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UNDERSTANDING SAFETY AND TOLERABILITY

See VOCABRIA and REKAMBYS SmPC's for important interactions, contraindications, warnings and precautions, adverse and severe events.[1,2]

  • Patient-related factors

    General Information

    VOCABRIA + REKAMBYS should not be administered with other antiretroviral medicinal products for HIV-1[1,2]

    Virologic suppression[1,2]

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

    Adherence to appointments[1,2]

    • Patients need to be able to adhere and agree to required injection appointments prior to starting long-acting therapy

    Use in pregnancy[1,2]

    • There are limited data on the use of VOCABRIA + REKAMBYS in pregnancy so it is not recommended unless the expected benefit justifies the potential risk to the foetus. VOCABRIA + REKAMBYS has been detected in systemic circulation for up to 4 years after an injection in some patients; consideration should be given to the potential for foetal exposure

    Patients with hepatitis B virus (HBV) / hepatitis C virus (HCV) co-infection or hepatic impairment[1,2]

    • 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 co-infection. Monitoring of liver function is recommended in patients with HCV co-infection
    • VOCABRIA + REKAMBYS is not recommended in patients with severe hepatic impairment, while caution is advised in patients with moderate hepatic impairment

    Drugs causing QT prolongation[2]

    • 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 therapy[3]

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

  • Injections and ongoing monitoring

    Post-injection reactions[2]

    • 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 reactions[1,2]

    • 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 monitoring[1,2]

    • 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 co-infection
    • Clinical monitoring is recommended for patients on methadone, as methadone maintenance therapy may need to be adjusted
    • VOCABRIA + REKAMBYS is not recommended during pregnancy unless the expected benefit justifies the potential risk; however, viral load should be monitored closely if used during pregnancy

  • Drug interactions and contraindications

  • Gastrointestinal (GI) considerations (oral vs long-acting)

Contact us for support and resources

GI=gastrointestinal; HBV=hepatitis B virus; HCV=hepatitis C virus; HIV-1=human immunodeficiency virus type 1; OAT=organic anion transporters; pH=power of hydrogen; RNA=ribonucleic acid.

References:

  1. VOCABRIA Summary of Product Characteristics. ViiV Healthcare.
  2. REKAMBYS Summary of Product Characteristics. Janssen.
  3. 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. REF-144092.
  4. Antzelevitch C, Sun ZQ, Zhang ZQ, et al. Cellular and ionic mechanisms underlying erythromycin-induced long QT intervals and torsade de pointes. J Am Coll Cardiol. 1996;28(7):1836–1848. doi: 10.1016/S0735-1097(96)00377-4.
  5. Vieweg WVR, Hancox JC, Hasnain M, et al. Clarithromycin, QTc interval prolongation and torsades de pointes: the need to study case reports. Ther Adv Infect Dis. 2013;1(4):121–138. doi: 10.1177/2049936113497203.
  6. EDURANT 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 - August 2023

Prescribing Information

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline 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.