Thoracic Oncology

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

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

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

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!

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

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

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

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

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

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

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

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

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. 

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