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Sunlenca LENACAPAVIR SODIUM Kit — NDC 61958-3002-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sunlenca LENACAPAVIR SODIUM Kit — NDC 61958-3002-1 (Billing 61958-3002-01)

by Gilead Sciences, Inc. · 1 KIT in 1 CARTON * 1.5 mL in 1 VIAL

This is a package of Sunlenca LENACAPAVIR SODIUM Kit from Gilead Sciences, Inc., marketed since Dec 2022 and currently FDA-listed. It is this product's only package size.

NDC 61958-3002-01
🏷️ FDA NDC (as labeled) 61958-3002-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 61958-3002-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61958 labeler · 3002 product · 1 package
Package marketed since
Dec 22, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6195830021 6
Medicaid fills, this package
83 prescriptions in the last four reported quarters
FDA record last changed
Sep 17, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61958-3002-1
Product NDC 61958-3002
11-digit billing NDC 61958300201
NCPDP billing unit ML — per mL (volume)
RxCUI 2625890, 2625896, 2625897, 2625898, 2625899, 2625900, 2625904, 2625909,
UNII BDT58WJ9WE
Application # NDA215973
SPL Set ID e5652804-29c4-40d7-aeb2-0142ed2a7b5b
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-12-22
Dosage form KIT

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 084227
GCN 53433
HICL code 048555
Ingredient (HICL) Lenacapavir Sodium
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W0
Therapeutic class — intermediate (HIC2) Antiviral Agents (Continued 1)
HIC3 code W0N
Therapeutic class — specific (HIC3) Antiretroviral - Capsid Inhibitors
AHFS code 08:18.08.24
AHFS class Hiv Capsid Inhibitors
FDB label name SUNLENCA 463.5 MG/1.5 ML VIAL
FDB brand name Sunlenca
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 084227
  • GCN: 53433
  • HICL (First Databank): 048555
  • AHFS class code: 08:18.08.24
  • RxCUI (RxNorm): 2625890
Why two NDCs? The FDA registers this code as 61958-3002-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 61958-3002-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Human Immunodeficiency Virus 1 Capsid Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus 1 Capsid Inhibitor
Drug family (ATC) Other antivirals
How it works P-Glycoprotein Inhibitors, Breast Cancer Resistance Protein Inhibitors, Cytochrome P450 3A Inhibitors, HIV Capsid Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name SUNLENCA 463.5 MG/1.5 ML VIAL Ingredient Lenacapavir Sodium
📖 What it is MedlinePlus · NLM

Lenacapavir injection is used to treat human immunodeficiency virus (HIV). Lenacapavir is also used along with practicing safer sex (e.g., condom use) to reduce the risk of HIV infection. Lenacapavir is in a class of medications called HIV capsid inhibitors. It works by decreasing the amount of HIV in the blood. Although lenacapavir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of giving the HIV v...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the brand. Sunlenca is used with other HIV medicines to treat HIV-1 in people whose HIV is resistant to many drugs. Yeztugo is used for PrEP to lower the risk of gett...
  • Yes. Lenacapavir tablets can be taken with or without food. Follow your prescriber's schedule closely.
  • If you miss the Day 2 tablets, take them as soon as you can. Do not take the Day 1 and Day 2 doses on the same day. Call your provider if you are unsure.
  • Headache and nausea are the most common, along with injection site reactions with Yeztugo. Call right away for severe skin problems at the injection site or flu-like symptoms such...
📖 Read our full Lenacapavir Oral guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $14,149.82 —
Medicare drug plans payPart D · Q2 2026 $812.00 —
Medicare Part B allowsASP · J1961 $22.936 / J1961 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)61958-3002-1
11-digit billing NDC61958-3002-01
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ1961
DescriptorINJECTION, LENACAPAVIR, 1 MG
Billing units / pkg309 units
How the units are derivedThis package is 1.5 ML; the HCPCS unit is 1 MG, so one package = 309 billing units.
Medicare Part B spend (2026 (Q1))$395,809 · 26 claims · $15,223.41 per claim (all NDCs under J1961)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61958-3002-01 You're viewing this Main listing 1 KIT in 1 CARTON * 1.5 mL in 1 VIAL 2022-12-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sunlencathis 61958-3002-01 Gilead 1 kit — — FDA listed —
Sunlenca 61958-3005-01 Gilead 1 kit — — FDA listed —
Yeztugo 61958-3402-01 Gilead 1 kit — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
First FDA approval
Dec 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 22, 2022 RLD RS ⏳ ~14.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11944611 — method of use (U-3507)
US 10654827 — method of use (U-3507)
US 9951043 — drug substance (U-3507)
US 12594267 — drug product
US 10071985 — drug substance
US 11267799 — drug substance
Exclusivity NCE
2022 2024 2026 2028 2030 2032 2034 2036 2038 2040
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (6)
PatentTypeUse codeExpires
US 11944611 ↗ Method of use U-3507 Aug 28, 2041
US 10654827 ↗ Method of use U-3507 Aug 17, 2037
US 9951043 ↗ Drug substance U-3507 Feb 28, 2034
US 12594267 ↗ Drug product — Jul 15, 2039
US 10071985 ↗ Drug substance — Aug 17, 2037
US 11267799 ↗ Drug substance — Aug 16, 2038
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Dec 22, 2027
Common questions
Is there a generic version of SUNLENCA 463.5 MG/1.5 ML VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for SUNLENCA 463.5 MG/1.5 ML VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Aug 2041 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Brown / Yellow
ShapeOval
ImprintGSI;62L
Size21 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Lenacapavir Oral inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

The FDA label contains product information, but this exact NDC could not be matched safely to one product block. We intentionally withheld sibling strengths’ ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGilead Sciences, Inc.
Application holderGILEAD SCIENCES INC
FDA applicationNDA215973 (NDA)
Labeler code61958
First marketedDec 2022
Product typeHuman Prescription Drug
Portfolio42 products on file

More NDCs from Gilead Sciences, Inc. labeler code 61958

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE SUNLENCA, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, is indicated: in combination with other antiretroviral(s), 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. ( 1.1 ) for oral loading as a component of the initiation regimen for BIXLENVO (bictegravir [BIC]/lenacapavir [LEN]), a complete regimen for the treatment of HIV-1 infection, in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO.

( 1.2 )

1.1Treatment of HIV-1 in Heavily Treatment-Experienced Adults 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.

1.2Oral Loading for Initiation of BIXLENVO SUNLENCA tablets are indicated for oral loading as a component of the initiation regimen for BIXLENVO (bictegravir [BIC]/lenacapavir [LEN]), a complete regimen for treatment of HIV-1 infection, in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO [see Dosage and Administration (2.3) ] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage in heavily treatment-experienced adults: Initiation with one of two options followed by once every 6 months maintenance injection dosing. Tablets may be taken without regard to food. ( 2.2 ) Initiation Option 1 Day 1 927 mg by subcutaneous injection (2 × 1.5 mL injections) 600 mg orally (2 × 300 mg tablets) Day 2 600 mg orally (2 × 300 mg tablets) Initiation Option 2 Day 1 600 mg orally (2 × 300 mg tablets) Day 2 600 mg orally (2 × 300 mg tablets) Day 8 300 mg orally (1 × 300 mg tablet) Day 15 927 mg by subcutaneous injection (2 × 1.5 mL injections) Maintenance 927 mg by subcutaneous injection (2 × 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection +/-2 weeks.

Recommended dosage for oral loading for initiation of BIXLENVO: Refer to Table 3 of the full prescribing information for dosing schedule. ( 2.3 ) Planned missed injections: If scheduled injection is to be missed by more than 2 weeks, SUNLENCA tablets may be used for oral bridging for up to 6 months until injections resume. Recommended dosage is 300 mg orally once every 7 days.

( 2.4 ) Unplanned missed injections: If more than 28 weeks have elapsed since last injection and tablets have not been taken for oral bridging, restart initiation from Day 1 (using Option 1 or Option 2) if clinically appropriate. ( 2.4 ) SUNLENCA injection is for subcutaneous administration only. Two 1.5 mL injections are required for complete dose.

( 2.5 )

2.1Adherence to Treatment Regimen in Heavily Treatment-Experienced Adults Prior to starting SUNLENCA for the treatment of HIV-1 in heavily treatment-experienced adults, healthcare providers should carefully select patients who agree to the required every 6 month injection dosing schedule and counsel patients about the importance of adherence to scheduled SUNLENCA dosing visits and concomitant oral antiretroviral therapy to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses [see Warnings and Precautions (5.2) , Microbiology (12.4) ] .

2.2Recommended Dosage for Treatment of HIV-1 in Heavily Treatment-Experienced Adults SUNLENCA can be initiated using one of the two recommended dosage regimens in Table 1 and Table 2 below. Maintenance dosing is administered by subcutaneous injection every 6 months regardless of the initiation regimen. Healthcare providers should determine the appropriate initiation regimen for the patient.

SUNLENCA oral tablets may be taken with or without food [see Clinical Pharmacology (12.3) ] . Table 1 Recommended Treatment Regimen for SUNLENCA Initiation and Maintenance for Treatment of HIV-1 in Heavily Treatment-Experienced Adults, Option 1 Treatment Time Dosage of SUNLENCA: Initiation Day 1 927 mg by subcutaneous injection (2 × 1.5 mL injections) and 600 mg orally (2 × 300 mg tablets) Day 2 600 mg orally (2 × 300 mg tablets) Dosage of SUNLENCA: Maintenance Every 6 months (26 weeks) From the date of the last injection. +/-2 weeks 927 mg by subcutaneous injection (2 × 1.5 mL injections) Table 2 Recommended Treatment Regimen for SUNLENCA Initiation and Maintenance for Treatment of HIV-1 in Heavily Treatment-Experienced Adults, Option 2 Treatment Time Dosage of SUNLENCA: Initiation Day 1 600 mg orally (2 × 300 mg tablets) Day 2 600 mg orally (2 × 300 mg tablets) Day 8 300 mg orally (1 × 300 mg tablet) Day 15 927 mg by subcutaneous injection (2 × 1.5 mL injections) Dosage of SUNLENCA: Maintenance Every 6 months (26 weeks) From the date of the last injection. +/-2 weeks 927 mg by subcutaneous injection (2 × 1.5 mL injections)

2.3Recommended Dosage for Oral Loading for Initiation of BIXLENVO SUNLENCA tablets are used as a component of the initiation regimen for BIXLENVO. See BIXLENVO prescribing information. The BIXLENVO dosing schedule in adults requires a two-day initiation regimen of BIXLENVO tablets plus SUNLENCA tablets taken orally, followed by a maintenance regimen of one… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 81 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 300 mg Injection: 463.5 mg/1.5 mL (309 mg/mL) in single-dose vials. ( 3 ) SUNLENCA tablets: Each tablet contains 300 mg of lenacapavir. The tablets are beige, capsule-shaped, film-coated, and debossed with 'GSI' on one side of the tablet and '62L' on the other side of the tablet.

SUNLENCA injection: Each single-dose vial contains 463.5 mg/1.5 mL (309 mg/mL) of lenacapavir. The lenacapavir injectable solution is sterile, preservative-free, clear, and yellow with no visible particles.

⛔ Contraindications 52 words ▾

4 CONTRAINDICATIONS 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 [see Drug Interactions (7.1) ] . Concomitant administration of SUNLENCA is contraindicated with strong CYP3A inducers. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Immune reconstitution syndrome: May necessitate further evaluation and treatment. ( 5.1 ) Residual concentrations of lenacapavir may remain in systemic circulation for up to 12 months or longer. Counsel patients regarding the dosing schedule; non-adherence could lead to loss of virologic response and development of resistance.

( 5.2 ) May increase exposure and risk of adverse reactions to drugs primarily metabolized by CYP3A initiated within 9 months after the last subcutaneous dose of SUNLENCA. ( 5.2 ) If discontinued, initiate an alternative, fully suppressive antiretroviral regimen where possible no later than 28 weeks after the final injection of SUNLENCA. If virologic failure occurs, switch to an alternative regimen if possible.

( 5.2 ) Injection site reactions may occur, and nodules and indurations may be persistent. Improper administration (intradermal injection) has been associated with serious injection site reactions. ( 5.3 )

5.1Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

5.2Long-Acting Properties and Potential Associated Risks with SUNLENCA Residual concentrations of lenacapavir may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer after the last subcutaneous dose). It is important to counsel patients that maintenance dosing by injection is required every 6 months, because missed doses or non-adherence to injections could lead to loss of virologic response and development of resistance [see Dosage and Administration (2.1) ] . Lenacapavir, a moderate CYP3A inhibitor, may increase the exposure to, and therefore potential risk of adverse reactions from, drugs primarily metabolized by CYP3A initiated within 9 months after the last subcutaneous dose of SUNLENCA [see Drug Interactions and Clinical Pharmacology (7.2 , 12.3) ] .

If SUNLENCA is discontinued, to minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen where possible no later than 28 weeks after the final injection of SUNLENCA. If virologic failure occurs during treatment, switch the patient to an alternative regimen if possible [see Dosage and Administration (2.1) ].

5.3Injection Site Reactions Administration of SUNLENCA may result in local injection site reactions (ISRs). If clinically significant ISRs occur, evaluate and institute appropriate therapy and follow-up. Manifestations of ISRs may include swelling, pain, erythema, nodule, induration, pruritus, extravasation or mass.

Nodules and indurations at the injection site may take longer to resolve than other ISRs. In clinical studies, after a median follow-up of 553 days, 30% of nodules and 13% of indurations (in 10% and 1% of participants, respectively) associated with the first injections of SUNLENCA had not fully resolved. Measurements and qualitative assessments of ISRs were not routinely reported.

Where described, the majority of the injection site nodules and indurations were palpable but not visible, and had a maximum size of approximately 1 to 4 cm [see Adverse Reactions (6.1) ] . The mechanism driving the persistence of injection site nodules and indurations in some patients is not fully understood, but b… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Immune Reconstitution Syndrome [see Warnings and Precautions (5.1) ] Injection Site Reactions [see Warnings and Precautions (5.3) ]. Most common adverse reactions (incidence greater than or equal to 3%, all grades) are nausea and injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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. Treatment of HIV-1 in Heavily Treatment-Experienced Adults 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) [see Clinical Studies (14.1) ] , as well as supportive data in treatment-naïve adult participants with HIV who received SUNLENCA in a Phase 2 trial (CALIBRATE; N=157) through Week 54 (median duration of exposure of 66 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 6 displays the frequency of adverse reactions (all Grades) greater than or equal to 3% in the SUNLENCA group.

Table 6 Adverse Reactions (All Grades) Reported in ≥ 3% Frequencies of adverse reactions are based on all adverse events attributed to trial drug by the investigator, based on all participants (cohorts 1 and 2) in CAPELLA. of Heavily Treatment Experienced Adults with HIV-1 Receiving SUNLENCA in CAPELLA (Week 52 Analysis) Adverse Reactions SUNLENCA + Background Regimen (N=72) Injection Site Reactions 65% Nausea 4% The majority (96%) of all adverse reactions associated with SUNLENCA were mild or moderate in severity. Injection-Associated Adverse Reactions Local Injection Site Reactions (ISRs) : The most frequent adverse reactions were ISRs.

Of the 72 participants in CAPELLA, 65% had experienced an ISR attributed to study drug through at least the Week 52 visit. Most participants had mild (Grade 1, 44%) or moderate (Grade 2, 17%) ISRs. Four percent of participants experienced a severe (Grade 3) ISR (erythema, pain, swelling) that resolved within 15 days.

The ISRs reported in more than 1% of participants were swelling (36%), pain (31%), erythema (31%), nodule (25%), induration (15%), pruritus (6%), extravasation (3%) and mass (3%). ISRs reported in 1% of participants included discomfort, hematoma, edema, and ulcer. Nodules and indurations at the injection site took longer to resolve than other ISRs.

The median time to resolution of all ISRs, excluding nodules and indurations, was 5 days (range: 1 to 183). The median time to resolution of nodules and indurations associated with the first injections of SUNLENCA was 148 (range: 41 to 727) and 70 (range: 3 to 252) days, respectively. After a median follow up of 553 days, 30% of nodules and 13% of indurations (in 10% and 1% of participants, respectively) associated with the first injections of SUNLENCA had not fully resolved.

Qualitative descriptions of injection site nodules and indurations were not routinely reported, but, where reported, the majority of injection site nodules and indurations were palpable but not visible. Measurements of injection site nodules and indurations were not routinely performed or standardized, but where measurements were reported, the maximum size for the majority of injection site nodules and indurations was approximately 1 to… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Consult the Full Prescribing Information prior to and during treatment for important drug interactions. ( 4 , 7 , 12.3 )

7.1Effect of Other Drugs on SUNLENCA Lenacapavir is a substrate of P-gp, UGT1A1, and CYP3A. Strong or Moderate CYP3A Inducers Drugs that are strong or moderate inducers of CYP3A may significantly decrease plasma concentrations of lenacapavir [see Clinical Pharmacology (12.3) ] , which may result in loss of therapeutic effect of SUNLENCA and development of resistance. Concomitant administration of SUNLENCA with strong CYP3A inducers during SUNLENCA treatment is contraindicated [see Contraindications (4) ] .

Concomitant administration of SUNLENCA with moderate CYP3A inducers during SUNLENCA treatment is not recommended. Combined P-gp, UGT1A1, and Strong CYP3A Inhibitors Combined P-gp, UGT1A1, and strong CYP3A inhibitors may significantly increase plasma concentrations of SUNLENCA. Concomitant administration of SUNLENCA with these inhibitors is not recommended.

7.2Effect of SUNLENCA on Other Drugs Lenacapavir is a moderate inhibitor of CYP3A. Due to the long half-life of lenacapavir following subcutaneous administration, SUNLENCA may increase the exposure of drugs primarily metabolized by CYP3A [see Clinical Pharmacology (12.3) ] initiated within 9 months after the last subcutaneous dose of SUNLENCA, which may increase the potential risk of adverse reactions. See the prescribing information of the sensitive CYP3A substrate for dosing recommendations with moderate inhibitors of CYP3A.

7.3Established and Other Potentially Significant Drug Interactions Table 8 provides a listing of clinically significant drug interactions with recommended prevention or management strategies, but is not all inclusive. The drug interactions described are based on studies conducted with SUNLENCA or are drug interactions that may occur with SUNLENCA [see Contraindications (4) and Clinical Pharmacology (12.3) ] . Table 8 Drug Interactions with SUNLENCA Concomitant Drug Class: Drug Name Effect on Concentration ↑ = Increase, ↓ = Decrease.

Clinical Comment Antiarrhythmics: digoxin ↑ digoxin Use with caution and monitor digoxin therapeutic concentration. Anticoagulants: Direct Oral Anticoagulants (DOACs) rivaroxaban dabigatran edoxaban ↑ DOAC Refer to the DOAC prescribing information for concomitant administration with moderate CYP3A inhibitors and/or P-gp inhibitors. Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin ↓ lenacapavir Concomitant administration of carbamazepine, oxcarbazepine, phenobarbital, or phenytoin may result in loss of therapeutic effect and development of resistance.

Concomitant administration of SUNLENCA with carbamazepine or phenytoin is contraindicated. Concomitant administration of SUNLENCA with oxcarbazepine or phenobarbital is not recommended. Consider use of alternative anticonvulsants.

Antiretroviral Agents: atazanavir/cobicistat Drug-drug interaction study was conducted. atazanavir/ritonavir ↑ lenacapavir (atazanavir/cobicistat, atazanavir/ritonavir) Concomitant administration of efavirenz, nevirapine, or tipranavir/ritonavir may result in loss of therapeutic effect and development of resistance. efavirenz nevirapine tipranavir/ritonavir ↓ lenacapavir (efavirenz, nevirapine, tipranavir/ritonavir) Concomitant administration with atazanavir/cobicistat, atazanavir/ritonavir, efavirenz, nevirapine, or tipranavir/ritonavir is not recommended.

Antimycobacterials: rifabutin rifampin rifapentine ↓ lenacapavir Concomitant administration of rifabutin, rifampin and rifapentine may result in loss of therapeutic effect and development of resistance. Concomitant administration of SUNLENCA with rifampin is contraindicated [see Contraindications (4) ] . Concomitant administration of SUNLENCA with rifabutin or rifapentine is not recommended.

Corticosteroids (systemic): cortisone/hydrocortisone dexamethasone ↑ corticosteroids (systemic) Concomitant administration with systemic corticost… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to SUNLENCA during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from a randomized, controlled trial with lenacapavir use during pregnancy in individuals without HIV-1 have not identified a drug-associated risk for miscarriage, or adverse maternal or fetal outcomes when compared to an active control (see Data ) .

The rate of major birth defects in lenacapavir-exposed pregnancies did not exceed the background prevalence rates. The risk estimates are imprecise due to small numbers of exposed pregnancies (see Data ) . In animal reproduction studies, no adverse developmental effects were observed when lenacapavir was administered to rats and rabbits at exposures (AUC) ≥16 times the exposure in humans at the recommended human dose (RHD) of SUNLENCA (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. The background rate of major birth defects in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) is 2.7%. The rate of miscarriage is not reported in the APR.

The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15 to 20%. Data Human Data In a randomized, controlled trial of individuals without HIV-1 in Uganda and South Africa, there were 208 pregnancies exposed to lenacapavir with known outcomes and 132 deliveries (both live and non-live). In the active control arm of this trial, there were 109 pregnancies with known outcomes and 61 deliveries (both live and non-live).

The adverse pregnancy outcomes of spontaneous abortion, stillbirth, preterm birth, and small for gestational age were similar across both treatment groups. There were two major birth defects in the lenacapavir arm. Both were ventricular septal defects.

This resulted in a rate of major birth defects that fell within the background prevalence rate for major birth defects. Concentrations of lenacapavir during each trimester of pregnancy and postpartum were comparable to those in non-pregnant participants. Animal Data Lenacapavir was administered intravenously to pregnant rabbits (up to 20 mg/kg/day on gestation days (GD) 7 to 19), orally to rats (up to 300 mg/kg/day on GD 6 to 17), and subcutaneously to rats (up to 300 mg/kg on GD 6).

No significant toxicological effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed at exposures (AUC) approximately 16 times (rats) and 39 times (rabbits) the exposure in humans at the RHD of SUNLENCA.

8.2Lactation Risk Summary Lenacapavir is present in human milk. Lenacapavir was detected at very low levels in infants who were breastfed by individuals who became pregnant while receiving lenacapavir (see Data ) . No adverse effects of lenacapavir in breastfed infants have been observed.

It is not known if lenacapavir affects milk production. Potential risks of breastfeeding include: (1) HIV-1 transmission (in infants without HIV-1), (2) developing viral resistance (in infants with HIV-1), and (3) adverse reactions in a breastfed infant similar to those seen in adults. Data Human data The median lenacapavir concentration in human breast milk to maternal plasma ratio in participants (n=8) who received lenacapavir was 0.63 (range: 0.29 to 1.90).

The median infant-to-mother plasma ratio for lenacapavir in infants (n=10) who were breastfed by individuals receiving lenacapavir from 0 to less than 13 weeks after delivery was 0.06 (range: 0.01 to 0.20).

8.4Pediatric Use The safety and effectiveness of SUNLENCA have not been established in pediatric patients.

8.5Geriatric Use Clinical studies of SUNLENCA did not include sufficient numbers of participants aged 65 an… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to SUNLENCA during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from a randomized, controlled trial with lenacapavir use during pregnancy in individuals without HIV-1 have not identified a drug-associated risk for miscarriage, or adverse maternal or fetal outcomes when compared to an active control (see Data ) .

The rate of major birth defects in lenacapavir-exposed pregnancies did not exceed the background prevalence rates. The risk estimates are imprecise due to small numbers of exposed pregnancies (see Data ) . In animal reproduction studies, no adverse developmental effects were observed when lenacapavir was administered to rats and rabbits at exposures (AUC) ≥16 times the exposure in humans at the recommended human dose (RHD) of SUNLENCA (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. The background rate of major birth defects in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) is 2.7%. The rate of miscarriage is not reported in the APR.

The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15 to 20%. Data Human Data In a randomized, controlled trial of individuals without HIV-1 in Uganda and South Africa, there were 208 pregnancies exposed to lenacapavir with known outcomes and 132 deliveries (both live and non-live). In the active control arm of this trial, there were 109 pregnancies with known outcomes and 61 deliveries (both live and non-live).

The adverse pregnancy outcomes of spontaneous abortion, stillbirth, preterm birth, and small for gestational age were similar across both treatment groups. There were two major birth defects in the lenacapavir arm. Both were ventricular septal defects.

This resulted in a rate of major birth defects that fell within the background prevalence rate for major birth defects. Concentrations of lenacapavir during each trimester of pregnancy and postpartum were comparable to those in non-pregnant participants. Animal Data Lenacapavir was administered intravenously to pregnant rabbits (up to 20 mg/kg/day on gestation days (GD) 7 to 19), orally to rats (up to 300 mg/kg/day on GD 6 to 17), and subcutaneously to rats (up to 300 mg/kg on GD 6).

No significant toxicological effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed at exposures (AUC) approximately 16 times (rats) and 39 times (rabbits) the exposure in humans at the RHD of SUNLENCA.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of SUNLENCA have not been established in pediatric patients.

🧓 Geriatric Use 27 words ▾

8.5Geriatric Use Clinical studies of SUNLENCA did not include sufficient numbers of participants aged 65 and over to determine whether they respond differently from younger patients.

🆘 Overdosage 65 words ▾

10 OVERDOSAGE 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action SUNLENCA is an HIV-1 antiretroviral agent [see Microbiology (12.4) ] .

12.2Pharmacodynamics Exposure-Response In CAPELLA, oral loading doses (600 mg on Day 1 and Day 2, 300 mg on Day 8) followed by subcutaneous doses (927 mg every 6 months starting on Day 15) of SUNLENCA in heavily treatment-experienced participants with multiclass resistant HIV-1, efficacy outcomes (change in plasma HIV-1 RNA from Day 1 to Day 14, and percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 26) were similar across the range of observed lenacapavir exposures. Cardiac Electrophysiology At supratherapeutic exposures of lenacapavir (9-fold higher than the therapeutic exposures of SUNLENCA), SUNLENCA does not prolong the QTcF interval to any clinically relevant extent.

12.3Pharmacokinetics The pharmacokinetic (PK) properties of lenacapavir are provided in Table 9 . The PK parameter estimates of SUNLENCA after oral and subcutaneous administration in heavily-treatment experienced participants with HIV-1 are provided in Table 10 . The estimated lenacapavir exposures are comparable between the two recommended dosing regimens.

Table 9 Pharmacokinetic Properties of Lenacapavir Oral Subcutaneous Absorption % Absolute bioavailability 6 to 10 100 Values reflect absolute bioavailability following subcutaneous administration of the 927 mg dose. T max Values reflect administration of lenacapavir with or without food. 4 hours 77 to 84 days Due to slow release from the site of subcutaneous administration, the absorption profile of subcutaneously administered lenacapavir is complex.

Effect of Food Effect of low-fat meal (relative to fasting) Values refer to geometric mean ratio [low-fat meal/fasting] in PK parameters and (90% confidence interval). Low fat meal is approximately 400 kcal, 25% fat. AUC inf ratio 98.6 (58.2,167.2) - C max ratio 115.8 (55.4, 242.1) - Effect of high-fat meal (relative to fasting) Values refer to geometric mean ratio [high-fat meal/fasting] in PK parameters and (90% confidence interval).

High fat meal is approximately 1000 kcal, 50% fat. AUC inf ratio 115.2 (72.0, 184.5) - C max ratio 145.2 (77.9, 270.5) - Distribution Apparent volume of distribution (Vd/F, L) 19240 9500 to 11700 % bound to human plasma proteins >98.5 Blood-to-plasma ratio 0.5 to

0.7Values reflect the blood-to-plasma ratio of lenacapavir following a single dose intravenous administration of [ 14 C] lenacapavir through 336 hours postdose. Elimination t 1/2 10 to 12 days 8 to 12 weeks Clearance (mean apparent clearance, L/h) 55 4.2 % of dose of unchanged drug in plasma Dosing in mass balance studies: single dose intravenous administration of [ 14 C] lenacapavir to participants without HIV-1. 69 Metabolism Metabolic pathway(s) CYP3A (minor) UGT1A1 (minor) Excretion Major routes of elimination Excretion of unchanged drug into feces Metabolized via oxidation, N-dealkylation, hydrogenation, amide hydrolysis, glucuronidation, hexose conjugation, pentose conjugation, and glutathione conjugation; primarily via CYP3A and UGT1A1 and no single circulating metabolite accounted for >10% of plasma drug-related exposure. % of dose excreted in urine <1 % of dose excreted in feces (% unchanged) 76 (33) Table 10 Lenacapavir Exposures Following Oral and Subcutaneous Administration of SUNLENCA in Heavily Treatment Experienced Participants with HIV-1 Parameter Mean (%CV) Recommended Dosing Regimen, Option 1 Predicted exposures utilizing population PK analysis.

Recommended Dosing Regimen, Option 2 Day 1: 600 mg (oral) + 927 mg (SC) Day 2: 600 mg (oral) Days 1 and 2: 600 mg (oral), Day 8: 300 mg (oral), Day 15: 927 mg (SC) Day 1 to end of Month 6 Days 1 to 15 Day 15 to end of Month 6 CV = coefficient of variation; NA = not applicable; SC = subcutaneous C max (ng/mL) 101.4 (53.1) 88.0 (72.4) 86.5 (51.7) AUC tau (h∙ng/mL) 242266 (46.0) 19496 (72.6) 239163 (47.2) C trough (ng/mL) 32.5 (57.2) 46.9 (72.3) 32.5 (57.5) Lenacapavir… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action SUNLENCA is an HIV-1 antiretroviral agent [see Microbiology (12.4) ] .

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING SUNLENCA tablets, 300 mg are beige, capsule-shaped, and film-coated with "GSI" debossed on one side and "62L" on the other side. SUNLENCA tablets are available in a bottle and blister packs, packaged as follows: Bottle SUNLENCA bottle contains 4 tablets (NDC 61958-3001-3). The bottle also contains a silica gel desiccant and polyester coil, and is closed with a child-resistant closure.

Do not remove the desiccant packet. Keep bottle tightly closed. Blister Packs SUNLENCA 4-Tablets™ blister pack contains 4 tablets (NDC 61958-3001-1) SUNLENCA 5-Tablets™ blister pack contains 5 tablets (NDC 61958-3001-2) Within the blister packs, tablets are packaged in a clear blister film sealed to a foil lidding material.

The blister card is fitted between two paperboard cards, and packaged with silica gel desiccant in a sealed child-resistant flexible laminated pouch. Store bottle and blister packs at 20 °C – 25 °C (68 °F – 77 °F), excursions permitted to 15 °C – 30 °C (59 °F – 86 °F) (see USP Controlled Room Temperature). Dispense and store only in original bottle or blister pack.

SUNLENCA injection is packaged in one of two different injection kits containing the following: Vial Access Device Injection Kit (NDC 61958-3002-1): 2 single-dose clear glass vials, each containing sufficient volume to allow withdrawal of 463.5 mg/1.5 mL (309 mg/mL) of lenacapavir. The injection solution is sterile, preservative-free, clear, and yellow with no visible particles. Vials are sealed with a stopper and aluminium overseal with flip-off cap.

2 vial access devices, 2 disposable syringes, and 2 injection safety needles for subcutaneous injection (22-gauge, ½ inch). Withdrawal Needle Injection Kit (NDC 61958-3005-1): 2 single-dose clear glass vials, each containing sufficient volume to allow withdrawal of 463.5 mg/1.5 mL (309 mg/mL) of lenacapavir. The injection solution is sterile, preservative-free, clear, and yellow with no visible particles.

Vials are sealed with a stopper and aluminium overseal with flip-off cap. 2 disposable syringes, 2 withdrawal needles (18-gauge, 1.5 inch; may be supplied with or without a safety shield), and 2 injection safety needles for subcutaneous injection (22-gauge, ½ inch). The vial stoppers are not made with natural rubber latex.

Store at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). Keep the vials in the original carton until just prior to preparation of the injections in order to protect from light. Once the solution has been drawn into the syringes, the injections should be administered as soon as possible.

Discard any unused portion of the solution.

📦 Storage and Handling 115 words ▾

Store bottle and blister packs at 20 °C – 25 °C (68 °F – 77 °F), excursions permitted to 15 °C – 30 °C (59 °F – 86 °F) (see USP Controlled Room Temperature). Dispense and store only in original bottle or blister pack.

Store at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). Keep the vials in the original carton until just prior to preparation of the injections in order to protect from light. Once the solution has been drawn into the syringes, the injections should be administered as soon as possible. Discard any unused portion of the solution.

📋 Description 210 words ▾

11 DESCRIPTION SUNLENCA tablets and SUNLENCA injection contain lenacapavir sodium, a capsid inhibitor. The chemical name of lenacapavir sodium is: Sodium (4-chloro-7-(2-(( S )-1-(2-((3b S ,4a R )-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1 H -cyclopropa[3,4]cyclopenta[1,2- c ]pyrazol-1-yl)acetamido)-2-(3,5-difluorophenyl)ethyl)-6-(3-methyl-3-(methylsulfonyl)but-1-yn-1-yl)pyridin-3-yl)-1-(2,2,2-trifluoroethyl)-1 H -indazol-3-yl)(methylsulfonyl)amide. Lenacapavir sodium has a molecular formula of C 39 H 31 ClF 10 N 7 NaO 5 S 2, a molecular weight of 990.3, and the following structural formula: Lenacapavir sodium is a light yellow to yellow solid and is practically insoluble in water.

Chemical Structure SUNLENCA tablets are for oral administration. Each film-coated tablet contains 300 mg of lenacapavir (present as 306.8 mg lenacapavir sodium) and the following inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, and poloxamer 407. The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

SUNLENCA injection is for subcutaneous administration. Each single-dose vial contains 463.5 mg/1.5 mL (309 mg/mL) of lenacapavir (present as 473.1 mg/1.5 mL of lenacapavir sodium) as a sterile, preservative-free, clear, yellow solution and the following inactive ingredients: 896.3 mg of polyethylene glycol 300 (as solvent) and water for injection. The apparent pH range of the injection is 9.0–10.2.

The vial stoppers are not made with natural rubber latex.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Drug Interactions SUNLENCA may interact with certain drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or non-prescription medication or herbal products, including St. John's wort, during treatment with SUNLENCA [see Contraindications (4) and Drug Interactions (7) ] .

If SUNLENCA is discontinued, advise patients that SUNLENCA may remain in the body and affect certain other drugs for up to 9 months after receiving their last injection [see Drug Interactions (7.2 , 7.3) ]. Immune Reconstitution Syndrome Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.1) ] .

Adherence to SUNLENCA Counsel patients about the importance of continued medication adherence and scheduled visits to maintain viral suppression and to reduce risk of loss of virologic response and development of resistance. Advise patients to contact their healthcare provider immediately if they stop taking SUNLENCA or any other drug in their antiretroviral regimen [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] . Missed Injection Dose: Treatment of HIV-1 in Heavily Treatment-Experienced Adults Inform patients that SUNLENCA can remain in the body for up to 12 months or longer after receiving their last injection.

Advise patients to contact their healthcare provider if they miss or plan to miss a scheduled injection visit and that oral SUNLENCA therapy may be used for up to 6 months to replace missed injections. Advise patients that oral dosing should be used on an interim basis only and that the maintenance injection dosage should be resumed at the earliest possible opportunity [see Dosage and Administration (2.2 , 2.4) and Warnings and Precautions (5.2) ] . Missed Oral Initiation Dose: Oral Loading for Initiation of BIXLENVO Inform patients that if they miss one of the two days of oral initiation doses of SUNLENCA given with BIXLENVO to take it as soon as possible [see Dosage and Administration (2.4) ].

Injection Site Reactions Inform patients that injection site reactions (ISRs), such as swelling, pain, erythema, nodule, induration, pruritus, extravasation or mass, may occur. Nodules and indurations at the injection site may take longer to resolve than other ISRs and may be persistent. Instruct patients when to contact their healthcare provider about these reactions [see Warnings and Precautions (5.3) ].

Pregnancy Registry Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant individuals exposed to SUNLENCA [see Use in Specific Populations (8.1) ]. Lactation Inform individuals with HIV-1 that the potential risks of breastfeeding include: (1) HIV-1 transmission (in infants without HIV-1), (2) developing viral resistance (in infants with HIV), and (3) adverse reactions in a breastfed infant similar to those seen in adults [see Use in Specific Populations (8.2) ].

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetic (PK) properties of lenacapavir are provided in Table 9 . The PK parameter estimates of SUNLENCA after oral and subcutaneous administration in heavily-treatment experienced participants with HIV-1 are provided in Table 10 . The estimated lenacapavir exposures are comparable between the two recommended dosing regimens.

Table 9 Pharmacokinetic Properties of Lenacapavir Oral Subcutaneous Absorption % Absolute bioavailability 6 to 10 100 Values reflect absolute bioavailability following subcutaneous administration of the 927 mg dose. T max Values reflect administration of lenacapavir with or without food. 4 hours 77 to 84 days Due to slow release from the site of subcutaneous administration, the absorption profile of subcutaneously administered lenacapavir is complex.

Effect of Food Effect of low-fat meal (relative to fasting) Values refer to geometric mean ratio [low-fat meal/fasting] in PK parameters and (90% confidence interval). Low fat meal is approximately 400 kcal, 25% fat. AUC inf ratio 98.6 (58.2,167.2) - C max ratio 115.8 (55.4, 242.1) - Effect of high-fat meal (relative to fasting) Values refer to geometric mean ratio [high-fat meal/fasting] in PK parameters and (90% confidence interval).

High fat meal is approximately 1000 kcal, 50% fat. AUC inf ratio 115.2 (72.0, 184.5) - C max ratio 145.2 (77.9, 270.5) - Distribution Apparent volume of distribution (Vd/F, L) 19240 9500 to 11700 % bound to human plasma proteins >98.5 Blood-to-plasma ratio 0.5 to

0.7Values reflect the blood-to-plasma ratio of lenacapavir following a single dose intravenous administration of [ 14 C] lenacapavir through 336 hours postdose. Elimination t 1/2 10 to 12 days 8 to 12 weeks Clearance (mean apparent clearance, L/h) 55 4.2 % of dose of unchanged drug in plasma Dosing in mass balance studies: single dose intravenous administration of [ 14 C] lenacapavir to participants without HIV-1. 69 Metabolism Metabolic pathway(s) CYP3A (minor) UGT1A1 (minor) Excretion Major routes of elimination Excretion of unchanged drug into feces Metabolized via oxidation, N-dealkylation, hydrogenation, amide hydrolysis, glucuronidation, hexose conjugation, pentose conjugation, and glutathione conjugation; primarily via CYP3A and UGT1A1 and no single circulating metabolite accounted for >10% of plasma drug-related exposure. % of dose excreted in urine <1 % of dose excreted in feces (% unchanged) 76 (33) Table 10 Lenacapavir Exposures Following Oral and Subcutaneous Administration of SUNLENCA in Heavily Treatment Experienced Participants with HIV-1 Parameter Mean (%CV) Recommended Dosing Regimen, Option 1 Predicted exposures utilizing population PK analysis.

Recommended Dosing Regimen, Option 2 Day 1: 600 mg (oral) + 927 mg (SC) Day 2: 600 mg (oral) Days 1 and 2: 600 mg (oral), Day 8: 300 mg (oral), Day 15: 927 mg (SC) Day 1 to end of Month 6 Days 1 to 15 Day 15 to end of Month 6 CV = coefficient of variation; NA = not applicable; SC = subcutaneous C max (ng/mL) 101.4 (53.1) 88.0 (72.4) 86.5 (51.7) AUC tau (h∙ng/mL) 242266 (46.0) 19496 (72.6) 239163 (47.2) C trough (ng/mL) 32.5 (57.2) 46.9 (72.3) 32.5 (57.5) Lenacapavir exposures after subcutaneous administration were similar between heavily treatment experienced participants with HIV-1 and participants without HIV-1 based on population pharmacokinetics analysis.

Lenacapavir exposures (AUC tau , C max and C trough ) after oral administration were 28% to 43% higher in participants with HIV-1 who were heavily treatment experienced, compared to participants without HIV-1 based on population PK analysis. These differences were not considered clinically relevant. For PK parameter estimates of SUNLENCA tablets following oral administration as part of the BIXLENVO initiation regimen, see BIXLENVO prescribing information.

Specific Populations There were no clinically significant differences in the pharmacokinetics of lenacapavir based on age (18 to 78 years), sex, ethnicity (hispanic or n… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 107 words ▾

12.2Pharmacodynamics Exposure-Response In CAPELLA, oral loading doses (600 mg on Day 1 and Day 2, 300 mg on Day 8) followed by subcutaneous doses (927 mg every 6 months starting on Day 15) of SUNLENCA in heavily treatment-experienced participants with multiclass resistant HIV-1, efficacy outcomes (change in plasma HIV-1 RNA from Day 1 to Day 14, and percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 26) were similar across the range of observed lenacapavir exposures. Cardiac Electrophysiology At supratherapeutic exposures of lenacapavir (9-fold higher than the therapeutic exposures of SUNLENCA), SUNLENCA does not prolong the QTcF interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Treatment of HIV-1 in Heavily Treatment-Experienced Adults 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 10 HIV-1 RNA decline compared to the screening visit. Participants were enrolled into the non-randomized cohort (cohort 2, N=36) if they had a ≥ 0.5 log 10 HIV-1 RNA decline compared to the screening visit or after cohort 1 reached its planned sample size.

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 10 copies/mL (range: 2.3 to 5.4).

19% of participants had baseline viral loads greater than 100,000 copies/mL. The mean baseline CD4 + cell count was 161 cells/mm 3 (range: 6 to 827). 75% of participants had CD4 + cell counts below 200 cells/mm 3 .

The mean number of years since participants first started HIV treatment was 24 years (range: 7 to 33); the mean number of antiretroviral agents in failing regimens at baseline was 4 (range: 1 to 7). The percentage of participants in the randomized cohort with known resistance to at least 2 agents from the NRTI, NNRTI, PI and INSTI classes was 97%, 94%, 78% and 75%, respectively. In cohort 1, 53% of participants had no fully active agents, 31% had 1 fully active agent, and 17% had 2 or more fully active agents within their initial failing regimen, including 6% of participants were who were receiving fostemsavir, which was an investigational agent at the start of the CAPELLA trial.

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 10 copies/mL (range: 1.3 to 5.7).

19% of participants had baseline viral loads greater than 100,000 copies/mL. The mean baseline CD4 + cell count was 258 cells/mm 3 (range: 3 to 1296). 53% of participants had CD4 + cell counts below 200 cells/mm 3 .

The mean number of years since participants first started HIV treatment was 19 years (range: 3 to 35); the mean number of antiretroviral agents in failing regimens at baseline was 4 (range: 2 to 7). The percentage of participants in the non-randomized cohort with known resistance to at least 2 agents from the NRTI, NNRTI, PI and INSTI classes was 100%, 100%, 83% and 64%, respectively. In cohort 2, 31% of participants had no fully active agents, 42% had 1 fully active agent, and 28% had 2 or more fully active agents within thei… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Lenacapavir was not carcinogenic in a 6-month rasH2 transgenic mouse study in males or females at doses of up to 300 mg/kg/dose once every 13 weeks. A 104-week carcinogenicity study was conducted in male and female rats at lenacapavir doses of 0, 102, 309, or 927 mg/kg by subcutaneous injection once every 13-weeks. A treatment-related increase in the incidence of malignant sarcoma at the injection site was observed in males and a treatment-related increase in combined benign fibroma and malignant fibrosarcoma at the injection site was observed in females, at the highest dose (927 mg/kg).

This dose in rats resulted in an exposure approximately 34-times the human exposure at the RHD, based on AUC. These tumors are considered to be a secondary response to chronic tissue irritation and granulomatous inflammation, due to the depot effect of lenacapavir following subcutaneous injection. The clinical relevance of these findings are unknown.

Mutagenesis Lenacapavir was not mutagenic in a battery of in vitro and in vivo genotoxicity assays, including microbial mutagenesis, chromosome aberration in human peripheral blood lymphocytes, and in in vivo rat micronucleus assays. Impairment of Fertility There were no effects on fertility, mating performance or early embryonic development when lenacapavir was administered to rats at systemic exposures (AUC) 5 times the exposure to humans at the RHD of SUNLENCA.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Lenacapavir was not carcinogenic in a 6-month rasH2 transgenic mouse study in males or females at doses of up to 300 mg/kg/dose once every 13 weeks. A 104-week carcinogenicity study was conducted in male and female rats at lenacapavir doses of 0, 102, 309, or 927 mg/kg by subcutaneous injection once every 13-weeks. A treatment-related increase in the incidence of malignant sarcoma at the injection site was observed in males and a treatment-related increase in combined benign fibroma and malignant fibrosarcoma at the injection site was observed in females, at the highest dose (927 mg/kg).

This dose in rats resulted in an exposure approximately 34-times the human exposure at the RHD, based on AUC. These tumors are considered to be a secondary response to chronic tissue irritation and granulomatous inflammation, due to the depot effect of lenacapavir following subcutaneous injection. The clinical relevance of these findings are unknown.

Mutagenesis Lenacapavir was not mutagenic in a battery of in vitro and in vivo genotoxicity assays, including microbial mutagenesis, chromosome aberration in human peripheral blood lymphocytes, and in in vivo rat micronucleus assays. Impairment of Fertility There were no effects on fertility, mating performance or early embryonic development when lenacapavir was administered to rats at systemic exposures (AUC) 5 times the exposure to humans at the RHD of SUNLENCA.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION SUNLENCA ® (sun-LEN-kuh) (lenacapavir) Tablets, for oral use SUNLENCA ® (sun-LEN-kuh) (lenacapavir) Injection, for subcutaneous use This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 08/2026 What is SUNLENCA?

SUNLENCA is a prescription medicine that is used with other human immunodeficiency virus-1 (HIV-1) medicines to treat HIV-1 in adults: who have received HIV-1 medicines in the past, and who have HIV-1 virus that is resistant to many HIV-1 medicines, and whose current HIV-1 medicines are failing. Your HIV-1 medicines may be failing because the HIV-1 medicines are not working or no longer work, you are not able to tolerate the side effects, or there are safety reasons why you cannot take them. OR, SUNLENCA tablets are used in adults when starting treatment with the prescription HIV-1 medicine called BIXLENVO.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). It is not known if SUNLENCA is safe and effective in children. Do not receive or take SUNLENCA if you take certain other medicines called strong CYP3A inducers.

Ask your healthcare provider if you are not sure. Before receiving or taking SUNLENCA, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant. Tell your healthcare provider if you become pregnant during treatment with SUNLENCA.

Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who receive or take SUNLENCA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry. are breastfeeding or plan to breastfeed.

A small amount of SUNLENCA is present in breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during treatment with SUNLENCA: The HIV-1 virus may pass to your baby if your baby does not have HIV-1. The HIV-1 virus may become harder to treat if your baby has HIV-1.

Your baby may get side effects from SUNLENCA. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, including St. John's wort.

Some medicines may interact with SUNLENCA. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with SUNLENCA.

Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to receive or take SUNLENCA with other medicines. SUNLENCA may affect certain other medicines for up to 9 months after your last injection.

How should I receive and take SUNLENCA? If you are receive or take SUNLENCA for the treatment of HIV-1 (not for starting treatment with BIXLENVO): Your SUNLENCA treatment will consist of injections and tablets. SUNLENCA injections will be given to you by your healthcare provider under the skin (subcutaneous injection) in your stomach-area (abdomen).

Take SUNLENCA tablets by mouth, with or without food. There are 2 options (Option 1 and Option 2) to start treatment with SUNLENCA. Your healthcare provider will decide which starting option is for you.

If Option 1 is chosen: On Day 1, you will receive 2 SUNLENCA injections and take 2 SUNLENCA tablets. On Day 2, you will take 2 SUNLENCA tablets. If Option 2 is chosen: On Day 1 and Day 2, you will take 2 SUNLENCA tablets each day.

On Day 8, you will take 1 SUNLENCA tablet. On Day 15, you will receive 2 SUNLENCA injections. After completing Option 1 or Option 2, you will receive 2 SUNLENCA injections every 6 months (26 weeks) from the date of your last injection.

Stay under the care of a healthcare provider during treatment with SUNLENCA. It is important that you attend your planned appointments to receive your… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 23 words ▾

Indications and Usage ( 1.2 ) 08/2026 Dosage and Administration ( 2.3 , 2.4 ) 08/2026 Dosage and Administration ( 2.5 ) 08/2026

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - 300 mg Tablet Blister Pack Pouch Carton NDC 61958-3001-1 Sunlenca ® (lenacapavir) tablets 300 mg per tablet 1 pouch containing 4 tablets Each tablet contains: 300 mg of lenacapavir (present as 306.8 mg lenacapavir sodium). 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: Gilead Sciences, Inc. Foster City, CA 94404 Made in Canada © 2022 Gilead Sciences, Inc.

PRINCIPAL DISPLAY PANEL - 300 mg Tablet Blister Pack Pouch Carton

PRINCIPAL DISPLAY PANEL - 5 Tablet Blister Pack Pouch Carton NDC 61958-3001-2 Sunlenca ® (lenacapavir) tablets 300 mg per tablet 1 pouch containing 5 tablets Each tablet contains: 300 mg of lenacapavir (present as 306.8 mg lenacapavir sodium). 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 Sunlenca tablets. Your healthcare provider will tell you when to take Sunlenca tablets.

GILEAD Manufactured for: Gilead Sciences, Inc. Foster City, CA 94404 Made in Canada © 2022 Gilead Sciences, Inc. PRINCIPAL DISPLAY PANEL - 5 Tablet Blister Pack Pouch Carton

PRINCIPAL DISPLAY PANEL - 4 Tablet Bottle Label NDC 61958-3001-3 4 tablets Sunlenca ® (lenacapavir) tablets 300 mg per tablet Talk to your healthcare provider before taking Sunlenca tablets. Your healthcare provider will tell you when to take Sunlenca tablets. PRINCIPAL DISPLAY PANEL - 4 Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - Kit Carton R x only NDC 61958-3002-1 Sunlenca ® (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 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 administered to receive the 927 mg dose. For Healthcare Professional administration only. GILEAD PRINCIPAL DISPLAY PANEL - Kit Carton

PRINCIPAL DISPLAY PANEL - Kit Carton - 3005 R x only NDC 61958-3005-1 Sunlenca ® (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 administered to receive the 927 mg dose. For Healthcare Professional administration only. GILEAD PRINCIPAL DISPLAY PANEL - Kit Carton - 3005

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
83
Units reimbursed last 4 qtrs
114
Gross reimbursed last 4 qtrs
$1.61M
Avg / prescription
$19,434.69
Avg / unit
$14,149.57
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
73% FFS 27% MCO
Fee-for-service · 61 Rx Managed care · 22 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 30 units · 0.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 23 units · 0.2 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 31 units · 0.2 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 30 units · 0.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.10.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Pennsylvania 0.2 /100k
2 Illinois 0.2 /100k
3 New York 0.2 /100k
4 California 0.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sunlenca — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sunlenca. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$8.63M
Claims incl. refills
553
Beneficiaries
453
Spend / beneficiary
$19,047.35
Spend / claim
$15,602.98
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for LENACAPAVIR SODIUM — the ingredient across all brands.

Top reported reactions

Injection Site Discharge141
Injection Site Pain137
Injection Site Nodule111
Injection Site Erythema40
Injection Site Mass36
Injection Site Swelling24
Injection Site Bruising15

Age at onset

Adult121
Elderly4

Reporter sex

462 reports
Male · 92%
Female · 8%

Serious outcomes

Disabling12
Hospitalization8
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 367 1
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Gilead Sciences, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gilead Sciences, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1961 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 61958-3001-01 · Gilead 61958-3005-01 · Gilead →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.