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SAFETY & TOLERABILITY

EFFICACY

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 SmPCs, FREQUENTLY REPORTED AEs INCLUDE: 1,2,4

Overall safety and tolerability profile

  • 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

  • Patient-related factors

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

    GENERAL INFORMATION

    VOCABRIA + REKAMBYS should not be administered with other ARV medicinal products for HIV-11,2

    VOCABRIA (cabotegravir) injection is indicated, in combination with REKAMBYS (rilpivirine) injection, for the treatment of HIV-1 infection 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 virological failure with agents of the NNRTI and INI class.1,2

    Virologic suppression1,2

    • VOCABRIA + REKAMBYS should only be prescribed in virologically suppressed patients; 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

    Risk of resistance following treatment discontinuation1,2

    If treatment is discontinued, it is essential to start alternative antiretroviral therapy no later than 2 months after the final injections (or 1 month if after the first initiation injections) in order to minimise the risk of resistance.

    If virological failure is suspected, an alternative regimen should be adopted as soon as possible.

    Long-acting properties of VOCABRIA and REKAMBYS injections1,2

    Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (cabotegravir: up to 12 months or longer; rilpivirine: up to 4 years in some patients), therefore, physicians should take the prolonged release characteristics of VOCABRIA and REKAMBYS injections into consideration when the treatment is discontinued.

    Baseline factors associated with virological failure1,2

    Before starting the regimen, it should be taken into account that multivariable analyses indicate that a combination of at least 2 of the following baseline factors may be associated with an increased risk of virological failure: archived rilpivirine resistance mutations, HIV-1 subtype A6/A1, or BMI ≥ 30 kg/m2. Available data suggest that virological failure occurs more often when these patients are treated according to the every 2 month dosing regimen as compared to the monthly dosing regimen. In patients with an incomplete or uncertain treatment history without pre-treatment resistance analyses, caution is warranted in the presence of either BMI ≥ 30 kg/m2 or HIV-1 A6/A1 subtype.

    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

    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

  • 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

    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
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Important drug interactions

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Learn about the dosing for every-2-month VOCABRIA + REKAMBYS

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Want to discuss further? Reach out to us

Anita Henriksen
Key Account Manager
anita.x.henriksen@gsk.com
Mobil: 995 25 487

Linda Marie Sørpebøl
Key Account Manager
lindamarie.x.sorpebol@gsk.com
Mobil: 952 32 576

PI-14375 :Basert på SPC godkjent av DMP/EMA: 13.01.2025 (Vocabria) og 01/2025 (Rekambys)

▼VOCABRIA (kabotegravir, 600 mg depotinjeksjonsvæske, suspensjon, 30 mg tabletter),ViiV Healthcare
▼REKAMBYS (rilpivirin, 900 mg depotinjeksjonsvæske, suspensjon, 25 mg tabletter), Janssen

Bare i kombinasjon til behandling av hiv-1-infeksjon hos voksne og ungdom (≥12 år og >35 kg) som er virologisk supprimert (hiv-1 RNA < 50 kopier/ml) på et stabilt antiretroviralt regime uten eksisterende eller tidligere tegn på viral resistens mot, og ingen tidligere virologisk svikt, med legemidler i NNRTI- og INI-gruppene.

VOCABRIA + REKAMBYS behandling kan startes og tolerabiliteten vurderes med enten tabletter eller depotinjeksjon. Ved oral startbehandling skal én kabotegravir 30 mg tablett tas sammen med én rilpivirin 25 mg tablett én gang daglig i ca. én måned (minst 28 dager), etterfulgt av innledende injeksjon. Følg doseringsanvisning i preparatomtalene nøyaktig. Tabletter: Når kabotegravir tas samtidig med rilpivirin, skal de tas sammen med et måltid. Injeksjon: i.m i ventrogluteal (anbefalt) eller dorsogluteal muskel. Skal administreres av helsepersonell. For instruksjoner om administrasjon, se pakningsvedlegget.

UTVALGT SIKKERHETSINFORMASJON

Forsiktighetsregler:

  • Overfølsomhetsreaksjoner: Risiko for utslett og leverskade.
  • Leversykdom: Brukes med forsiktighet ved alvorlig nedsatt leverfunksjon.
  • Forsiktighet ved alvorlig nedsatt nyrefunksjon.
  • Immunt reaktiveringssyndrom: Inflammatoriske reaksjoner kan oppstå ved behandlingsstart
  • Viktige potensielle risikoer: Medisineringsfeil (dvs. manglende overholdelse av doseringsplanen, feil administrasjonsmåte)

Kontraindikasjoner:

  • Vocabria: Samtidig bruk med rifampicin, rifapentin, karbamazepin, okskarbazepin, fenytoin eller fenobarbital.
  • Rekambys: Samtidig bruk med karbamazepin, okskarbazepin, fenobarbital, fenytoin, rifabutin, rifampicin, rifapentin, deksametason (systemisk), johannesurt.

Bivirkninger:

  • Svært vanlige: Reaksjoner på injeksjonsstedet (76%), hodepine (7%), pyreksi (7%).

Pasientpopulasjoner:

  • Gravid: Ikke anbefalt under graviditet med mindre nytten oppveier risikoen.
  • Barn: Sikkerhet og effekt ikke fastslått for barn under 12 år eller som veier under 35 kg.
  • Amming: Anbefales ikke for hiv-smittede kvinner å amme for å unngå smitte.

Ved uønskede medisinske hendelser, kontakt GSK på telefon 22 70 20 00.

Reseptgruppe C
Pakninger og maksimalpriser: VOCABRIA Injeksjon: 3 ml (hettegl.) 17302,80 kr. Tabletter: 30 stk. (boks) 9390,90 kr
REKAMBYS 3 ml (hettegl.) 7118,70 kr. Refusjon: Der det er utarbeidet nasjonale handlingsprogrammer/nasjonal faglig retningslinje og/eller anbefalinger fra RHF/LIS spesialistgruppe skal rekvirering gjøres i tråd med disse. Vilkår: 216 Refusjon ytes kun etter resept fra sykehuslege eller avtalespesialist. Fra 01.05.2021 har Beslutningsforum innført Vocabria i kombinasjon med rilpivirin-injeksjon (Rekambys) til behandling av hiv-infeksjon hos voksne som er virologisk supprimert på et stabilt antiretroviralt regime og som er motivert for behandling, men som har utfordringer med daglig tablettbehandling. Vocabria + Rekambys inngår i Sykehusinnkjøps anbefalinger for antiretroviral behandling av hiv i perioden 01.12.2022-30.11.2025.

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;
  2. REKAMBYS Summary of Product Characteristics. Janssen-Cilag International NV;
  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;

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.

5/2025, PM-NO-CBR-WCNT-250006