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Community Advice: SQ Formulation of Daratumumab

INSIGHTS FROM: AJAI CHARI, MD, MOUNT SINAI HEALTH SYSTEM; DANIEL VERINA, NP, MOUNT SINAI HEALTH SYSTEM
Tuesday, June 30, 2020


Transcript: 

Ajai Chari, MD: 
I think from a physician’s point of view and a practice management point of view, one of the biggest barriers to getting DARA [daratumumab] has been that first dose issue, that long infusion, the 1:1 nursing staffing, the chair time. All of those barriers I think are challenging. Danny, what do you think, we hope daratumumab subQ [subcutaneous] will be approved very soon. What do you think might be helpful for community doctors to know about this new formulation?

Daniel Verina, NP: I think it is safe to give, the efficacy is there, and the low adverse events, infusion-related events are extremely low compared to the intravenous [IV]. I think for them, because most communities have limited time availability, that I feel that it’s a great option that their patients, instead of coming to a big institution, bringing them in. Yes, Mount Sinai Health System is in the city, or even other institutions in the community—they travel very far. So, if there’s a community physician who can give this drug instead of the patient driving 2 hours in each direction, it’s also saving them the wear and tear, even emotionally, of driving to the institution. I think if they’re nervous about it, if your community physicians and practices are nervous, then maybe give the drug in the beginning of the week, Monday, Tuesday, Wednesday, because if patients do have a delayed effect, then they can still manage them up front. But I think in the whole, it’s going to revolutionize how patients are treated.

Ajai Chari, MD:  I think it’s interesting. In some ways, comparing IV and subQ, probably the people who are affected the least are the physicians because we write the order, but then it’s everybody else who benefits, right? The pharmacists are mixing this small vial of fluid, the nurses clearly are benefitting from much less chair time and 1:1 monitoring, and patients. But I’m curious if you could expand a little bit more on the nursing involvement in terms of how long this drug is infused over, daratumumab subQ, and logistics of premedications, monitoring. What are your thoughts? What would you instruct community nurses about this drug?

Daniel Verina, NP: The premedications are again the same standard of 1 to 3 hours prior to getting the infusion. And definitely, in the community, once they’ve received their first dose and they’ve tolerated it, most of the premedications can go to an oral formulation. You can instruct your patients to take them 1 to 3 hours prior, so now you’ve even freed up an extra hour of time of chairs, excluding having laboratory monitoring that might be necessary per week. And again, the drug is given over 3 to 5 minutes, the first dose within the first 5 minutes, and then if tolerated, can go over 3 minutes. I think in the community, a follow-up phone call might be an insight on patients to see how well they tolerate it. If it was in the morning, are they feeling OK that evening? And then having another phone call, having a nurse navigator follow up with the patient the next day to see if they had any kind of infusion reaction for tolerability. But again, it’s maybe more phone call driven, or maybe on the side of administration, but again the patients will enjoy it.

Ajai Chari, MD:  A couple of other things that came to mind are of course, here we have a flat dosing, so 1800 mg. That’s nice because most likely that dose will be targeted to, the typical patient will be 80 kg, so obviously they want to avoid underdosing patients because we’re trying to go for myeloma disease control. So it will be a flat dose, which is convenient and nice for everyone. You don’t have to keep re-signing orders because of weight changes. And I think as you very well outlined for first dose in getting things going, this is pretty clear in terms of same premedications and administration.

Some of the things I guess that we need to discuss a little bit more are how long to keep somebody in the clinic. That first dose, we have a 5 minute injection, but then how long do you have to keep the patient around? The rates of allergic reaction we said are quite low, but the median time to allergic reaction or infusion-related reaction was about 3.4 hours. It is slightly delayed. So, depending on how folks want to do it, whether they want to keep them in the waiting area of just be around in case of issues, check vital signs, etc. Maybe for those patients with respiratory issues, keep them around for sure and be getting the vital signs. That may  be something to consider on a case-by-case and infusion center-by-infusion center basis.

Daniel Verina, NP: I think if you compare the first subQ versus the IV, asking a patient to remain in your clinic for 4 hours versus 8 hours, I think they still would be happy to wait to see in 4 hours, no adverse effects, go home, versus leaving at 8 o’clock at night.

Ajai Chari, MD:  And again, most of these were grade 1 and 2 as well. I think as we get more experience with this in the community, that may change or we may even be doing phone calls, as you suggested, especially for those patients who are young, healthy, compliant, no respiratory issues. I think the other thing that we will need to think about is it’s easy to get somebody started on subQ daratumumab, but there may be also the issue of transitioning patients.

People who are on their umpteenth dose of daratumumab, part of their maintenance once monthly, transitioning those people to subQ, because some of those, as you said, at our center we’ve weaned off a lot of the premedications. And we’ll need to look into the guidance on that, whether at least for 1 dose we need to give those premedications just because there is this hyaluronidase being mixed in. So I think we’ll have to stay tuned for that, but I think again it will be very minor issues.

And again, these patients will all have been tolerating IV daratumumab, which is much more likely to cause infusion-related reactions. And the likelihood of that after you’ve been on it for a long time should be pretty low. That's another concern or issue that we may have to think about with the transition. I think daratumumab subQ is going to be great for everyone, and I would say in particular probably, as I said, the patient, the nurse, the pharmacist more so than the physician. Danny, any final thoughts?

Daniel Verina, NP: I agree. I think it really embodies the quality of life when you talk about therapy and the patient with myeloma themselves. Convenience, efficacy, and then to still be able to do their own daily living and not be trapped, like you said earlier, chained to the infusion chair for 8 hours and stare at us when they can at least stare at their grandkids, I think is a great asset to the myeloma paradigm.

Ajai Chari, MD:  Great. Well, thank you, Danny, for joining me, and we hope this has been helpful to everyone and that you enjoyed this session. Thank you very much.

Daniel Verina, NP: Thank you.


Transcript Edited for Clarity

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