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EFFICACY AND SAFETY

Safety and tolerability results

In ATLAS-2M, every 2-Month dosing was generally well tolerated

ADVERSE EVENTS (AEs) AT 96 WEEKS1–3
Table detailing the adverse events reported during the ATLAS-2M study
  • 96% of non-ISR, drug-related AEs were mild or moderate2

Overall safety profile of VOCABRIA + REKAMBYS

BASED ON CABOTEGRAVIR AND RILPIVIRINE SMPCS FREQUENTLY REPORTED ADVERSE REACTIONS INCLUDE4–7
Table listing the drug drug interactions for Vocabria and Rekambys in the SmPC

Please see SmPC complete list of clinical considerations for prescribing here and here

  • Rare and serious adverse events

    Pancreatitis4

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

    Cellulitis and abscess ISRs4,6 

    • Cellulitis and abscesses were an uncommon complication of intramuscular injection
    Hepatotoxicity4
     
    • Hepatotoxicity has been reported in a limited number of patients receiving VOCABRIA + REKAMBYS 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

Injection site reactions (ISRs) decreased over time4

ATLAS-2M: INCIDENCE OF ISRs (ALL GRADES*) REPORTED BY PATIENTS WITH NO PRIOR EXPOSURE TO MONTHLY DOSING.8–10
Graph showing the incidence of the ISRs during the ATLAS-2M trial
1% (N=6/522) OF PATIENTS IN THE EVERY 2-MONTH TREATMENT ARM DISCONTINUED DUE TO INJECTION-RELATED REASONS11
ONLY 1 PATIENT IN Q2M ARM WITHDREW DUE TO INJECTION-RELATED REASONS BETWEEN 48-96 WEEKS

*Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=potentially life-threatening; Grade 5=death.12

98% of ISRs were mild or moderate11,13

ISRs lasted a median of 3 days.4

  • ATLAS-2M outcomes, ITT-E: ISR types

    Table detailing ISR types from the ATLAS-2M trial

    *In the Q2M arm, 5 participants had an ISR leading to withdrawal and 1 participant withdrew consent from the study due to injection intolerability; in the Q1M arm, 5 participants had an ISR leading to withdrawal and 6 participants withdrew consent from the study due to injection intolerability.11

Drug-drug interactions4 –7,14,15

Contraindications and recommendations for dose adjustments

  • See drug-drug interactions

    Drug metabolism

    Contraindications:

    • Hypersensitivity to the active substance or to any of the excipients
    • Concomitant use with rifampicin, rifabutin, rifapentine, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, dexamethasone (except as a single dose treatment) or St John's wort
    Table listing the drug drug interactions for Vocabria and Rekambys in the SmPC
    INTERACTIONS BY FORMULATION
    Table listing the drug drug interactions for Vocabria and Rekambys in the SmPC

Colleague Testimonials

Hear what colleagues say about their experiences with long-acting therapy

Q1M=monthly; Q2M=once every 2 months.

References:

  1. Data on file. Overall summary of adverse events: REF 76829. ViiV Healthcare group of companies.
  2. Overton ET, Richmond G, Rizzardini G, et al. Cabotegravir + rilpivirine every 2-months is noninferior to monthly dosing: Week 48 results from the ATLAS-2M Study. Presented at Conference on Retroviruses and Opportunistic Infections (CROI): March 8–11, 2020; Boston, MA.
  3. Data on file. Summary of common drug related AEs (≥1%) in either treatment group during the maintenance phase (safety population): REF 73476. ViiV Healthcare group of companies.
  4. VOCABRIA Summary of Product Characteristics. ViiV Healthcare. 
  5. VOCABRIA Tablets Summary of Product Characteristics. ViiV Healthcare.
  6. REKAMBYS Summary of Product Characteristics. Janssen Healthcare.
  7. EDURANT Summary of Product Characteristics. Janssen Healthcare.
  8. Data on file. Overall ISRs overtime: REF 73473. ViiV Healthcare group of companies.
  9. Data on file. Prior exposure to CAB + RPV: REF 74123. ViiV Healthcare group of companies.
  10. Quercia RP, Overton ET, Benn PD, et al. ATLAS-2M subanalysis based on prior injection exposure: efficacy, injection site reactions and preference of cabotegravir + rilpivirine every 2 months. P030, BHIVA, 2020, Virtual.
  11. Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. Published online ahead of print: December 9, 2020. doi: 10.1016/S0140-6736(20)32666-0.
  12. National Institute of Allergy and Infectious Diseases. DAIDS RSC Regulatory Support Center. DAIDS Adverse Event Grading Tables. Corrected version 2.1, July 2017. https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables. Accessed: February 2, 2021.
  13. Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. Published online ahead of print: December 9, 2020. doi: 10.1016/S0140-6736(20)32666-0. Supplementary material.
  14. Antzelevitch C, Sun ZQ, Zhang ZQ, Yan GX. Cellular and ionic mechanisms underlying erythromycin-induced long QT intervals and torsade de pointes. J Am Coll Cardiol. 1996;28(7):1836-1848.
  15. Vieweg WV, Hancox JC, Hasnain M, Koneru JN, Gysel M, Baranchuk A. Clarithromycin, QTc interval prolongation and torsades de pointes: the need to study case reports. Ther Adv Infect Dis. 2013;1(4):121-38.

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 GlaxoSmithKline on 0800 221 441.

REKAMBYS (rilpivirine long acting injection), 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 by the ViiV Healthcare group.

PM-GB-CBR-WCNT-210001v3 I April 2022

Prescribing Information

Report an adverse event

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.