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INSTI (long-acting injectable) Pregnancy: SPC 4.6 Pregnancy: there are limited data from the use of cabotegravir in pregnant women; the effect of Vocabria on human pregnancy is unknown. Cabotegravir was not teratogenic when studied in pregnant rats and rabbits, but exposures higher than the therapeutic dose showed reproductive toxicity in animals; the relevance to human pregnancy is unknown. 'Vocabria injection is not recommended during pregnancy unless the expected benefit justifies the potential risk to the foetus.' Cabotegravir has been detected in systemic circulation for up to 12 months or longer after an injection. Breast-feeding: cabotegravir is expected to be secreted into human milk based on animal data (not confirmed in humans) and may be present in human milk for up to 12 months or longer after the last injection; it is recommended that women living with HIV do not breast-feed their infants in order to avoid transmission of HIV. Fertility: no human data; animal studies indicate no effects on male or female fertility.

Cabotegravir

Brand names: Vocabria, Apretude

Cabotegravir is an integrase strand transfer inhibitor available as a long-acting injectable, used with rilpivirine for HIV-1 treatment and alone for HIV pre-exposure prophylaxis.

Adult dose

Dose: HIV-1 infection treatment, in combination with rilpivirine injection, in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and integrase inhibitor class. Product: Vocabria 600 mg prolonged-release suspension for injection (vial = 600 mg cabotegravir in 3 mL; the 400 mg dose is 2 mL), with cabotegravir 30 mg tablets for the optional oral lead-in. OPTIONAL ORAL LEAD-IN: one cabotegravir 30 mg tablet once daily together with one rilpivirine 25 mg tablet once daily, taken with a meal, for approximately one month (at least 28 days), followed by the initiation injection; or proceed directly to injections. EVERY 2 MONTH DOSING: initiation injections - 600 mg (3 mL) intramuscularly on the final day of current antiretroviral therapy or oral lead-in, then a second 600 mg intramuscular injection one month later; continuation injections - 600 mg (3 mL) intramuscularly every 2 months, the first two months after the last initiation injection. MONTHLY DOSING: initiation injection 600 mg (3 mL) intramuscularly on the final day of current antiretroviral therapy or oral lead-in; continuation injection 400 mg (2 mL) intramuscularly monthly, starting one month after the initiation injection.
Route: Intramuscular injection into the gluteal muscle (ventrogluteal site recommended; dorsogluteal also acceptable), given by a healthcare professional, at a separate gluteal site from the rilpivirine injection at the same visit. Optional oral lead-in with 30 mg tablets (oral) before the first injection.
Frequency: Every 2 months after two initiation injections one month apart, or monthly after one initiation injection. Injections may be given up to 7 days before or after the scheduled date.
SCOPE: these figures are the UK SPC for ONE product only, Vocabria 600 mg prolonged-release suspension for injection (ViiV Healthcare UK Limited, PLGB357280057), whose only indication is HIV-1 treatment together with rilpivirine injection. This page also names Apretude and a PrEP use; the SPC does not cover pre-exposure prophylaxis, so NO PrEP dose is given here. For the rilpivirine injection dosing the SPC says: 'the prescribing information for rilpivirine injection should be consulted for recommended dosing.' PRESCRIBING: Vocabria should be prescribed by physicians experienced in the management of HIV infection; each injection should be administered by a healthcare professional; the injection should always be co-administered with rilpivirine injection (order not important). Take the patient's BMI into consideration so that the needle length is sufficient to reach the gluteus muscle; shake the vial vigorously for a full 10 seconds, invert and check the resuspension is uniform; avoid inadvertent injection into a blood vessel. SWITCHING: monthly to every 2 months - a single 600 mg intramuscular injection one month after the last 400 mg continuation dose, then 600 mg every 2 months; every 2 months to monthly - a single 400 mg intramuscular injection 2 months after the last 600 mg continuation dose, then 400 mg monthly. MISSED DOSES: reassess clinically. If a planned injection visit will be missed by more than 7 days, oral therapy (one cabotegravir 30 mg tablet and one rilpivirine 25 mg tablet once daily) may replace up to 2 consecutive monthly injection visits or one every-2-month injection visit; for oral durations greater than two months an alternative oral regimen is recommended; the first oral dose is taken one month (+/- 7 days) after the last injections for monthly dosing, or two months (+/- 7 days) after for every-2-month dosing; injection dosing resumes on the day oral dosing completes. After a missed MONTHLY injection (time since last injection): 2 months or less - continue the monthly 400 mg schedule as soon as possible; more than 2 months - re-initiate with the 600 mg dose, then continue the monthly 400 mg schedule. After a missed EVERY-2-MONTH injection: injection 2 - 2 months or less since last injection, resume with 600 mg as soon as possible then the every-2-month schedule; more than 2 months, re-initiate with 600 mg followed by a second 600 mg one month later, then the every-2-month schedule; injection 3 or later - 3 months or less, resume with 600 mg as soon as possible then the every-2-month schedule; more than 3 months, re-initiate with 600 mg followed by a second 600 mg one month later, then the every-2-month schedule (all injections are 3 mL). AFTER DISCONTINUATION: adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the final injection when dosed monthly, and no later than two months after the final injection when dosed every 2 months; residual cabotegravir concentrations may remain in the circulation for up to 12 months or longer. Elderly: no dose adjustment is required. The SPC prints no maximum dose. Some sections of the product information we used were incomplete — check the full SPC.

Paediatric dose

Dose: Adolescents at least 12 years of age and weighing at least 35 kg: the SPC doses 'Adults and adolescents (at least 12 years of age and weighing at least 35 kg)' together, so the regimen is the same as for adults (see adult dose).
Route: Intramuscular (optional oral lead-in with 30 mg tablets)
Frequency: As for adults
SPC 4.2: 'The safety and efficacy of Vocabria in children aged less than 12 years or adolescents weighing less than 35 kg have not been established. No data are available.' No dose is given for those groups and none is written here. Verify against a children's formulary.

Dose adjustments

Renal

SPC 4.2: no dosage adjustment is required in patients with mild (creatinine clearance 60 to <90 mL/min), moderate (30 to <60 mL/min) or severe renal impairment (creatinine clearance 15 to <30 mL/min and not on dialysis). Cabotegravir has not been studied in patients with end-stage renal disease on renal replacement therapy; as cabotegravir is greater than 99% protein bound, dialysis is not expected to alter exposures; if administered in a patient on renal replacement therapy, cabotegravir should be used with caution.

Hepatic

SPC 4.2: no dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). Cabotegravir has not been studied in patients with severe hepatic impairment (Child-Pugh score C); if administered in a patient with severe hepatic impairment, cabotegravir should be used with caution.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (the vial contains polysorbate 20, which may cause allergic reactions)
  • Concomitant use with rifampicin, rifapentine, carbamazepine, oxcarbazepine, phenytoin or phenobarbital (strong UGT1A1/UGT1A9 inducers expected to decrease cabotegravir plasma concentrations leading to lack of efficacy)
  • Precaution (4.4): it is not recommended to initiate Vocabria in patients with hepatitis B co-infection (excluded from studies)
  • Precaution (4.4): concomitant use with rifabutin is not recommended; caution with medicinal products that may reduce cabotegravir exposure

Side effects

  • Most frequently reported: injection site reactions, headache, and pyrexia (4.8)
  • Very common: headache; injection site reactions (pain and discomfort, nodule, induration); pyrexia (grouped term including feeling hot and body temperature increased; most events within one week of injections)
  • Common: depression, anxiety, abnormal dreams, insomnia; dizziness; nausea, vomiting, abdominal pain, flatulence, diarrhoea; rash; myalgia; injection site reactions (swelling, erythema, pruritus, bruising, warmth, haematoma); fatigue, asthenia, malaise; weight increased
  • Uncommon: hypersensitivity; suicide attempt, suicidal ideation (particularly in patients with a pre-existing history of psychiatric illness); somnolence; vasovagal reactions (in response to injections); hepatotoxicity; urticaria, angioedema; injection site reactions (cellulitis, abscess, anaesthesia, haemorrhage, discolouration); transaminase increased, blood bilirubin increased
  • Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis (post-marketing)
  • SPC 4.8 is truncated at the source-fetch limit and its table was flattened by PDF extraction (frequency read from the order of the text), so this list is not guaranteed complete

Interactions

  • Strong inducers of UGT1A1 or UGT1A9 are expected to decrease cabotegravir concentrations (see contraindications: rifampicin, rifapentine, carbamazepine, oxcarbazepine, phenytoin, phenobarbital); rifabutin concomitant use not recommended
  • UGT1A1 inhibitors (e.g. atazanavir, erlotinib, sorafenib): no dosing adjustment for Vocabria recommended
  • Cabotegravir inhibited organic anion transporters OAT1 and OAT3 in vitro: caution is advised when co-dosing with narrow therapeutic index OAT1/3 substrates (e.g. methotrexate)
  • Cabotegravir did not affect midazolam (CYP3A4 probe) in vivo
  • Vocabria and rilpivirine injections are a complete regimen and should not be administered with other antiretroviral medicinal products for HIV; consult the rilpivirine injection prescribing information for associated interactions
  • SPC 4.5 is truncated at the source-fetch limit (it stops inside the introduction to Table 6), so further interactions may exist that were not retrieved

Monitoring

  • Liver chemistries: monitoring is recommended and treatment should be discontinued if hepatotoxicity is suspected; oral lead-in was used in clinical studies to help identify patients at risk of hepatotoxicity
  • Hypersensitivity: discontinue immediately if signs or symptoms develop (severe rash, rash with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia, angioedema); monitor clinical status including liver aminotransferases
  • Liver function monitoring is recommended in patients with hepatitis C co-infection (limited data)
  • Baseline factors associated with virological failure: a combination of at least 2 of archived rilpivirine resistance mutations, HIV-1 subtype A6/A1, or BMI 30 kg/m2 or more may increase risk; virologic failure occurs more often with every-2-month dosing than monthly dosing in these patients
  • If virologic failure is suspected, adopt an alternative regimen as soon as possible
  • Evaluate any inflammatory symptoms of immune reactivation syndrome after starting combination antiretroviral therapy
  • Residual cabotegravir concentrations may persist for up to 12 months or longer after the last injection: take this into account on discontinuation and in pregnancy

Clinical monograph

How it works

It inhibits HIV integrase, blocking the strand-transfer step that inserts viral DNA into the host cell genome and so preventing viral replication.

Prescribing in practice

  • For pre-exposure prophylaxis, HIV-negative status must be confirmed before each injection, because undiagnosed infection during use risks integrase-inhibitor resistance.
  • Its long-acting depot means drug persists for many months after the last dose, so coverage with an alternative agent is needed if injections are stopped.
  • Strong inducers such as rifampicin and certain anticonvulsants are contraindicated as they reduce cabotegravir exposure.

Monitoring

Repeat HIV testing before each injection (especially for prophylaxis) and monitor for injection-site reactions and hypersensitivity.

Counselling the patient

  • Keep every appointment on schedule, as late injections reduce protection or treatment effect.
  • Injection-site soreness, swelling or a small lump is common and usually settles.
  • If injections are stopped, you must use another agreed method to stay protected for several months.

Evidence & guidelines

Long-acting cabotegravir prophylaxis efficacy was demonstrated in the HPTN 083 and HPTN 084 trials.

Reference: BHIVA HIV / PrEP guidelines; EACS; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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