Breastfeeding and Afrezza

So, I am highly considering Afrezza at my upcoming endo (well, endo np) appointment this week, but it seems like breastfeeding is a murky area. Thoughts?
Baby is 12 months this week, but I do want to continue breastfeeding her.

@anon15668421? @Sam?

I don’t quite understand the concern or ‘murkiness’ because it’s just regular human insulin… if anything I’d think the concerns would be less than with synthetic insulin analogues… to my knowledge there are no contraindications for mothers with regular human insulin regardless of delivery method

Yes, I recently read this in the FDA’s analysis of Afrezza. I wondered how it would compare to injected insulin. Perhaps not at all? Some sites say not to use it while breastfeeding at all.

Section 8.3

I’m considering using it for runaway bg and not as a primary (for now), so I wouldn’t be using it daily. Maybe once or twice per week?

Keep in mind that the concern would not just be the insulin, but the inhalant “package” that carries the insulin. I don’t think the insulin part of the equation is a problem at all.

I asked Shelly to review it, but as she has a lot more letters behind her name than the “BS” that ol’ captain Sam has it will probably take her a little more time;)

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I think breastfeeding typically results in so little of most drugs winding up in milk that I can’t imagine it being a problem.

Hello Irish. I did a little research for you on this and had to do a bit of exploration as Afrezza is such a new drug that very few studies have been done on it. It is classified as category C, which are generally medications that we advise people to stay away from while pregnant or breastfeeding. The one journal article I found (yes quite literally 1) mentioned that “transported particles” were found in animal testing, so they theorize that it’s possible that human milk would also contain these substances. At this point the recommendations are to discontinue this medication if pregnant or breastfeeding. Recommendations evolve and this one may change as further studies/research of Afrezza are done. I am curious to know what your endo says! My husband has had such great success with this medication that when you are given the green light I hope you will still highly be considering it. Hope this was helpful.

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@anon15668421, thank you so much for looking into this! I am very grateful for your detailed analysis. It would seem that it hasn’t yet been thoroughly enough researched for me to be comfortable using it, but as soon as our baby weans, I’m on it! Thanks again!

I was just prescribed Afrezza by my doc, who is usually very conservative about drugs while breastfeeding. Has anyone found any new info on this? Currently breastfeeding a 2.5 month old, so I’m not planning to wean anytime soon. :confused:

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Shelly pretty much just did a google search on the topic when she wrote that, I’d tend to suspect your doc that prescribed it was probably referring to more valid info and weighing the risks and benefits for your particular case more appropriately

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Thanks! When she prescribed it, I didn’t even think to ask about breastfeeding safety, as I assumed it was just like other insulins. Oops. I’m pretty excited about trying it out, honestly. :smiley:

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But by all means it’s a perfectly reasonable question for your doc if you have concerns… I sure have had great success with it as have a number of others here… we’all be more than happy to help you along the way

Maybe I’m being dumb but is there a way that insulin could get from your lungs into your breastmilk other than through your blood? Because if not I would assume Affrezza accumulates roughly at the same amounts as other insulins, or possibly a little less because it’s faster in and out, and isn’t it literally bioidentical human insulin with just a carrier to get it into the lungs, in which case as long as the levels are physiological I’d assume it has minimal effect on infants?

I’m not an expert – Sam knows a ton more. But still I wouldn’t worry too much.

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I don’t know, I certainly wouldn’t be worried about it myself, but I know how moms with babies are… insulin is a natural substance in the body all that any of us are doing is supplementing a lack of a natural resource… I’d be more concerned about elevated insulin levels in T2 than i would be in normal but supplemented insulin levels in T1 and LADA in terms of breastfeeding… and we also know that you can eat insulin all day long and it has no effect on anything… so it wouldn’t be high on my list of concerns… but that’s the way the FDA works, they give higher classifications to any drug until its been specifically studied in terms of pregnancy and lactation whether it makes sense or not… and that’s the doctors job to decipher the nonsense

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In the case of Afrezza, the FDA concern for pregnant and breastfeeding women is not the insulin, but the additives they use in it that allow it to be transported via inhalation.

do we know what those additives are?

I don’t remember what the additives are, but here’s the section from that PDF to which I’d referred earlier.

8.3 Nursing Mothers
Many drugs are excreted in human milk. A study in rats indicated that the carrier is excreted in
milk at approximately 10% of maternal exposure levels. It is therefore highly likely that the
insulin and carrier in AFREZZA is excreted in human milk. A decision should be made
whether to discontinue nursing or suspend use of the drug since AFREZZA has not been studied
in lactating women

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fumaryl diketopiperazine (FDKP) and polysorbate 80

http://www.mannkindcorp.com/Collateral/Documents/English-US/Innovation%20In%20Drug%20Delivery%20by%20Inhalation.pdf

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hmm, yeah so the second one I think is common in food but don’t know anything about fumaryl diketopiperazine.

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so I found this study from 2010 suggesting that the additive (FDKP) is excreted virtually unchanged by the kidney, which suggests it’s not actually absorbed or processed by the body.
Personally I’d think it’s pretty safe for breastfeeding. But I also don’t stress about things like drinking a glass of wine and not “pumping and dumping”–so your risk threshold may be different.

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