Patient leaflet - Vocabria 30 mg film-coated tablets
1 What Vocabria is and what it is used for
Vocabria tablets contain the active ingredient cabotegravir. Cabotegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).
Vocabria tablets are 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 taking another antiretroviral medicine called rilpivirine and whose HIV-1 infection is under control. Vocabria tablets 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. Your doctor will advise you to take Vocabria tablets before you are given a Vocabria injection for the first time.
If you are being given Vocabria injection, but you are not able to receive your injection, your doctor may also recommend that you take Vocabria tablets instead, until you can receive the injection again.
Vocabria tablets are always given in combination with another anti-retroviral medicine called rilpivirine tablets to treat HIV infection. Vocabria and rilpivirine tablets will replace your current antiretroviral medicines. Refer to the rilpivirine package leaflet for information on that medicine.
2 What you need to know before you take Vocabria
Do not take Vocabria tablets:
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: — 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 taking 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.
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.
Other medicines and Vocabria tablets
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 taken with some other medicines (see ‘Do not take Vocabria tablets’ 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 any of the medicines in the following list:
Medicines called antacids, to treat
indigestion and heartburn. Antacids can stop the medicine in Vocabria tablets from being absorbed into your body.
Do not take these medicines in the 2 hours before you take Vocabria or for at least 4 hours after you take it.
rifabutin (to treat some bacterial infections
such as tuberculosis).
➔ Tell your doctor or pharmacist if you are
taking any of these. 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 taking Vocabria.
Pregnancy
Vocabria is not recommended during
pregnancy. If needed, your doctor will consider the benefit to you and the risk to your baby of taking Vocabria 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
taking Vocabria 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 tablets can pass into breast milk. 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
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3 How to take Vocabria
Always take this medicine exactly as your
doctor has told you. Check with your doctor or pharmacist if you are not sure.
Vocabria tablets must always be taken with another HIV medicine (rilpivirine tablets). You should also follow the instructions for rilpivirine carefully. The leaflet is supplied in the rilpivirine carton.
Dosing schedule for Vocabria tablets followed by monthly injections
| Which medicine | When | ||
| During month 1 (at least 28 days) | At month 2 following one month of tablets | Month 3 onwards | |
| Vocabria | 30 mg tablet once daily | 600 mg injection | 400 mg injection monthly |
| Rilpivirine | 25 mg tablet once daily | 900 mg injection | 600 mg injection monthly |
Dosing schedule for Vocabria tablets followed by every 2 month injections
| Which medicine | When | ||
| Month 1 (at least 28 days) | At Month 2 and Month 3 following one month of tablets | Month 5 onwards | |
| Vocabria | 30 mg tablet once a day | 600 mg injection | 600 mg injection every 2 months |
| Rilpivirine | 25 mg tablet once a day | 900 mg injection | 900 mg injection every 2 months |
When you first start treatment with Vocabria, you and your doctor may decide to either start treatment with Vocabria 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.
The 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.
How to take the tablets
Vocabria tablets should be swallowed with a small amount of water.
Vocabria can be taken with or without food. However, when Vocabria is taken at the same time as rilpivirine, both tablets should be taken with a meal.
If you cannot receive your Vocabria injection
If you are not able to receive your Vocabria injection, your doctor may recommend you take Vocabria tablets or another HIV treatment instead, until you can receive an injection again.
Antacid medicines
Antacids, to treat indigestion and heartburn, can stop Vocabria tablets being absorbed into your body and make it less effective. Do not take an antacid during the 2 hours before you take a Vocabria tablet or for at least 4 hours after you take it. Talk to your doctor for further advice on taking acid-lowering (antacid) medicines with Vocabria tablets.
If you take more Vocabria than you should
If you take too many tablets of Vocabria, contact your doctor or pharmacist for advice. If possible, show them the Vocabria tablet bottle.
If you forget to take Vocabria
If you notice within 12 hours of the time you usually take Vocabria, take the missed tablet as soon as possible. If you notice after 12 hours, then skip that dose and take the next dose as usual.
➔ 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 Vocabria you do not need to take another tablet until your next scheduled dose.
Don’t stop taking Vocabria without advice from your doctor
Take Vocabria for as long as your doctor recommends. Don’t stop unless your doctor advises you to.
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)
- 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
- feeling hot (pyrexia).
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.
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)
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)
changes in liver blood tests (increase in
transaminases or increase in bilirubin).
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 taking 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 and inflammation or if you notice any of the symptoms above:
➔ 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 pharmacist. 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 after EXP on the carton and bottle. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Vocabria contains
The active substance is cabotegravir. Each tablet contains 30 mg cabotegravir. The other ingredients are:
Tablet core
Lactose Monohydrate
Microcrystalline Cellulose (E460)
Hypromellose (E464)
Sodium Starch Glycolate
Magnesium Stearate
Tablet coating
Hypromellose (E464)
Titanium Dioxide (E171)
Macrogol (E1521)
What Vocabria looks like and contents of the pack
Vocabria film-coated tablets are white, oval, film-coated tablets, debossed with ‘SV CTV’ on one side.
The film-coated tablets are provided in bottles closed with child-resistant closures. Each bottle contains 30 film-coated tablets. Marketing Authorisation Holder
ViiV Healthcare UK Limited
79 New Oxford Street
London
WC1A 1DG
United Kingdom
Manufacturer
Glaxo Wellcome, S.A.
Avda. Extremadura, 3
Aranda De Duero
Burgos 09400
Spain
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Product name Vocabria 30 mg Tablets
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This leaflet was last revised in March 2026.
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