SAFETY & TOLERABILITY

Overall safety and tolerability profile

Based on VOCABRIA + REKAMBYS injectable Summary of Product Characteristics (SmPCs), frequently reported adverse reactions include:[1,2]

See SmPCs for full list of adverse events.

* Very common ISRs = pain and discomfort, nodule, induration
** Common ISRs = swelling, erythema, pruritus, bruising, warmth, haematoma

  • Adverse Events (AEs)

    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

    Pancreatitis[1,2]

    • 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

    Injection site reaction cellulitis and abscess[1,2]

    • Cellulitis and abscess were uncommon complications of intramuscular injection

    Oral lead-in

    • For specific adverse reactions for oral cabotegravir and rilpivirine tablets, please see their respective SmPCs

Important prescribing considerations for VOCABRIA + REKAMBYS[1–3]

See the SmPCs for more important interactions and contraindications, warnings and precautions, and adverse and serious adverse events.

  • Patient-related factors

    General information

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

    License indication[1,2]

    • VOCABRIA injection in combination with REKAMBYS injection is indicated for the treatment of HIV-1 in adults and adolescents (at least 12 years of age and weighing at least 35 kg), 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 failure with agents of NNRTI and INI class

    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 special patient populations

    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
    •  Lower exposures of oral rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy
    • After discontinuation of VOCABRIA + REKAMBYS, drug may remain in systemic circulation for up to 12 months and 4 years respectively in some patients

    Patients with HBV/HCV coinfection 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 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 prolongation[2]

    • At the recommended dose, oral rilpivirine is not associated with a clinically relevant effect on QTc. Rilpivirine plasma concentrations after REKAMBYS injections at the recommended dose of 600 mg monthly or 900 mg every 2 months, are comparable to those achieved with oral rilpivirine at a dose of 25 mg qd. 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]

    • 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 HCV coinfection
    • 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

Important drug interactions[1,2,4–6]

Learn about the dosing for 2-monthly VOCABRIA + REKAMBYS

Review injection site reaction data of 2-monthly VOCABRIA + REKAMBYS

Contact us for support

#QM CABOTEGRAVIR + RILPIVIRINE is not available in the UK.

AE=adverse event; ARV=antiretroviral; CYP3A=cytochrome P450 3A; GI=gastrointestinal; HBV=hepatitis B virus; HCV=hepatitis C virus; HIV-1=human immunodeficiency virus type 1; ISR=injection site reaction; OAT=organic anion transporter; QTc=QT interval corrected; RNA=ribonucleic acid; SmPC=Summary of Product Characteristics;

References:

  1. VOCABRIA (cabotegravir) 600 mg suspension for injection Summary of Product Characteristics (SmPC).
  2. REKAMBYS (rilpivirine) 900 mg suspension for injection Summary of Product Characteristics (SmPC).
  3. Oxford University Hospitals NHS Foundation Trust. Medicines Management and Therapeutics Committee. Treatment of venous thromboembolism (VTE) in adults with dalteparin (Fragmin®). MIL. 2019;2(2):1−4.
  4.  EDURANT (rilpivirine) 25 mg film-coated tablets Summary of Product Characteristics (SmPC).
  5. 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.
  6. 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.

REKAMBYS (rilpivirine long-acting), including the trademark, is owned by the Janssen Pharmaceutical Companies and used under license by the ViiV Healthcare group of companies. All other trademarks are owned or licensed by the ViiV Healthcare group. ©2025 ViiV Healthcare group of companies or its licensor. All rights reserved.

PM-GB-CBR-WCNT-250008 | March 2026

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.