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Hirtenstraße 19, 10178 Berlin, Germany
(+44) 871.075.0336
ouroffice@cortex.com
 

FAQ

What is the relationship between MannKind Corporation and Vdex?

Vdex and MannKind are completely separate companies with no direct ties.  MannKind Corporation is the manufacturer of Afrezza along with other medications utilizing their proprietary Technosphere molecule.  Vdex is a diabetes treatment company that happens to utilize MannKind’s product, Afrezza, in most of its treatments.  The companies do not coordinate their activities in any way.

Does use of Afrezza replace all injections?

Afrezza is a prandial or mealtime insulin and as such, will replace mealtime injections. However, some patients take basal insulin injections.  Afrezza does not directly replace those.

Type 1 diabetic patients need both basal and prandial insulin.  Afrezza will replace the 3 – 4 mealtime injections for these patients, but the patients may still have a daily basal injection.  Type 2 diabetic patients are different.  They may be taking prandial injections only.  In those cases, Afrezza can replace all of those.

What is the effect of Afrezza on the lungs?

While Afrezza is an inhaled medication, it does not remain in the lungs very long at all.  It is absorbed into the bloodstream in seconds.   The developer of Afrezza, MannKind Corporation, extensively studied the effects of Afrezza on the lungs.  They looked at the effect of Afrezza on pulmonary function and the carcinogenicity of the product.  They determined that use of Afrezza produced a slight diminution in lung function which was well below the threshold for concern by the FDA.  In fact, the vast majority of patients never notice any change.  Also, any change that occurs, reverses upon discontinuation of the product.

There is no evidence that Afrezza is carcinogenic.  MannKind carefully investigated this concern in studies with laboratory animals exposed to high concentrations of the product and saw no safety signals even upon performing detailed histological examinations of their tissues.  While there were two patients in studies who developed lung cancer after using Afrezza, both were previous smokers.  Finally, insulin has been used for 80 years with no evidence of carcinogenicity.  Despite the thousands of injections that insulin-dependent diabetic patients perform, we see no evidence of injection site cancer.

Is Afrezza the only medication Vdex prescribes?

No. Vdex is a diabetes treatment practice and as such, may use any medication it desires.  Vdex believes strongly that Afrezza is the best medication for blood sugar control, but will prescribe other medications where appropriate.

When will Vdex have a location near me?

Vdex is committed to nationwide, and worldwide, expansion.  However, we do not release development plans in advance.  We are working on many new locations simultaneously.  It is impossible to predict the order in which different markets will come online.

Can Afrezza be used by Type 1 & 2s?

Afrezza is a prandial insulin product.  Since mealtime control of blood sugar is deficient in both Type 1 and Type 2 diabetic sufferers, Afrezza can be used by both.

Is Afrezza covered by insurances?

Insurance coverage of Afrezza is steadily improving, but there are restrictions with some plans.  We advise you to check with your particular plan in advance.  We at Vdex can often help you get your medication covered.

How long do I have to be on Afrezza insulin?

Afrezza is used as long as the patient has an inability to properly metabolize blood sugar.  For Type 2 patients, treatment can often be discontinued if the patient makes changes to diet and/or increases their level of exercise.  The important point is that we at Vdex believe Afrezza is the single best therapy a person with diabetes can use.  It should be the first therapy used.  Research indicates that early intervention with insulin can actually drive some patients into remission.  Other medications do not do this.

What is Afrezza?

Afrezza is a bio-identical insulin bound to an inert carrier molecule.  The human body can only use monomeric insulin and that’s what Afrezza is.  It is chemically identical to what the pancreas excretes normally.  By contrast, all other insulins are hexamer molecules that must be broken down by the body into monomers.

The Afrezza insulin is then bound to a carrier molecule called Technosphere to form a powder.  When inhaled, the powder alights on the aveolar surface of the deep lung where it liquefies and is rapidly absorbed into the bloodstream.  In the bloodstream the insulin and carrier molecule break apart.  The insulin goes on to perform its normal function of metabolizing blood sugar, and the carrier molecule is execreted unchanged in urine.  The carrier molecule does not accumulate in the body, nor is it metabolized by body.

How safe is Afrezza?

As noted above, Afrezza has been extensively studied for its effects on the lungs.  There is no evidence of adverse effects.  In addition, other than a single, slight cough which is caused by the tickle from inhaling a powder, there are no side effects from the use of Afrezza.  The cough typically disappears after a week or two of use.  (see below for comments regarding hypoglycemia)

Some people have speculated about a risk of lung cancer from using Afrezza. They point to cases of lung cancer that occurred with Pfizer’s inhaled insulin product, Exubera.

As stated elsewhere in these FAQs, this subject has been extensively investigated and there is no evidence of a greater risk of lung cancer, or any other cancers from the use of Afrezza.  There were two cases of lung cancer among test subjects, but both patients were former smokers.  It was not determined that Afrezza caused the cancer.

More generally, elevated blood sugar is correlated with a significant increased risk of cancer.  It is well-established that people with poorly controlled diabetes develop cancer at a significantly higher rate that the population in general.  Because use of Afrezza allows patients to safely maintain lower blood sugar than other therapies, it is speculated that Afrezza patients may well have a lower overall cancer risk than other patients with diabetes whose blood sugar is less well controlled.

Who/what is Vdex?

Vdex is a diabetes treatment business founded by people who believed the care of people with diabetes was inadequate.  The focus of the company is simply the control of blood sugar.  They believed that simply with the use of Afrezza patient care could be significantly advanced.  The Vdex Founders developed their own proprietary treatment protocols after experimenting with Afrezza for more than a year.  To their surprise, the care was even better than they expected.

What is the risk of hypoglycemia with Afrezza?

We at Vdex have investigated this risk extensively.  While it would be irresponsible to say that a patient can’t become hypoglycemic while using Afrezza, it is difficult.  We tested Afrezza in non-diabetic patients, prediabetic patients, diabetic patients well-controlled on medication and severely uncontrolled.  With each group, the risk of hypoglycemia was very low, far lower than with any other insulin.  Further, we administered Afrezza to the same groups in the presence of a meal and without any meal at all.  Still no hypoglycemia.  It may seem difficult to believe that one could administer insulin to a person with diabetes who has been fasting and not produce hypoglycemia, but that’s exactly what we observed.  In all our use of Afrezza to date, we have not seen a single case of severe hypoglycemia.

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