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HSA Product

VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600 MG/3 ML

Product approved by Health Sciences Authority (SG)

Basic Information

VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600 MG/3 ML

INJECTION, SUSPENSION

Regulatory Information

SIN16542P

July 5, 2022

Prescription Only

Therapeutic

INTRAMUSCULAR

August 10, 2023

June 3, 2025

XJ05AJ04

Company Information

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Active Ingredients

Cabotegravir

Strength: 200mg/ml

Detailed Information

Contraindications

**Contraindications** _VOCABRIA_ is contraindicated in patients: - with known hypersensitivity to cabotegravir or to any of the excipients in the tablets or the injection formulation. - receiving rifampicin, rifapentine, phenytoin, phenobarbital, carbamazepine and oxcarbazepine. _VOCABRIA_ is only indicated for treatment of HIV in combination with rilpivirine, therefore, the prescribing information for rilpivirine should also be consulted.

Indication Information

**Indications** **Film-coated Tablets:** _VOCABRIA_ tablets are indicated in combination with rilpivirine tablets for short term ( _see Dosage and Administration_) treatment of human immunodeficiency virus (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: - oral lead-in to assess tolerability of cabotegravir prior to administration of long acting (LA) _VOCABRIA_ injection. - oral therapy for adults who will miss planned dosing with _VOCABRIA_ injection. **Suspension for Injection:** _VOCABRIA_ injection is indicated in combination with rilpivirine injection for treatment of 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 ( _see Clinical studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

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