Approved Drug Products containing Afrezza listed with Health Canada. Original Data : Health Canada Website Afrezza Canada
What is Afrezza used for?
Afrezza is a man-made insulin that is breathed-in through your lungs (inhaled) and is used to control high blood sugar in adults with diabetes mellitus. Afrezza is not for use in place of long-acting insulin. Afrezza must be used with long-acting insulin in people who have type 1 diabetes mellitus.
Who should not take Afrezza?
Afrezza can be prescribed to adults with type 1 or type 2 diabetes who need a prandial insulin or want to discontinue or avoid insulin injections with meals. It should not be used by patients with certain lung problems, such as COPD or asthma, or patients who currently smoke or have stopped smoking in the last 6 months.
Can Afrezza be used to treat type 1 diabetes?
Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus. Afrezza is not recommended for the treatment of diabetic ketoacidosis [see Warning and Precautions (5.6) ]. The safety and efficacy of Afrezza in patients who smoke have not been established.
How many cartridges do I need to use Afrezza?
For Afrezza doses exceeding 12 units, inhalations from multiple cartridges are necessary. To achieve the required total mealtime dose, patients should use a combination of 4 unit, 8 unit and 12 unit cartridges. Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1.
Is Afrezza still on the market?
No. Afrezza insulin is not discontinued and is available by prescription for adults with type 1 or type 2 diabetes.
Why was Afrezza discontinued?
Afrezza has suffered from the same lack of market share that plagued its predecessor, Pfizer's Exubera, which was pulled from the market in 2007 after disappointing sales numbers. There are a number of issues which may have contributed to Afrezza's low number of prescriptions and subsequent underwhelming sales numbers.
How do I get Afrezza?
If Afrezza® is right for you, you can have your prescription mailed right to your home or filled at the pharmacy of your choice.Request physician visit.Complete medical questionnaire.Provide payment information.Visit with a physician & fill your prescription at your pharmacy of choice.
Is there an inhaled insulin on the market?
Afrezza® inhaled insulin Afrezza® is the only ultra rapid-acting inhaled insulin that starts lowering blood sugars in ~12 minutes for adults living with type 1 or type 2 diabetes.
Why did inhaled insulin fail?
The cause is likely multifactorial and could involve poor injection site rotation or poor injection technique, but also the growth factor properties of insulin (12–14). During clinical trials of Afrezza, there were two cases of lung cancer during 2,750 patient-years of exposure.
Does Afrezza cause weight gain?
Weight gain may occur with some insulin therapies, including AFREZZA. Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria.
How expensive is afrezza?
The cost for Afrezza inhalation powder 4 units is around $457 for a supply of 90 powder, depending on the pharmacy you visit....Inhalation Powder.QuantityPer unitPrice90$5.08$457.49
Who should not use afrezza?
It is not for people with certain types of lung disease (such as asthma or COPD) or who smoke. Do not use Afrezza® if you are allergic to regular human insulin or any of the ingredients in Afrezza®. Afrezza® is not for children under 18 years of age.
What is the price of inhaled insulin?
Insulin Inhalation Powder (Exubera) for Diabetes MellitusNameStarting dosageApproximate cost*Insulin inhalation powder (Exubera)Recommended dosing is based on the patient's body weight$188May 15, 2007
How safe is Afrezza?
This drug has a boxed warning . This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous. You shouldn't take Afrezza if you have asthma or chronic obstructive pulmonary disease (COPD).
Does Afrezza need to be refrigerated?
*If a foil package, blister card, or strip is not refrigerated, the content must be used within 10 days. Do not put a blister card or strip back into the refrigerator after being stored at room temperature.
Is there a way to get insulin without a needle?
Insulin jet injectors can allow people with diabetes to inject insulin without using a needle. However, many people shy away from these small devices because they can be expensive and complex to use.
Is inhaled insulin approved by FDA?
On June 27, 2014, the FDA approved Afrezza, an inhaled insulin for mealtime use, bringing this form of therapy back to the market after a 7-year absence.
Is there a nasal insulin?
Intranasal insulin is a method to increase brain insulin levels by administering insulin with a spray device through the nasal cavity.
Which of the following insulin products is an inhaled insulin product?
Two new insulin products were recently FDA-approved, Exubera (inhaled human insulin, Pfizer/Nektar) and Levemir (insulin detemir, Novo Nordisk).
Can insulin be taken nasally?
Administering insulin via a nasal spray is an attractive alternative to injections because it is a much easier and less painful way for diabetic patients to control their condition.
Why is afrezza contraindicated?
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 (FEV 1) in all patients to identify potential lung disease [see Contraindications (4) and Warnings and Precautions (5.1)] .
How many people have coughed with Afrezza?
Approximately 27% of patients treated with Afrezza reported cough, compared to approximately 5.2% of patients treated with comparator. In clinical trials, cough was the most common reason for discontinuation of Afrezza therapy (2.8% of Afrezza-treated patients).
What color is the Afrezza inhaler?
The cartridges are color-coded, blue for 4 units, green for 8 units and yellow for 12 units. Each cartridge is marked with " Afrezza " and "4 units", "8 units" or "12 units". The Afrezza Inhaler is individually packaged in a clear overwrap. The inhaler is fully assembled with a removable mouthpiece cover.
How many units of Afrezza inhaler?
Afrezza (insulin human) Inhalation Powder is available as 4 unit, 8 unit and 12 unit single use cartridges to be administered via oral inhalation with the Afrezza Inhaler only [see How Supplied/Storage and Handling (16)] .
What is Afrezza insulin?
Afrezza ® is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.
How old are the patients in Afrezza?
In the Afrezza clinical studies, 381 patients were 65 years of age or older, of which 20 were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients over 65 and younger patients.
Does Afrezza cause bronchospasm?
Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza [see Warnings and Precautions (5.1)] .
How many units of Afrezza?
*Based on 4-12 unit dosing, respectively. On average, the pharmacodynamic effect of Afrezza, measured as area under the glucose infusion rate—time curve (AUC GIR)—increased linearly with doses up to 48 units. 1
What is Afrezza in a physiology?
CHANGE THE CONVERSATION WITH INHALED INSULIN. Afrezza is the only ultra-rapid acting inhaled insulin with a time-action profile that mimics physiologic insulin , for prandial control without the need for mealtime injections. 1. Get Product &.
Can you take Afrezza with COPD?
It should not be used by patients with certain lung problems, such as COPD or asthma, or patients who currently smoke or have stopped smoking in the last 6 months.
Does AFREZZA cause lung cancer?
Lung Cancer: In clinical trials, 2 cases of lung cancer were reported in patients exposed to AFREZZA while no cases were reported for the comparators. In both cases, a prior history of heavy tobacco use was identified as a risk factor for lung cancer.
Is Afrezza a one-of-a-kind therapy?
6 Afrezza is a one-of-a-kind therapy for improved mealtime control. 1
Can you use Afrezza with insulin?
Limitations of Use. AFREZZA is not a substitute for long-acting insulin. AFREZZA must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus. AFREZZA is not recommended for the treatment of diabetic ketoacidosis.
How many units of Afrezza?
So if you might take 5 units of injectable insulin, you’d want to plan for roughly 7.5 to 8 units of Afrezza — or an 8-unit cartridge.
What is afrezza insulin?
Afrezza is an ultra rapid-acting insulin that you inhale rather than inject subcutaneously with a syringe or insulin pen. Instead of being a liquid formulation, it’s a dry white powder that you breathe into the lungs.
How long does it take for glucose to drop in Afrezza?
Many Afrezza users — including our DiabetesMine team — have seen our CGMs showing glucose starting to drop within 15 to 20 minutes. By comparison, it can often take at least 30 minutes or more to start seeing glucose level drops when we inject or bolus through an insulin pump.
How long does Afrezza stay in your system?
It’s also important to remember how fast Afrezza works and leaves your system. It peaks at about half an hour and is generally out by an hour and a half. So it doesn’t stay in the body and continue lowering blood sugars as long as traditional insulin does.
How many breaths do you have to hold after taking Afrezza?
While it’s not required, some Afrezza users report they hold their breath and count to 5 after inhaling their insulin to make sure it’s adequately absorbed.
When did Sanofi stop selling Afrezza?
This question often comes up because Sanofi initially sold and marketed Afrezza in 2015, but the pharma giant decided to drop the drug after that first year. They handed it back to the manufacturer MannKind, which has been selling and distributing this inhaled insulin ever since.
Is Afrezza insulin monomer?
As Afrezza inventor Al Mann himself explained once: “We’re actually delivering insulin monomers (molecules). Nobody ever did that before. It behaves much like normal pancreatic insulin does. Normal people don’t get hypoglycemia, and people (with type 2 diabetes) taking Afrezza don’t either, even if they dose and don’t eat.”
What is the name of the insulin that Pfizer makes?
Confused? Let’s go back in time! About 10 years ago, the pharmaceutical manufacturer Pfizer introduced its form of inhaled insulin – called Exubera – to the Canadian marketplace. Exubera was already being used in the U.S., and was just about to hit the pharmacy shelves in Canada, when the company decided not to continue to market the inhaled insulin.
Why is Afrezza different from Exubera?
First, Afrezza has a much smaller delivery device than the one previously available, so it is much easier to administer. Second, the requirement for lung testing is not as frequent with Afreeza as it was with Exubera; in the U.S., people using Afreeza must have a pulmonary function test prior to use, after 6 months of use, after one year of use, and then every year after that (the test schedule might be different in Canada, if and when Afreeza is approved here).
When was Afrezza approved?
In June 2014, the United States Food and Drug Administration (FDA) approved the inhaled insulin called Afrezza for use in the treatment of type 1 diabetes. Afrezza is a rapid-acting insulin that is taken at mealtimes. Unfortunately, there’s no word yet on when we might see this form of inhaled insulin approved in Canada.
How does eating unhealthy foods affect your health?
Unhealthy foods can affect your diabetes management by causing weight gain and increasing blood sugar. Read this article to learn about the 10 foods to avoid if you have diabetes.
What is a screen reader?
A screen-reader is software that is installed on the blind user’s computer and smartphone, and websites should ensure compatibility with it.
Why is heart health important for diabetics?
Heart health is very important for people with diabetes, since there is a higher risk of heart disease than for people who don’t have diabetes.
Is inhaled insulin sold in Canada?
Did you know that another inhaled insulin has already been licensed for use in both Canada and the U.S.? Although approved by both Health Canada and the FDA, it has never been marketed, meaning that no one is selling it.
