VOCABRIA

What it is

VOCABRIA is a film-coated tablet containing 30 mg cabotegravir (as cabotegravir sodium). Cabotegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid integration which is essential for the HIV replication cycle.

Approved indications

— Oral lead-in to assess tolerability of cabotegravir prior to administration of cabotegravir prolonged-release suspension for injection plus rilpivirine prolonged-release suspension for injection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) and have no known or suspected resistance to either cabotegravir or rilpivirine. — Oral therapy for adults who will miss planned dosing with cabotegravir prolonged-release suspension for injection.

Dosing overview

One VOCABRIA tablet (30 mg) should be taken together with one rilpivirine tablet (25 mg) once daily. When used for oral lead-in, VOCABRIA tablets are recommended for approximately one month (at least 28 days) in virologically suppressed patients prior to the initiation of cabotegravir injections. If a patient misses an oral dose of VOCABRIA, the patient should take the missed dose as soon as possible. No dose adjustment is required in elderly patients, patients with mild, moderate or severe renal impairment, or patients with mild or moderate hepatic impairment. The safety and efficacy of VOCABRIA in children and adolescents aged under 18 years has not been established.

Key safety warnings

Hypersensitivity reactions have been reported in association with integrase inhibitors, characterised by rash, constitutional findings and sometimes organ dysfunction, including liver injury. VOCABRIA and other suspected medicinal products should be discontinued immediately should signs or symptoms of hypersensitivity develop, including severe rash, or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia or angioedema. Hepatotoxicity has been reported in a limited number of patients receiving cabotegravir with or without known pre-existing hepatic disease. Monitoring of liver chemistries is recommended and treatment with VOCABRIA should be discontinued if hepatotoxicity is suspected. To minimise the risk of developing viral resistance, it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the final injection of cabotegravir and rilpivirine when dosed monthly and no later than two months after the final injection when dosed every 2 months. A combination of at least 2 of the following baseline factors may be associated with an increased risk of virological failure: archived rilpivirine resistance mutations, HIV-1 subtype A6/A1, or BMI ≥30 kg/m². In patients with an incomplete or uncertain treatment history, caution is warranted in the presence of either BMI ≥30 kg/m² or HIV-1 A6/A1 subtype.

Contraindications

VOCABRIA is contraindicated in patients with known hypersensitivity to cabotegravir or any excipients, and in patients receiving rifampicin, rifapentine, phenytoin, phenobarbital, carbamazepine and oxcarbazepine.

PBS listing

VOCABRIA 30 mg tablet is listed on the PBS with streamlined restriction, with an ex-manufacturer price of A$632.27.

Regulatory history

VOCABRIA was first registered on the ARTG on 16 February 2021. The AusPAR approval date was 10 February 2021. PBAC recommended the medicine in November 2021 for treatment of human immunodeficiency virus infection, and subsequently recommended it in September 2023 for pre-exposure prophylaxis for human immunodeficiency virus infection. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.