Patient leaflet - Vocabria 400 mg prolonged-release suspension for injection
1. What Vocabria is and what it is used for
Vocabria injection contains the active ingredient cabotegravir. Cabotegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).
Vocabria injection is used to treat HIV (human immunodeficiency virus) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg), who are also receiving another antiretroviral medicine called rilpivirine and whose HIV-1 infection is under control.
Vocabria injections do not cure HIV infection; they keep the amount of virus in your body at a low level. This helps maintain the number of CD4 cells in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Vocabria injection is always given in combination with another injection of an anti-retroviral medicine called rilpivirine injection. Refer to the rilpivirine package leaflet for information on that medicine.
2. What you need to know before you are given Vocabria
Do not receive a Vocabria injection:
if you are allergic (hypersensitive) to cabotegravir or any of the other ingredients of this medicine
(listed in section 6).
if you are taking any of these medicines as they may affect the way Vocabria works: Text Issue and Draft No.: Issue 13 Draft 1
- carbamazepine, oxcarbazepine, phenytoin, phenobarbital (medicines to treat epilepsy and prevent fits).
- rifampicin or rifapentine (medicines to treat some bacterial infections such as tuberculosis).
➔ If you think this applies to you, tell your doctor.
Warnings and precautions
Allergic reaction
Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors including cabotegravir can cause a serious allergic reaction known as a hypersensitivity reaction. You need to know about important signs and symptoms to look out for while you’re receiving Vocabria.
➔ Read the information in section 4 of this leaflet.
Liver problems including hepatitis B and/or C
Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take Vocabria.
Look out for important symptoms
Some people taking medicines for HIV infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you’re taking Vocabria. These include:
- symptoms of infections
- symptoms of liver damage.
➔ Read the information in section 4 of this leaflet (‘Possible side effects’).
If you get any symptoms of infection or liver damage:
➔ Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice.
Regular appointments are important
It is important that you attend your planned appointments to receive your Vocabria injection, to control your HIV infection, and to stop your illness from getting worse. Talk to your doctor if you are thinking about stopping treatment. If you are late receiving your Vocabria injection, or if you stop receiving Vocabria, you will need to take other medicines to treat HIV infection and to reduce the risk of developing viral resistance.
Vocabria injection is a long acting medicine. If you stop treatment, low levels of cabotegravir (the active ingredient of Vocabria) can remain in your system for up to 12 months or more after your last injection. These low levels of cabotegravir will not protect you against the virus and the virus may become resistant. You must start a different HIV treatment within one month of your last Vocabria injection if you are having monthly injections, and within two months of your last Vocabria injection if you are having injections every two months.
Children and adolescents
This medicine is not for use in children less than 12 years of age or adolescents weighing less than 35 kg because it has not been studied in these patients.
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Other medicines and Vocabria injection
Tell your doctor if you are taking, have recently taken or might take any other medicines including other medicines bought without a prescription.
Vocabria must not be given with some other medicines. (see ‘Do not receive a Vocabria injection’ earlier in section 2).
Some medicines can affect how Vocabria works or make it more likely that you will have side effects. Vocabria can also affect how some other medicines work.
Tell your doctor if you are taking:
- rifabutin (to treat some bacterial infections such as tuberculosis).
➔ Tell your doctor or pharmacist if you are taking this medicine. Your doctor may decide that you need extra check-ups.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby:
➔ Talk to your doctor before receiving a Vocabria injection.
Pregnancy
- Vocabria is not recommended during pregnancy. If needed, your doctor will consider the benefit to you and the risk to your baby of receiving Vocabria injections while you're pregnant. If you are planning to have a baby, talk to your doctor in advance.
- If you have become pregnant, do not stop attending your appointments to receive a Vocabria injection without consulting your doctor.
Breast-feeding
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.
It is not known whether the ingredients of Vocabria injection can pass into breast milk. However, it is possible that cabotegravir may still pass into breast milk for 12 months after the last injection of Vocabria.
If you’re breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.
Driving and using machines
Vocabria can make you dizzy and have other side effects that make you less alert.
➔ Don’t drive or use machines unless you are sure you’re not affected.
Important information about some of the ingredients of Vocabria
Vocabria injection contains polysorbate. This medicine contains 40 mg of polysorbate per 2 mL dose. Tell your doctor if you have any known allergies.
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3. How Vocabria injections are given
You will be given Vocabria as an injection, either once every month or once every 2 months, together with another injection of medicine called rilpivirine. Your doctor will advise you of your dosing schedule.
A nurse or doctor will give you Vocabria through an injection in the muscle of your buttock (intramuscular, or IM, injection).
When you first start treatment with Vocabria you and your doctor may decide to either start treatment with cabotegravir tablets or start treatment directly with a Vocabria injection: If you decide to start treatment with tablets, your doctor will tell you:
- to take one 30 mg Vocabria tablet and one 25 mg rilpivirine tablet, once a day, for approximately one month
- after that receive monthly or every 2 month injections.
This first month of Vocabria and rilpivirine tablets is called the oral lead-in period. It allows your doctor to assess whether it’s appropriate to proceed with injections.
Injection schedule for monthly dosing
| When | ||
| Which medicine | First injection | Second injection onwards, every month |
| Vocabria | 600 mg injection | 400 mg injection every month |
| Rilpivirine | 900 mg injection | 600 mg injection every month |
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Injection Schedule for every 2 month dosing
| Which medicine | When | |
| First and second injections, one month apart | Third injection onwards, every two months | |
| Vocabria | 600 mg injection | 600 mg injection every 2 months |
| Rilpivirine | 900 mg injection | 900 mg injection every 2 months |
If you miss a Vocabria injection
➔ Contact your doctor immediately to make a new appointment
It is important that you keep your regular planned appointments to receive your injection to control your HIV and to stop your illness from getting worse. Talk to your doctor if you are thinking about stopping treatment.
Talk to your doctor if you think you will not be able to receive your Vocabria injection at the usual time. Your doctor may recommend you take Vocabria tablets or another HIV treatment instead, until you are able to receive Vocabria injection again.
If you are given too much Vocabria injection
A doctor or nurse will give this medicine to you, so it is unlikely that you will be given too much. If you are worried, tell the doctor or nurse.
Don’t stop receiving Vocabria injections without advice from your doctor.
Keep receiving Vocabria injections for as long as your doctor recommends. Don’t stop unless your doctor advises you to. If you stop, your doctor must start you on another HIV treatment within a month of your last Vocabria injection if you are having monthly injections, and within two months of your last Vocabria injection if you are having injections every two months, to reduce the risk of developing viral resistance.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors including cabotegravir can cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions are uncommon (may affect up to 1 in 100 people).
If you get any of the following symptoms:
- skin reaction (rash, hives)
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- a high temperature (fever)
- lack of energy (fatigue)
- swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
- muscle or joint aches.
➔ See a doctor straight away. Your doctor may decide to carry out tests to check your liver, kidneys or blood, and may tell you to stop taking Vocabria.
Very common side effects
These may affect more than 1 in 10 people:
- headache
injection site reactions. In clinical studies, most were generally mild to moderate and became less frequent over time. Symptoms may include:
- pain and discomfort, a hardened mass or lump
- feeling hot (pyrexia), which may occur within one week after injections.
Common side effects
These may affect up to 1 in 10 people:
- depression
- anxiety
- abnormal dreams
- difficulty in sleeping (insomnia)
- dizziness
- feeling sick (nausea)
- vomiting
- stomach pain (abdominal pain)
- wind (flatulence)
- diarrhoea
- rash
- muscle pain (myalgia)
- lack of energy (fatigue)
- feeling weak (asthenia)
- generally feeling unwell (malaise)
- weight gain
- injection site reactions. In clinical studies, most were generally mild to moderate and became less frequent over time. Symptoms may include: redness, itching, swelling, warmth, bruising, (which may include discolouration or a collection of blood under the skin).
Uncommon side effects
These may affect up to 1 in 100 people:
- suicide attempt and suicidal thoughts (particularly in patients who have had depression or mental health problems before)
- allergic reaction (hypersensitivity)
- hives (urticaria)
- swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing feeling drowsy (somnolence)
- feeling lightheaded, during or following an injection. This may lead to fainting
- liver damage (signs may include yellowing of the skin and the whites of the eyes, loss of appetite, itching, tenderness of the stomach, light-coloured stools or unusually dark urine) Text Issue and Draft No.: Issue 13 Draft 1
- changes in liver blood tests (increase in transaminases or increase in bilirubin)
- injection site reactions. In clinical studies, most were generally mild to moderate and became less frequent over time. Symptoms may include: numbness, minor bleeding, an abscess (collection of pus) or cellulitis (heat, swelling or redness).
Very rare side effects
These may affect up to 1 in 10,000 people:
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are serious life-threatening conditions which usually start with flu-like symptoms. A few days later other symptoms appear including:
- Painful red or purple skin that looks burned and peels off
- Blisters on your skin, mouth, nose and genitals
- Red, painful, watery eyes
➔ Contact your doctor urgently if you notice any of these symptoms.
Other side effects that may show up in blood tests
- an increase in lipases (a substance produced by the pancreas)
Other possible side effects
People receiving Vocabria and rilpivirine therapy for HIV may get other side effects.
Pancreatitis
If you get severe pain in the abdomen (tummy), this may be caused by inflammation of your pancreas (pancreatitis).
➔ Tell your doctor, especially if the pain spreads and gets worse.
Symptoms of infection and inflammation
People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When they start treatment, the immune system becomes stronger, so the body starts to fight infections.
Symptoms of infection and inflammation may develop, caused by either:
- old, hidden infections flaring up again as the body fights them
- the immune system attacking healthy body tissue (autoimmune disorders).
The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Symptoms may include:
- muscle weakness and/or muscle pain
- joint pain or swelling
- weakness beginning in the hands and feet and moving up towards the trunk of the body
- palpitations or tremor
- hyperactivity (excessive restlessness and movement).
If you get any symptoms of infection:
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➔ Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vocabria
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Do not freeze.
6. Contents of the pack and other information
What Vocabria contains
- The active substance is cabotegravir.
Each 2 ml vial contains 400 mg cabotegravir.
The other ingredients are:
Mannitol (E421)
Polysorbate 20 (E432)
Macrogol (E1521)
Water for injections
What Vocabria looks like and contents of the pack
Cabotegravir prolonged release suspension for injection is presented in a brown glass vial with a rubber stopper. The pack also contains 1 syringe, 1 vial adaptor, and 1 injection needle.
Marketing Authorisation Holder
ViiV Healthcare UK Limited
79 New Oxford Street
London
WC1A 1DG
United Kingdom
Manufacturer
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Harmire Road
Barnard Castle
County Durham DL12 8DT
UK
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Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name Vocabria 400mg Injection
Reference number 35728/0056
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in March 2026.
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The following information is intended for healthcare professionals only:
Vocabria 2 mL injection Instructions for use:
Overview A complete dose requires two injections: VOCABRIA and rilpivirine 2 mL of cabotegravir and 2 mL of rilpivirine. Cabotegravir and rilpivirine are suspensions that do not need further dilution or reconstitution. The preparation steps for both medicines are the same. Carefully follow these instructions when preparing the suspension for injection to avoid leakage. Cabotegravir and rilpivirine are for intramuscular use only. Both injections must be administered to the gluteal sites. Note: The ventrogluteal site is recommended. The administration order is not important. | |
| Storage information | |
| Do not freeze. | |
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Your pack contains
- 1 vial of cabotegravir
- 1 vial adaptor
- 1 syringe
- 1 injection needle (0.65 mm, 38 mm [23 gauge, 1.5 inches])
Consider the patient’s build and use medical judgment to select an appropriate injection needle length.
You will also need
- Non-sterile gloves
- 2 alcohol swabs
- 2 gauze pads
- A suitable sharps container
Make sure to have the rilpivirine pack close by before starting.
Preparation
- 1. Inspect vial
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Check expiry date and medicine E XP MO NT H / YE AR |
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- Place the vial on a flat surface.
- Press the vial adaptor straight down onto the vial, as shown.
- The vial adaptor should click securely into place.
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| Injection | |
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| Ventrogluteal Dorsogluteal | Injections must be administered to the gluteal sites. Select from the following areas for the injection:
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| 2 mL |
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| 2.5 cm (1 inch) | Use the z-track injection technique to minimise medicine leakage from the injection site.
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| After injection | |
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| Repeat for 2nd medicine | |
| Repeat all steps for 2nd medicine | If you have not yet injected both medicines, use the steps for preparation and injection for rilpivirine which has its own specific Instructions for Use. |
| Questions and Answers | |
Once the suspension has been drawn into the syringe, the injection should be used immediately, from a microbiological point of view. Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C.
Injecting 1 mL of air into the vial makes it easier to draw up the dose into the syringe. | |
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Without the air, some liquid may flow back into the vial unintentionally, leaving less than intended in the syringe.
- 3. Does the order in which I give the medicines matter?
No, the order is unimportant.
- 4. If the pack has been stored in the fridge, is it safe to warm the vial up to room temperature more quickly?
It is best to let the vial come to room temperature naturally. However, you can use the warmth of your hands to speed up the warm up time.
Do not use any other heating methods.
- 5. Why is the ventrogluteal administration approach recommended?
The ventrogluteal approach, into the gluteus medius muscle, is recommended because it is located away from major nerves and blood vessels. A dorso-gluteal approach, into the gluteus maximus muscle, is acceptable, if preferred by the health care professional. The injection should not be administered in any other site.