bac
Lab Rat
Posts: 37
|
Post by bac on Jan 16, 2018 13:22:49 GMT -5
Thread Motivation: Could inhaling Afrezza at the start of meals contribute to low Afrezza retention rates?
Two types of entries are solicited in this thread: 1. Afrezza users are solicited to respond with when (with respect to meal start) they inhale Afrezza. 2. Literature references stating recommended Afrezza inhale timing.
As a non-Afrezza user, I limit my responses to literature references.
Reference 1: Website Afrezza.com, “Take AFREZZA at the beginning of your meal.”
Reference 2: VDEX White Paper, p. 21 “…we recommend administering Afrezza about 15 minutes after the start of a normal meal.”
Reference 3: Improving Efficacy of Inhaled Technosphere Insulin (Afrezza) by Postmeal Dosing: In-silico Clinical Trial with the Universityof Virginia/Padova Type 1 Diabetes Simulator “The simulations suggest that postmeal dosing and split dosing of TI can provide a flatter postprandial glucose profile with lower fluctuation amplitudes than at-meal dosing.” “Results obtained for postmeal doses administered at t = 15 or 30 min after start of the meal were similar to each other...”
|
|
|
Post by sportsrancho on Jan 16, 2018 14:30:49 GMT -5
The kids take theirs 10 minutes into a meal, they eat fast.
|
|
|
Post by peppy on Jan 16, 2018 14:34:26 GMT -5
The kids take theirs 10 minutes into a meal, they eat fast. the latest and greatest I read/saw is 20 mins after the start of the meal. I was surprised. vex saids 15 to 20 mins. it was the tube video of Matt B mattdownunder he said 20 mins into the meal. I would do VDEX. So much proof and work there. Teenagers, they do eat fast, they can be done in 10 mins. dosing: www.seventhform.com/vdexdownloads/vdex-whitepaper-072817.pdf page 22. Comments Afrezza’s speed of action is both a blessing and a curse. Clearly, it is a large factor in the safety of the product, but for longer meals, you may need more Afrezza to keep the post prandial levels in check. We recommend follow-on doses. For example, we advise with a standard meal to dose Afrezza 15-20 minutes after the start of the meal, and then another dose of the same size about 45 minutes later. With very long meals, we have even advised patients to administer two follow-on doses, for very tight control. Read more: mnkd.proboards.com/thread/7878/afrezza-starting-titrating#ixzz54NUHT5aq
|
|
|
Post by alethea on Jan 16, 2018 14:37:07 GMT -5
The kids take theirs 10 minutes into a meal, they eat fast. I aim for 12 to 15 minutes after I begin eating. It seems pretty effective.
|
|
|
Post by sportsrancho on Jan 16, 2018 14:47:55 GMT -5
The kids take theirs 10 minutes into a meal, they eat fast. the latest and greatest I read/saw is 20 mins after the start of the meal. I was surprised. vex saids 15 to 20 mins. it was the tube video of Matt B mattdownunder he said 20 mins into the meal. I would do VDEX. So much proof and work there. Teenagers, they do eat fast, they can be done in 10 mins. dosing: www.seventhform.com/vdexdownloads/vdex-whitepaper-072817.pdf page 22. Comments Afrezza’s speed of action is both a blessing and a curse. Clearly, it is a large factor in the safety of the product, but for longer meals, you may need more Afrezza to keep the post prandial levels in check. We recommend follow-on doses. For example, we advise with a standard meal to dose Afrezza 15-20 minutes after the start of the meal, and then another dose of the same size about 45 minutes later. With very long meals, we have even advised patients to administer two follow-on doses, for very tight control. Read more: mnkd.proboards.com/thread/7878/afrezza-starting-titrating#ixzz54NUHT5aq The kids don’t very often need a second dose. Maybe if they eat a whole pizza. Will be interesting to see how the pediatric trails are laid out.
|
|
|
Post by joeypotsandpans on Jan 16, 2018 14:55:41 GMT -5
The kids take theirs 10 minutes into a meal, they eat fast. the latest and greatest I read/saw is 20 mins after the start of the meal. I was surprised. vex saids 15 to 20 mins. it was the tube video of Matt B mattdownunder he said 20 mins into the meal. I would do VDEX. So much proof and work there. Teenagers, they do eat fast, they can be done in 10 mins. dosing: www.seventhform.com/vdexdownloads/vdex-whitepaper-072817.pdf page 22. Comments Afrezza’s speed of action is both a blessing and a curse. Clearly, it is a large factor in the safety of the product, but for longer meals, you may need more Afrezza to keep the post prandial levels in check. We recommend follow-on doses. For example, we advise with a standard meal to dose Afrezza 15-20 minutes after the start of the meal, and then another dose of the same size about 45 minutes later. With very long meals, we have even advised patients to administer two follow-on doses, for very tight control.
Read more: mnkd.proboards.com/thread/7878/afrezza-starting-titrating#ixzz54NUHT5aqThis is spot on, this is how I have been dosing and with the Libre it really helps regarding your altitude, I liken the Libre to an altimeter and flying, it lets me know if I need to pull back on the throttle or give it some gas (afrezza) and depending on meal, when and how much. It has only taken me about two weeks with the Libre now to fine tune and hone in keeping my "flight path" closer to in-range. So again, depending on one's metabolism, diet, exercise, etc. it would correlate with timing and frequency of dosing. It varies from day to day depending on the variables. Hope that helps make sense but that is what Vdex is basically saying in the above statement. Here's the bottom line however, having the ability to control spikes with Afrezza and "dial in" has brought my BG avg down over 100 mg/dL (milligrams/deciliter) since I started my readings on 1/3. I so look forward to my next set of labs , can't wait to see quite a few reactions AND collect on some family bets
|
|
|
Post by hillsave on Jan 16, 2018 14:58:36 GMT -5
So I’ve been using Afrezza for 33 months for T2. My A1C is 5.4. Depending on what my BG level is before I eat and what I’m eating will determine when I take my Afrezza. It’s very forgiving so I know I can’t take too much and go too low.
|
|
|
Post by alethea on Jan 16, 2018 15:00:37 GMT -5
Joey, is your Libre covered by insurance? Either way what does it cost you out-of-pocket? (if you don't mind sharing). Thanks.
|
|
|
Post by joeypotsandpans on Jan 16, 2018 15:09:09 GMT -5
Joey, is your Libre covered by insurance? Either way what does it cost you out-of-pocket? (if you don't mind sharing). Thanks. Express Scripts covered it with the reader costing me $65 co-pay and $75/mo. co-pay for the box of 3 10 day sensors. So going forward I am at $125/mo. all in for the 180 ct. (60/60/60) box of Afrezza and the sensors. Both scripts are scheduled with 11 refills.
|
|
|
Post by jonny80s on Jan 16, 2018 15:09:42 GMT -5
Way before FDA approval the guidance from Al Mann/Mannkind was that Afrezza was most effective when taken after starting a meal... 10-20 minutes depending on the users variables.
Knowing this was case is why so many of us believed the FDA trials were absolutely absurd... and a miracle that Afrezza was still proven equally effective. Equally effective even though it was being taken incorrectly.... by trial design.
***Use as directed by your doctor/prescriber.
|
|
bac
Lab Rat
Posts: 37
|
Post by bac on Jan 16, 2018 17:38:20 GMT -5
The following quote from Al Mann (AM) is from 15Sept2014 and appeared in Medication, Type 2 Diabetes, Medical Devices, Insulin, Diabetes Clinical Mastery Series Issue 206.
AM: No, I think that a problem during the trials was that some patients took their dose of Afrezza even before starting to eat. The trial protocols called for Afrezza to be dosed "at the beginning of the meal," but sometimes it was taken even before. We need to do additional trials to gain more experience with optimized dosing times. Actual ingestion of food in most meals in the United States except in restaurants takes only about 30 minutes, so I believe that the first Afrezza dose really ought to be taken ten or fifteen minutes after starting to eat. For a longer meal, which is not very common, a second dose might be taken fifty or sixty minutes after starting to eat. For a long feast that lasts for an hour and a half or more, I suggest a third dose be taken at maybe one and a half hours after start. Interestingly I believe the size of all those doses should probably be the same for most patients. Unfortunately the trial protocols called for dosing at the beginning of the meal so we will need to do more trials to be able to gain FDA label approval of optimized dosing.
|
|
|
Post by dreamboatcruise on Jan 16, 2018 18:01:39 GMT -5
The following quote from Al Mann (AM) is from 15Sept2014 and appeared in Medication, Type 2 Diabetes, Medical Devices, Insulin, Diabetes Clinical Mastery Series Issue 206. AM: No, I think that a problem during the trials was that some patients took their dose of Afrezza even before starting to eat. The trial protocols called for Afrezza to be dosed "at the beginning of the meal," but sometimes it was taken even before. We need to do additional trials to gain more experience with optimized dosing times. Actual ingestion of food in most meals in the United States except in restaurants takes only about 30 minutes, so I believe that the first Afrezza dose really ought to be taken ten or fifteen minutes after starting to eat. For a longer meal, which is not very common, a second dose might be taken fifty or sixty minutes after starting to eat. For a long feast that lasts for an hour and a half or more, I suggest a third dose be taken at maybe one and a half hours after start. Interestingly I believe the size of all those doses should probably be the same for most patients. Unfortunately the trial protocols called for dosing at the beginning of the meal so we will need to do more trials to be able to gain FDA label approval of optimized dosing. If only Al had enough money to have run additional trials concurrent with the flawed ones required by FDA. He probably believed we'd get a partner and that all these follow on studies would have been quickly funded.
|
|
|
Post by peppy on Jan 16, 2018 22:32:50 GMT -5
The following quote from Al Mann (AM) is from 15Sept2014 and appeared in Medication, Type 2 Diabetes, Medical Devices, Insulin, Diabetes Clinical Mastery Series Issue 206. AM: No, I think that a problem during the trials was that some patients took their dose of Afrezza even before starting to eat. The trial protocols called for Afrezza to be dosed "at the beginning of the meal," but sometimes it was taken even before. We need to do additional trials to gain more experience with optimized dosing times. Actual ingestion of food in most meals in the United States except in restaurants takes only about 30 minutes, so I believe that the first Afrezza dose really ought to be taken ten or fifteen minutes after starting to eat. For a longer meal, which is not very common, a second dose might be taken fifty or sixty minutes after starting to eat. For a long feast that lasts for an hour and a half or more, I suggest a third dose be taken at maybe one and a half hours after start. Interestingly I believe the size of all those doses should probably be the same for most patients. Unfortunately the trial protocols called for dosing at the beginning of the meal so we will need to do more trials to be able to gain FDA label approval of optimized dosing. welcome welcome welcome. please stay.
|
|
bac
Lab Rat
Posts: 37
|
Post by bac on Jan 28, 2018 11:42:45 GMT -5
This thread addresses “when to inhale Afrezza”.
All of the quotes above in this thread say to inhale AFTER beginning a meal except Afrezza.com says to “Take AFREZZA at the beginning of your meal.”
Afrezza .com contains MannKind prescribing instructions; presumably new patients will be prescribed by their doctors to inhale Afrezza at the beginning of meals. This leads to ineffective use as described in the VDEX White Paper and contradicts Al Mann’s advice above, “I (Al Mann) believe that the first Afrezza dose really ought to be taken ten or fifteen minutes after starting to eat.”
Why do MannKind prescribing instructions contradict all the info out there regarding WHEN to inhale Afrezza?
|
|
|
Post by mnholdem on Jan 28, 2018 12:00:34 GMT -5
Because that is what the FDA has on the Afrezza label. Doctors may fine-tune the dosing instruction they give patients (assuming they, themselves, understand it) but MannKind is not able to market new dosing information without it first being sanctioned by the FDA. There may be another label change submitted following the STAT study results being published but, whether in literature or on the Afrezza Patient/HCP website, MannKind is required to stick to the current label.
|
|