Thoracic Oncology

  • 1.  SQ Amivantamab ARR Monitoring

    Posted 3 days ago

    Hi All, 

    I'm working through our institution's subcutaneous amivantamab treatment plan with it's recent approval and I wanted to see what everyone else's approach has been to post-C1D1 monitoring?

    Technically the package insert does not recommend any specific period of monitoring, however, there were meaningful amount of ARRs. PALOMA-3 implemented a 4h monitoring period on trial, but median onset appears to be 2h per labeling. I'm curious if y'all are doing any post-dose monitoring for C1D1, and if so - are y'all doing 2h, 4h, or something else?

    Thanks!

    -Kevin



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    Kevin Chen PharmD, MS, BCOP
    Thoracic Oncology and Sarcoma Clinical Pharmacist
    UNC Medical Center
    Chapel Hill NC
    (984) 974-9116
    KevinChen
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  • 2.  RE: SQ Amivantamab ARR Monitoring

    Posted 2 days ago

    Hey Kevin,

    We ended up going with 3 hours. We probably would be okay with 2 hours too, but we ended up splitting the difference given PALOMA-2's median onset was a little longer at 2.3 hours out of an abundance of caution. We weren't planning on doing any observation for any subsequent doses.

    Hope this helps - let me know if you have any thoughts about our approach.

    Darren



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    Darren Luon PharmD, BCOP
    Clinical Pharmacy Specialist, Medical Oncology
    Yale-New Haven Hospital
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  • 3.  RE: SQ Amivantamab ARR Monitoring

    Posted 2 days ago

    Also curious how the 3 hour observation has gone, if you've experienced any ARRs after that 2-hour mark. We're in the process of building our SubQ plans into Epic and were going to go with 2 hours, but now I'm rethinking this!



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    Courtney Cavalieri, PharmD, BCOP
    Clinical Oncology Pharmacist
    Huntsman Cancer Institute at the University of Utah
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  • 4.  RE: SQ Amivantamab ARR Monitoring

    Posted 2 days ago

    Admittedly we haven't had any standard of care patients yet. We have had some of the clinical trials here and from that experience, did not have any issues with delayed reactions (though very aware that there were some rare delayed reactions that were reported in the PALOMA trials). Of the very few that we had, typically within the first two hours. 



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    Darren Luon PharmD, BCOP
    Clinical Pharmacy Specialist, Medical Oncology
    Yale-New Haven Hospital
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  • 5.  RE: SQ Amivantamab ARR Monitoring

    Posted 2 days ago

    Eek, maybe we are cowboys over here, but we did not build in a observation time. There isn't an observation time in the PI, but please correct me if I am wrong! Gives me flashbacks to when subq dara went live and we had a very long post-dose observation time.

     

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    Eve Segal, PharmD, BCOP
    Pronouns:She/Her/Hers
    Clinical Pharmacy Operations Manager
    Fred Hutchinson Cancer Center

    O 206.606.1845
    segaleve@fredhutch.org

     

     






  • 6.  RE: SQ Amivantamab ARR Monitoring

    Posted 2 days ago

    One more thing to add, Kevin you brought up a good point, but the IRRs incidence was 13% and our group felt it wasn't very impressive. Our other experience with SQ data, like daratumumab, shows something similar.

     

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    Eve Segal, PharmD, BCOP
    Pronouns:She/Her/Hers
    Clinical Pharmacy Operations Manager

    Fred Hutchinson Cancer Center
    O 206.606.1845
    segaleve@fredhutch.org

     

     






  • 7.  RE: SQ Amivantamab ARR Monitoring

    Posted 2 days ago

    I'm curious to see the replies to this question as well.   We are still discussing the exact time, but our monitoring will be in the 2-4 hour range.  I think our first patient will be next week.  

    Thanks 



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    Betsy Fujimoto, PharmD, BCPS, BCOP
    Oncology Pharmacist
    Straub Benioff Medical Center
    Honolulu, HI
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  • 8.  RE: SQ Amivantamab ARR Monitoring

    Posted 2 days ago

    For Rybrevant FasPro, I discussed a plan with MSL to mirror what we do for Darzalex FasPro below- which they said was reasonable (as industry not providing clear guidance). 

    Place IV line C1D1 only in case of systemic reaction

    Observation: 1st dose 2hrs, 2nd dose 30 mins, if well tolerated no further obs. 



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    Jon Blazawski
    Oncology Pharmacy Program Manager
    Hartford Healthcare
    Manchester CT
    (860) 533-5807
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