Is Kevzara that has been rerefrigerated still any good?

Posted by stonewheel @stonewheel, 2 days ago

Is Kevzara (sarilumab) that has been refrigerated still any good or should I dispose of it? It came in a “two-pack.” Two pens, to be taken two weeks, or 14 days, apart.
I am scheduled to take my second dose tomorrow, so I googled Kevzara and started reading and mentally prepping. One site, drugs.com says that Kevzara can reach room temperature in only a few minutes and that it should then be administered within 14 days. It goes on to say DO NOT REFRIGERATE AGAIN. (Other sites seem to copy their statement.) It doesn’t say why or what happens to it if you do though.
The Kevzara website does not say that. It just says to use it within 14 days and it can be kept at room temperature for 14 days. Nothing that I can find about refrigerating after it reaches room temperature.
Does anybody know what happens to Kevzara if it is at room temperature for 1 hour, then put back in a refrigerator?
When I picked it up from the pharmacy, it was NOT cold. I ran a few errands and when I got home I saw (right away) in the paperwork that it should be refrigerated and that it could be administered up to 14 days after reaching room temperature. No where did it say not to refrigerate it. So, I put it in my refrigerator. Three days later I took my first dose (injector pen, preloaded) at my rheumatologist’s office. The next day I was fatigued. A lot!
I’m wondering if refrigerating it made it bad chemically. Poison? Just ineffective? Lost its potency? What?
I’ve messaged my rheumatologist’s office but haven’t heard back.
Why wouldn’t that be in the Kevzara paperwork?
I can’t find any reason why refrigerating causes it to go bad or causes harm to the user.
Does anybody have this answer?
I’ll ask, but I don’t think my pharmacist knows. She had never dispensed it befote me. She had to see if it was something she could get. She gave it to me the day after she received it, and it wasn’t cold, so I’m assuming she didn’t refrigerate it. But between my receiving it from her and arriving home, it certainly reached room temperature.
Has anybody rerefrigerated it after it reached room temperature? Was it safe?

Interested in more discussions like this? Go to the Polymyalgia Rheumatica (PMR) Support Group.

Thanks everybody who replied.

I called 844-KEVZARA .
“ Sanofi “
They transferred me twice, so I spoke with three personel in three departments. All wanting to help.

Bottom line. They don’t know.

And, I was also informed that testing has not been done on re-refrigerated Kevzara to see if it is still the same chemically and/or safe after it has been warmed to room temperature and then refrigerated again.

My lesson is this (lesson to me):

When I pick up Kevzara at my pharmacy, I will take a cooler with ice packs in it so that on the drive home (from the pharmacy to my house, where my refrigerator is) it won’t reach room temperature, before I can put it in my refrigerator.

Why? Because they haven’t tested it in that way. That was the answer. They wanted to help me but they didn’t have testing for that.

Like I said, when I brought it home the first thing I did was immediately read all of the paperwork (and it is mostly all fine print) and it said to keep refrigerated so I put it in the refrigerator.

I think prescribers and pharmacists should make the patient or their “pick-up” representative aware that it should not reach room temperature and then be refrigerated again; and that it must leave the pharmacy in a cooler or refrigerated device. Adding that it must not be frozen either.

I also learned (condensed version):

Kevzara was developed jointly by Sanofi and Regeneron.

The prefilled auto pens are sold from Japan.

Marketing responsibility is done by Sanofi.
For medical inquiries, Sanofi can be reached at 1-800-633-1610.

So,
Keep it refrigerated from the check-out at the pharmacy to your refrigerator.
Or, keep it unopened in the original packaging, so that it is not exposed to light and at room temperature for up to 14 days; and inject it before the end of day 14.

I read about people saying that the injection hurt or it made them feel ill on this website and others. Maybe it had to do with refrigeration to room temperature and then re-refrigerated before it was again brought up to room temperature and injected.

Yes, this was long. I just want to help educate(fill in blanks) so everyone stays safe.

My rheumatologist told me to take it.

REPLY

Take it out of the fridge and let it warm at least 1 hour so it won't feel cold if you inject it right away. Once out of the fridge, it must be used within 15 days or throw it away.

REPLY
Profile picture for stonewheel @stonewheel

Thanks everybody who replied.

I called 844-KEVZARA .
“ Sanofi “
They transferred me twice, so I spoke with three personel in three departments. All wanting to help.

Bottom line. They don’t know.

And, I was also informed that testing has not been done on re-refrigerated Kevzara to see if it is still the same chemically and/or safe after it has been warmed to room temperature and then refrigerated again.

My lesson is this (lesson to me):

When I pick up Kevzara at my pharmacy, I will take a cooler with ice packs in it so that on the drive home (from the pharmacy to my house, where my refrigerator is) it won’t reach room temperature, before I can put it in my refrigerator.

Why? Because they haven’t tested it in that way. That was the answer. They wanted to help me but they didn’t have testing for that.

Like I said, when I brought it home the first thing I did was immediately read all of the paperwork (and it is mostly all fine print) and it said to keep refrigerated so I put it in the refrigerator.

I think prescribers and pharmacists should make the patient or their “pick-up” representative aware that it should not reach room temperature and then be refrigerated again; and that it must leave the pharmacy in a cooler or refrigerated device. Adding that it must not be frozen either.

I also learned (condensed version):

Kevzara was developed jointly by Sanofi and Regeneron.

The prefilled auto pens are sold from Japan.

Marketing responsibility is done by Sanofi.
For medical inquiries, Sanofi can be reached at 1-800-633-1610.

So,
Keep it refrigerated from the check-out at the pharmacy to your refrigerator.
Or, keep it unopened in the original packaging, so that it is not exposed to light and at room temperature for up to 14 days; and inject it before the end of day 14.

I read about people saying that the injection hurt or it made them feel ill on this website and others. Maybe it had to do with refrigeration to room temperature and then re-refrigerated before it was again brought up to room temperature and injected.

Yes, this was long. I just want to help educate(fill in blanks) so everyone stays safe.

My rheumatologist told me to take it.

Jump to this post

@stonewheel That's good advice if you are picking up your Kevzara or Actemra from a pharmacy. But I doubt very many people pick up one of those medications. I live in the Raleigh area of NC, but I think my Actemra is shipped to me from Delaware. It would be nice to be able to pick it up locally. I have to schedule a delivery date every month with the specialty pharmacy, and then be around at the expected delivery time so that I can unpack it and put it in the fridge.

REPLY
Profile picture for jeff97 @jeff97

@stonewheel That's good advice if you are picking up your Kevzara or Actemra from a pharmacy. But I doubt very many people pick up one of those medications. I live in the Raleigh area of NC, but I think my Actemra is shipped to me from Delaware. It would be nice to be able to pick it up locally. I have to schedule a delivery date every month with the specialty pharmacy, and then be around at the expected delivery time so that I can unpack it and put it in the fridge.

Jump to this post

@jeff97 thanks for the reply.

I live in a national forest in Texas. Rural. For thirty plus years, delivery of any kind is “ iffy” at best.

I went to my pharmacist and asked her if she could get Kevzara. She checked and called me at home stating that she can. I messsged my rheum. and told her to send the order to my pharmacist.
The next day my pharmacist called me and said it arrived. I told her I’d be right there.

This time I’ll take a cooler, a thermometer, and more that enough ice packs.

REPLY
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