Thoracic Oncology

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

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

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

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

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. 

Thank you all for your thoughts - I'm glad I'm not alone in struggling to define what the optimal observation time is for the first dose!

I did reach out to the J&J MSL to see if they could provide a bit more granularity to rates of ARR based on observation time, specifically was it linear in nature (e.g. 50% at 2h, 75% at 3h, and 100% a 4h), or what is something more normally distributed (e.g. 50% at 2h, 90% at 3h, and 100% at 4h), as I think that would help me make the decision between 2h vs 3h vs 4h. I'll keep everyone posted on when I hear back. 

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 Kevin,

Did you end up hearing back from J&J with more information on this? I am curious to hear also what your group settled on for observation time following first and subsequent doses of subQ ami. We ended up with the same plan as Jon above; 2 hours observation after C1D1 and 30 minutes after C1D8. Thanks for any insight!

------------------------------
Michael Thomas, PharmD
Thoracic Oncology and Multiple Myeloma Clinical Pharmacist
Huntsman Cancer Institute at the University of Utah
------------------------------

Thank you all for your thoughts - I'm glad I'm not alone in struggling to define what the optimal observation time is for the first dose!

I did reach out to the J&J MSL to see if they could provide a bit more granularity to rates of ARR based on observation time, specifically was it linear in nature (e.g. 50% at 2h, 75% at 3h, and 100% a 4h), or what is something more normally distributed (e.g. 50% at 2h, 90% at 3h, and 100% at 4h), as I think that would help me make the decision between 2h vs 3h vs 4h. I'll keep everyone posted on when I hear back. 

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.