Vocabria – Cabotegravir uses, dose and side effects


30 mg film-coated tablets

What Vocabria tablets are and what they are used for

Vocabria tablets contain the active substance cabotegravir. Cabotegravir belongs to a group of antiretroviral drugs called integrase inhibitors (INIs).

Vocabria tablets are used to treat HIV (human immunodeficiency virus) infection in adults aged 18 and over whose HIV ‑1‑ infection is under control and who are also receiving another antiretroviral medicine called rilpivirine.

Vocabria tablets do not cure HIV infection, but they do keep the amount of virus in the body at a low level. This helps to maintain the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that is important for the body’s ability to fight infection.

The doctor will tell you to take Vocabria tablets before you are given your first injection of Vocabria.

If you are treated with Vocabria injection but cannot receive your injection, the doctor may also recommend that you take Vocabria tablets instead until you can receive an injection again.

Vocabria tablets are always given in combination with another medicine, rilpivirine tablets, to treat HIV. The Vocabria and rilpivirine tablets replace the antiretroviral drugs you have been taking so far. Read the package insert for rilpivirine for information about that medicine.

What you need to know before taking Vocabria tablets

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 the following medicines as they may affect how Vocabria works:
    • carbamazepine, oxcarbazepine, phenytoin, and phenobarbital (medicines used to treat epilepsy and prevent seizures).
    • rifampicin or rifapentine (medicines used to treat certain bacterial infections, such as tuberculosis ).
  • If you think this applies to you, tell the doctor.

Warnings and precautions

Allergic reaction

Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir can cause a serious allergic reaction, a so-called hypersensitivity reaction. You need to know the important signs and symptoms to look out for while taking Vocabria.

  • Read the information in section 4 of this leaflet.

Liver problems including hepatitis B and/or C

Tell the doctor if you have or have had liver problems, including hepatitis B and/or C. Before deciding on treatment with Vocabria, the doctor may need to assess the severity of your liver disease.

Pay attention to important symptoms

Some people who take medicines for HIV infection develop other problems, which can be serious. You need to know the important signs and symptoms to look out for while taking Vocabria. These are:

  • symptoms of infection
  • symptoms of liver damage.
  • Read the information in section 4 of this leaflet (“Potential side effects”).

If you develop symptoms of infection or liver damage:

  • Talk to your doctor immediately. Do not take other anti-infection medicines unless the doctor has recommended it.

Children and young people

This medicine should not be used in children or adolescents under 18 years of age as it has not been adequately studied in these patients.

Other medicines and Vocabria tablets

Tell your doctor if you are taking, have recently taken, or might be taking any other medicines, including over-the-counter medicines.

Vocabria must not be taken with certain other medicines (see “Do not take Vocabria tablets” above in section 2).

Some medicines can affect how Vocabria works, or increase the risk of side effects. Vocabria can also affect how some other medicines work.

Tell your doctor if you are taking any of the medicines listed below:

  • Medicines called antacids for indigestion and heartburn. Antacids can prevent the body from absorbing the medicine in Vocabria tablets. Do not take such medicines within 2 hours before taking Vocabria, or within the next 4 hours after taking Vocabria.
  • rifabutin (for the treatment of certain bacterial infections, eg tuberculosis ).
  • Tell your doctor or pharmacist if you are taking any of these medicines. The doctor may decide that you need to go for more checks.

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.


  • Vocabria is not recommended during pregnancy. If necessary, the doctor will consider the benefits to you and the risks to your baby if you were to take Vocabria during pregnancy. If you are planning to have children, talk to your doctor first.
  • If you have become pregnant, do not stop taking Vocabria without talking to your doctor.


Breastfeeding is not recommended for women who are HIV positive because HIV infection can be transmitted to the infant in breast milk.

It is not known whether the ingredients in Vocabria tablets can pass into breast milk.

If you are breastfeeding or planning to breastfeed, you should discuss this with your doctor as soon as possible.

Driving ability and use of machinery

Vocabria can make you dizzy and have other side effects that reduce your attention span.

  • Do not drive or use machines if you are not sure that the medicine has no such effect on you.

Important information about some content topics in Vocabria

If you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.

How to take Vocabria tablets

Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.

Vocabria tablets must always be taken together with another HIV medicine (rilpivirine tablets). You should also be careful to follow the directions for rilpivirine. The package leaflet is in the carton with rilpivirine.

Dosage schedule for Vocabria tablets before monthly injection

What medicineWhen
During month 1 (at least 28 days)Month two after one month of tablets.From month 3
Vocabulary30 mg tablet once dailyinjection of 600 mginjection of 400 mg monthly
Rilpivirine25 mg tablet once dailyinjection of 900 mginjection of 600 mg monthly

Dosage schedule for Vocabria tablets before injection every two months

What medicineWhen
Month 1  (minimum 28 days)Month 2 and month 3 after a month of tabletsFrom month 5
Vocabulary30 mg tablet once dailyinjection of 600 mginjection of 600 mg every two months
Rilpivirine25 mg tablet once dailyinjection of 900 mginjection of 900 mg every two 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 daily for one month.
  • to then come to get an injection every or every other month.

This first month with Vocabria and rilpivirine tablets is called the oral lead-in period. It allows the doctor to assess whether it is appropriate to proceed to treatment with injections.

How to take the tablets

Vocabria tablets should be swallowed with a little water.

Vocabria can be taken with or without food. When Vocabria is taken at the same time as rilpivirine, both tablets should be taken with a meal.

If you can’t get your Vocabria injection

If you cannot have your Vocabria injection, your doctor may also recommend that you take Vocabria tablets or another HIV treatment instead until you can have another injection.


Antacids, which are used for indigestion and heartburn, can make Vocabria tablets not absorbed by the body and therefore have less effect.

Do not take antacids within 2 hours before taking a Vocabria tablet or within the next 4 hours after taking it. Talk to your doctor for more information about taking antacids and Vocabria tablets.

If you take too much Vocabria

If you take too many Vocabria tablets, contact your doctor or pharmacist for advice. Show them the jar of Vocabria tablets if possible.

If you forget to take Vocabria

If you notice that you have missed a dose within 12 hours of the time you usually take Vocabria, you should take the tablet as soon as possible. If you notice it later than after 12 hours, skip the missed dose and take the next dose as usual.

  • Do not take a double dose to make up for a missed dose.

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 you take the next tablet on the regular schedule.

Do not stop taking Vocabria without talking to your doctor

Take Vocabria for as long as your doctor recommends. Do not stop unless your doctor tells you to.

If you have any further questions about this medicine, ask your doctor or pharmacist.

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 severe allergic reaction, a so-called hypersensitivity reaction.

If you experience any of the following symptoms:

• skin reaction ( skin rash, hives )

• high temperature (fever)

• lack of energy

• swelling, sometimes of the face and mouth ( angioedema ), which causes breathing difficulties

• muscle or joint pain.

→ Seek medical attention immediately. The doctor may decide to take samples to check your liver, kidneys, or blood and possibly stop you from taking Vocabria.

Very common side effects are

These may affect more than 1 in 10 people:

  • headache
  • elevated body temperature ( fever ).

Common side effects are

These may affect up to 1 in 10 people:

  • Depression
  • anxiety
  • abnormal dreams
  • sleep difficulties ( insomnia )
  • dizziness
  • nausea
  • vomiting
  • stomach pains ( abdominal pain )
  • gas in the stomach ( flatulence )
  • diarrhea
  • rash
  • muscle pain ( myalgia )
  • lack of energy
  • weakness ( asthenia )
  • general malaise
  • weight gain.

Less common side effects are

These may affect up to 1 in 100 people:

  • suicide attempts and suicidal thoughts (especially in patients who previously had depression or problems with mental illness)
  • allergic reaction (type I hypersensitivity)
  • hives ( urticaria )
  • swelling, sometimes of the face and mouth ( angioedema ), which causes breathing difficulties
  • drowsiness ( somnolence )
  • liver damage (signs may be yellowing of the skin and the whites of the eyes, decreased appetite, itching, stomach ache, light-colored stools, or unusually dark urine)
  • changes in liver values ​​(increase in transaminases or increase in bilirubin ).

Other side effects that can be detected in blood tests

  • increased lipase (a substance produced in the pancreas)

Other possible side effects are

People taking Vocabria and rilpivirine for HIV may experience other side effects.

Inflammation of the pancreas

If you experience severe pain in the abdomen (stomach), it may be due to inflammation of the pancreas ( pancreatitis ).

  • Talk to your doctor, especially if the pain spreads and gets worse.

Symptoms of infection and inflammation

People with advanced HIV infection ( AIDS ) have a weak immune system and the risk is greater that they will get serious infections ( opportunistic infections ). When they start the treatment, the immune system becomes stronger and the body starts to fight infection.

Symptoms of infection or inflammation may develop, caused either by:

  • old, hidden infections flare up again as the body fights them off
  • the immune system attacks healthy tissue ( autoimmune diseases ).

The symptoms of autoimmune diseases can develop several months after you start your treatment for HIV infection.

The symptoms can be:

  • muscle weakness and/or muscle pain
  • joint pain or joint swelling
  • weakness that starts in the hands and feet and moves up the trunk
  • heart palpitations ( palpitations ) or tremors ( tremors )
  • hyperactivity (excessive restlessness and excessive movements).

If you develop symptoms of an infection or inflammation or if you notice any of the symptoms mentioned above:

  • Talk to your doctor immediately. Do not take other anti-infection medicines unless the doctor has recommended it.

How to store Vocabria tablets

Keep this medicine out of the sight and reach of children.

Use before the expiry date which is stated on the carton and can after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

The active substance is cabotegravir. One tablet contains 30 mg of cabotegravir.

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)

Appearance and package sizes of the medicine

Vocabria film-coated tablets are white, oval film-coated tablets marked with “SV CTV” on one side.

The film-coated tablets are available in jars with child-resistant lids.

Each jar contains 30 film-coated tablets.

Marketing Authorisation Holder

ViiV Healthcare BV

Van Asch van Wijckstraat 55H

3811 LP Amersfoort



Glaxo Wellcome, SA

Abda. Extremadura, 3

Aranda De Duero

Burgos 09400


For further information about this medicinal product, contact the representative of the marketing authorization holder:

België/Belgique/BelgienViiV Healthcare srl/bvTel/Tel: + 32 (0) 10 85 65 00LithuaniaViiV Healthcare BVPhone: + 370 80000334
BulgariaViiV Healthcare BVTel.: + 359 80018205Luxembourg/LuxembourgViiV Healthcare srl/bvBelgique/BelgiumTel/Tel: + 32 (0) 10 85 65 00
Czech RepublicGlaxoSmithKline, Serophene: + 420 222 001 111cz.info@gsk.comMagyarországViiV Healthcare BVTel.: + 36 80088309
DenmarkGlaxoSmithKline Pharma A/SPhone: + 45 36 35 91 00dk-info@gsk.comMaltaViiV Healthcare BVPhone: + 356 80065004
DeutschlandViiV Healthcare GmbHTel.: + 49 (0)89 203 0038-10viiv.med.info@viivhealthcare.com The NetherlandsViiV Healthcare BV Phone: + 31 (0) 33 2081199
EstoniaViiV Healthcare BVPhone: + 372 8002640NorwayGlaxoSmithKline iPhone: + 47 22 70 20 00
GreeceGlaxoSmithKlineΜονοπροσωπη AEBETel: + 30 210 68 82 100AustriaGlaxoSmithKline Pharma GmbHTel: + 43 (0)1 97075 0at.info@gsk.com
SpainLaboratorios ViiV Healthcare, SLPhone: + 34 900 923 501es-ci@viivhealthcare.comPolishGSK Services Sp. z o. oTel.: + 48 (0)22 576 9000
FranceViiV Healthcare SASTel.: + 33 (0)1 39 17 69 69Infomed@viivhealthcare.comPortugalVIIVHIV HEALTHCARE, UNIPESSOAL, LDAPhone: + 351 21 094 08 01viiv.fi.pt@viivhealthcare.com
HrvatskaViiV Healthcare BVPhone: + 385 800787089RomaniaViiV Healthcare BVPhone: + 40 800672524
IrelandGlaxoSmithKline (Ireland) LimitedPhone: + 353 (0)1 4955000SlovenijaViiV Healthcare BVPhone: + 386 80688869
IcelandVistor hf.Phone: +354 535 7000Slovenian RepublicViiV Healthcare BVPhone: + 421 800500589
ItalyViiV Healthcare Srl Phone: + 39 (0)45 7741600Finland/FinlandGlaxoSmithKline OyPhone/Tel: + 358 (0)10 30 30 30
CyprusViiV Healthcare BVTel: + 357 80070017SwedenGlaxoSmithKline ABPhone: + 46 (0)8 638 93 00info.produkt@gsk.com
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