Vocabria: Uses, Dosage & Side Effects
An integrase strand transfer inhibitor (INSTI) for the treatment of HIV-1 infection in adults and adolescents, used in combination with rilpivirine
Vocabria (cabotegravir) is a prescription integrase strand transfer inhibitor (INSTI) used in combination with rilpivirine to treat HIV-1 infection in adults and adolescents aged 12 years and older weighing at least 35 kg. Cabotegravir works by blocking the HIV integrase enzyme, preventing viral DNA from integrating into the host cell genome and thereby stopping the virus from replicating. Vocabria tablets are primarily used as an oral lead-in period of at least 28 days before transitioning to long-acting injectable cabotegravir plus rilpivirine, or as bridging therapy when an injection cannot be administered. This two-drug regimen represents a significant advancement in HIV treatment, offering effective viral suppression with fewer antiretroviral agents than traditional three-drug combinations.
Quick Facts: Vocabria
Key Takeaways
- Vocabria (cabotegravir) is an integrase strand transfer inhibitor (INSTI) used with rilpivirine as a complete two-drug regimen for HIV-1 treatment in virologically suppressed adults and adolescents aged 12+ weighing at least 35 kg.
- The oral tablets serve as a 28-day lead-in period to assess tolerability before switching to long-acting injectable cabotegravir plus rilpivirine, which can be given monthly or every two months.
- Vocabria must not be taken with strong enzyme inducers such as carbamazepine, phenytoin, rifampicin, or rifapentine, as they drastically reduce cabotegravir blood levels and may cause treatment failure and HIV resistance.
- The most common side effects are headache and fever; serious but rare adverse events include Stevens-Johnson syndrome and severe hypersensitivity reactions.
- Cabotegravir is also available under the brand name Apretude as a long-acting injectable for HIV pre-exposure prophylaxis (PrEP) in at-risk individuals who are HIV-negative.
What Is Vocabria and What Is It Used For?
Vocabria tablets contain the active substance cabotegravir, which belongs to a class of antiretroviral medications known as integrase strand transfer inhibitors (INSTIs). Integrase inhibitors represent one of the most important advances in modern HIV treatment, targeting a critical step in the viral replication cycle that had not been exploited by earlier drug classes such as reverse transcriptase inhibitors or protease inhibitors.
HIV-1 replication depends on the viral integrase enzyme to insert a DNA copy of the viral RNA genome into the chromosomal DNA of the infected human cell. Once integrated, the viral DNA (provirus) becomes a permanent part of the host cell’s genetic material, enabling the cell to produce new virus particles for the lifetime of that cell. By blocking the strand transfer activity of the integrase enzyme, cabotegravir prevents this integration step and effectively stops the virus from establishing new productive infections in CD4+ T lymphocytes and other susceptible immune cells.
Vocabria tablets are indicated for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older who weigh at least 35 kg, and whose HIV-1 infection is already suppressed (viral load below 50 copies/mL) on a stable antiretroviral regimen. The tablets are always used in combination with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), forming a complete two-drug regimen. This approach represents a paradigm shift in HIV management: traditionally, HIV treatment required at least three antiretroviral agents from two or more drug classes. The cabotegravir plus rilpivirine combination demonstrated in clinical trials that two carefully selected drugs can maintain viral suppression just as effectively as three-drug regimens, while reducing overall pill burden and potential for drug toxicity.
The primary role of Vocabria tablets is to serve as an oral lead-in period of at least 28 days (one month) before the patient transitions to long-acting injectable cabotegravir plus rilpivirine. During this lead-in phase, patients take one 30 mg cabotegravir tablet and one 25 mg rilpivirine tablet once daily. The purpose of this oral phase is to assess the patient’s tolerability of both medications before committing to long-acting injections, which remain in the body for extended periods. If a patient develops significant side effects during the oral lead-in, it is much easier to discontinue tablets than to reverse the effects of a long-acting injection.
Alternatively, if a patient who is already receiving long-acting injectable cabotegravir plus rilpivirine is unable to attend their scheduled injection appointment, Vocabria tablets (along with rilpivirine tablets) can be used as bridging oral therapy to maintain continuous HIV treatment until the next injection can be administered. This flexibility is a practical advantage that helps prevent treatment interruptions and the associated risk of viral rebound and drug resistance.
The Vocabria treatment pathway begins with oral tablets for at least one month, followed by a transition to long-acting injections given monthly or every two months. The injectable form of cabotegravir (combined with rilpivirine, marketed as Cabenuva) replaces daily pills entirely, requiring only 6–12 clinic visits per year for injections. Clinical trials (ATLAS, FLAIR, ATLAS-2M) demonstrated that injectable cabotegravir plus rilpivirine was non-inferior to standard three-drug oral regimens in maintaining viral suppression, with high patient satisfaction rates due to the freedom from daily pill-taking.
What Should You Know Before Taking Vocabria?
Contraindications
There are several situations in which Vocabria must not be used. Understanding these contraindications is essential for patient safety and effective treatment outcomes.
- You have ever had a severe skin reaction with blistering, peeling skin, or sores in the mouth (Stevens-Johnson syndrome or toxic epidermal necrolysis)
- You are allergic (hypersensitive) to cabotegravir or any other ingredient in the tablets
- You are taking carbamazepine, oxcarbazepine, phenytoin, or phenobarbital (anti-epileptic medicines)
- You are taking rifampicin or rifapentine (antibiotics used for tuberculosis and other bacterial infections)
The concomitant use of strong enzyme inducers with Vocabria is absolutely contraindicated because these drugs dramatically increase the activity of the metabolic enzymes (particularly UGT1A1) responsible for breaking down cabotegravir. This results in significantly reduced blood levels of cabotegravir, potentially to the point where the drug is no longer effective at suppressing HIV replication. Subtherapeutic drug levels not only allow the virus to replicate but also create ideal conditions for the development of drug-resistant HIV variants, which can severely limit future treatment options.
Warnings and Precautions
Severe skin reactions: Although very rare (affecting up to 1 in 10,000 patients), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with cabotegravir use. These are potentially life-threatening conditions characterized by target-like red spots on the trunk, often with central blisters, peeling skin, and erosions of the mucous membranes (mouth, throat, nose, eyes, and genitals). These reactions may be preceded by fever and flu-like symptoms. If you notice any of these signs, stop taking Vocabria immediately and seek emergency medical attention.
Hypersensitivity reactions: As with other integrase inhibitors, cabotegravir can cause serious allergic (hypersensitivity) reactions in uncommon cases (up to 1 in 100 patients). Symptoms may include skin rash, hives (urticaria), high temperature (fever), fatigue, swelling of the face or mouth (angioedema) causing breathing difficulties, and muscle or joint pain. If you experience any combination of these symptoms, contact your healthcare provider immediately, as they may need to perform blood tests to check liver, kidney, and blood function.
Liver problems: Tell your doctor if you have or have had liver disease, including hepatitis B and/or hepatitis C. Your doctor may need to assess the severity of your liver condition before deciding whether Vocabria is appropriate for you. Patients with hepatitis B co-infection require particular attention, as changes in antiretroviral therapy can sometimes lead to hepatitis B flares.
Immune reconstitution inflammatory syndrome (IRIS): Some people starting or changing HIV treatment may develop symptoms of infections or inflammatory conditions that were previously dormant. This occurs because the recovering immune system begins to mount responses against infections that it was previously too weak to fight. Symptoms can include fever, swollen lymph nodes, cough, or other signs of infection. In some cases, autoimmune disorders (such as Graves’ disease, polymyositis, or Guillain-Barré syndrome) may also develop months after starting treatment. If you notice any new or worsening symptoms after beginning Vocabria, inform your doctor promptly.
Vocabria should not be used in children under 12 years of age or in adolescents weighing less than 35 kg, as it has not been studied sufficiently in these populations. Safety and efficacy data are only available for patients aged 12 years and older who weigh at least 35 kg.
Pregnancy and Breastfeeding
Vocabria is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or are planning to have a baby, discuss your treatment options with your doctor before taking Vocabria. Your doctor will weigh the potential benefits of continued treatment against the risks to the unborn child. If you become pregnant while taking Vocabria, do not stop your HIV medication without consulting your doctor first, as uncontrolled viral replication during pregnancy increases the risk of mother-to-child transmission of HIV.
Breastfeeding is not recommended for women living with HIV regardless of whether they are taking antiretroviral therapy, because the virus can be transmitted to the infant through breast milk. It is also not known whether cabotegravir passes into breast milk. If you are breastfeeding or considering breastfeeding, talk to your doctor about safe alternatives for feeding your baby.
Driving and operating machinery: Vocabria may cause dizziness and other side effects that reduce your alertness. Do not drive vehicles or operate machinery unless you are certain that the medication does not affect your ability to do so safely.
Vocabria tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The tablets also contain less than 1 mmol (23 mg) of sodium per tablet, meaning they are essentially sodium-free.
How Does Vocabria Interact with Other Drugs?
Drug interactions are a critical consideration in HIV treatment, as subtherapeutic drug levels can lead to viral rebound and the emergence of drug resistance. Cabotegravir is primarily metabolized by UDP-glucuronosyltransferase 1A1 (UGT1A1), with a minor contribution from UGT1A9. Drugs that induce these enzymes can significantly reduce cabotegravir plasma concentrations. Additionally, cabotegravir has pH-dependent solubility, meaning that drugs that raise gastric pH (such as antacids) can impair its oral absorption.
Major Interactions (Contraindicated)
| Drug | Drug Class | Effect | Clinical Significance |
|---|---|---|---|
| Carbamazepine | Anti-epileptic | Significantly reduces cabotegravir levels | Risk of HIV treatment failure and resistance |
| Oxcarbazepine | Anti-epileptic | Significantly reduces cabotegravir levels | Risk of HIV treatment failure and resistance |
| Phenytoin | Anti-epileptic | Significantly reduces cabotegravir levels | Risk of HIV treatment failure and resistance |
| Phenobarbital | Anti-epileptic / Sedative | Significantly reduces cabotegravir levels | Risk of HIV treatment failure and resistance |
| Rifampicin | Antibiotic (TB treatment) | Significantly reduces cabotegravir levels | Risk of HIV treatment failure and resistance |
| Rifapentine | Antibiotic (TB treatment) | Significantly reduces cabotegravir levels | Risk of HIV treatment failure and resistance |
Minor Interactions (Use with Caution)
| Drug | Drug Class | Effect | Recommendation |
|---|---|---|---|
| Antacids (aluminium/magnesium hydroxide) | Gastrointestinal | Reduced absorption of cabotegravir | Take antacids at least 2 hours before or 4 hours after Vocabria |
| Rifabutin | Antibiotic (TB treatment) | May reduce cabotegravir levels | Inform your doctor; additional monitoring may be needed |
Always tell your doctor about all medicines you are currently taking, have recently taken, or might take in the future, including over-the-counter medicines, herbal products, and dietary supplements. Your HIV specialist can review potential interactions and adjust your treatment plan accordingly. When starting any new medication while on Vocabria, always check with your doctor or pharmacist first to ensure there are no harmful interactions.
What Is the Correct Dosage of Vocabria?
Vocabria tablets must always be taken together with rilpivirine tablets as part of a two-drug HIV treatment regimen. The dosing schedule depends on whether you are using the tablets as a lead-in before monthly injections or before every-two-month injections. Always follow your doctor’s instructions exactly and read the patient information leaflet for rilpivirine as well.
Adults and Adolescents (12 years and older, weighing at least 35 kg)
Oral Lead-In Before Monthly Injections
Month 1 (at least 28 days): Vocabria 30 mg tablet once daily + rilpivirine 25 mg tablet once daily, taken together with a meal.
Month 2 onward: Transition to injectable cabotegravir 600 mg + rilpivirine 900 mg as first injection, then cabotegravir 400 mg + rilpivirine 600 mg monthly.
Oral Lead-In Before Every-Two-Month Injections
Month 1 (at least 28 days): Vocabria 30 mg tablet once daily + rilpivirine 25 mg tablet once daily, taken together with a meal.
Months 2 and 3: Injectable cabotegravir 600 mg + rilpivirine 900 mg given one month apart.
Month 5 onward: Injectable cabotegravir 600 mg + rilpivirine 900 mg every two months.
| Phase | Vocabria Dose | Rilpivirine Dose | Frequency |
|---|---|---|---|
| Oral lead-in (at least 28 days) | 30 mg tablet | 25 mg tablet | Once daily with a meal |
| First injection (monthly regimen) | 600 mg injection | 900 mg injection | Once at transition |
| Maintenance (monthly regimen) | 400 mg injection | 600 mg injection | Every month |
| First two injections (Q2M regimen) | 600 mg injection | 900 mg injection | One month apart |
| Maintenance (Q2M regimen) | 600 mg injection | 900 mg injection | Every 2 months |
How to Take the Tablets
Swallow Vocabria tablets whole with some water. The tablets can be taken with or without food on their own, but when taken at the same time as rilpivirine (which is the standard approach), both tablets must be taken with a meal. This is because rilpivirine requires food for proper absorption. Taking rilpivirine on an empty stomach significantly reduces its blood levels and can lead to treatment failure.
Missed Dose
If you notice that you have missed a dose within 12 hours of the time you normally take Vocabria, take the tablet as soon as possible. If more than 12 hours have passed since your usual dosing time, skip the missed dose and take the next dose at your regular time. Do not take a double dose to make up for a forgotten tablet. If you vomit less than 4 hours after taking Vocabria, take another tablet. If you vomit more than 4 hours after taking the tablet, you do not need to take another dose until your next scheduled time.
Overdose
If you take more Vocabria tablets than prescribed, contact your doctor or pharmacist immediately for advice. If possible, show them the container of Vocabria tablets. There is no specific antidote for cabotegravir overdose; treatment is supportive and directed at managing any symptoms that may occur.
Continue taking Vocabria for as long as your doctor recommends. Do not stop taking it unless your doctor instructs you to do so. Stopping HIV treatment without medical supervision can lead to viral rebound, immune system deterioration, and the development of drug-resistant HIV, which can limit future treatment options. If you need to switch medications, your doctor will plan a safe transition to an alternative regimen.
What Are the Side Effects of Vocabria?
Like all medicines, Vocabria can cause side effects, although not everyone will experience them. It is important to be aware of both common and serious potential adverse reactions so that you can recognize them early and seek appropriate medical attention if needed.
- Red, flat, target-like or round spots on the trunk, often with central blisters, skin peeling, sores in the mouth, throat, nose, genitals, and eyes – these may be preceded by fever and flu-like symptoms (signs of Stevens-Johnson syndrome or toxic epidermal necrolysis)
- Skin rash, hives, swelling of face or mouth causing breathing difficulties, high fever, fatigue, muscle or joint pain (signs of severe hypersensitivity reaction)
Very Common
- Headache
- Fever (pyrexia)
Common
- Depression
- Anxiety
- Abnormal dreams
- Difficulty sleeping (insomnia)
- Dizziness
- Nausea
- Vomiting
- Abdominal pain (stomach pain)
- Flatulence (gas)
- Diarrhea
- Rash
- Muscle pain (myalgia)
- Fatigue (tiredness)
- Weakness (asthenia)
- General feeling of being unwell (malaise)
- Weight gain
Uncommon
- Suicidal thoughts and suicide attempt (particularly in patients with a previous history of depression or mental health problems)
- Allergic reaction (hypersensitivity)
- Hives (urticaria)
- Swelling of the face or mouth (angioedema) causing breathing difficulties
- Drowsiness (somnolence)
- Liver damage (signs may include yellowing of skin and eyes, loss of appetite, itching, tender abdomen, light-coloured stools, or unusually dark urine)
- Changes in liver blood tests (elevated transaminases or bilirubin)
Very Rare
- Stevens-Johnson syndrome (SJS)
- Toxic epidermal necrolysis (TEN)
Other Effects Detected in Blood Tests
- Increased lipase (an enzyme produced by the pancreas)
Immune Reconstitution Inflammatory Syndrome (IRIS)
People with advanced HIV infection (AIDS) have a weakened immune system, and when they begin treatment, the strengthening immune system may start fighting previously hidden infections. This can cause symptoms of infection and inflammation to appear, caused either by old latent infections flaring up or by the immune system attacking healthy tissue (autoimmune disorders). Symptoms may include muscle weakness, joint pain or swelling, weakness beginning in the hands and feet that moves upward, palpitations, tremor, or hyperactivity. These autoimmune symptoms can develop several months after starting HIV treatment.
Pancreatitis
If you experience severe abdominal pain, this could be caused by inflammation of the pancreas (pancreatitis). Tell your doctor, especially if the pain spreads and becomes worse. This is a recognized but uncommon adverse effect in patients taking cabotegravir with rilpivirine.
Depression and suicidal ideation have been reported with Vocabria, particularly in patients with a prior history of depression or psychiatric illness. If you experience persistent feelings of sadness, hopelessness, or thoughts of self-harm, contact your healthcare provider immediately. Do not wait for your next scheduled appointment. Support is available through mental health crisis lines and your treatment team.
How Should You Store Vocabria?
Proper storage of medications is essential to ensure they remain safe and effective throughout their shelf life. Vocabria tablets do not require any special storage conditions, making them convenient for patients to store at home.
General storage instructions: Keep Vocabria tablets in the original container with the child-resistant cap securely closed. Store at room temperature. No refrigeration is required. Do not use this medicine after the expiry date printed on the carton and bottle (after “EXP”). The expiry date refers to the last day of the stated month.
Keep out of reach of children: As with all medications, store Vocabria in a location that is not accessible to children. The original container has a child-resistant closure for added safety.
Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines you no longer use. These measures are important for protecting the environment and preventing accidental exposure.
What Does Vocabria Contain?
Understanding the composition of your medication is important, especially if you have known allergies or intolerances to specific pharmaceutical ingredients. Below is a detailed breakdown of what Vocabria contains.
Active Ingredient
The active substance is cabotegravir. Each film-coated tablet contains 30 mg of cabotegravir. Cabotegravir is an integrase strand transfer inhibitor that blocks the HIV-1 integrase enzyme, preventing the virus from integrating its genetic material into the host cell DNA.
Inactive Ingredients (Excipients)
| Ingredient | Role | Notes |
|---|---|---|
| Cabotegravir | Active substance (integrase inhibitor) | 30 mg per tablet |
| Lactose monohydrate | Filler / diluent | Not suitable for patients with galactose intolerance |
| Microcrystalline cellulose (E460) | Binder / filler | Provides tablet structure |
| Hypromellose (E464) | Binder (core) / film-coating agent | Used in both core and coating |
| Sodium starch glycolate | Disintegrant | Helps tablet break down for absorption |
| Magnesium stearate | Lubricant | Facilitates tablet manufacturing |
| Titanium dioxide (E171) | Colorant / opacifier | Provides white color to coating |
| Macrogol (E1521) | Plasticizer | Film-coating flexibility |
Appearance and Pack Sizes
Vocabria film-coated tablets are white, oval, and marked with “SV CTV” on one side. They are supplied in bottles with child-resistant closures, with each bottle containing 30 film-coated tablets – sufficient for one month of treatment.
Marketing Authorization Holder and Manufacturer
Vocabria is manufactured by Glaxo Wellcome S.A. (Aranda de Duero, Spain) and marketed by ViiV Healthcare, a specialist HIV company majority owned by GSK with Pfizer and Shionogi as shareholders. The marketing authorization holder in the European Union is ViiV Healthcare BV (Amersfoort, Netherlands). ViiV Healthcare is dedicated exclusively to HIV research and treatment, reflecting a focused commitment to advancing care for people living with HIV worldwide.
Frequently Asked Questions About Vocabria
Vocabria (cabotegravir) tablets are used in combination with rilpivirine to treat HIV-1 infection in adults and adolescents aged 12 years and older weighing at least 35 kg whose virus is already suppressed. The primary purpose of the oral tablets is to serve as a lead-in period (at least 28 days) before transitioning to long-acting injectable cabotegravir plus rilpivirine, or as temporary oral therapy when an injection cannot be given on schedule. Vocabria does not cure HIV but keeps the viral load at undetectable levels when taken as directed.
Vocabria is part of a revolutionary two-drug HIV treatment regimen (with rilpivirine), replacing the traditional three-drug approach. This means fewer medications while maintaining the same level of viral suppression. Additionally, Vocabria oral tablets serve as a gateway to long-acting injectable therapy – after the oral lead-in period, patients can switch to injections given monthly or every two months, eliminating the need for daily pill-taking. This represents one of the most significant advances in HIV treatment convenience since the introduction of single-tablet regimens.
You can use antacids, but timing is critical. Antacids (such as those containing aluminium or magnesium hydroxide) can interfere with the absorption of cabotegravir if taken too close together. You must not take antacids within 2 hours before or 4 hours after taking your Vocabria tablet. If you need regular antacid use for heartburn or indigestion, talk to your doctor about finding a dosing schedule that works safely with your HIV treatment.
Both Vocabria and Apretude contain the same active ingredient, cabotegravir, but they are used for different purposes. Vocabria (oral tablets and injection) is used for the treatment of existing HIV-1 infection in people already living with HIV, always in combination with rilpivirine. Apretude (long-acting injection only) is used for pre-exposure prophylaxis (PrEP) – preventing HIV infection in people who are HIV-negative but at high risk of acquiring the virus. Despite sharing the same drug, these are distinct products with different indications, dosing schedules, and regulatory approvals.
Vocabria (cabotegravir) itself can be taken with or without food. However, since Vocabria is always taken together with rilpivirine, and rilpivirine must be taken with a meal for proper absorption, in practice you should take both tablets together with a meal. A meal is defined as at least 390 kilocalories – a typical breakfast, lunch, or dinner will suffice. Taking rilpivirine without food can significantly reduce its blood levels and compromise treatment effectiveness.
If you are unable to attend your scheduled injection appointment for long-acting cabotegravir plus rilpivirine, your doctor may recommend that you take Vocabria oral tablets (30 mg once daily) along with rilpivirine tablets (25 mg once daily) as bridging therapy until your next injection can be given. This ensures that you maintain continuous HIV treatment and avoid the risk of viral rebound and resistance that can occur with treatment interruptions. Contact your healthcare team as soon as possible to reschedule your injection.
References
- European Medicines Agency (EMA). Vocabria (cabotegravir) – Summary of Product Characteristics. Last updated 2025. Available at: EMA Vocabria EPAR.
- U.S. Food and Drug Administration (FDA). Vocabria (cabotegravir) – Prescribing Information. ViiV Healthcare. Revised 2024.
- Swindells S, Andrade-Villanueva JF, Richmond GJ, et al. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020;382(12):1112–1123. doi:10.1056/NEJMoa1904398.
- Orkin C, Arasteh K, Hernandez-Mora MG, et al. Long-Acting Cabotegravir and Rilpivirine After Oral Induction for HIV-1 Infection (FLAIR). N Engl J Med. 2020;382(12):1124–1135. doi:10.1056/NEJMoa1909512.
- Overton ET, Richmond GJ, Rizzardini G, et al. Long-Acting Cabotegravir and Rilpivirine Dosed Every 2 Months in Adults with HIV-1 Infection (ATLAS-2M). Lancet. 2021;396(10267):1994–2005. doi:10.1016/S0140-6736(20)32666-0.
- European AIDS Clinical Society (EACS). EACS Guidelines for the Clinical Management and Treatment of HIV-Infected Adults. Version 12.0. 2024.
- U.S. Department of Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. 2024.
- World Health Organization (WHO). Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring. 2024. Available at: WHO HIV Guidelines.
- British National Formulary (BNF). Cabotegravir. National Institute for Health and Care Excellence (NICE). 2025.
- Jaeger H, Overton ET, Richmond GJ, et al. Long-term efficacy and safety of cabotegravir plus rilpivirine for HIV-1: 96-week results from the ATLAS and FLAIR studies. AIDS. 2021;35(3):419–428.
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