Generic Name
Lenacapavir
Brand Names
Sunlenca, Yeztugo
FDA approval date: December 22, 2022
Classification: Human Immunodeficiency Virus 1 Capsid Inhibitor
Form: Tablet, Kit
What is Sunlenca (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
Sunlenca (LENACAPAVIR SODIUM)
1INDICATIONS AND USAGE
SUNLENCA, 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 whose current antiretroviral regimen is failing due to resistance, intolerance, or safety considerations.
2CONTRAINDICATIONS
Concomitant administration of SUNLENCA with strong CYP3A inducers is contraindicated due to decreased lenacapavir plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to SUNLENCA
3ADVERSE REACTIONS
The following adverse reactions are discussed in other sections of the labeling:
- Immune Reconstitution Syndrome
- Injection Site Reactions
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 SUNLENCA was based on data from heavily treatment-experienced adult participants with HIV who received SUNLENCA in a Phase 2/3 trial (CAPELLA; N=72) through Week 52 (median duration on study of 71 weeks)
The most common adverse reactions (all Grades) reported in at least 3% of participants in CAPELLA were nausea and injection site reactions. The proportion of participants in CAPELLA who discontinued treatment with SUNLENCA due to adverse events, regardless of severity, was 1% (Grade 1 injection site nodule in 1 participant). Table 3 displays the frequency of adverse reactions (all Grades) greater than or equal to 3% in the SUNLENCA group.
The majority (96%) of all adverse reactions associated with SUNLENCA were mild or moderate in severity.
3.2Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing use. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
4OVERDOSAGE
No data are available on overdose of SUNLENCA in patients. If overdose occurs, monitor the patient for evidence of toxicity. Treatment of overdose with SUNLENCA consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. As lenacapavir is highly bound to plasma proteins, it is unlikely to be significantly removed by dialysis.
5DESCRIPTION
SUNLENCA tablets and SUNLENCA 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 SUNLENCA in heavily treatment-experienced participants with multidrug resistant HIV-1 is based on 52-week data from CAPELLA, a randomized, placebo-controlled, double-blind, multicenter trial (NCT 04150068).
CAPELLA was conducted in 72 heavily treatment-experienced participants with multiclass resistant HIV-1. Participants were required to have a viral load ≥ 400 copies/mL, documented resistance to at least two antiretroviral medications from each of at least 3 of the 4 classes of antiretroviral medications (NRTI, NNRTI, PI and INSTI), and ≤ 2 fully active antiretroviral medications from the 4 classes of antiretroviral medications remaining at baseline due to resistance, intolerability, drug access, contraindication, or other safety concerns.
The trial was composed of two cohorts. Participants were enrolled into the randomized cohort (cohort 1, N=36) if they had a < 0.5 log
In the 14-day functional monotherapy period, participants in cohort 1 were randomized in a 2:1 ratio in a blinded fashion to receive either SUNLENCA or placebo, while continuing their failing regimen. This period was to establish the virologic activity of SUNLENCA. After the functional monotherapy period, participants who had received SUNLENCA continued on SUNLENCA along with an OBR; participants who had received placebo during this period initiated SUNLENCA along with an OBR.
Participants in cohort 1 had a mean age of 52 years (range: 24 to 71), 72% were male, 46% were White, 46% were Black, and 9% were Asian. 29% percent of participants identified as Hispanic/Latino. The mean baseline plasma HIV-1 RNA was 4.3 log
Participants in cohort 2 initiated SUNLENCA and an OBR on Day 1.
Participants in cohort 2 had a mean age of 48 years (range: 23 to 78), 78% were male, 36% were White, 31% were Black, 33% were Asian, and 14% of participants identified as Hispanic/Latino. The mean baseline plasma HIV-1 RNA was 4.1 log
The primary efficacy endpoint was the proportion of participants in cohort 1 achieving ≥ 0.5 log
The results at Weeks 26 and 52 are provided in Table 11 and Table 12.
In cohort 1, at Weeks 26 and 52, the mean change from baseline in CD4
In cohort 2, at Weeks 26 and 52, 81% (29/36) and 72% (26/36) of participants achieved HIV-1 RNA < 50 copies/mL, respectively, and the mean change from baseline in CD4
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
8PRINCIPAL DISPLAY PANEL - 300 mg Tablet Blister Pack Pouch Carton
NDC 61958-3001-1
Sunlenca
1 pouch containing 4 tablets
Each tablet contains: 300 mg of lenacapavir
Store at 20 °C - 25 °C (68 °F - 77 °F).
Dispense only in original container.
Recommended Dosage: See prescribing information.
KEEP OUT OF THE REACH OF CHILDREN
GILEAD
Manufactured for:
© 2022 Gilead Sciences, Inc.
9PRINCIPAL DISPLAY PANEL - 5 Tablet Blister Pack Pouch Carton
NDC 61958-3001-2
Sunlenca
1 pouch containing 5 tablets
Each tablet contains: 300 mg of lenacapavir
Store at 20 °C - 25 °C (68 °F - 77 °F).
Dispense only in original container.
Recommended Dosage: See prescribing information.
KEEP OUT OF THE REACH OF CHILDREN
Talk to your healthcare provider before taking
Your healthcare provider will tell you when to take
GILEAD
Manufactured for:
© 2022 Gilead Sciences, Inc.
10PRINCIPAL DISPLAY PANEL - 4 Tablet Bottle Label
NDC 61958-3001-3
Sunlenca
Talk to your healthcare provider
Your healthcare provider will tell you
11PRINCIPAL DISPLAY PANEL - Kit Carton
R
Sunlenca
463.5 mg/1.5 mL (309 mg/mL)
For Subcutaneous Injection
Contents
- 2 x 1.5 mL lenacapavir single-dose vials
- 2 vial access devices
- 2 syringes
- 2 injection needles (22 gauge, 1/2 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.
GILEAD
12PRINCIPAL DISPLAY PANEL - Kit Carton - 3005
R
NDC 61958-3005-1
NDC 61958-3005-1
Sunlenca
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.
GILEAD
