Generic Name
Lenacapavir
Brand Names
Yeztugo, Sunlenca
FDA approval date: December 22, 2022
Classification: Human Immunodeficiency Virus 1 Capsid Inhibitor
Form: Tablet, Kit
What is Yeztugo (Lenacapavir)?
SUNLENCA, in combination with other antiretroviral, is indicated for the treatment of human immunodeficiency virus type 1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 whose current antiretroviral regimen is failing due to resistance, intolerance, or safety considerations. SUNLENCA, a human immunodeficiency virus type 1 capsid inhibitor, in combination with other antiretroviral, is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 whose current antiretroviral regimen is failing due to resistance, intolerance, or safety considerations.
Approved To Treat
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Brand Information
Yeztugo (LENACAPAVIR SODIUM)
1INDICATIONS AND USAGE
YEZTUGO is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating YEZTUGO
2CONTRAINDICATIONS
YEZTUGO is contraindicated in individuals with unknown or positive HIV-1 status
3ADVERSE REACTIONS
The following adverse reactions are discussed in other sections of the labeling:
- Serious Injection Site Reactions with Improper Administration
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The primary safety assessment of YEZTUGO is based on data from two randomized, double-blind, active-controlled trials, PURPOSE 1 and PURPOSE 2, in which a total of 8616 adult and adolescent participants received YEZTUGO (N=4323), DESCOVY (emtricitabine [FTC]/tenofovir alafenamide [TAF]; N=2135) once daily, or TRUVADA (FTC/tenofovir disoproxil fumarate [TDF]; N=2158) once daily for HIV-1 PrEP. In PURPOSE 1, the median duration of exposure to YEZTUGO, DESCOVY, and TRUVADA was 43, 42, and 41 weeks, respectively. In PURPOSE 2, the median duration of exposure to both YEZTUGO and TRUVADA was 39 weeks.
The most common adverse reactions (all Grades) reported in at least 5% of participants receiving YEZTUGO in either PURPOSE 1 or PURPOSE 2 were injection site reactions, headache, and nausea. In PURPOSE 1, <1% of participants in the groups receiving YEZTUGO, DESCOVY or TRUVADA, discontinued due to adverse events (all causality). In PURPOSE 2, 1% of participants in the group receiving YEZTUGO and <1% of participants receiving TRUVADA discontinued due to adverse events (all causality).
Injection-Associated Adverse Reactions
Local Injection Site Reactions (ISRs)
The most frequent adverse reactions associated with lenacapavir injection for subcutaneous use in PURPOSE 1 and PURPOSE 2 were ISRs. The most commonly reported ISRs (all grades) in at least 2% of participants who received YEZTUGO in either PURPOSE 1 or PURPOSE 2 are presented in
PURPOSE 1
In PURPOSE 1, 69% of participants receiving YEZTUGO experienced ISRs, compared to 35% of participants receiving placebo injections (and DESCOVY or TRUVADA). Most participants who received YEZTUGO had mild (Grade 1, 50%) or moderate (Grade 2, 19%) severity ISRs. Grade 3 ISRs were reported in 4 (0.2%) participants, and included ulcer and nodule. YEZTUGO was discontinued due to ISRs in 4 (0.2%) participants. None of the ISRs were serious. The incidence of reported ISRs decreased with subsequent injections.
Nodules: Injection site nodule was reported in 64% of participants who received YEZTUGO and resolved more slowly than other ISRs. The median duration of nodules associated with the first injections of YEZTUGO was 350 (interquartile range: 182, 470) days. The median of the maximum observed nodule diameter from each participant was 3.0 (interquartile range: 2.0, 3.5) cm.
Other ISRs: The other ISRs reported in more than 2% of participants who received YEZTUGO were pain (31%), swelling (4%), induration (4%), and pruritus (2%). The median duration of induration, which resolved more slowly than most other ISRs, was 173 (interquartile range: 22, 267) days. The median duration of ISRs, excluding nodules and indurations, was 9 (interquartile range: 4 to 30) days.
PURPOSE 2
In PURPOSE 2, 83% of participants receiving YEZTUGO experienced ISRs, compared to 69% of participants receiving placebo injections (and TRUVADA). Most participants had mild (Grade 1, 66%) or moderate (Grade 2, 17%) severity ISRs. Grade 3 ISRs were reported in 14 (0.6%) participants, and included ulcer, pain, erythema, edema, and dermatitis. YEZTUGO was discontinued due to ISRs in 26 (1.2%) participants. None of the ISRs were serious. The incidence of reported ISRs decreased with subsequent injections.
Nodules: Injection site nodule was reported in 63% of participants who received YEZTUGO and resolved more slowly than other ISRs. The median duration of nodules associated with the first injections of YEZTUGO was 297 (interquartile range: 176, 423) days. The median of the maximum observed nodule diameter for each participant was 3.0 (interquartile range: 2.0, 4.0) cm.
Other ISRs: The other ISRs reported in more than 2% of participants who received YEZTUGO were pain (56%), erythema (17%), induration (16%), swelling (7%), bruising (3%), pruritus (3%), and warmth (2%). The median duration of induration, which resolved more slowly than most other ISRs, was 151 (interquartile range: 15, 267) days. The median duration of ISRs, excluding nodules and indurations, was 4 (interquartile range: 2 to 8) days.
4OVERDOSAGE
No data are available on overdose of YEZTUGO. If overdose occurs, monitor the individual for evidence of toxicity. Treatment of overdose with YEZTUGO 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 bound to plasma proteins, it is unlikely to be significantly removed by dialysis.
5DESCRIPTION
YEZTUGO tablets and YEZTUGO injection contain lenacapavir sodium, a capsid inhibitor.
The chemical name of lenacapavir sodium is: Sodium (4-chloro-7-(2-((
Lenacapavir sodium has a molecular formula of C
Lenacapavir sodium is a light yellow to yellow solid and is practically insoluble in water.
6CLINICAL STUDIES
The efficacy and safety of YEZTUGO in reducing the risk of HIV-1 acquisition were evaluated in two randomized, double-blind, active-controlled, multinational trials (PURPOSE 1 and PURPOSE 2).
PURPOSE 1 was in cisgender adolescent girls and young women between 16 and 25 years of age in South Africa and Uganda who had unknown HIV-1 status at screening and who were at risk of acquiring HIV-1 based on sexual activity with male partners. Participants who tested negative for HIV-1 at screening and baseline were randomized to receive YEZTUGO (N=2134), once daily DESCOVY (N=2136), or once daily TRUVADA (N=1068) in a 2:2:1 ratio.
PURPOSE 2 was in cisgender men, transgender women, transgender men, and gender nonbinary individuals 16 years of age and older who had unknown HIV-1 status at screening and who were at risk of acquiring HIV-1 based on sexual activity with male partners. PURPOSE 2 enrolled participants in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States. Participants who tested negative for HIV-1 at screening and baseline were randomized to receive YEZTUGO (N=2179) or once daily TRUVADA (N=1086) in a 2:1 ratio.
PURPOSE 1
In PURPOSE 1, the median age of participants was 21 years (range, 16-26); and 99.9% were Black. Baseline characteristics in the randomized participants were similar to the screened population. Over 99% of YEZTUGO injections were administered into the abdomen and each dose was administered in two locations. A total of 32 pregnant participants received YEZTUGO injections into the thigh and each dose was administered bilaterally (i.e., one injection in the right thigh and one injection in the left thigh).
The efficacy endpoint was the rate of incident HIV-1 infections per 100 person-years in participants randomized to YEZTUGO compared with the rate of incident HIV-1 infections per 100 person-years in participants randomized to TRUVADA. YEZTUGO demonstrated superiority with a 100% reduction in the risk of incident HIV-1 infection over TRUVADA (
PURPOSE 2
In PURPOSE 2, the median age of participants was 29 years (range, 17-74); 67% were non White; 63% were Hispanic/Latine; and 22% identified as gender-diverse (transgender women, transgender men, and gender nonbinary people). Baseline characteristics in the randomized participants were similar to the screened population. YEZTUGO injections were administered into the abdomen and each dose was administered in two locations.
The efficacy endpoint was the rate of incident HIV-1 infections per 100 person-years in participants randomized to YEZTUGO compared with the rate of incident HIV-1 infections per 100 person-years in participants randomized to TRUVADA. YEZTUGO demonstrated superiority with an 89% reduction in the risk of incident HIV-1 infection over TRUVADA (
7PATIENT COUNSELING INFORMATION
Advise the individual to read the FDA-approved patient labeling (
8PRINCIPAL DISPLAY PANEL - 4 Tablet Bottle Label
NDC 61958-3401-1
Yeztugo
(lenacapavir) tablets
300 mg per tablet
(lenacapavir) tablets
300 mg per tablet
Talk to your healthcare provider
Your healthcare provider will tell you
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© 2025 Gilead Sciences, Inc.
© 2025 Gilead Sciences, Inc.
9PRINCIPAL DISPLAY PANEL - Kit Carton
Rx only
NDC 61958-3402-1
NDC 61958-3402-1
Yeztugo
(lenacapavir) injection
(lenacapavir) injection
463.5 mg/1.5 mL (309 mg/mL)
For Subcutaneous Injection
Contents
- 2 x 1.5 mL lenacapavir single-dose vials
- 2 withdrawal needles (18 gauge, 1½ inch)
- 2 syringes
- 2 injection needles (22 gauge, ½ inch)
- Prescribing Information
- Instructions for Use
- Patient Information
Both 463.5 mg/1.5 mL (2 single-dose vials) must be
For Healthcare Professional administration only.
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