You are now leaving GSK’s website

You are now leaving a GSK Website. By clicking this link, you will be taken to a website that is not owned or controlled by GSK, and GSK is not responsible for the content provided on that site.

Continue

Go back

Product menu

OVERALL SAFETY & TOLERABILITY PROFILE

IT STARTS WITH

UNDERSTANDING SAFETY AND TOLERABILITY

Every-2-month VOCABRIA + REKAMBYS is generally well-tolerated with data out to 3 years.1-3

Overall safety and tolerability profile

Based on Cabotegravir and Rilpivirine SmPC, frequently reported AEs include:1,2,4

NA

  • NA Rare and Serious AEs

    Hepatotoxicity1

    • Hepatotoxicity has been reported in a limited number of patients receiving VOCABRIA with or without known pre-existing hepatic disease
    • Monitoring of liver chemistries is recommended, and treatment with VOCABRIA + REKAMBYS should be discontinued if hepatotoxicity is suspected

    Pancreatitis1,2

    • One case of fatal pancreatitis with Grade 4 lipase and confounding factors (including history of pancreatitis) has been reported in ATLAS-2M, for which causality to the injection regimen could not be ruled out

    ISR cellulitis and abscess1,2

    • Cellulitis and abscess were uncommon complications of intramuscular injection

Important prescribing considerations for VOCABRIA + REKAMBYS1,2

  • NA Patient-Related Factors

    See the SmPCs for important interactions and contraindications, warnings and precautions, AEs and serious AEs.1,2

    GENERAL INFORMATION1,2

    • VOCABRIA + REKAMBYS should not be administered with other ARV medicinal products for HIV-1

    Virologic suppression1,2

    • VOCABRIA + REKAMBYS should only be prescribed in virologically suppressed adults; i.e. those with HIV-1 RNA <50 copies/mL

    Adherence to appointments1,2

    • Patients must be able to adhere to required injection appointments prior to starting long-acting therapy

    USE IN SPECIAL POPULATIONS

    Use in pregnancy1,2

    • There are limited data on the use of VOCABRIA + REKAMBYS in pregnant women, so it is not recommended unless the expected benefit justifies the potential risk to the foetus

    Patients with HBV/HCV coinfection or hepatic impairment1,2

    • Patients with HBV were excluded from studies with VOCABRIA + REKAMBYS. Initiating VOCABRIA + REKAMBYS in patients with HBV is not recommended
    • Limited data are available in patients with HCV coinfection. Monitoring of liver function is recommended in patients with HCV coinfection
    • VOCABRIA + REKAMBYS is not recommended in patients with severe hepatic impairment, while caution is advised in patients with moderate hepatic impairment

    OTHER CONSIDERATIONS

    Drugs causing QT prolongation2

    • At the recommended dose, oral rilpivirine is not associated with a clinically relevant effect on QTc. Nevertheless, VOCABRIA + REKAMBYS should be used with caution when co-administered with a medicinal product with a known risk of Torsade de Pointes

    Patients on anticoagulation therapy5

    • Intramuscular injections are generally not recommended for patients taking long-term anticoagulation therapy

  • NA Injections and Ongoing Monitoring

    Post-injection reactions2

    • Partial intravenous administration may result in rapid, serious post-injection reactions
    • These events were very rare in clinical trials and began to resolve within a few minutes after the injection. Observe patients briefly for 10 minutes after the injections for any post-injection reactions

    Hypersensitivity reactions1

    • Hypersensitivity reactions have been reported in association with VOCABRIA. VOCABRIA and other suspected medicinal products should be discontinued immediately, should signs or symptoms of hypersensitivity develop

    Additional monitoring1,2

    • Monitoring of liver chemistries is recommended, and treatment with VOCABRIA + REKAMBYS should be discontinued if hepatotoxicity is suspected
    • Monitoring of liver function is recommended in patients with hepatitis C coinfection
    • Clinical monitoring is recommended for patients on methadone, as methadone maintenance therapy may need to be adjusted

AE=adverse event; ARV=antiretroviral; BIC/FTC/TAF=bictegravir/emtricitabine/tenofovir alafenamide; ISR=injection site reaction; HBV=hepatitis B virus; HCV=hepatitis C virus; HIV-1=human immunodeficiency virus type 1; QTc=QT interval corrected; RNA=ribonucleic acid; SmPC=Summary of Product Characteristics.

References
  1. VOCABRIA Summary of Product Characteristics. ViiV Healthcare; 2024. Available at https://www.medicines.ie/medicines/vocabria-600-mg-prolonged-release-suspension-for-injection-35220/spc#tabs [Last Accessed: February 2024].
  2. REKAMBYS Summary of Product Characteristics. Janssen-Cilag International NV; 2024. Available at: https://www.medicines.ie/medicines/rekambys-35258/spc [Last Accessed: February 2024].
  3. Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with human immunodeficiency virus 1 type 1 (HIV-1) infection: 152-week results from ATLAS-2M, a randomized, open-label, phase 3b noninferiority study. Clin Infect Dis. 2023;76(9):1646-1654; ciad020. doi: 10.1093/cid/ciad020.
  4. EDURANT Summary of Product Characteristics. Janssen-Cilag International NV; 2024.
  5. Oxford University Hospitals NHS Foundation Trust. Medicines Management and Therapeutics Committee. Treatment of venous thromboembolism (VTE) in adults with dalteparin. MIL. 2019;2(2):1-4.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼ These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

REKAMBYS (rilpivirine long acting), including the trademark, is owned by the Janssen Pharmaceutical Companies and used under licence by the ViiV Healthcare group of companies.

All other trademarks are owned by the ViiV Healthcare group, or its licensor.

©2024 GSK group of companies. All rights reserved.

Date of Preparation: February 2024 | PM-IE-CBR-WCNT-240006