Prescription medicine
Cabotegravir Brand names: Apretude, Vocabria
Cabotegravir (Apretude) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the cabotegravir FDA label on DailyMed (effective April 11, 2025, ViiV Healthcare Company); the NDA 212887 record on Drugs@FDA; every cabotegravir label on DailyMed.
Highlights of the record
FDA label of April 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE‑EXPOSURE PROPHYLAXIS.
(PrEP) IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen [see Dosage and Administration ( 2.2 ), Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION See full prescribing information for complete boxed warning. Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE for HIV-1 PrEP by individuals with undiagnosed HIV-1 infection. […]
Used for
From the label: indications and usageAPRETUDE is indicated for 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.
Forms and strengths
- 30 mg
Kit; film-coated tablet.
On the market
- Earliest approval on file
- January 21, 2021 Vocabria, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 15, 2031 Apretude injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 9,398 through July 30, 2026
What is cabotegravir used for?
From the label: indications and usageAPRETUDE is indicated for 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 APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP [see Dosage and Administration ( 2.2 , 2.4 ), Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. APRETUDE is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated for 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. […]
Conditions named in the indications of cabotegravir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor.
Source: FDA drug label (Apretude), ViiV Healthcare Company, effective April 11, 2025 (SPL set 4338428e-43d4-4e02-ac9d-bd98e738a7da), via openFDA; the full label on DailyMed
What does the patient leaflet for cabotegravir say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about APRETUDE?Important information for people who receive APRETUDE to help reduce their risk of getting human immunodeficiency virus-1 (HIV-1) infection, also called pre-exposure prophylaxis or “PrEP”: Before receiving APRETUDE to reduce your risk of getting HIV-1: • You must be HIV-1 negative to start APRETUDE. You must get tested to make sure that you do not already have HIV-1 infection. • Do not receive APRETUDE 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 APRETUDE or at any time while receiving APRETUDE. Symptoms of new HIV-1 infection include: ○ tiredness ○ joint or muscle aches ○ sore throat ○ rash ○ enlarged lymph nodes in the neck or groin ○ fever ○ headache ○ vomiting or diarrhea ○ night sweats While you are receiving APRETUDE for HIV-1 PrEP: • APRETUDE 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 receiving APRETUDE 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 medicine 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. […]
Source: FDA drug label (Apretude), ViiV Healthcare Company, effective April 11, 2025 (SPL set 4338428e-43d4-4e02-ac9d-bd98e738a7da), via openFDA; the full label on DailyMed
Is there a generic for cabotegravir (Apretude)?
No generic cabotegravir is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Apretude injection: the compound patent runs to February 4, 2031, and the last listed entry to September 15, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the cabotegravir label say about other medicines?
The cabotegravir label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name cabotegravir. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Calcium carbonate | drug interactions | Concomitant Drug Class/Drug Name: Antacids containing polyvalent cations (e.g., aluminum or magnesium hydroxide, calcium carbonate); Effect on Concentration: ↓Cabotegravir; Clinical Comment: Administer antacid products at least 2 hours before or 4 hours after taking VOCABRIA. |
| Carbamazepine | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifampin, rifapentine Unknown or positive HIV-1 status. |
| Etravirine | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Levonorgestrel | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Magnesium hydroxide | drug interactions | Concomitant Drug Class/Drug Name: Antacids containing polyvalent cations (e.g., aluminum or magnesium hydroxide, calcium carbonate); Effect on Concentration: ↓Cabotegravir; Clinical Comment: Administer antacid products at least 2 hours before or 4 hours after taking VOCABRIA. |
| Midazolam | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Oxcarbazepine | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifampin, rifapentine Unknown or positive HIV-1 status. |
| Phenobarbital | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifampin, rifapentine Unknown or positive HIV-1 status. |
| Phenytoin | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifampin, rifapentine Unknown or positive HIV-1 status. |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterial: Rifabutin; Effect on Concentration: ↓Cabotegravir; Clinical Comment: When rifabutin is started before or concomitantly with the first initiation injection of APRETUDE, the recommended dosing of APRETUDE is one 600-mg (3-mL) injection, followed 2 weeks later by a … |
| Rifampin | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifampin, rifapentine Unknown or positive HIV-1 status. |
| Rifapentine | contraindications | Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifampin, rifapentine Unknown or positive HIV-1 status. |
| Rilpivirine | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
Source: FDA drug label (Apretude), ViiV Healthcare Company, effective April 11, 2025 (SPL set 4338428e-43d4-4e02-ac9d-bd98e738a7da), via openFDA; the full label on DailyMed
What do FAERS reports show for cabotegravir?
The FDA Adverse Event Reporting System holds 9,398 reports that list cabotegravir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 183 are coded as a death and 524 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2024 (2,940, against a median of 40 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cabotegravir?
44 other medicines are given the same way (oral) and in the same FDA class as cabotegravir or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Raltegravir | HIV | 1 labeler | $34.54 per tablet 400 mg tablet | No current entry |
| Dolutegravir | HIV | none listed | $77.64 per tablet 50 mg tablet | No current entry |
| Abacavir and dolutegravir and lamivudine | HIV | none listed | $130.01 per tablet 600-50-300 mg tablet | No current entry |
| Cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide | HIV | none listed | $143.35 per tablet Genvoya tablet | No current entry |
| Cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil | HIV | none listed | $150.14 per tablet Stribild tablet | No current entry |
| Dolutegravir and lamivudine | HIV | none listed | $105.22 per tablet 50-300 mg tablet | No current entry |
| Dolutegravir and rilpivirine | HIV | none listed | $121.87 per tablet 50-25 mg tablet | No current entry |
| Emtricitabine and tenofovir disoproxil | HIV | 25 labelers | $0.529 per tablet 200-300 mg tablet | No current entry |
Every medicine labeled for the same conditions as cabotegravir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to cabotegravir
- 44 medicines for the same use
- Other human immunodeficiency virus integrase strand transfer inhibitors
- the pharmacologic class, with prices and generics
- Cabotegravir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other