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UNDERSTANDING SAFETY AND TOLERABILITY

Overall safety profile based on cabotegravir and rilpivirine SmPCs, frequently reported adverse events (AEs) include:[1–3]

Please see the SmPCs’ complete list of clinical considerations for prescribing VOCABRIA and REKAMBYS.

  • Rare and serious adverse events

    Pancreatitis[1]

    • 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

    Cellulitis and abscess ISRs[1,2]

    • Cellulitis and abscesses were uncommon complications of intramuscular injection

    Hepatotoxicity[1]

    • 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

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AE=adverse event; SmPC=summary of product characteristics.

References:

  1. VOCABRIA (cabotegravir) Summary of Product Characteristics. ViiV Healthcare.
  2. REKAMBYS (rilpivirine) Summary of Product Characteristics. Janssen.
  3. EDURANT (rilpivirine) Summary of Product Characteristics. Janssen.

REKAMBYS (rilpivirine long-acting injection), 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.

PM-GB-CBR-WCNT-230001 | March 2024

Prescribing Information

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GSK via the GSK Reporting Tool or on 0800 221441.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.