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Post by mnholdem on Aug 21, 2019 15:29:31 GMT -5
As I understand it, MannKind’s dosing instructions must follow the label. A common result, as we’re hearing more and more from Afrezza users, is that patients are underdosing and this getting substandard results. It’s also my understanding that patients hesitate taking “too many” units due to the fear of hypos, which has become ingrained into their thinking by injectable insulins’ long duration.
The label is still problematic for training patients.
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Post by cretin11 on Aug 21, 2019 15:39:53 GMT -5
I don't know what you all know, I don't dial in to conference calls. This was my first time filling my script with the savings card and I ended up getting called asking if I wanted training on how to use Afrezza. They go over "inhalation technique, dosing, and storage/handling along with any questions you have" via video. Even though I think I know those things I'm taking the video call anyways to learn what maybe I do wrong. So I think they are trying to address that part of retention. That's welcome news, and I hope they have somebody really good fulfilling this role. When they call, how do they introduce themselves, i.e. do they say they are with MannKind, or is it Afrezza Helpline or something? Just curious. I wonder how many people are doing those calls. I would guess only one or two, based on how low scripts are, but I wonder about that and also what department of MannKind they're in. Are you on video with the person who walks you through everything and answers Qs, or is it a pre-recorded video that you watch?
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Post by mnholdem on Aug 21, 2019 15:51:00 GMT -5
A few years ago, MannKind contracted an outside company (I cannot recall the name) to run MannKind Cares, which handles patient and physician support. I haven’t heard that the contract was ended.
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Post by shawnonafrezza on Aug 21, 2019 16:38:27 GMT -5
I don't know what you all know, I don't dial in to conference calls. This was my first time filling my script with the savings card and I ended up getting called asking if I wanted training on how to use Afrezza. They go over "inhalation technique, dosing, and storage/handling along with any questions you have" via video. Even though I think I know those things I'm taking the video call anyways to learn what maybe I do wrong. So I think they are trying to address that part of retention. That's welcome news, and I hope they have somebody really good fulfilling this role. When they call, how do they introduce themselves, i.e. do they say they are with MannKind, or is it Afrezza Helpline or something? Just curious. I wonder how many people are doing those calls. I would guess only one or two, based on how low scripts are, but I wonder about that and also what department of MannKind they're in. Are you on video with the person who walks you through everything and answers Qs, or is it a pre-recorded video that you watch? Said they were from Mannkind, the company that makes Afrezza to make sure the connection was made I guess. No idea on what department. Video will be on demand it sounds like because I chose a date and time so I would assume it'll be live with someone since they're going over things a prerecorded video can't. I wouldn't be surprised if the dosing instructions were "dose light" because of FDA things. If so that's the big challenge I think I've talked about and everyone here as well; that the label has to change somehow. EDIT - Footer of the email I got for title and all that. Patient Experience Guide | MannKind Customer Experience Center
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paul
Researcher
Posts: 134
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Post by paul on Aug 21, 2019 17:02:16 GMT -5
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Post by mnholdem on Aug 22, 2019 4:28:10 GMT -5
There is an inconsistency in dosing instructions between the Afrezza Patient site... www.afrezza.com/pdf/Afrezza-IFU-Mar-2017.pdf...and the Afrezza Healthcare Professional site. www.afrezza.com/hcp/prescribing-afrezzaThe patient site illustrates a 1:1 unit conversion between Afrezza and injected insulin while the Afrezza HCP site recommends a 1.5 unit Afrezza to 1 unit injectable insulin conversion: " Conversion: Based on clinical trials, consider a ~1.5x conversion from injectable insulin units to Afrezza Units, to achieve a comparable glucose effect.14,18 Additional dose adjustments might be needed."MannKind is unable to explain why Afrezza's short duration makes it safer to administer higher and/or follow on doses, other than to say that "additional dose adjustments might be needed".
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paul
Researcher
Posts: 134
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Post by paul on Aug 22, 2019 5:16:01 GMT -5
There is an inconsistency in dosing instructions between the Afrezza Patient site... www.afrezza.com/pdf/Afrezza-IFU-Mar-2017.pdf...and the Afrezza Healthcare Professional site. www.afrezza.com/hcp/prescribing-afrezzaThe patient site illustrates a 1:1 unit conversion between Afrezza and injected insulin while the Afrezza HCP site recommends a 1.5 unit Afrezza to 1 unit injectable insulin conversion: " Conversion: Based on clinical trials, consider a ~1.5x conversion from injectable insulin units to Afrezza Units, to achieve a comparable glucose effect.14,18 Additional dose adjustments might be needed."MannKind is unable to explain why Afrezza's short duration makes it safer to administer higher and/or follow on doses, other than to say that "additional dose adjustments might be needed". They should resize their doses so that x units of afrezza equals x units of injectable. As it is, a 4U dose of afrezza approximately equals 2.67U of injectable. That comes across as confusing to me.
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Post by shawnonafrezza on Aug 22, 2019 9:16:01 GMT -5
There is an inconsistency in dosing instructions between the Afrezza Patient site... www.afrezza.com/pdf/Afrezza-IFU-Mar-2017.pdf...and the Afrezza Healthcare Professional site. www.afrezza.com/hcp/prescribing-afrezzaThe patient site illustrates a 1:1 unit conversion between Afrezza and injected insulin while the Afrezza HCP site recommends a 1.5 unit Afrezza to 1 unit injectable insulin conversion: " Conversion: Based on clinical trials, consider a ~1.5x conversion from injectable insulin units to Afrezza Units, to achieve a comparable glucose effect.14,18 Additional dose adjustments might be needed."MannKind is unable to explain why Afrezza's short duration makes it safer to administer higher and/or follow on doses, other than to say that "additional dose adjustments might be needed". They should resize their doses so that x units of afrezza equals x units of injectable. As it is, a 4U dose of afrezza approximately equals 2.67U of injectable. That comes across as confusing to me. It's actually a mess for insulin across the board. Your dose of Lantus is not the same (probably) as your dose in Tresiba. How well insulin works in a pump vs syringe vs even a different pump can be different. With Afrezza it's a marked and known difference so I really do hope they're able to get it fixed. Would help with rx writing too because so many doctors go by the units (thus many patients will lie on how much insulin they take so they can get an over prescription and not run out).
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Post by prcgorman2 on Aug 22, 2019 10:54:53 GMT -5
shawnflynn - thank you for joining and posting. You provide information grounded in experience and that is very helpful.
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Post by ktim on Aug 26, 2019 19:49:57 GMT -5
There is an inconsistency in dosing instructions between the Afrezza Patient site... www.afrezza.com/pdf/Afrezza-IFU-Mar-2017.pdf...and the Afrezza Healthcare Professional site. www.afrezza.com/hcp/prescribing-afrezzaThe patient site illustrates a 1:1 unit conversion between Afrezza and injected insulin while the Afrezza HCP site recommends a 1.5 unit Afrezza to 1 unit injectable insulin conversion: " Conversion: Based on clinical trials, consider a ~1.5x conversion from injectable insulin units to Afrezza Units, to achieve a comparable glucose effect.14,18 Additional dose adjustments might be needed."MannKind is unable to explain why Afrezza's short duration makes it safer to administer higher and/or follow on doses, other than to say that "additional dose adjustments might be needed". Presumably this means FDA would allow sales reps to tell doctors the correct conversion. That's a good step forward. I don't see them ever "correcting" the "unit" since that would create a logistic nightmare, and potential safety issue with patients not realizing the difference between old "units" and new "units".
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Post by shawnonafrezza on Aug 27, 2019 8:49:07 GMT -5
There is an inconsistency in dosing instructions between the Afrezza Patient site... www.afrezza.com/pdf/Afrezza-IFU-Mar-2017.pdf...and the Afrezza Healthcare Professional site. www.afrezza.com/hcp/prescribing-afrezzaThe patient site illustrates a 1:1 unit conversion between Afrezza and injected insulin while the Afrezza HCP site recommends a 1.5 unit Afrezza to 1 unit injectable insulin conversion: " Conversion: Based on clinical trials, consider a ~1.5x conversion from injectable insulin units to Afrezza Units, to achieve a comparable glucose effect.14,18 Additional dose adjustments might be needed."MannKind is unable to explain why Afrezza's short duration makes it safer to administer higher and/or follow on doses, other than to say that "additional dose adjustments might be needed". Presumably this means FDA would allow sales reps to tell doctors the correct conversion. That's a good step forward. I don't see them ever "correcting" the "unit" since that would create a logistic nightmare, and potential safety issue with patients not realizing the difference between old "units" and new "units". I don't know about sales, but I was told it in my 1:1 call.
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Post by ktim on Aug 27, 2019 10:31:11 GMT -5
Presumably this means FDA would allow sales reps to tell doctors the correct conversion. That's a good step forward. I don't see them ever "correcting" the "unit" since that would create a logistic nightmare, and potential safety issue with patients not realizing the difference between old "units" and new "units". I don't know about sales, but I was told it in my 1:1 call. It was suggested you start at a 1.5 to 1 ratio from your previous RAA dosing? as starting point or possible/likely need after first trying 1 to 1? Would be interesting to hear the details of the standard part of that call. Do they convey the water sipping trick to prevent cough? Was your call well timed with when you filled the prescription? Sorry for all the questions. With rather poor retention rates in the past, this is very exciting if they are now allowed and taking advantage of real world experience that wasn't first on the label.
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Post by shawnonafrezza on Aug 27, 2019 11:07:22 GMT -5
I don't know about sales, but I was told it in my 1:1 call. It was suggested you start at a 1.5 to 1 ratio from your previous RAA dosing? as starting point or possible/likely need after first trying 1 to 1? Would be interesting to hear the details of the standard part of that call. Do they convey the water sipping trick to prevent cough? Was your call well timed with when you filled the prescription? Sorry for all the questions. With rather poor retention rates in the past, this is very exciting if they are now allowed and taking advantage of real world experience that wasn't first on the label. The guy on the call was also T1. I scheduled the call, they reached out maybe 2 days post fill. Said dosing was about half as strong and just to expect that. Covered starting with smaller doses to get used to the feeling. Covered water. Covered follow up dosing. Covered action time. Covered about how much you'd typically go through in a month based on previous insulin regime. Covered inhale technique.
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