Cabotegravir
Cabotegravir is an HIV-1 antiretroviral medicine used in tablet form (Vocabria) and as an extended-release injection (Apretude) for HIV-1 treatment and for lowering the risk of getting HIV-1 (pre-exposure prophylaxis, or PrEP).
🧬 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 1 clinical label set 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 →
Cabotegravir is an HIV-1 integrase inhibitor (it blocks the enzyme HIV uses to insert its genes into cells), on the U.S. market since about 2019 as Apretude injections for PrEP (HIV prevention) and Vocabria tablets, used briefly with rilpivirine for treatment or as a lead-in. Most people tolerate it well, and sore injection sites are what Apretude users notice most, with headache or nausea also possible. The boxed warning is that undiagnosed HIV-1 can become drug-resistant on cabotegravir alone, so you must test negative before starting and before every injection. Report allergic reactions, liver symptoms or low mood promptly, because the injection lingers in the body for a year or longer.
Clinical pearls
- Take Vocabria with a meal, at the same time each day as Edurant, so both drugs absorb properly.
- Take aluminum, magnesium or calcium antacids at least 2 hours before or 4 hours after Vocabria.
- Carbamazepine, oxcarbazepine, phenytoin, phenobarbital, rifampin and rifapentine must not be taken with Vocabria because they drain cabotegravir levels.
- On Apretude, call right away after a possible HIV exposure or with fever, fatigue, muscle aches or rash.
Patient information guide A plain-language walkthrough of Cabotegravir, written from its FDA label.
What Cabotegravir is used for
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Cabotegravir is used for HIV-1 treatment and prevention, depending on the product.
- Vocabria tablets: short-term HIV-1 treatment with Edurant in virologically suppressed adults and adolescents 12 and older weighing at least 35 kg.
- Vocabria tablets: oral lead-in before CABENUVA or Apretude, or to replace planned missed CABENUVA injections.
- Apretude injection: HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection.
How Cabotegravir works
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Cabotegravir is an HIV-1 antiretroviral medicine. Vocabria is described as an HIV-1 integrase strand transfer inhibitor (INSTI). It is also made in a long-acting formulation.
Cabotegravir dosage
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Vocabria tablets are taken by mouth once daily. For HIV-1 treatment they are taken with Edurant at about the same time each day with a meal.
- Oral lead-in before injections lasts about 1 month.
- To replace planned missed CABENUVA injections, oral therapy is used for up to 2 months.
- Apretude is given only by a healthcare provider as a buttock injection, starting one month apart for 2 months and then every 2 months.
Follow your prescriber and the label for your exact schedule.
Dosing details from the FDA-approved label
From the Cabotegravir 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.
- HIV-1 treatment: oral lead-in before CABENUVA (adults and adolescents 12 years and older weighing at least 35 kg)
- One 30-mg tablet of VOCABRIA with one 25-mg tablet of EDURANT once daily with a meal for approximately 1 month (at least 28 days)
- The last oral dose is taken on the same day injections with CABENUVA are started
- Take with a meal at approximately the same time each day
- HIV-1 treatment: oral therapy to replace planned missed monthly CABENUVA injections (more than 7 days)
- One 30-mg tablet of VOCABRIA and one 25-mg tablet of EDURANT once daily with a meal for up to 2 months
- First oral dose 1 month (+/-7 days) after the last CABENUVA injection and continued until the day injection dosing is restarted
- Maximum: Up to 2 months of oral therapy
- For durations greater than 2 months, an alternative oral regimen is recommended
- HIV-1 treatment: oral therapy to replace a planned missed every-2-month CABENUVA injection (more than 7 days)
- One 30-mg tablet of VOCABRIA and one 25-mg tablet of EDURANT once daily with a meal for up to 2 months to replace 1 missed injection
- First oral dose approximately 2 months after the last CABENUVA injection and continued until the day injection dosing is restarted
- Maximum: Up to 2 months of oral therapy
- For durations greater than 2 months, an alternative oral regimen is recommended
- HIV-1 PrEP: oral lead-in before APRETUDE (adults and adolescents weighing at least 35 kg)
- One 30-mg tablet of VOCABRIA once daily for approximately 1 month (at least 28 days)
- Start APRETUDE initiation injection on the last day of oral lead-in or within 3 days
- Oral lead-in is optional
- HIV-1 PrEP: oral dosing to replace a planned missed APRETUDE injection (one every-2-month injection, more than 7 days)
- One 30-mg tablet of VOCABRIA once daily
- First dose approximately 2 months after the last APRETUDE injection
- Restart injection on the day oral dosing completes or within 3 days
- Replaces one every-2-month injection visit
- APRETUDE for HIV-1 PrEP: initiation injections
- A single 600-mg (3-mL) gluteal intramuscular injection given 1 month apart for 2 consecutive months, on the last day of oral lead-in if used or within 3 days
- Second injection may be given up to 7 days before or after the scheduled date
- APRETUDE for HIV-1 PrEP: continuation injections
- A single 600-mg (3-mL) gluteal intramuscular injection every 2 months after the 2 initiation injections
- May be given up to 7 days before or after the scheduled date
Read the label’s full dosing text
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 ) 2.1 Treatment 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.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Cabotegravir side effects
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Side effects seen with Apretude in clinical trials include:
Common side effects
- Injection site reactions (with Apretude)
- Diarrhea
- Headache
- Fever
- Fatigue
- Nausea
- Dizziness
- Sleep problems
When to get medical help
- Get help right away for signs of a serious allergic reaction, including a severe skin reaction such as Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Call your doctor if you notice possible liver problems. Liver toxicity has been reported.
- Tell your doctor promptly about depressed mood or other depression symptoms.
- If you take Apretude for PrEP and think you may have been exposed to HIV-1, or have fever, fatigue, muscle aches or rash, contact your provider right away.
Cabotegravir warnings and precautions
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- Drug resistance with Apretude for PrEP if HIV-1 infection is undiagnosed. Testing is required before starting and before each injection.
- Apretude does not always prevent HIV-1. Use it with other prevention measures.
- Cabotegravir may stay in the body for 12 months or longer.
- Serious allergic reactions, including severe skin reactions, have been reported.
- Liver toxicity and depression have been reported.
Cabotegravir interactions
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Some medicines lower cabotegravir levels or its absorption.
- Carbamazepine, oxcarbazepine, phenobarbital, phenytoin: lower cabotegravir levels, so they are contraindicated with Vocabria.
- Rifampin, rifapentine: lower cabotegravir levels, so they are contraindicated with Vocabria.
- Rifabutin: no Vocabria dose change; Apretude needs a dose change; CABENUVA is contraindicated.
- Antacids with aluminum, magnesium or calcium: can reduce absorption. Separate the doses.
- Other HIV medicines for PrEP: not recommended together.
Interactions listed in the FDA-approved label
From the Cabotegravir prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Antacids containing polyvalent cations (e.g., aluminum or magnesium hydroxide, calcium carbonate): Decrease cabotegravir concentrations. Administer antacid products at least 2 hours before or 4 hours after taking VOCABRIA.
- Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin: Decrease cabotegravir concentrations. Coadministration is contraindicated with VOCABRIA due to potential for loss of efficacy and development of resistance.
- Antimycobacterials: rifampin, rifapentine: Decrease cabotegravir concentrations. Coadministration with VOCABRIA is contraindicated.
- Rifabutin: Decreases cabotegravir concentrations, but it can be coadministered with cabotegravir without a dose adjustment. 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.
- Strong inducers of UGT1A1 or UGT1A9: Expected to decrease cabotegravir plasma concentrations and may result in loss of efficacy. Coadministration with VOCABRIA is contraindicated.
- Other antiretroviral medications for PrEP: VOCABRIA in combination with EDURANT is a complete regimen for HIV-1 treatment. Coadministration of VOCABRIA with other antiretroviral medications for PrEP is not recommended.
- Etravirine, midazolam, oral contraceptives containing levonorgestrel and ethinyl estradiol, rilpivirine: No clinically significant interaction with cabotegravir. Can be coadministered with cabotegravir without a dose adjustment.
Read the label’s full interactions text
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 ) 7.1 Concomitant 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. 7.2 Potential 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 )] . 7.3 Established and Other Potentially Significant Drug Interactions Information regarding potential drug interactions with cabotegravir are provided in Table 1 .
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 Cabotegravir
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- Do not use with a past allergic reaction to cabotegravir.
- For PrEP, HIV-1 status must be confirmed negative.
- Discuss pregnancy and breastfeeding with your provider. Human pregnancy data are insufficient, and breastfeeding carries risks.
- Vocabria is established for adolescents 12 and older weighing at least 35 kg.
- Older adults: no dose change, but limited data in people 65 and older.
- Severe liver impairment and end-stage kidney disease not on dialysis have not been studied.
Cabotegravir overdose
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For Apretude, there is no known specific treatment for overdose. Your care team would monitor you and give standard supportive care. Because the drug stays in the body for a long time after an injection, this is taken into account.
What Cabotegravir does in the body
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At a dose ten times the recommended daily oral lead-in dose, cabotegravir did not prolong the QT interval (a heart rhythm measure) to any clinically relevant extent.
How your body processes Cabotegravir
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Oral cabotegravir peaks in about 3 hours. A high-fat meal slightly increased absorption. It is over 99.8% bound to plasma proteins and is broken down mainly by the UGT1A1 enzyme, with a minor role for UGT1A9.
Oral half-life averages about 41 hours. After an Apretude injection, the half-life is about 5.6 to 11.5 weeks because the drug is absorbed slowly from the muscle. Age, sex, race, BMI and mild to moderate liver or kidney impairment had no clinically significant effect.
How to store Cabotegravir
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Store below 30°C (86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Cabotegravir
29 supplements and herbal products have documented interactions with Cabotegravir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 18
- Minor · 10
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.
Cabotegravir: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Cabotegravir — the kind of thing our pharmacy team would talk through with you at the counter.
What is cabotegravir for?
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How do I take Vocabria?
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What side effects should I expect?
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Why do I need an HIV test before PrEP?
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Can I take it with my other medicines?
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Is it safe in pregnancy?
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Is Cabotegravir available over the counter?
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When was Cabotegravir first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Cabotegravir on HelloPharmacist
Cabotegravir forms and strengths (how it comes)
Cabotegravir 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 Cabotegravir inactive ingredients by manufacturer.
Tablet
How this form is used
- Vocabria is used with Edurant for short-term HIV-1 treatment in virologically suppressed adults and adolescents 12 and older weighing at least 35 kg.
- Vocabria can be used as an oral lead-in before CABENUVA or Apretude, or to cover planned missed CABENUVA injections.
- Vocabria is also used as an oral lead-in before Apretude for HIV-1 PrEP.
- Vocabria is taken by mouth once daily.
- For HIV-1 treatment, Vocabria is taken with Edurant at about the same time each day with a meal.
- Vocabria oral lead-in lasts about 1 month; as a bridge for missed CABENUVA injections it is used for up to 2 months.
- Take antacids at least 2 hours before or 4 hours after Vocabria.
Cabotegravir on the U.S. market: products, makers and brands
How Cabotegravir 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 3 Cabotegravir product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2019. Brand names on the directory include Vocabria, Apretude; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (6) · Kit (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Cabotegravir is used (Medicaid data)
A general measure of how commonly Cabotegravir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Cabotegravir 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.
How commonly is Cabotegravir prescribed? Of the 1,601 medications we measure, Cabotegravir ranks #541 by Medicaid prescriptions — more than 66% of them.
Utilization by Cabotegravir 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.
3 ML cabotegravir 200 MG/ML Injection
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2588077
Other Cabotegravir products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 2 of 9 listed NDC products with Medicaid activity.
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 Cabotegravir, 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 3 of 15 listed Cabotegravir NDCs with Medicaid activity.
Compare Cabotegravir products
A representative set of FDA-listed product records for Cabotegravir — 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 | ||||
| 30 mg | Oral | ViiV Healthcare Company | NDA | View NDC → |
| 💊Kits | ||||
| — | — | ViiV Healthcare Company × 2 listings | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Cabotegravir NDCs →
Cabotegravir side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Cabotegravir — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Cabotegravir in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Cabotegravir FDA approval history
How Cabotegravir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Cabotegravir 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 Cabotegravir recalls since July 2021.
✅No Cabotegravir recalls on record since July 2021Source: 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.
RxCUI 2475077 2 dose forms · 3 strengths
-
Dose form (SCDF) Injection RxCUI 2588076No current FDA listingClinical drug / strength (SCD) 2 ML cabotegravir 200 MG/MLRxCUI 25949783 ML cabotegravir 200 MG/MLRxCUI 2588077 -
Dose form (SCDF) Oral Tablet RxCUI 2475198In current FDA listingsClinical drug / strength (SCD) 30 MGRxCUI 2475199
Look up RxCUI 2475077 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.
Cabotegravir supply and shortage status
Whether Cabotegravir is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Cabotegravir brand names
Cabotegravir is sold under 2 brand names in the FDA directory — Vocabria, Apretude. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Cabotegravir: manufacturers and labelers
One company lists Cabotegravir products with the FDA. By number of product records, the largest are ViiV Healthcare Company. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Cabotegravir drug class (RxNorm)
Cabotegravir belongs to the Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor class.
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 Cabotegravir 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.
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. ViiV Healthcare Company 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 →