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Lenacapavir Oral

Lenacapavir tablets are an HIV-1 antiretroviral used as part of treatment for HIV-1 infection (Sunlenca) and as part of the starting doses for HIV-1 pre-exposure prophylaxis, or PrEP (Yeztugo).

Brand names SunlencaYeztugo
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Other forms & routes:
Lenacapavir Oral at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Lenacapavir is a newer HIV-1 medicine (on the U.S. market since about 2022) that blocks the capsid, the protein shell the virus depends on; Sunlenca is a specialist add-on for HIV-1 that resists many drugs, and Yeztugo tablets help start a long-acting PrEP (HIV prevention) plan built around injections. The tablets are usually well tolerated, with headache and nausea the most common complaints, and Yeztugo's injections can leave tender spots. The boxed warning is the key point for Yeztugo, which must start only after a negative HIV-1 test, with a retest before every injection, because using it with undiagnosed HIV-1 can produce drug-resistant virus.

Clinical pearls

  • Rifampin, carbamazepine, phenytoin and St. John's wort can drain lenacapavir levels and invite resistance, so they must never be combined with it.
  • It can raise levels of some statins, opioids, blood thinners and digoxin, so every prescriber should know you take it.
  • Never take Yeztugo's Day 1 and Day 2 starting tablets on the same day, and report fever, aches or rash promptly.
  • Lenacapavir lingers a year or more after the last injection, so arrange other PrEP if you stop but remain at risk.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Yeztugo must only be started in people confirmed to be HIV-1 negative. If someone has HIV-1 without knowing it, using Yeztugo alone can lead to drug-resistant HIV-1.

You must be tested before starting and before each injection. If you get HIV-1 while using Yeztugo, you must switch to a complete HIV-1 treatment regimen. Watch for fever, fatigue, muscle aches, or rash, and tell your provider promptly.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2022
Companies listing it with the FDA1
FDA label last updatedAug 27, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Lenacapavir Oral, written from its FDA label.

What Lenacapavir Oral is used for

▾

Lenacapavir tablets are used in different ways depending on the brand.

  • Sunlenca tablets treat HIV-1 infection, together with other antiretrovirals, in heavily treatment-experienced adults with multidrug resistant HIV-1 whose regimen is failing.
  • Sunlenca tablets are also used for oral loading when starting Bixlenvo in virologically suppressed adults with no known or suspected resistance to its components.
  • Yeztugo is used for HIV-1 PrEP, with tablets as part of the starting doses and as a short-term bridge if injections are delayed.

How Lenacapavir Oral works

▾

Lenacapavir is an HIV-1 antiretroviral. Sunlenca is a capsid inhibitor, and Yeztugo has long-acting properties.

HIV-1 can develop resistance to lenacapavir, which is why it must be used as directed.

Lenacapavir Oral dosage

▾

Lenacapavir tablets are taken by mouth, with or without food. Your plan depends on the brand and your reason for taking it.

  • Yeztugo starts with tablets and an injection on Day 1, plus tablets on Day 2. Injections then continue about every 6 months.
  • If the Day 2 Yeztugo dose is missed, take it as soon as possible. Never double up Day 1 and Day 2 on the same day.
  • If a Yeztugo injection will be delayed by more than 2 weeks, tablets may be used weekly for up to 6 months until injections resume.

Follow your prescriber and the label for exact doses.

Dosing details from the FDA-approved label

From the Lenacapavir Oral prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Initiation (adults and adolescents weighing at least 35 kg), Day 1
    • 927 mg by subcutaneous injection (2 x 1.5 mL injections) and 600 mg orally (2 x 300 mg tablets)
    • Tablets may be taken with or without food
  • Initiation (adults and adolescents weighing at least 35 kg), Day 2
    • 600 mg orally (2 x 300 mg tablets)
    • If missed, take as soon as possible; do not take Day 1 and Day 2 oral initiation doses on the same day
  • Continuation
    • 927 mg by subcutaneous injection (2 x 1.5 mL injections) every 6-months (26 weeks) from the date of the last injection, +/-2 weeks
  • Anticipated delayed injections (more than 2 weeks delay; 26 to 28 weeks since last injection)
    • 300 mg orally once every 7 days
    • Maximum: Interim use for up to 6 months if needed
    • Resume continuation injection dosage within 7 days after the last oral dose
  • Missed injections (more than 28 weeks since last injection and tablets not taken)
    • Reinitiate with initiation dosing schedule from Day 1 and then continue with continuation injection dosing
  • Initiating strong CYP3A inducers (supplemental doses), Step 1 on the day the inducer is initiated
    • 927 mg subcutaneously (2 x 1.5 mL injections) and 600 mg orally (2 x 300 mg tablets), plus continue scheduled once every 6-months continuation dosing
    • Inducer should be started at least 2 days after YEZTUGO is first initiated; not available for those already on inducers or on weekly oral dosage
  • Initiating strong CYP3A inducers (supplemental doses), Step 2 on the day after the inducer is initiated
    • 600 mg orally (2 x 300 mg tablets)
    • If inducer is co-administered longer than 6 months, repeat Steps 1 and 2 every 6-months 26 weeks +/-2 weeks
  • Initiating moderate CYP3A inducers (supplemental dose)
    • 463.5 mg subcutaneously (1 x 1.5 mL injection) on the day the inducer is initiated, plus continue scheduled once every 6-months continuation dosing
    • Repeat every 6-months 26 weeks +/-2 weeks if co-administered longer than 6 months
    • Moderate inducers may be started any time after YEZTUGO is first initiated
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION HIV-1 screening: Screen all individuals for HIV-1 infection prior to initiating YEZTUGO, prior to each injection of YEZTUGO, and additionally as clinically appropriate. ( 2.1 ) Dosing schedule: Initiation dosing (injection and tablets) followed by once every 6-months continuation injection dosing. Tablets may be taken without regard to food. ( 2.3 ) Initiation Day 1 927 mg by subcutaneous injection (2 x 1.5 mL injections) and 600 mg orally (2 x 300 mg tablets) Day 2 600 mg orally (2 x 300 mg tablets) Continuation 927 mg by subcutaneous injection (2 x 1.5 mL injections) every 6-months (26 weeks) from the date of the last injection +/-2 weeks. Anticipated delayed injections: If scheduled injection is anticipated to be delayed by more than 2 weeks, YEZTUGO tablets may be used on an interim basis (for up to 6 months if needed) until injections resume. Dosing schedule for delayed injection is 300 mg orally once every 7 days. ( 2.4 ) Missed injections: If more than 28 weeks have elapsed since last injection and tablets have not been taken, restart initiation from Day 1 if clinically appropriate. ( 2.4 ) Dosage modifications (supplemental doses) of YEZTUGO are recommended when initiating strong or moderate CYP3A inducers. ( 2.5 ) YEZTUGO injection is for subcutaneous administration only. Two 1.5 mL injections are required for complete dose. ( 2.6 ) 2.1 HIV-1 Screening for Individuals Receiving YEZTUGO for HIV-1 Pre-Exposure Prophylaxis Screen all individuals for HIV-1 infection prior to initiating YEZTUGO, prior to each subsequent injection of YEZTUGO, and additionally as clinically appropriate, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. When screening for HIV-1 infection prior to initiating YEZTUGO, if an antigen/antibody-specific test is used and provides negative results, then such negative results should be confirmed using an RNA-specific assay, even if the results of the RNA-assay are available after YEZTUGO initiation. When screening for HIV-1 infection prior to continuing YEZTUGO, negative results from a rapid, point-of-care antigen/antibody test should be confirmed using a more sensitive assay [see Indications and Usage (1) , Contraindications (4) , Warnings and Precautions (5.1 , 5.2) and Clinical Studies (14) ].

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Lenacapavir Oral side effects

▾

The most common side effects in Yeztugo trials were:

Common side effects

  • Injection site reactions (with Yeztugo's injection)
  • Headache
  • Nausea

When to get medical help

  • Tell your provider right away if you have a fever, fatigue, muscle aches, or a skin rash while using Yeztugo. These can be signs of early HIV-1 infection.
  • Call your provider if you test positive for HIV-1 while using Yeztugo. You need a complete HIV-1 treatment regimen right away.
  • Get help for severe injection site problems such as skin ulcers or tissue damage. These have been linked to improper injection (into the skin instead of under it).
  • Call your provider before starting any new medicine or herbal product, since some can make lenacapavir stop working.

Serious injection site reactions, including ulcers and tissue damage, have happened when the injection was given improperly. Report any severe skin reaction right away.

Lenacapavir Oral warnings and precautions

▾
  • Yeztugo can cause drug-resistant HIV-1 if used by someone with undiagnosed HIV-1. Testing is required before starting and before each injection.
  • It does not always prevent HIV-1. Use condoms and get tested regularly.
  • Lenacapavir can stay in your body for up to 12 months or longer after the last injection.
  • Missed injections can lead to HIV-1 infection and resistance.

Lenacapavir Oral interactions

▾

Some medicines can lower or raise lenacapavir levels, or lenacapavir can change theirs.

  • Rifampin, carbamazepine, phenytoin, and St. John's wort must not be used with Sunlenca because they lower lenacapavir levels.
  • Oxcarbazepine, phenobarbital, rifabutin, rifapentine, efavirenz, and nevirapine are not recommended with Sunlenca.
  • Dexamethasone may reduce lenacapavir's effect.
  • Lenacapavir can raise levels of CYP3A-processed drugs such as certain opioids, simvastatin, lovastatin, midazolam, triazolam, and digoxin.
  • Ergot medicines and naloxegol should be avoided with Sunlenca.

Interactions listed in the FDA-approved label

From the Lenacapavir Oral prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort): May significantly decrease lenacapavir plasma concentrations, which may result in loss of therapeutic effect and development of resistance. Concomitant administration with SUNLENCA is contraindicated.
  • Moderate CYP3A inducers (e.g., oxcarbazepine, phenobarbital): May significantly decrease lenacapavir plasma concentrations, which may result in loss of therapeutic effect and development of resistance. Concomitant administration with SUNLENCA is not recommended.
  • Combined P-gp, UGT1A1, and strong CYP3A inhibitors: May significantly increase plasma concentrations of SUNLENCA. Concomitant administration is not recommended.
  • Drugs primarily metabolized by CYP3A initiated within 9 months after the last subcutaneous dose: Lenacapavir is a moderate CYP3A inhibitor and may increase exposure of these drugs, 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.
  • Digoxin: Increases digoxin. Use with caution and monitor digoxin therapeutic concentration.
  • Direct oral anticoagulants (rivaroxaban, dabigatran, edoxaban): Increases DOAC. Refer to the DOAC prescribing information for concomitant administration with moderate CYP3A inhibitors and/or P-gp inhibitors.
  • Atazanavir/cobicistat, atazanavir/ritonavir, efavirenz, nevirapine, tipranavir/ritonavir: Atazanavir combinations increase lenacapavir; efavirenz, nevirapine and tipranavir/ritonavir decrease lenacapavir and may result in loss of therapeutic effect and development of resistance. Concomitant administration is not recommended.
  • Systemic corticosteroids (cortisone/hydrocortisone, dexamethasone): Increases systemic corticosteroids, raising the risk for Cushing's syndrome and adrenal suppression; dexamethasone may decrease lenacapavir and cause loss of therapeutic effect and resistance. Initiate with the lowest starting dose and titrate carefully while monitoring for safety; consider alternative corticosteroids to dexamethasone, particularly for long-term use.
  • Ergot derivatives (dihydroergotamine, ergotamine, methylergonovine): Increases dihydroergotamine, ergotamine and methylergonovine. Concomitant administration is not recommended.
  • Drugs without clinically significant interactions (darunavir/cobicistat, cobicistat, famotidine, pitavastatin, rosuvastatin, tenofovir alafenamide, voriconazole): No clinically significant drug interactions have been observed in drug interaction studies.
Read the label’s full interactions text

7 DRUG INTERACTIONS Consult the Full Prescribing Information prior to and during treatment for important drug interactions. ( 4 , 7 , 12.3 ) 7.1 Effect 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. 7.2 Effect 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. 7.3 Established 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) ] .

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Lenacapavir Oral

▾
  • Yeztugo requires a confirmed negative HIV-1 test first.
  • Do not take Sunlenca with strong CYP3A inducers.
  • Tell your provider if you are pregnant or breastfeeding. Lenacapavir is present in breast milk.
  • Yeztugo has not been established for people under 35 kg.
  • Older adults should use it with caution.
  • Yeztugo has not been studied in end-stage kidney disease or severe liver impairment.

Lenacapavir Oral overdose

▾

No data are available on overdose of Sunlenca. If it happens, you should be monitored for signs of toxicity and given general supportive care. Dialysis is unlikely to remove much lenacapavir.

What Lenacapavir Oral does in the body

▾

In a Sunlenca study of heavily treatment-experienced people, how well it worked was similar across the range of lenacapavir levels seen. At levels 9 times higher than normal, Sunlenca did not prolong the QTcF interval (a heart rhythm measure) to any clinically relevant extent.

How your body processes Lenacapavir Oral

▾

Only about 6 to 10 percent of an oral lenacapavir dose is absorbed, and food does not change this in a meaningful way. Lenacapavir is highly bound to proteins in the blood. It is broken down mainly by CYP3A and UGT1A1, and unchanged drug is cleared mainly in the feces. The half-life is about 10 to 12 days after oral dosing.

How to store Lenacapavir Oral

▾

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). store only in original bottle or blister pack.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

138

Supplements & herbs that interact with Lenacapavir Oral

138 supplements and herbal products have documented interactions with Lenacapavir Oral in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 94
  • Minor · 41
Every supplement checked against Lenacapavir Oral — ranked by severity The full interaction hub: 3 major · 94 moderate · 41 minor · every one linked to its full report. Check Lenacapavir Oral against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Lenacapavir Oral: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Lenacapavir Oral — the kind of thing our pharmacy team would talk through with you at the counter.

What is lenacapavir for?

▾
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 getting HIV-1.

Can I take the tablets with food?

▾
Yes. Lenacapavir tablets can be taken with or without food. Follow your prescriber's schedule closely.

What if I miss a Yeztugo starting dose?

▾
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.

What side effects should I expect?

▾
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 as fever, fatigue, and rash.

Can I take other medicines with it?

▾
Many medicines can interact, so check with me first. Rifampin, carbamazepine, phenytoin, and St. John's wort must not be used with Sunlenca. Some herbal products and prescriptions can stop it from working.

Is it safe in pregnancy or breastfeeding?

▾
In Yeztugo studies, no increased risk to pregnancy was found, though the data are limited. Lenacapavir passes into breast milk at low levels. Talk with your provider about your situation.

Is Lenacapavir Oral available over the counter?

▾
No. Lenacapavir Oral is a prescription medicine: every Lenacapavir Oral product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Lenacapavir Oral first available?

▾
The earliest FDA record we hold for Lenacapavir Oral is from 2022: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Lenacapavir Oral was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Lenacapavir Oral on HelloPharmacist

Detailed data & references for Lenacapavir Oral Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Lenacapavir Oral forms and strengths (how it comes)

Lenacapavir Oral is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Lenacapavir Oral inactive ingredients by manufacturer.

Tablet

By mouth
Brands Sunlenca Yeztugo
How this form is used
What it may be used for
  • Sunlenca tablets are used with other antiretrovirals to treat HIV-1 in heavily treatment-experienced adults with multidrug resistant HIV-1.
  • Sunlenca tablets are used for oral loading when starting Bixlenvo in certain virologically suppressed adults.
  • Yeztugo tablets are part of the starting doses for HIV-1 PrEP.
  • Yeztugo tablets can be used short-term if a scheduled injection will be delayed.
Important instructions
  • Yeztugo tablets may be taken with or without food.
  • Yeztugo starting doses are given on two days. If the Day 2 dose is missed, take it as soon as possible, and never take Day 1 and Day 2 doses on the same day.
  • Yeztugo tablets are taken once weekly only as a short-term bridge if an injection is delayed. Resume injections as directed.
Available strengths 1 strength
7 FDA-listed product records ⓘ

Lenacapavir Oral on the U.S. market: products, makers and brands

How Lenacapavir Oral appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 2 Lenacapavir Oral product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2022. Brand names on the directory include Sunlenca, Yeztugo; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
2
Brand names
2
FDA-listed product records ⓘ
2022
Earliest FDA record ⓘ

How widely Lenacapavir Oral is used (Medicaid data)

A general measure of how commonly Lenacapavir Oral is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q2–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Lenacapavir Oral is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,517
Medicaid prescriptions filled (Q2–Q4 2025)
$3.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Lenacapavir Oral prescribed? Of the 1,601 medications we measure, Lenacapavir Oral ranks #1,225 by Medicaid prescriptions — more than 23% of them.

Where Lenacapavir Oral ranks among the drugs we measure · Q2–Q4 2025 · neighbors ±5

Utilization by Lenacapavir Oral product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

lenacapavir 300 MG Oral Tablet

1,517 Medicaid prescriptions (Q2–Q4 2025) 100% of Lenacapavir Oral prescriptions shown $3.6M gross reimbursement (before rebates) ≈ $2,391 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2625890

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lenacapavir Oral, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 3 listed Lenacapavir Oral NDCs with Medicaid activity.

Compare Lenacapavir Oral products

A representative set of FDA-listed product records for Lenacapavir Oral — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
300 mg Oral Gilead Sciences, Inc. × 2 listings NDA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Lenacapavir Oral NDCs →

Lenacapavir Oral recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Lenacapavir recalls since July 2021.

✅No Lenacapavir recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Lenacapavir Oral RxCUI 2625651 2 dose forms · 2 strengths
  1. Dose form (SCDF) Injection RxCUI 2625903 No current FDA listing
    Clinical drug / strength (SCD) 1.5 ML lenacapavir 309 MG/ML RxCUI 2625904
  2. Dose form (SCDF) Oral Tablet RxCUI 2625889 In current FDA listings
    Clinical drug / strength (SCD) 300 MG RxCUI 2625890

Look up RxCUI 2625651 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Lenacapavir Oral brand names

Lenacapavir Oral is sold under 2 brand names in the FDA directory — Sunlenca, Yeztugo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Sunlenca Yeztugo

Who makes Lenacapavir Oral: manufacturers and labelers

One company lists Lenacapavir Oral products with the FDA. By number of product records, the largest are Gilead Sciences, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Gilead Sciences, Inc. 2

Lenacapavir Oral drug class (RxNorm)

Lenacapavir Oral 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

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Lenacapavir Oral page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 27, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Lenacapavir Oral.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Lenacapavir Oral after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
2
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Gilead Sciences
Linked label effective
Aug 27, 2026
Composite sections available
23
Linked SPL Set ID
e5652804-29c4-40d7-aeb2-0142ed2a7b5b
Linked SPL Document ID
142b440e-6eae-4d76-8312-b094de1380c3
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Gilead Sciences is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →