Afrezza and decreasing basal

Type 1 and LADA
#1

I have LADA, dx 1/1/16 and have been using Afrezza for about 4-5 months. In the beginning I needed to increase Tresiba basal, but now I’ve needed to decrease dramatically because of severe nighttime lows. The last few weeks I’ve been eating most of the night and last night was in the 30’s even after eating a ton of fruit. I am insulin-sensitive and have decreased my basal starting from 7 units until yesterday was down to 3 units. Today I discontinued Tresiba and will use Levemir 2 or 3 units at night and none during the day. Levemir is supposed to clear in about 12 hours.

Also, when I first started using Afrezza I needed to make 2 unit cartridges to accommodate my insulin sensitivity. Now, I use the 8 unit cartridges routinely and no longer need 2 units. The onset isn’t as fast either. It is still relatively quick, but not like it was.

Of note, my A1c last week was 5.4!!! Decreased from 6.6.

Does anyone have similar experience? Does anyone have literature to explain? The decreased basal requirement makes me excited to think that maybe some beta cells are kicking into gear. I also wonder, if somehow, the Afrezza is having a delayed effect. Especially since my sensitivity to it has changed compared to when I first started using slight_smile: I am very sensitive to the side-effects of high blood sugar so I treat aggressively to avoid going high. I wonder if the decease in Afrezza sensitivity is actually Afrezza-storing for slow release later… as if it were fat soluable. Instead of Afrezza clearing in 90 minutes as it appeared to in the beginning, it is clearing much more slowly.

#2

I’ve been type 1 for 26 years so nothing as dramatic as that but this week I had to start decreasing my Tresiba because of nighttime lows (60’s not anything serious). I’m still as sensitive to my Afrezza as I was when I started it so 4 unit cartridges but not as often as when I started taking it.

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#3

Firenza, I asked my CDE about trying Afreeza and was told that it is almost unavailable now. Something about it being bought by another company and not doing any marketing at all. Can you still get Afreeza?

#4

Mannkind had a rough patch in the beginning of 2017. They’re in good shape now though. I got my prescription a few weeks back in the mail from CVS Caremark.

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#5

And in today’s news …

[MannKind] has reduced or restructured over $80 million in debt, clearing the runway for MannKind to focus on growing sales for its inhaled insulin product Afrezza. MannKind has also hired a sales team that is already doing a better job than Sanofi did when it owned rights for Afrezza. …

There’s also no question that Afrezza is gaining momentum. MannKind reported Afrezza net revenue totaling $4.5 million in Q4 – a 238% year-over-year jump and 125% quarter-over-quarter increase.

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#6

Perhaps your CDE was thinking about a couple years ago… Sanofi had the rights to Afrezza, did little or no marketing, and dropped it. Mannkind recovered the rights and have been building back the market.

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#7

I live in the boonies of Wisconsin. What my CDE told me was that no salesman has even looked in on her recently and she has no Afreeza samples for me to try. I also asked my pharmacist and he said they have never sold any Afreeza. I understand now the fiasco with Sanofi and that MannKind is restarting their marketing themselves. I will attempt a trial run again now that I understand what happened. Thanks to all who responded.

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#8

Get a hold of Mannkind Cares. That is who facilitates getting my prescriptions to the pharmacies that carry Afrezza. I too live way out in the boonies and cannot get it at any of my local pharmacies.

#9

Thank you! That is very helpful as I was having trouble finding contact number.

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#10

I live in Minneapolis and, when I started on Afrezza 2 years ago, There were 2 patients in the region getting Afrezza (me being one of them). It has to be ordered from the pharmacy a couple days in advance.

It is now in the supply chain and can be gotten from any pharmacy that doesn’t stock it in 1 day.

If your CDE requested samples from Mannkind, she would get them. Can you imagine the cost of every clinic that had diabetic patients was sent samples?

However, there are currently no sales reps in the northern Midwest. This is primarily due to the “managed entru” philosophy of the region, which makes it hard for reps to get in to see doctors and CDEs.

If you need to, ping Mike Castagna on Twitter (@castagna2011). He supposedly has an account here, but I’ve never seen him here.

#11

This is what she replied to my email inquiry:

“It requires pulmonary function tests before start and every 6 months due to patients on study getting lung cancer. There were 4 cases. It only doses in 4 unit increments. They have 4 unit 8, and 12 unit cartridges so you can take multiple cartridges to get more but insulin but you cannot take less than 4 units. Hope that helps.”

I suspect this is a dead issue so far as she is concerned. I did not know that one needed to get a pulmonary assessment. I did know about the limited unit cartridges. If she feels that I’ll need pulmonary function tests before I even test it out and then every 6 months after, then she is very negative about this product. I know I do not want to undergo those tests to pacify her. My mantra is less medication, tests and health practitioner visits, not more. This CDE is probably the most enlightened health practitioner I have run into out here and, if she feels this negatively about Afrezza, I will not push for it. It doesn’t make that much difference at my age anyway. I may let things settle a bit and try again later on… or maybe not.

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#12

The pulmonary function test required is just a spirometry test. It’s actually not as complicated as it all sounds. I had trouble with my endo figuring out how to order the test, so I ended up going to an endo who had prescribed Afrezza in the past. I found that endo on this website: https://www.afrezza.com/find-a-doctor/. It was a pain for me to work with an endo who had no experience with Afrezza, so I would understand if you were hesitant to pursue it further; however, I do think Afrezza has had a very positive impact on my life so I would naturally recommend it to anyone :slight_smile:

The spirometry test is required to ensure that you don’t have lung disease. Afrezza is contraindicated for people with lung disease (e.g. asthma or COPD). The test is also done at the six month mark to ensure there hasn’t been a decrease in FEV1. This is unlikely to happen, but I think it’s a good idea to double check anyway.

Regarding lung cancer, there were two lung cancer cases in smokers during the clinical trial. Because lung cancer takes years and years to develop, these cases were deemed attributable to smoking. There were two additional cases after the trial of lung cancer in nonsmoking patients who participated in the clinical trial. There is much debate about these two cases, but I’ve read that those individuals had previously worked in jobs that were considered high risk for the development of lung cancer. I can’t say if that is true or not. The FDA did not consider these cases sufficient to show that Afrezza causes lung cancer. The package insert describes most of what I just stated here: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf

The 4 unit minimum is actually more like 2-2.5 units of fast-acting insulin. The unit measurements are different. Gary Sheiner wrote up an article that mentions this here: http://integrateddiabetes.com/my-review-of-afrezza-fast-acting-inhaled-insulin/.

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#13

Not exactly. It sounds like the Doc was in the ballpark but not quite exactly on spot.
(ie - A full blown pulmonary function test may be far more than is required.)
I have not personally had the spirometry (FEV) test but my understanding it this is something done quickly in the Doctor’s office and should just take a handful of seconds. If the test is more elaborate or more involved than very possible it is far far more than is required by the FDA.

Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV ) to identify potential lung disease in all patients. (2.5), (5.1)

2.5 Lung Function Assessment Prior to Administration
AFREZZA is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients. Before initiating AFREZZA, perform a medical history, physical examination and spirometry (FEV1) in all patients to identify potential lung disease [see Contraindications (4) and Warnings and Precautions (5.1)].

5.1 Acute Bronchospasm in Patients with Chronic Lung Disease
Because of the risk of acute bronchospasm, AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD [see Contraindications (4)].
Before initiating therapy with AFREZZA, evaluate all patients with a medical history, physical examination and spirometry (FEV1) to identify potential underlying lung disease.
Acute bronchospasm has been observed following AFREZZA dosing in patients with asthma and patients with COPD. In a study of patients with asthma, bronchoconstriction and wheezing following AFREZZA dosing was reported in 29% (5 out of 17) and 0% (0 out of 13) of patients with and without a diagnosis of asthma, respectively. In this study, a mean decline in FEV1 of 400 mL was observed 15 minutes after a single dose in patients with asthma. In a study of patients with COPD (n=8), a mean decline in FEV1 of 200 mL was observed 18 minutes after a single dose of AFREZZA. The long-term safety and efficacy of AFREZZA in patients with chronic lung disease has not been established.

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#14

Thank you for the link to Gary Scheiner’s assessment of Afrezza. As usual, he is right on. Thank you also for the explanation of the “lung assessment” requirement.

My CDE, while broadminded on self-management, is slow to warm up to “new” or “different” ideas. My Animas Ping was a first for her and she was not amused. She reluctantly helped me get a second one when my warranty had expired. My inclination now change to a T-slim, now that Animas is defunct, is not enthusing her either.

I think I will go slow with this. I have seriously thought of finding someone else who will monitor my DM for Medicare who is closer than the hour and a half that I now have to travel. All factors to consider.

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#15

I agree that my CDE was somewhere in left field and totally missed the ball. I never heard of a spirometry test but will look into it. None of it sounds like a big deal. Maybe my age is putting her off. I am 77. But I have not had lung disease of any sort. Ever. She is probably simply overworked and reluctant to add to her work load. As I said above, I will take this slowly. Am considering changing health practitioners. But there is a definite lack of them out here in the country and I have been with her for over 10 years. Thank you for your input. It is most helpful.

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