Is this diabetes week at the FDA?
“Fiasp® is a new formulation of NovoLog®, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in approximately 2.5 minutes.”
“Fiasp® will launch at the same list price as NovoLog®”
“The clinical trials enrolled more than 2,000 adults with type 1 and type 2 diabetes to evaluate the efficacy and safety of Fiasp® administered both at mealtime and after starting a meal.”
“It is not known if FIASP is safe and effective in children.”
Definitely not younger children <2 years of age. I don’t believe any insulin is tested on children <2. The below is the Novolog FDA approval statement as it pertains to pediatrics.
From the FDA site for Novolog approval:
"-----------------------USE IN SPECIFIC POPULATIONS-----------------------
• Pediatric: Has not been studied in children with type 2 diabetes. Has not
been studied in children with type 1 diabetes <2 years of age (8.4). "
I found some info on FIASP age, but this is from the European EPA equivelant (EMA - European Medicines Agency). Anyone have the US FDA approval for Fiasp and know the age that’s been tested on/approved for?
The safety and efficacy of Fiasp in children and adolescents below 18 years of age have not been
established. Currently available data are described in section 5.2, but no recommendation on a
posology can be made.
Great! Now I won’t feel like a criminal.
The forbidden fruit tastes twice as sweet.
So true! When I was a kid we had a saying in the family: “it tastes better if it is somebody else’s.”
I looked for a more recent thread but haven’t found one. Are people using Fiasp?? How has it been working? I don’t know if my insurance would cover it but I’m seeing my endo in less than a month and want to ask her about using this, either as MDI or with a pump.
@allison FIASP for me is just very slightly faster onset than novolog. There seems to be no difference in DIA. I have a pretty quick onset with Novolog though, so FIASP might be a lot faster for you.
All in all, it doesn’t seem to be all that it’s cracked up to be.
@docslotnick out of curiosity have you compared Novolog and Humalog for speed or effectiveness?
I have heard that it is a bit faster, but tends to require more.
Insurance made me change from Novolog to Humalog a few years ago and I didn’t notice any difference.
I vaguely recall reading some posts where people were complaining that Fiasp in a pump seemed to be giving more occlusions. But I could be completely wrong about that, just something to look for.
I’ve tried it before in my pump and I’m trying it again as I’ve struggled to pre-bolus lately and have been suffering the consequences of it using NovoRapid! For me it works very fast and the DIA is much shorter. I don’t pre-bolus at all using it and for some foods have to use a half-hour extended bolus when I would normally take a straight bolus since it works too fast. I have lowered the DIA on my pump to 2 hours. I have to use extended boluses for almost everything, as the shorter effective duration means that delayed protein/fat spikes are much more noticeable and won’t be covered as well by the initial meal bolus. I also find it doesn’t work as well in higher quantities.
I don’t think Fiasp has been approved for use in a pump yet in the U.S… I’m not sure if that’s because there’s a problem with it or if the research just hasn’t been done yet.
It isn’t approved for pumping in Canada either. My endo is a type 1 and said he uses it last time I asked him though. He said the research shows it actually works faster in a pump than injecting it. I tried it right away since you can buy any insulin over the counter here without a prescription, and many doctors will prescribe it for a pump off label.
Actually, I’ve never used Humalog.
Do we have the same endo? Mine is also T1, uses Fiasp in his pump, and said studies (though they haven’t been published yet, only presented at conferences) show it works faster in pumps than injected.
I’ve been using it in my pump since it came available in Canada (about six months ago) and love it. I find it much faster (both in onset and tail) than Apidra. I’ve shorted my DIA to 3 hours, and often I can see it start to work nearly instantly.
Hi @allison - I have been using Fiasp since April 2017 in my Omnipod. I am in Canada. My endo prescribed it off label for pump use. He said it was not approved for pump use yet becasue they had not completed some studies of using Fiasp in a pump. I think the issue was there is no guidance for doctors on the pump settings given - as in how the pump settings should change with Fiasp.
Here is my experience summary that may appear elsewhere on the internet.
Changing from Humalog to Fiasp in an Omnipod:
I used to prebolus with Humalog between 45 minutes and 30 minutes for meals. With Fiasp usually 15 minutes is enough. For slow carbs I just give the bolus with the carbs. For me this improves my quality of life, because I can come home and just eat dinner without having to wait a long time for the Humalog to kick in.
I also see less of a sharp rise in BG after carbs. More of the insulin is active up front so it stops the spike.
I sometimes see after an hour my BGs start to rise. I usually either just hit it with another bolus if I am lazy, or I will set-up an extended bolus with my meal to flatline when I am feeling organized.
I have heard negative comments from T1 people I have met in my community (one commenter was a nurse with T1). Generally the complaints fall into three groups:
- It stings when I bolus
- The bolus gets used up really quickly and then I go high after 1 hour
- It is not really faster than the rapid acting analog that I used to take.
I do not have any of these problems. I am just posting as some people (like the nurse I was talking about) think that just because it does not work for them means it does not work for anyone. I think with Fiasp you are either in the love it camp or the hate it camp, but it gets to me when people in the hate it camp deny that the people in the love it camp have a valid positive experience