dosing period (oral tablets and subcutaneous injections) and twice yearly (once every 6-months) maintenance dosing (subcutaneous injections).
SUNLENCA oral tablets may be taken with or Product Monograph Page 5 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium without food. • Initiation: On treatment Day 1 and Day 2, the recommended dose of SUNLENCA is 600 mg per day (2 x 300 mg tablets) taken orally.
On treatment Day 8, the recommended dose is 300 mg taken orally. 5 mL injections) administered by subcutaneous injection. 5 mL injections) of SUNLENCA administered by subcutaneous injection every 6 months (26 weeks) from the date of last injection (+/- 2 weeks) (see Table 1).
Table 1. 5 mL injections)a a. Two injections, each at a separate site in the abdomen b. From the date of last injection. If a patient vomits within 3 hours after taking SUNLENCA tablets, the patient should take an extra oral dose, and the scheduled dosing regimen should continue.
If a patient vomits more than 3 hours after taking SUNLENCA tablets, the patient should not take an extra oral dose of SUNLENCA tablets, and the scheduled dosing regimen should continue. 1 Pediatrics). Geriatrics (> 65 years of age) No dose adjustment of SUNLENCA is required for elderly patients.
Clinical studies of SUNLENCA did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from adult patients < 65 years of age. Renal Impairment No dose adjustment of SUNLENCA is required in patients with mild, moderate, or severe renal impairment (CrCl ≥15 mL/min).
SUNLENCA has not been studied in patients with end stage renal disease (ESRD), therefore it should be administered with caution in these patients. Product Monograph Page 6 of 36 <SUNLENCA> lenacapavir* injection and tablets *as lenacapavir sodium Hepatic Impairment No dose adjustment of SUNLENCA is required in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B).
SUNLENCA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), therefore it should be administered with caution in these patients. 3 Administration SUNLENCA injection is only for subcutaneous administration into the abdomen by a health professional.

This is not medical advice. Consult a qualified healthcare professional.

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.
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).

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised February 10, 2026[2]

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.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised February 10, 2026[2]

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.
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).
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.

This is not medical advice. Consult a qualified healthcare professional.

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.
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).

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised May 4, 2026[3]

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.
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.

EUOfficial regulatory label· Warnings and precautions· revised May 4, 2026[3]

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).
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.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

CACanada· Health Canada

GBUnited Kingdom· MHRA

EUEuropean Union· EMA

Drugs in the same class

Sources & citations