Vocabria
Authorised
This medicine is authorised for use in the European Union
cabotegravir
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Vocabria is used together with another medicine called rilpivirine to treat adults and adolescents aged 12 years and older infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used when the infection is under control with antiretroviral medicines (medicines for HIV). Adolescents must weigh at least 35 kg to take Vocabria.
Vocabria contains the active substance cabotegravir.
Vocabria is available as tablets to be taken by mouth or as an injection given into a muscle of the hip or buttock. After being injected, the active substance is released slowly over a few weeks into the bloodstream.
Before starting treatment, the doctor ensures that the patient agrees to keep to the schedule of injections because this is important to keep the virus under control and there is a risk that levels of the virus could increase or the virus could become resistant to treatment if doses are missed.
Cabotegravir and rilpivirine tablets are taken daily by mouth for one month, after which Vocabria and rilpivirine injections are given monthly or every 2 months.
If treatment with Vocabria is stopped, another treatment to suppress the virus must be started to minimise the risk that the virus could become resistant to treatment.
Vocabria can only be obtained with a prescription and should be prescribed by a doctor who has experience in the management of HIV infection.
For more information about using Vocabria, including the schedule for the injections, see the package leaflet or contact your doctor or pharmacist.
Vocabria is an integrase inhibitor. This is a medicine that blocks an enzyme called integrase that the virus needs to make new copies of itself in the body. By blocking this enzyme, Vocabria, taken together with rilpivirine, reduces the amount of HIV in the blood and keeps it at a low level. Vocabria does not cure HIV infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Vocabria, taken together with rilpivirine, was as effective as other HIV medicines in maintaining HIV-1 level in the blood (viral load) below a defined level (less than 50 HIV-1 RNA copies/ml) in 3 main studies involving adults with HIV-1 infection. The studies involved patients who had not taken HIV medicines before or who had been taking these medicines for at least 6 months.
In the first two studies, patients were treated with Vocabria and rilpivirine or with combinations of other medicines. After 48 weeks of treatment, the HIV-1 level was above the limit in 1.9% of patients (11 out of 591) taking monthly injections of Vocabria and rilpivirine and in 1.7% of patients (10 out of 591) taking other medicines.
The third study showed that injections of Vocabria and rilpivirine given monthly or every 2 months were similarly effective. After 48 weeks of treatment, the HIV-1 level was above the limit in 1.7% of patients (9 out of 522) given injections every 2 months, compared with 1% of patients (5 out of 523) who had monthly injections.
A further study showed that giving Vocabria to adolescents aged 12 years and older and weighing at least 35 kg resulted in blood levels of the active substance similar to those seen in adults. Therefore, the medicine is expected to have similar effects in adolescents.
For the full list of side effects and restrictions with Vocabria, see the package leaflet.
The most common side effects with Vocabria and rilpivirine monthly injections (which may affect more than 1 in 10 people) include injection site reactions, headache and fever.
Vocabria must not be used with the following medicines as they may lead to reduced blood levels of the medicine, reducing its effectiveness:
- carbamazepine, oxcarbazepine, phenobarbital and phenytoin (medicines for epilepsy);
- rifampicin and rifapentine (antibiotics).
Injections of Vocabria every month or every 2 months may be more convenient for patients than taking medicines every day. Studies showed that the medicine was as effective at keeping the virus level low as other standard medicines. It is important that patients keep to the schedule of injections to avoid the virus becoming resistant to treatment, and further studies will determine whether this is happening while the medicine is on the market.
The company that markets Vocabria will carry out 2 studies on how the medicine is used and its effectiveness. The outcomes for patients who switch to other treatments after taking Vocabria will also be studied.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vocabria have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Vocabria are continuously monitored. Side effects reported with Vocabria are carefully evaluated and any necessary action taken to protect patients.
Vocabria received a marketing authorisation valid throughout the EU on 17 December 2020.
Product information
Latest procedure affecting product information:
IB/0025
22/01/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Vocabria
- Active substance
- Cabotegavir sodium
- Cabotegravir
- International non-proprietary name (INN) or common name
- cabotegravir
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AX
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class for:
- Oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting cabotegravir injection plus long acting rilpivirine injection.
- Oral therapy for adults and adolescents who will miss planned dosing with cabotegravir injection plus rilpivirine injection.
Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adoloscents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse trascriptase.
News on Vocabria
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