cabotegravir
Apretude, Vocabria · ATC code J05AJ04
Also known as: Kabotegravir
- Key facts
- Active substance
- cabotegravir
- Drug class
- Direct acting antiviral
- ATC code
- J05AJ04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Apretude 600 mg prolonged-release suspension for injection · Apretude 30 mg film-coated tablets · 400 mg / Vocabria 400 mg prolonged-release suspension for injection / 600 mg · Vocabria 30 mg film-coated tablets
- Marketing authorisation holder
- ViiV Healthcare B.V.
- Information as of
- 2026-10-28
Key facts
Cabotegravir is an HIV-1 integrase inhibitor; as Apretude it is used for pre-exposure prophylaxis (PrEP), and as Vocabria, with rilpivirine, for treatment of HIV-1 infection.
What it is used for
- Apretude (600 mg injection; 30 mg tablets): with safer sex practices, PrEP to reduce the risk of sexually acquired HIV-1 in high-risk adults and adolescents weighing at least 35 kg; tablets short-term as oral lead-in or to cover missed injections.
- Vocabria (injection; 30 mg tablets): with rilpivirine, treatment of HIV-1 in adults and adolescents (at least 12 years, at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) with no present or past resistance to, and no prior virological failure with, NNRTI and integrase inhibitor agents.
Dosing
- Apretude injection: 600 mg intramuscularly, a second 600 mg one month later, then 600 mg every 2 months (each up to 7 days before or after the scheduled date); HIV-1 tests (antigen/antibody and HIV-RNA) must be negative before each injection.
- Apretude tablets: oral lead-in 30 mg once daily for about one month (at least 28 days), with or without food.
- Vocabria injection, monthly: 600 mg initiation, then 400 mg monthly; every 2 months: 600 mg, 600 mg one month later, then 600 mg every 2 months; each with rilpivirine injection at separate gluteal sites.
- Vocabria tablets: oral lead-in with cabotegravir 30 mg plus rilpivirine 25 mg once daily for about one month (at least 28 days), with a meal.
- After stopping Vocabria injections, start another fully suppressive regimen no later than one month (monthly dosing) or two months (every-2-month dosing) after the last injection. Further details: see the full text.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Concomitant rifampicin, rifapentine, carbamazepine, oxcarbazepine, phenytoin or phenobarbital.
- Apretude: individuals with unknown or positive HIV-1 status.
Important warnings
- Apretude may not always prevent HIV-1 and should be part of an overall prevention strategy (e.g. condoms, testing for other sexually transmitted infections).
- Risk of cabotegravir resistance if HIV-1 is acquired before, during or after Apretude; anyone diagnosed should start antiretroviral therapy immediately.
- Cabotegravir may remain in the body for 12 months or longer after an injection.
- Severe cutaneous reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) and hypersensitivity reactions: withdraw immediately; never restart after a serious reaction.
- Vocabria: certain baseline factors (rilpivirine resistance mutations, HIV-1 subtype A6/A1, BMI ≥ 30 kg/m²) may be associated with virological failure.
Side effects
- Apretude injection: in HPTN 083 most frequent were injection site reactions (82%), headache (17%) and diarrhoea (14%); in HPTN 084 injection site reactions (38%), headache (23%) and transaminase increased (19%).
- Vocabria plus rilpivirine: most frequent injection site reactions, headache and pyrexia.
- Common: depression, anxiety, abnormal dreams, insomnia, dizziness, nausea, rash; uncommon hepatotoxicity, suicidal ideation; very rare Stevens-Johnson syndrome and toxic epidermal necrolysis.
Interactions
- Strong inducers of UGT1A1 or UGT1A9 decrease cabotegravir levels and may lead to lack of efficacy.
- With Vocabria, rilpivirine interactions also apply. Further interactions: see the full text.
Pregnancy and breastfeeding
- Apretude injection is not recommended in pregnancy unless the benefit justifies the risk; Vocabria injection may be used if the benefit justifies the risk. Consider possible foetal exposure due to the long persistence.
- Breast-feed only if the expected benefit justifies the risk to the infant (Apretude).
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
Source: European Medicines Agency (EMA), product information
Turkey
- VocabriaGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Apretude, Vocabria
- Liechtenstein
- Apretude, Vocabria
- Norway
- Apretude, Vocabria
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Apretude – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/apretude-epar-product-information_en.pdf
- European Medicines Agency. Vocabria – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/vocabria-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC J05AJ.
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.