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Vocabria cabotegravir sodium 30 mg Tablet, Film Coated, 30-count — NDC 49702-0248-13 package photo

Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vocabria cabotegravir sodium 30 mg Tablet, Film Coated, 30-count — NDC 49702-248-13 (Billing 49702-0248-13)

by ViiV Healthcare Company · 30 TABLET, FILM COATED in 1 BOTTLE

This is a package of 30 tablets of Vocabria cabotegravir sodium 30 mg Tablet, Film Coated from ViiV Healthcare Company, marketed since Jan 2021 and currently FDA-listed. It is this product's only package size.

NDC 49702-0248-13

🏷️ FDA NDC (as labeled) 49702-248-13 billing pads the product 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 Jul 24, 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 Dr. Brian Staiger, PharmD

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 49702-248-13 alone.

Record: FDA NDC Directory package listing · Human prescription drug
Code segments: 49702 labeler · 248 product · 13 package
Package marketed since: Jan 21, 2021
Sample package: No — commercial package
Listing certified through: Dec 31, 2026
Billing quantity: 30 EA per package
Barcode (UPC-A, from the NDC): 3 4970224813 7
FDA record last changed: Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49702-248-13

Product NDC 49702-248

11-digit billing NDC 49702024813

NCPDP billing unit EA — each (per item)

RxCUI 2475199, 2475205

UNII 3L12PT535M

Application # NDA212887

SPL Set ID 66d450fb-cca4-476c-b0c7-c0730e3e4cf3

Established class (EPC) Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor

Mechanism of action HIV Integrase Inhibitors; Organic Anion Transporter 1 Inhibitors; Organic Anion Transporter 3 Inhibitors

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-01-21

Route ORAL

Dosage form TABLET, FILM COATED

Substance CABOTEGRAVIR SODIUM

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

GPI-14 12103010200320

GPI class Vocabria

GCN Seq No 081868

GCN 49106

HICL code 046411

Ingredient (HICL) Cabotegravir Sodium

HIC1 code W

Therapeutic class — broad (HIC1) Anti-Infecting Agents

HIC2 code W5

Therapeutic class — intermediate (HIC2) Antiviral Agents

HIC3 code W5U

Therapeutic class — specific (HIC3) Antivirals,Hiv-1 Integrase Strand Transfer Inhibtr

AHFS code 08:18.08.12

AHFS class Hiv Integrase Inhibitor Antiretrovirals

FDB label name VOCABRIA 30 MG TABLET

FDB brand name Vocabria

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 081868
GCN: 49106
GPI-14 (Medi-Span): 12103010200320
HICL (First Databank): 046411
AHFS class code: 08:18.08.12
RxCUI (RxNorm): 2475199

Why two NDCs? The FDA registers this code as 49702-248-13 — a 5-3-2 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 product segment → 49702-0248-13. 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.

FDA openFDA NDC Directory · synced Oct 8, 2026
FDA label on DailyMed · label index refreshed Oct 6, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 8, 2026

RxNorm drug class

This medicine belongs to the Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor

Drug family (ATC) Integrase inhibitors

How it works HIV Integrase Inhibitors, Organic Anion Transporter 1 Inhibitors, Organic Anion Transporter 3 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.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

Label name VOCABRIA 30 MG TABLET Ingredient Cabotegravir Sodium

📖 What it is MedlinePlus · NLM

Cabotegravir is used to treathuman immunodeficiency virus type 1 (HIV-1) infection. Cabotegravir is also used for certain periods to prevent human immunodeficiency virus type 1 (HIV-1) infection. Cabotegravir is in a class of medications called HIV integrase inhibitors. It works by decreasing the amount of HIV in the blood. Although cabotegravir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications and making other life-style changes may decrease the risk of giving the HIV virus to other people...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It depends on the product. Vocabria tablets are used with rilpivirine to treat HIV-1 in people whose virus is already suppressed, and as an oral lead-in before injections. Apretude...
Take one tablet by mouth once a day at about the same time. When it is used for HIV-1 treatment, take it with Edurant and a meal. Follow the schedule your prescriber gives you.
With Apretude, the most common ones are injection site reactions, diarrhea, headache, fever, tiredness, nausea, dizziness and sleep problems. Call your provider if you get a rash,...
If you already have HIV-1 and take Apretude alone, the virus can become resistant to treatment. That is why you must test negative before starting and before each injection. If you...

📖 Read our full Cabotegravir guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Cabotegravir Sodium — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Cabotegravir Sodium (29 interactions) — ranked by severity →

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 6, 2026

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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
49702-0248-13 You're viewing this Main listing	30 TABLET, FILM COATED in 1 BOTTLE	2021-01-21	—	Active

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Vocabria 30 mgthis 49702-0248-13	ViiV	30 tablets	—	—	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.

FDA openFDA NDC Directory · synced Oct 8, 2026
FDA Orange Book · refreshed Oct 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2021

First FDA approval

Jan 2021

📍

2026

Currently FDA-listed

5 years listed

🛡️

2031

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 Feb 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Jan 21, 2021 RLD RS ⏳ ~4.3 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 8410103 — drug substance (U-3348)

US 10927129 — drug substance

Exclusivity NCE

2021 2023 2025 2027 2029 2031

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 (2)

Patent	Type	Use code	Expires
US 8410103 ↗	Drug substance	U-3348	Feb 4, 2031
US 10927129 ↗	Drug substance	—	Apr 28, 2026

FDA exclusivity

Code	What it grants	Expires
NCE	New Chemical Entity (5-year)	Jan 21, 2026

Common questions

Is there a generic version of VOCABRIA 30 MG TABLET?

No FDA-approved generic equivalent is currently listed in the FDA Orange Book for VOCABRIA 30 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2031 — 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.

FDA Orange Book · refreshed Oct 3, 2026

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 Cabotegravir 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII AG9B65PV6B
A starch derivative made from corn that helps tablets and capsules break apart quickly when swallowed. It acts as a disintegrant, allowing the medicine to dissolve and be absorbed in your stomach and intestines.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

FDA label on DailyMed · label index refreshed Oct 6, 2026
FDA openFDA NDC Directory · synced Oct 8, 2026

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

LabelerViiV Healthcare Company

Application holderVIIV HEALTHCARE CO

FDA applicationNDA212887 (NDA)

Labeler code49702

First marketedJan 2021

Product typeHuman Prescription Drug

Portfolio26 products on file

More NDCs from ViiV Healthcare Company labeler code 49702

🔎 All NDCs from ViiV Healthcare Company

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.

FDA openFDA NDC Directory · synced Oct 8, 2026
Drugs@FDA

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 📋 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 ~2 min read ▾

1 INDICATIONS AND USAGE HIV-1 Treatment: VOCABRIA is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with EDURANT (rilpivirine) for short-term treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. ( 1.1 ) HIV-1 Pre-Exposure Prophylaxis: VOCABRIA is indicated for short-term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition.

Individuals must have a negative HIV-1 test prior to initiating VOCABRIA for HIV-1 PrEP. ( 1.2 ) VOCABRIA may be used as: • oral lead-in to assess the tolerability of cabotegravir prior to administration of CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension) for HIV-1 treatment or APRETUDE (cabotegravir extended-release injectable suspension) for HIV-1 PrEP. ( 1.1 , 1.2 ) • oral therapy for patients who will miss planned injection dosing with CABENUVA for HIV-1 treatment or APRETUDE for HIV-1 PrEP.

( 1.1 , 1.2 )

1.1Treatment of HIV-1 Infection VOCABRIA is indicated in combination with EDURANT (rilpivirine) tablets for short-term treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as [see Microbiology ( 12.4 ), Clinical Studies ( 14.1 )] : • oral lead-in to assess the tolerability of cabotegravir prior to administration of cabotegravir extended-release injectable suspension, a component of CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension). • oral therapy for patients who will miss planned injection dosing with CABENUVA.

1.2HIV-1 Pre-Exposure Prophylaxis VOCABRIA is indicated for short-term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating VOCABRIA for HIV-1 PrEP. VOCABRIA may be used as [see Dosage and Administration ( 2.2 ), Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Clinical Studies ( 14.2 )] : • oral lead-in to assess the tolerability of cabotegravir prior to administration of APRETUDE (cabotegravir extended-release injectable suspension). • oral PrEP for patients who will miss planned injection dosing with APRETUDE.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • One tablet of VOCABRIA 30 mg taken orally once daily in combination with 1 tablet of EDURANT 25 mg taken orally once daily with a meal: • for approximately 1 month if oral lead-in is used for HIV-1 treatment. ( 2.1 ) • for up to 2 months to replace up to 2 consecutive missed monthly injections of CABENUVA ( 2.2 ) Refer to 2.1 for dosing recommendations for missed injections. ( 2.1 ) • HIV-1 Screening: Screen all individuals for HIV-1 infection prior to initiating VOCABRIA and APRETUDE for HIV-1 PrEP and at least once every 3 months while taking APRETUDE.

( 2.2 ) • One tablet of VOCABRIA 30 mg taken orally once daily for approximately 1 month if oral lead-in is used for HIV-1 PrEP. Refer to 2.2 for dosing recommendations for missed injections. ( 2.2 )

2.1Treatment of HIV-1 Infection in Adults and Adolescents 12 Years of Age and Older and Weighing at Least 35 kg Oral Lead-In Dosing to Assess Tolerability of Cabotegravir Consult the prescribing information for CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension) before initiating VOCABRIA to ensure therapy with CABENUVA is appropriate. See full prescribing information for CABENUVA. Oral lead-in may be used to assess the tolerability of cabotegravir prior to the initiation of CABENUVA.

The recommended oral lead-in daily dose is one 30-mg tablet of VOCABRIA with one 25-mg tablet of EDURANT for approximately 1 month (at least 28 days). The last oral dose should be taken on the same day injections with CABENUVA are started. Take VOCABRIA once daily with EDURANT at approximately the same time each day with a meal [see Clinical Pharmacology ( 12.3 )] .

Because VOCABRIA is indicated in combination with EDURANT tablets, the prescribing information for EDURANT should also be consulted. Recommended Oral Dosing to Replace Planned Missed Injections of CABENUVA Planned Missed Injections for Patients on the Monthly Dosing Schedule: If a patient plans to miss a monthly scheduled injection of CABENUVA by more than 7 days, take daily oral therapy for up to 2 months to replace missed injection visits. For oral therapy with VOCABRIA and EDURANT, the recommended oral daily dose is one 30‑mg tablet of VOCABRIA and one 25-mg tablet of EDURANT.

Take VOCABRIA with EDURANT at approximately the same time each day with a meal. The first dose of oral therapy should be taken 1 month (+/-7 days) after the last injection dose of CABENUVA and continued until the day injection dosing is restarted. For oral therapy with VOCABRIA and EDURANT of durations greater than 2 months, an alternative oral regimen is recommended.

See full prescribing information for CABENUVA to resume monthly injection dosing. Planned Missed Injections for Patients on the Every-2-Month Dosing Schedule: If a patient plans to miss a scheduled every-2-month injection of CABENUVA by more than 7 days, take daily oral therapy for up to 2 months to replace 1 missed scheduled every-2-month injection. For oral therapy with VOCABRIA and EDURANT of durations greater than 2 months, the recommended oral daily dose is one 30-mg tablet of VOCABRIA and one 25-mg tablet of EDURANT.

Take VOCABRIA with EDURANT at approximately the same time each day with a meal. The first dose of oral therapy should be taken approximately 2 months after the last injection dose of CABENUVA and continued until the day injection dosing is restarted. For oral therapy with VOCABRIA and EDURANT of durations greater than 2 months, an alternative oral regimen is recommended.

See full prescribing information for CABENUVA to resume every-2-month injection dosing.

2.2HIV-1 Pre-Exposure Prophylaxis in Adults and Adolescents Weighing at Least 35 kg HIV-1 Screening for Individuals for HIV-1 Pre-Exposure Prophylaxis Individuals must be tested for HIV-1 infection prior to initiating VOCABRIA and APRETUDE for HIV-1 PrEP, and with each subsequent injection of APRETUDE, using a test approved or cleared… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 14 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 30 mg. Tablets: 30 mg ( 3 )

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Treatment of HIV-1 Infection VOCABRIA is contraindicated in patients: • with previous hypersensitivity reaction to cabotegravir [see Warnings and Precautions ( 5.2 )] . • receiving the following coadministered drugs for which significant decreases in cabotegravir plasma concentrations may occur due to uridine diphosphate glucuronosyltransferase (UGT)1A1 enzyme induction, which may result in loss of virologic response [see Drug Interactions ( 7.2 , 7.3 ), Clinical Pharmacology ( 12.3 )] : o Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifampin, rifapentine Prior to initiation of VOCABRIA, note that use of CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension) with rifabutin is contraindicated.

Since VOCABRIA is taken in combination with EDURANT tablets, the prescribing information for EDURANT should be consulted for additional contraindications. HIV-1 Pre-Exposure Prophylaxis VOCABRIA is contraindicated in individuals: • with unknown or positive HIV-1 status [see Warnings and Precautions ( 5.1 )] . • with previous hypersensitivity reaction to cabotegravir [see Warnings and Precautions ( 5.2 )] . • receiving the following coadministered drugs for which significant decreases in cabotegravir plasma concentrations may occur due to UGT1A1 enzyme induction, which may result in loss of efficacy [see Drug Interactions ( 7.2 , 7.3 ), Clinical Pharmacology ( 12.3 )] : o Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifampin, rifapentine • Previous hypersensitivity reaction to cabotegravir.

( 4 ) • Coadministration with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine. ( 4 ) • Positive HIV-1 status for HIV-1 PrEP. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • HIV-1 PrEP: Comprehensive management to reduce the risk of HIV-1 acquisition. ( 5.1 ) • Serious or severe hypersensitivity reactions have been reported with cabotegravir and include Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN). Discontinue VOCABRIA immediately if signs or symptoms of hypersensitivity reactions develop.

( 5.2 ) • Hepatotoxicity has been reported in patients receiving cabotegravir. Monitoring of liver chemistries is recommended when VOCABRIA is used for HIV-1 treatment. Clinical and laboratory monitoring should be considered when VOCABRIA is used for HIV-1 PrEP.

Discontinue VOCABRIA if hepatotoxicity is suspected. ( 5.3 ) • Depressive disorders have been reported with VOCABRIA when used with EDURANT for HIV-1 treatment. Prompt evaluation is recommended for depressive symptoms.

( 5.4 ) • Risks Associated with Combination Treatment: Review the prescribing information for EDURANT for information on rilpivirine prior to initiation of VOCABRIA in combination with EDURANT. ( 5.6 )

5.1Comprehensive Management to Reduce the Risk of HIV-1 Infection When VOCABRIA is Used for HIV-1 Pre-Exposure Prophylaxis Use of VOCABRIA for HIV-1 PrEP should be part of a comprehensive prevention strategy including adherence to the dosing schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). VOCABRIA is not always effective in preventing HIV-1 acquisition [see Clinical Studies ( 14.2 )] . The time from initiation of VOCABRIA for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown.

Risk for HIV-1 acquisition includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Counsel individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner(s)’ HIV-1 status, including viral suppression status; regular testing for STIs that can facilitate HIV-1 transmission).

Inform individuals about and support their efforts in reducing sexual risk behavior. VOCABRIA for HIV-1 PrEP to reduce the risk of acquiring HIV-1 should be used only in individuals confirmed to be HIV-1 negative [see Contraindications ( 4 )] . HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only VOCABRIA, because VOCABRIA alone does not constitute a complete regimen for HIV-1 treatment [see Microbiology ( 12.4 )] ; therefore, care should be taken to minimize the risk of initiating or continuing VOCABRIA before confirming the individual is HIV-1 negative. • Prior to initiating VOCABRIA for HIV-1 PrEP, ask seronegative individuals about recent (in past month) potential exposure events (e.g., condomless sex or condom breaking during sex with a partner of unknown HIV-1 status or unknown viremic status, a recent STI), and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). • If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection.

Testing should be repeated prior to each injection of APRETUDE and upon diagnosis of any other STIs [see Dosage and Administration ( 2.2 )]. • If an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent with acute HIV-1 infection develop following an exposure event, additional HIV testing to determine HIV status is needed. If an individual has confirmed HIV-1 infection, then the individual must be transitioned to a complete HIV-1 treatment regimen. Counsel individuals without HIV-1 to strictly adhere to the recommended dosing schedule for VOCABRIA in order to reduce… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described below and in other sections of the labeling: • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] • Hepatotoxicity [see Warnings and Precautions ( 5.3 )] • Depressive disorders [see Warnings and Precautions ( 5.4 )] • In patients with HIV-1, the most common adverse reactions observed in at least 3 participants receiving VOCABRIA were fatigue, headache, diarrhea, nausea, dizziness, abnormal dreams, anxiety, insomnia, abdominal discomfort, abdominal distension, and asthenia.

( 6.1 ) • In individuals without HIV-1 receiving VOCABRIA, the most common adverse reactions reported in ≥1% were headache, diarrhea, nausea, dizziness, upper respiratory tract infection, somnolence, fatigue, abnormal dreams, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 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 with rates in the clinical trials of another drug and may not reflect rates observed in practice. See full prescribing information for CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension) for additional safety information. Since VOCABRIA is taken in combination with EDURANT tablets, the prescribing information for EDURANT (rilpivirine) should be consulted for relevant information on rilpivirine.

Adverse Reactions of VOCABRIA in Clinical Trials for the Treatment of HIV-1 Infection Clinical Trials Experience in Adults: The safety assessment of VOCABRIA for oral lead-in therapy prior to therapy with CABENUVA is based on the analysis of 48-week data from virologically suppressed participants with HIV-1 infection in 3 international, multicenter, open-label trials, where 590 of 1,182 participants received oral lead-in within the pivotal trials FLAIR and ATLAS (pooled analysis) and 655 of 1,045 participants received oral lead-in within ATLAS-2M [see Clinical Studies ( 14.1 )] .

Adverse reactions were reported following exposure to VOCABRIA tablets and EDURANT tablets administered in combination as oral lead-in therapy (median time exposure: 5.3 weeks). Adverse reactions included those attributable to the oral formulation of cabotegravir and rilpivirine administered as a combination regimen. Refer to the prescribing information for EDURANT for other adverse reactions associated with oral rilpivirine.

The most common adverse reactions during the oral lead-in period in the pooled analyses of FLAIR and ATLAS at Week 48 were headache, nausea, abnormal dreams, anxiety, and insomnia, all of which occurred in at least 3 participants with an incidence ≤1%. The most common adverse reactions during the oral lead-in period for ATLAS-2M were fatigue, diarrhea, headache, nausea, dizziness, abdominal discomfort, abdominal distension, insomnia, and asthenia, all of which occurred in at least 3 participants across both arms, with an incidence ≤2%.

During the oral lead-in period for FLAIR and ATLAS, 6 (1%) participants discontinued due to adverse events, including asthenia, myalgia, depression suicidal, and headache. During the oral lead-in period for ATLAS-2M, 4 (<1%) participants discontinued due to adverse events, including asthenia, skin lesion, fatigue, transaminases increased, and depression. In the extension phase of the FLAIR study at Week 124, the overall safety profile was consistent with that observed at Week 48 and when injection therapy with CABENUVA was initiated directly without the oral lead-in phase.

Clinical Trial Experience in Adolescents: Based on data from the Week 24 analysis of the MOCHA study in 144 adolescents (aged 12 to younger than 18 years and weighing ≥35 kg), the safety profile of oral cabotegravir and oral rilpivirine administered in combina… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS • Refer to the full prescribing information for important drug interactions with VOCABRIA. ( 4 , 5.5 , 7 ) • VOCABRIA in combination with EDURANT is a complete regimen for HIV-1 treatment. Coadministration with other antiretroviral medications for PrEP is not recommended. ( 7.1 ) • Drugs that induce uridine diphosphate glucuronosyltransferase (UGT)1A1 may decrease the plasma concentrations of cabotegravir. ( 4 , 7.2 , 7.3 )

7.1Concomitant Use with Other Antiretroviral Medicines VOCABRIA in combination with EDURANT (rilpivirine) is a complete regimen for the treatment of HIV-1 infection. Refer to the prescribing information for EDURANT for relevant information on rilpivirine. Coadministration of VOCABRIA with other antiretroviral medications for PrEP is not recommended [see Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )] .

Prior to initiating dosing with VOCABRIA, the prescribing information for CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension) or APRETUDE should be consulted to ensure use of CABENUVA or APRETUDE will be appropriate for either the treatment of HIV-1 infection or HIV-1 PrEP, respectively.

7.2Potential for Other Drugs to Affect VOCABRIA Cabotegravir is primarily metabolized by UGT1A1 with some contribution from UGT1A9. Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease cabotegravir plasma concentrations and may result in loss of efficacy; therefore, coadministration of VOCABRIA with these drugs is contraindicated [see Contraindications ( 4 )] . Coadministration of oral cabotegravir with polyvalent cation-containing products may lead to decreased absorption of cabotegravir [see Drug Interactions ( 7.3 )] .

7.3Established and Other Potentially Significant Drug Interactions Information regarding potential drug interactions with cabotegravir are provided in Table 1 . These recommendations are based on either drug interaction trials or predicted interactions due to the expected magnitude of the interaction and potential for loss of efficacy [see Contraindications ( 4 ), Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.3 )] . Table 1 includes potentially significant interactions but is not all inclusive.

Refer to the prescribing information for EDURANT (rilpivirine) for established or potentially significant interactions that should be considered during concomitant administration of VOCABRIA and EDURANT for HIV-1 treatment. Table 1. Drug Interactions with VOCABRIA ↓ = Decrease; PrEP = Pre-exposure prophylaxis. a Rifabutin can be coadministered with cabotegravir; however, it is contraindicated with CABENUVA for HIV-1 treatment.

Dosage modification is recommended with APRETUDE for HIV-1 PrEP. Concomitant Drug Class: Drug Name Effect on Concentration Clinical Comment Antacids containing polyvalent cations (e.g., aluminum or magnesium hydroxide, calcium carbonate) ↓Cabotegravir Administer antacid products at least 2 hours before or 4 hours after taking VOCABRIA. Anticonvulsants: Carbamazepine Oxcarbazepine Phenobarbital Phenytoin ↓Cabotegravir Coadministration is contraindicated with VOCABRIA due to potential for loss of efficacy and development of resistance [see Contraindications ( 4 )] .

Antimycobacterials a : Rifampin Rifapentine ↓Cabotegravir Antimycobacterial: Rifabutin ↓Cabotegravir Dose modification is not required for VOCABRIA. Dose modification is recommended for APRETUDE for HIV-1 PrEP. Coadministration is contraindicated with CABENUVA for HIV-1 treatment.

7.4Drugs without Clinically Significant Interactions with Cabotegravir Based on drug interaction study results, the following drugs can be coadministered with cabotegravir without a dose adjustment: etravirine, midazolam, oral contraceptives containing levonorgestrel and ethinyl estradiol, rifabutin, and rilpivirine [see Clinical Pharmacology ( 12.3 )] . Prior to initiating oral therapy, note that use of CABENUVA (cabotegravi… [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 VOCABRIA during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary There are insufficient human data on the use of VOCABRIA during pregnancy to adequately assess a drug-associated risk of birth defects and miscarriage.

Discuss the benefit-risk of using VOCABRIA with individuals of childbearing potential or during pregnancy. The APR has been established to monitor for birth defects following prenatal exposure to antiretrovirals. The rate of miscarriage is not reported in the APR.

The background risk for major birth defects and miscarriage for the indicated population is unknown. The background rate for major birth defects in a United States (U.S.) reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) is 2.7%. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%.

The APR uses the MACDP as the U.S. reference population for birth defects in the general population. The MACDP evaluates mothers and infants from a limited geographic area and does not include outcomes for births that occurred at <20 weeks’ gestation. In animal reproduction studies with oral cabotegravir, a delay in the onset of parturition and increased stillbirths and neonatal deaths were observed in a rat pre- and postnatal development study at >28 times the exposure at the recommended human dose (RHD).

No evidence of adverse developmental outcomes was observed with oral cabotegravir in rats or rabbits (>28 times or similar to the exposure at the RHD, respectively) given during organogenesis (see Data ) . Data Animal Data: Cabotegravir was administered orally to pregnant rats at 0, 0.5, 5, or 1,000 mg/kg/day from 15 days before cohabitation, during cohabitation, and from Gestation Days 0 to 17. There were no effects on fetal viability when fetuses were delivered by caesarean, although a minor decrease in fetal body weight was observed at 1,000 mg/kg/day (>28 times the exposure in humans at the RHD).

No drug-related fetal toxicities were observed at 5 mg/kg/day (approximately 13 times the exposure in humans at the RHD), and no drug-related fetal malformations were observed at any dose. Cabotegravir was administered orally to pregnant rabbits at 0, 30, 500, or 2,000 mg/kg/day from Gestation Days 7 to 19. No drug-related fetal toxicities were observed at 2,000 mg/kg/day (approximately 0.7 times the exposure in humans at the RHD).

In a rat pre- and postnatal development study, cabotegravir was administered orally to pregnant rats at 0, 0.5, 5, or 1,000 mg/kg/day from Gestation Day 6 to Lactation Day 21. A delay in the onset of parturition and increases in the number of stillbirths and neonatal deaths by Lactation Day 4 were observed at 1,000 mg/kg/day (>28 times the exposure in humans at the RHD); there were no alterations to growth and development of surviving offspring. In a cross-fostering study, similar incidences of stillbirths and early postnatal deaths were observed when rat pups born to cabotegravir-treated mothers were nursed from birth by control mothers.

There was no effect on neonatal survival of control pups nursed from birth by cabotegravir-treated mothers. A lower dose of 5 mg/kg/day (13 times the exposure at the RHD) was not associated with delayed parturition or neonatal mortality in rats. Studies in pregnant rats showed that cabotegravir crosses the placenta and can be detected in fetal tissue.

8.2Lactation Risk Summary There are no data on the presence of cabotegravir in human milk, the effects on the breastfed infant, or the effects on milk production. Cabotegravir is present in animal milk (see Data ) . When a drug is present in animal milk, it is likely that the drug will be pr… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Treatment of HIV-1 Infection The safety and effectiveness of VOCABRIA have been established in adolescents aged 12 to younger than 18 years and weighing at least 35 kg, which is supported by the following: • Trials in adults [see Clinical Studies ( 14.1 )] • MOCHA (NCT03497676) trial in adolescents, in which virologically suppressed adolescents (aged 12 to younger than 18 years and weighing at least 35 kg) with HIV-1 received either cabotegravir or rilpivirine in addition to their background antiretroviral regimen (cohort 1), or cabotegravir plus rilpivirine as a complete regimen (cohort 2) [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.3 )] .

The safety and efficacy of VOCABRIA in adolescents (aged 12 to younger than 18 years and weighing at least 35 kg) were similar to that in adults and there was no clinically significant change in drug exposure [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 )] . Please refer to the CABENUVA prescribing information for additional information. The safety, efficacy, and pharmacokinetics of VOCABRIA have not been established in pediatric patients younger than 12 years of age or weighing <35 kg.

HIV-1 Pre-Exposure Prophylaxis The safety and effectiveness of VOCABRIA for HIV-1 PrEP in adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition is supported by data from 2 adequate and well-controlled trials of VOCABRIA for HIV-1 PrEP in adults with additional safety and pharmacokinetic data from studies in adults with HIV-1 who were administered CABENUVA and in adolescent participants with HIV-1 who were administered separate components of CABENUVA in addition to their current antiretroviral therapy [see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.2 )] .

APRETUDE for HIV-1 PrEP was evaluated in 2 open-label multicenter clinical trials, HPTN 083-01 and HPTN 084-01, in adolescent individuals 12 to less than 18 years of age weighing at least 35 kg who are at risk for HIV-1 acquisition. Sixty-four adolescents were enrolled. Of these, 62 adolescent participants received one or more injections after receiving VOCABRIA.

In adolescents receiving VOCABRIA and APRETUDE for HIV-1 PrEP, the safety data were comparable to the safety data reported in adults receiving APRETUDE for HIV-1 PrEP. While using APRETUDE, HIV-1 testing should be conducted prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) and prior to each injection of APRETUDE. Adolescents may benefit from more frequent visits and counseling to support adherence to the dosing schedule [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 )].

The safety, efficacy, and pharmacokinetics of VOCABRIA in pediatric participants younger than 12 years of age or weighing <35 kg have not been established.

🧓 Geriatric Use 66 words ▾

8.5Geriatric Use Clinical trials of VOCABRIA did not include sufficient numbers of participants aged 65 years and older to determine whether they respond differently from younger participants. In general, caution should be exercised in administration of VOCABRIA in elderly patients, reflecting greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy [see Clinical Pharmacology ( 12.3 )] .

🆘 Overdosage 55 words ▾

10 OVERDOSAGE There is no known specific treatment for overdose with VOCABRIA. If overdose occurs, monitor the patient and apply standard supportive treatment as required as well as observation of the clinical status of the individual. As cabotegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.2Pharmacodynamics Cardiac Electrophysiology At a dose of cabotegravir 150 mg orally every 12 hours (10 times the recommended total daily oral lead-in dosage of VOCABRIA), the QT interval is not prolonged to any clinically relevant extent. Administration of 3 doses of cabotegravir 150 mg orally every 12 hours resulted in a geometric mean C max approximately 2.8-fold above the geometric mean steady-state C max associated with the recommended 30-mg dose of oral cabotegravir. For additional QT information related to the injectable formulations of cabotegravir and rilpivirine (CABENUVA), the injectable formulation of cabotegravir (APRETUDE), and the oral formulation of rilpivirine (EDURANT), refer to the prescribing information for CABENUVA, APRETUDE, and EDURANT.

12.3Pharmacokinetics Absorption, Distribution, and Elimination The pharmacokinetic properties of cabotegravir are provided in Table 2 . The multiple-dose pharmacokinetic parameters are provided in Table 3 . Table 2.

Pharmacokinetic Properties of Cabotegravir CSF = Cerebrospinal fluid. a Geometric mean ratio (fed/fasted) in pharmacokinetic parameters and 90% confidence interval. High‑calorie/high-fat meal = 870 kcal, 53% fat. b Dosing in mass balance studies: single-dose oral administration of [ 14 C] cabotegravir. Absorption T max (h), median 3 Effect of high-fat meal (relative to fasting):

1.14AUC (0-inf) ratio a (1.02, 1.28) Distribution % Bound to human plasma proteins >99.8 Blood-to-plasma ratio

0.52CSF-to-plasma concentration ratio (median [range]) b 0.003 (0.002 to 0.004) Elimination t 1/2 (h), mean 41 Metabolism Metabolic pathways UGT1A1 UGT1A9 (minor) Excretion Major route of elimination Metabolism % of dose excreted as total 14 C (unchanged drug) in urine b 27 (0) % of dose excreted as total 14 C (unchanged drug) in feces b 59 (47) Table 3. Multiple-Dose Pharmacokinetic Parameters of Oral Cabotegravir in Adults a Pharmacokinetic parameter values were based on individual post-hoc estimates from the final population pharmacokinetic model for participants receiving 30 mg of oral cabotegravir once daily in FLAIR and ATLAS trials. b tau is dosing interval: 24 hours for oral cabotegravir.

Parameter Geometric Mean (5 th , 95 th Percentile) a C max (mcg/mL) 8.0 (5.3, 11.9) AUC (0-tau) (mcg•h/mL) b 145 (93.5, 224) C tau (mcg/mL) b 4.6 (2.8, 7.5) Specific Populations No clinically significant differences in the pharmacokinetics of cabotegravir were observed based on age, sex, race/ethnicity, body mass index, or UGT1A1 polymorphisms. The effect of hepatitis B and C virus co-infection on the pharmacokinetics of cabotegravir is unknown. Renal Impairment: No clinically significant differences in the pharmacokinetics of cabotegravir are expected with mild, moderate, or severe renal impairment.

Cabotegravir has not been studied in patients with end-stage renal disease not on dialysis. As cabotegravir is >99% protein bound, dialysis is not expected to alter exposures of cabotegravir [see Use in Specific Populations ( 8.6 )] . Hepatic Impairment: No clinically significant differences in the pharmacokinetics of cabotegravir are expected in mild to moderate (Child-Pugh A or B) hepatic impairment.

The effect of severe hepatic impairment (Child-Pugh C) on the pharmacokinetics of cabotegravir has not been studied [see Use in Specific Populations ( 8.7 )] . Gender: Population pharmacokinetic analyses revealed no clinically relevant effect of gender on the exposure of cabotegravir. In addition, no clinically relevant differences in plasma cabotegravir concentrations were observed in PrEP studies by gender, including cisgender men and transgender women (+/-hormone use).

Therefore, no dose adjustment is necessary based on gender. Geriatric Patients: No dose adjustment is required in elderly individuals. There are limited data available on the use of cabotegrav… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 16 words ▾

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

📦 How Supplied / Storage and Handling 41 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Each VOCABRIA tablet contains 30 mg of cabotegravir and is a white, oval, film-coated, biconvex tablet debossed with “SV CTV” on one side. Bottle of 30 tablets with child-resistant closure NDC 49702-248-13. Store below 30°C (86°F).

📋 Description 119 words ▾

11 DESCRIPTION VOCABRIA contains cabotegravir, as cabotegravir sodium, an HIV integrase strand transfer inhibitor (INSTI). The chemical name of cabotegravir sodium is sodium ( 3S,11aR )-N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido [1,2-d]pyrazine-8-carboxamide. The empirical formula is C 19 H 16 F 2 N 3 NaO 5 and the molecular weight is 427.34 g/mol.

It has the following structural formula: Cabotegravir sodium is a white to almost white crystalline solid that is slightly soluble in water. Each immediate-release film-coated tablet of VOCABRIA for oral administration contains 30 mg of cabotegravir (equivalent to 31.62 mg cabotegravir sodium) and the inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating contains hypromellose, polyethylene glycol, and titanium dioxide.

Cabotegravir sodium chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Important Information for Individuals without HIV-1 Taking VOCABRIA for HIV-1 PrEP Advise individuals without HIV-1 about the following [see Warnings and Precautions ( 5.1 )] : • VOCABRIA should be used for PrEP as part of an overall HIV-1 infection prevention strategy, including adherence to the dosing schedule and safer sex practices, including condoms, to reduce the risk of STIs. • VOCABRIA is not always effective in preventing HIV-1 acquisition [see Clinical Studies ( 14.2 )] .

The time from initiation of VOCABRIA for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown. • Counsel individuals on the use of other prevention measures (e.g., knowledge of partner HIV-1 status, testing for STIs condom use). Inform individuals about and support their efforts in reducing sexual risk behavior. • VOCABRIA should be used to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-1 negative [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only VOCABRIA, because VOCABRIA alone does not constitute a complete regimen for HIV-1 treatment; therefore, care should be taken to minimize the risk of initiating or continuing VOCABRIA before confirming the individual is HIV-1 negative. • If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection. • If an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent with acute HIV-1 infection develop following an exposure event, additional HIV testing to determine HIV status is needed.

If an individual has confirmed HIV-1 infection, then the individual must be transitioned to a complete HIV-1 treatment regimen. Hypersensitivity Reactions Advise patients to immediately contact their healthcare provider if they develop a rash. Instruct patients to immediately stop taking VOCABRIA and seek medical attention if they develop a rash associated with any of the following symptoms as it may be a sign of a more serious reaction such as Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN): fever; generally ill feeling; extreme tiredness; muscle or joint aches; blisters; oral blisters or lesions; eye inflammation; facial swelling; swelling of the eyes, lips, tongue, or mouth; difficulty breathing; and/or signs and symptoms of liver problems (e.g., yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored stools or bowel movements; nausea; vomiting; loss of appetite; or pain, aching, or sensitivity on the right side below the ribs).

Advise patients that if hypersensitivity occurs, they will be closely monitored, laboratory tests will be ordered, and appropriate therapy will be initiated [see Warnings and Precautions ( 5.2 )] . Hepatotoxicity Inform patients that hepatotoxicity has been reported with cabotegravir [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . Inform patients that monitoring for liver transaminases is recommended when VOCABRIA is used for HIV-1 treatment.

Inform individuals that clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatoxicity is confirmed when VOCABRIA is used for HIV-1 PrEP [see Warnings and Precautions ( 5.3 )] . Depressive Disorders Inform patients that depressive disorders (including depressed mood, depression, mood altered, mood swings, suicidal ideation/suicide attempt) have been reported with VOCABRIA for treatment of HIV-1. Inform patients that depressive disorders (including depression, depressed mood, persistent depressive disorder, suicidal ideation/suicide attempt) have been reported with VOCABRIA for HIV-1 PrEP.

Prom… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

1.14AUC (0-inf) ratio a (1.02, 1.28) Distribution % Bound to human plasma proteins >99.8 Blood-to-plasma ratio

In general, caution should be exercised in administration of cabotegravir in elderly individuals, reflecting greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy [see Use in Specific Populations ( 8.5 )] . Pediatric Patients: Population pharmacokinetic analyses revealed no clinically relevant differences in exposure between adolescent participants (weighing ≥35 kg) and adult participants with and without HIV-1 from the cabotegravir development program; therefore, no dosage adjustment is needed for adolescents weighing ≥35 kg ( Table 4 ).

Table 4. Pharmacokinetic Parameters following Once-Daily Oral Cabotegravir in Adolescents Aged 12 to Younger than 18 Years (≥35 kg) a Pharmacokinetic parameter values were based on individual post-hoc estimates from population pharmacokinetic models… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 111 words ▾

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Clinical Trials in Adults for Treatment of HIV-1 Infection The use of VOCABRIA in combination with EDURANT as an oral lead-in and in patients who miss planned injections with CABENUVA was evaluated in 3 Phase 3 randomized, multicenter, active-controlled, parallel-arm, open-label, non-inferiority trials (Trial 201584: FLAIR [NCT02938520], Trial 201585: ATLAS [NCT02951052], and Trial 207966: ATLAS‑2M [NCT03299049]) in participants who were virologically suppressed (HIV-1 RNA <50 copies/mL). Please refer to the CABENUVA prescribing information for additional information.

In the FLAIR study during the Extension Phase (Week 100 to Week 124), the efficacy of CABENUVA was evaluated in participants who switched (at Week 100) from their current antiretroviral regimen to CABENUVA, with and without an oral lead-in phase. A total of 121 participants chose to start the treatment with oral lead-in and 111 participants chose direct to injection. Participants were not randomized during the Extension Phase.

At Week 124, the proportion of participants with HIV-1 RNA ≥50 copies/mL was 0.8% and 0.9% for the oral lead-in and direct to injection groups, respectively. The rates of virologic suppression (HIV-1 RNA <50 copies/mL) were similar in both the oral lead-in (93%) and direct to injection (99%) groups.

14.2Clinical Trials in Adults for HIV-1 Pre-Exposure Prophylaxis The use of VOCABRIA as an oral lead-in and in participants who miss planned injections with APRETUDE to reduce the risk of acquiring HIV-1 infection were evaluated in 2 randomized, double-blind, controlled, multinational trials, Trial 201738 (HPTN 083 [NCT02720094]) in men and transgender women without HIV-1 who have sex with men and have evidence of high-risk behavior for HIV-1 infection and Trial 201739 (HPTN 084 [NCT03164564]) in cisgender women without HIV-1 at risk of acquiring HIV-1.

Please refer to the APRETUDE prescribing information for additional information.

14.3Clinical Trial in Adolescents for Treatment of HIV-1 Infection Trial 208580 (MOCHA, [NCT03497676]) The safety, tolerability, and pharmacokinetics of oral and injectable cabotegravir and oral and injectable rilpivirine were assessed in an ongoing Phase 1/2 multicenter, open-label, non‑comparative study, MOCHA (IMPAACT 2017), in virologically suppressed adolescents with HIV-1 aged 12 to younger than 18 years and weighing ≥35 kg [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 )] . The primary objective at Week 24 was to confirm the safety of injectable cabotegravir plus injectable rilpivirine in virologically suppressed adolescents with HIV-1.

Antiviral activity was assessed as a secondary objective. A total of 144 adolescent participants with HIV-1 received oral cabotegravir in combination with oral rilpivirine as an oral lead-in. Please refer to the CABENUVA prescribing information for additional information.

🧪 Nonclinical Toxicology 130 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Two-year carcinogenicity studies in mice and rats were conducted with cabotegravir. In mice, no drug-related increases in tumor incidence were observed at cabotegravir exposures (AUC) up to approximately 8 times (males) and 7 times (females) higher than those in humans at the RHD. In rats, no drug-related increases in tumor incidence were observed at cabotegravir exposures up to approximately 26 times higher than those in humans at the RHD.

Mutagenesis Cabotegravir was not genotoxic in the bacterial reverse mutation assay, mouse lymphoma assay, or in the in vivo rodent micronucleus assay. Impairment of Fertility In rats, no effects on fertility were observed at cabotegravir exposures (AUC) >20 times (male) and 28 times (female) the exposure in humans at the RHD.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 127 words ▾

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION VOCABRIA [voe-KAB-ree-ah] (cabotegravir) tablets, for oral use This Patient Information provides information about two different ways that VOCABRIA may be used. See the section “What is VOCABRIA?” for detailed information about how VOCABRIA may be used. What is the most important information I should know about VOCABRIA?

Important information for people who take VOCABRIA to help reduce their risk of getting human immunodeficiency virus-1 (HIV-1) infection, also called pre-exposure prophylaxis or “PrEP”: Before taking VOCABRIA to reduce your risk of getting HIV-1: • You must be HIV-1 negative to start VOCABRIA. You must get tested to make sure that you do not already have HIV-1 infection. • Do not take VOCABRIA for HIV-1 PrEP unless you are confirmed to be HIV-1 negative. • Some HIV-1 tests can miss HIV-1 infection in a person who has recently become infected.

If you have flu-like symptoms, you could have recently become infected with HIV-1. Tell your healthcare provider if you had a flu‑like illness within the last month before starting VOCABRIA or at any time while taking VOCABRIA. Symptoms of new HIV-1 infection include: o tiredness o joint or muscle aches o sore throat o rash o enlarged lymph nodes in the neck or groin o fever o headache o vomiting or diarrhea o night sweats While you are taking VOCABRIA for HIV-1 PrEP: • VOCABRIA does not prevent other sexually transmitted infections.

Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting sexually transmitted infections. • You must stay HIV-1 negative to keep taking VOCABRIA for HIV-1 PrEP. o Know your HIV-1 status and the HIV-1 status of your partners. o Ask your partners with HIV-1 if they are taking anti-HIV-1 medicines and have an undetectable viral load. An undetectable viral load is when the amount of virus in the blood is too low to be measured in a lab test. To maintain an undetectable viral load, your partners must keep taking HIV-1 medicine as prescribed.

Your risk of getting HIV-1 is lower if your partners with HIV-1 are taking effective treatment. o Get tested for HIV-1 when your healthcare provider tells you. o Get tested for other sexually transmitted infections such as syphilis, chlamydia, and gonorrhea. These infections make it easier for HIV-1 to infect you. o If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to be sure you are still HIV-1 negative. o Get information and support to help reduce sexual risk behaviors. o Do not miss any doses of VOCABRIA.

Missing doses increases your risk of getting HIV-1 infection. o If you do become HIV-1 positive, you will need to take other medicines to treat HIV-1. VOCABRIA by itself is not a complete treatment for HIV-1. If you have HIV-1 and take only VOCABRIA, over time your HIV-1 may become harder to treat.

What is VOCABRIA? VOCABRIA is a prescription medicine that may be used in two different ways when a person’s healthcare provider determines that they meet certain requirements. VOCABRIA is used: • to treat HIV-1 infection o in combination with another HIV-1 medicine called EDURANT (rilpivirine) for short-term treatment of HIV-1 infection in people 12 years of age and older who weigh at least 77 pounds (35 kg) to replace their current HIV-1 medicines to assess the tolerability of cabotegravir before receiving the long-acting medicine called CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension). o as oral therapy for people who will miss planned injection dosing with CABENUVA. • for HIV-1 PrEP to reduce the risk of getting HIV-1 infection o for short-term PrEP in adults and adolescents who weigh at least 77 pounds (at least 35 kg) to assess the tolerability of cabotegravir before receiving the long-acting medicine called APRETUDE (cabotegravir extended-release injectable suspension). o as oral dosing for people who will miss planned injectio… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 9 words ▾

Warnings and Precautions, Hypersensitivity Reactions ( 5.2 ) 4/2025

📄 Package Label / Principal Display Panel 122 words ▾

PRINCIPAL DISPLAY PANEL NDC 49702-248-13 VOCABRIA (cabotegravir) Tablets 30 mg Rx Only Note to pharmacist: Do not cover ALERT box with pharmacy label. ALERT: Find out about medicines that should NOT be taken with VOCABRIA. 30 tablets Each tablet contains 30 mg of cabotegravir equivalent to 31.62 mg of cabotegravir sodium.

This package is child-resistant. Keep out of reach of children. Store below 30°C (86°F).

Do not accept if safety seal under cap is missing or broken. See prescribing information for dosage information. ViiV Healthcare Mfd for: ViiV Healthcare Durham, NC 27701 by: GlaxoSmithKline Durham, NC 27701 Trademarks owned or licensed by ViiV Healthcare. ©2023 ViiV Healthcare of licensor.

Made in Singapore Rev.4/23 A087339 (62000000087339) Vocabria 30 mg tablet 30 count label

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal distension: A swollen or stretched feeling in the belly, often from gas or fluid.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

active-controlled: Describes a study that compares a new medicine against another medicine already known to work, instead of a dummy pill.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Carcinogenesis, Mutagenesis, Impairment of Fertility: A label section reporting whether lab or animal studies found effects on cancer risk, genes, or the ability to have children.

Child-Pugh: A scoring system doctors use to grade how severe long-term liver disease is, often to help set the right medicine dose.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crosses the placenta: When a substance passes from a pregnant mother's blood, through the placenta, and into the developing baby.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

end-stage renal disease: The most advanced, permanent stage of kidney failure, usually needing dialysis or a kidney transplant.

enzyme induction: When a substance makes the body produce more of an enzyme, speeding up how fast certain drugs are removed.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

fertility: The natural ability to become pregnant or to father a child.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myalgia: Muscle pain or aching.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

non-inferiority: A study designed to show a new treatment works about as well as an existing one, not necessarily better.

Nonclinical Toxicology: The label section summarizing safety findings from laboratory and animal studies, rather than from studies in people.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pooled analysis: Combining the results of several separate studies into one larger group to look at the overall pattern.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

suicidal ideation: Thoughts about wanting to end your own life, which can range from a passing wish to a detailed plan.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

transaminases: Liver enzymes measured in a blood test; higher-than-normal levels can be a sign that the liver is irritated or damaged.

UGT: A family of enzymes that attach a sugar-like molecule to a drug, making it easier for the body to remove.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

viral load: The amount of a virus measured in a sample of blood or body fluid, often used to track an infection over time.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

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 Cabotegravir sodium — the ingredient across all brands.

Top reported reactions

Viral Load Increased109

Injection Site Pain105

Virologic Failure64

Hepatitis B63

Pathogen Resistance61

Nausea58

Fatigue56

Reporter sex

Serious outcomes

Hospitalization208

Life-threatening43

Disabling10

Reports over time (by year) — tap or hover for the count & year

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.

FDA Adverse Event Reporting System (FAERS)

About this NDC listing & data coverage

Finished prescription product

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)	✓ 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	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“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 ViiV Healthcare Company. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

ViiV Healthcare Company 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.

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.

← 49702-0246-13 · ViiV 49702-0250-18 · ViiV →

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.

Vocabria cabotegravir sodium 30 mg Tablet, Film Coated, 30-count — NDC 49702-248-13 (Billing 49702-0248-13)

NDC database record

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

RxNorm drug class

Clinical

Patient education

Supplement & herbal interactions

Pricing

Packaging — all sizes for this product

Therapeutic equivalents

Availability & generic status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from ViiV Healthcare Company labeler code 49702

Full prescribing information FDA SPL

8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

14 CLINICAL STUDIES

13 NONCLINICAL TOXICOLOGY

Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

About this NDC listing & data coverage

Questions about this listing

Related NDC lookups

Related drugs in this class