Reported in 26.9% of Afrezza patients vs. 5.2% of comparator treated patients.
94% of cough episodes were characterized as intermittent or single defined episodes.
Cough was generally mild, dry, occurred within 10 minutes of inhalation, was transient and declined with continued use.
Cough leading to discontinuation was uncommon (2.8%).
Study Design: This open-label noninferiority trial compared the change in A1C from baseline to week 24 of prandial Afrezza (n = 174) with that of subcutaneous insulin aspart (n = 170), both with basal insulin, in adult patients (≥ 18 years old) with type 1 diabetes and A1C of 7.5% to 10%.
Afrezza provided less A1C reduction than insulin aspart, and the difference was statistically significant. More subjects in the insulin aspart group achieved the A1C target of less than or equal to 7%.
Forced expiratory volume in 1 second referred to as FEV1 test.15
Average adult male total lung capacity is 6L.16
The FEV1 is conducted to identify patients who have a decline in lung function over time.
Afrezza patients experienced a small (40ml), but greater, FEV1 decline than comparator.
Consider discontinuing Afrezza in patients with > 20% decline in FEV1 from baseline.
Common adverse reactions (excluding hypoglycemia) from pooled safety results in patients with type 2 diabetes.1
Common adverse reactions, excluding hypoglycemia, associated with the use of Afrezza in the pool of active-controlled trials in patients with type 2 diabetes. These adverse reactions were not present at baseline, occurred more commonly on Afrezza than on comparator, and occurred in at least 2% of patients treated with Afrezza.
Common adverse reactions (excluding hypoglycemia) from pooled safety results in patients with type 1 diabetes.1
Common adverse reactions, excluding hypoglycemia, associated with the use of Afrezza in the pool of active-controlled trials in patients with type 1 diabetes. These adverse reactions were not present at baseline, occurred more commonly on Afrezza than on comparator, and occurred in at least 2% of patients treated with Afrezza.
MannKind Corporation is dedicated to providing answers to any questions you may have about Afrezza®. We work with patients, caregivers, and healthcare professionals to ensure Afrezza users get the best possible start and have continued success with their diabetes treatment.
The MannKind Customer Experience Center provides patients with a convenient, personalized resource to support their treatment.
8:30am – 8:00pm ET
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Afrezza is available on 70% of commercial plans with an average Out-Of-Pocket (OOP) cost of approximately $45 per month.
1. Afrezza® (insulin human) Inhalation Powder Prescribing Information. MannKind Corporation.
7. Data on file.
14. Bode BW, McGill JB, Lorber DL, et al. Inhaled Technosphere® insulin compared with injected prandial insulin in type 1 diabetes: a randomized 24-week trial. Diabetes Care. 2015; 38(12):2266-2273.
15. Lange P, Groth S, Mortensen J, et al. Diabetes mellitus and ventilatory capacity: a five year follow-up study. Eur Resp J. 1990:3(3):288-292.
16. Barrett K, et al. Mechanics of Respiration. Ganong’s Review of Medical Physiology; 2010.
17. Rosenstock, J., Franco, D., Korpachev, V., et al. Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naïve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents. Diabetes Care. 2015a;38:2274–2281.
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE. Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
Limitations of Use
AFREZZA is contraindicated in patients:
Warnings and Precautions
Acute Bronchospasm: Before initiating therapy, evaluate 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. The long-term safety and efficacy of AFREZZA in patients with chronic lung disease have not been established.
Changes in Insulin Regimen: Monitor blood glucose in all patients treated with insulin. Modify insulin regimen
and dose cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment to help mitigate the risk of hypoglycemia or hyperglycemia.
Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin therapy, including AFREZZA,
and may be serious and life-threatening. Educate patients and caregivers on mitigating the risks associated
with hypoglycemia. Increased frequency of blood glucose monitoring is recommended for patients at higher
risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia.
Decline in Pulmonary Function: AFREZZA has been shown to cause a decrease in lung function as measured by FEV1. In clinical trials lasting up to 2 years, AFREZZA treated patients experienced a small (40 mL) but greater FEV1 decline than comparator-treated patients. Assess pulmonary function with spirometry at baseline, after the initial 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. Consider more frequent lung function assessment in patients with pulmonary symptoms, e.g., wheezing, bronchospasm, breathing difficulties, or persistent or recurring cough. If symptoms persist, discontinue AFREZZA.
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. Two additional cases of lung cancer (squamous cell and lung blastoma) were reported in non-smokers exposed to AFREZZA after the trial completion. These data are insufficient to determine whether AFREZZA has an effect on lung or respiratory tract tumors. In patients with active lung cancer, a prior history of lung cancer, or in patients at risk of lung cancer, consider whether the benefits of AFREZZA outweigh the risks.
Diabetic Ketoacidosis (DKA): Increase the frequency of glucose monitoring and consider an alternate route of administration of insulin in patients at risk for DKA.
Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including AFREZZA. If hypersensitivity reactions occur, discontinue AFREZZA, treat per standard of care and monitor if indicated.
Hypokalemia: Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of TZDs and insulin. Observe these patients for signs and symptoms of heart failure. If heart failure occurs, manage according to current standards and consider TZD dose reduction or discontinuation.
The most common adverse reactions associated with AFREZZA (2% or greater incidence) are hypoglycemia, cough, and throat pain or irritation.
Certain drugs may affect glucose metabolism, increasing the risk of hypoglycemia or decreasing the blood glucose lowering effect of AFREZZA. Dose adjustment and increased frequency of blood glucose monitoring may be required. Co-administration of beta-blockers, clonidine, guanethidine, and reserpine with AFREZZA may reduce the signs and symptoms of hypoglycemia. For full list, please see Full Prescribing Information.