VOCABRIA▼

Vocabria (cabotegravir injections and tablets) in Europe

Vocabria (cabotegravir injections and tablets) is an integrase inhibitor. Vocabria in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys▼ (rilpivirine injection) and Edurant (rilpivirine tablets), is authorised in the European Union, for the treatment of HIV-1 infection in adults who are virologically suppressed. Cabotegravir injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults 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 NNRTI and INI class.

The long-acting injectable treatment of cabotegravir and rilpivirine removes the need to take daily oral tablets, Marketing Authorisation for Vocabria was granted by the European Commission on 17 December 2020.

Cabotegravir injection used in combination with rilpivirine injection is a complete long-acting regimen dosed once-monthly or once every 2-months, for virologically suppressed people living with HIV-1. Cabotegravir and rilpivirine injections are administered as two intramuscular (IM) injections in the buttocks by a Healthcare Professional at the same appointment. Prior to the initiation of the injections, cabotegravir and rilpivirine oral tablets are taken for approximately one month (at least 28 days) to assess tolerability to the medicines.

In Europe, cabotegravir and rilpivirine is available as two separately packaged injectable medicines administered at the same time.

Vocabria (tablets) in the United States

Vocabria (tablets) was approved by the US Food and Drug Administration on 21 January 2021 indicated, in combination with Edurant (rilpivirine tablets), as a complete regimen for short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. Vocabria is used as an oral lead-in to assess tolerability of cabotegravir prior to initiating Cabenuva and as an oral bridging therapy for missed Cabenuva injections.1

For the co-packaged kit of the two injectable medicines of cabotegravir and rilpivirine please visit the Cabenuva page.

[1] Vocabria (cabotegravir) Prescribing Information. US Approval 2021.

Prescribing information

Europe

Vocabria EU Summary of Product Characteristics

United States

Prescribing Information and Patient Information for Vocabria