30 mg film-coated tablets
cabotegravir
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.
Pregnancy
- 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.
Breast-feeding
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 medicine | When | ||
| During month 1 (at least 28 days) | Month two after one month of tablets. | From month 3 | |
| Vocabulary | 30 mg tablet once daily | injection of 600 mg | injection of 400 mg monthly |
| Rilpivirine | 25 mg tablet once daily | injection of 900 mg | injection of 600 mg monthly |
Dosage schedule for Vocabria tablets before injection every two months
| What medicine | When | ||
| Month 1 (minimum 28 days) | Month 2 and month 3 after a month of tablets | From month 5 | |
| Vocabulary | 30 mg tablet once daily | injection of 600 mg | injection of 600 mg every two months |
| Rilpivirine | 25 mg tablet once daily | injection of 900 mg | injection 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
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)
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
Netherlands
Manufacturer
Glaxo Wellcome, SA
Abda. Extremadura, 3
Aranda De Duero
Burgos 09400
Spain
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 00 | LithuaniaViiV Healthcare BVPhone: + 370 80000334 |
| BulgariaViiV Healthcare BVTel.: + 359 80018205 | Luxembourg/LuxembourgViiV Healthcare srl/bvBelgique/BelgiumTel/Tel: + 32 (0) 10 85 65 00 |
| Czech RepublicGlaxoSmithKline, Serophene: + 420 222 001 111cz.info@gsk.com | MagyarországViiV Healthcare BVTel.: + 36 80088309 |
| DenmarkGlaxoSmithKline Pharma A/SPhone: + 45 36 35 91 00dk-info@gsk.com | MaltaViiV 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 8002640 | NorwayGlaxoSmithKline iPhone: + 47 22 70 20 00 |
| GreeceGlaxoSmithKlineΜονοπροσωπη AEBETel: + 30 210 68 82 100 | AustriaGlaxoSmithKline Pharma GmbHTel: + 43 (0)1 97075 0at.info@gsk.com |
| SpainLaboratorios ViiV Healthcare, SLPhone: + 34 900 923 501es-ci@viivhealthcare.com | PolishGSK Services Sp. z o. oTel.: + 48 (0)22 576 9000 |
| FranceViiV Healthcare SASTel.: + 33 (0)1 39 17 69 69Infomed@viivhealthcare.com | PortugalVIIVHIV HEALTHCARE, UNIPESSOAL, LDAPhone: + 351 21 094 08 01viiv.fi.pt@viivhealthcare.com |
| HrvatskaViiV Healthcare BVPhone: + 385 800787089 | RomaniaViiV Healthcare BVPhone: + 40 800672524 |
| IrelandGlaxoSmithKline (Ireland) LimitedPhone: + 353 (0)1 4955000 | SlovenijaViiV Healthcare BVPhone: + 386 80688869 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovenian RepublicViiV Healthcare BVPhone: + 421 800500589 |
| ItalyViiV Healthcare Srl Phone: + 39 (0)45 7741600 | Finland/FinlandGlaxoSmithKline OyPhone/Tel: + 358 (0)10 30 30 30 |
| CyprusViiV Healthcare BVTel: + 357 80070017 | SwedenGlaxoSmithKline ABPhone: + 46 (0)8 638 93 00info.produkt@gsk.com |
| LatviaViiV Healthcare BVPhone: + 371 80205045 | United Kingdom (Northern Ireland)ViiV Healthcare BVPhone: + 44 (0)800 221441customercontactuk@gsk.com |