Afrezza has a time action profile that mimics physiologic insulin.13
Data from a randomized, controlled, six-treatment, crossover dose-response study compared Afrezza with the rapid-action insulin analog, lispo, in 30 patients with type 1 diabetes.
On average, the pharmacodynamics effect of Afrezza, measured as area under the glucose infusion rate - time curve (AUC GIR) - increased linearly with doses up to 48 units.
Intrapatient variability in AUC GIR and GIRmax is approximately 28% (95% CI 21-42%) and 27% (95% CI 20-40%), respectively.
Afrezza can be prescribed to adults with type 2 or type 1 diabetes who need a rapid acting 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.
Study design: Afrezza efficacy was studied in a 24-week, double-blind, placebo-controlled trial of adults with type 2 diabetes (n=353) uncontrolled (A1C >7%) on optimal/maximally tolerated doses of either metformin alone or 2 or more OAs. Patients were treated with Afrezza + OAs or inhaled placebo powder without insulin + OAs. In clinical trials, the average dose was 12-247 Afrezza Units per meal.
When your patients are receiving basal insulin and struggling to reach their glycemic target, consider Afrezza as your prandial insulin of choice for rapid glucose control.
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1. Afrezza® (insulin human) Inhalation Powder Prescribing Information. MannKind Corporation
2. Riddle MC. Basal glucose can be controlled. but the prandial problem persists—it's the next target! Diabetes Care. 2017: Mar: 40(3): 291-300.
3. Selvin E, Parrinello CM, Daya N, Bergenstal RM. Trends in insulin use and diabetes control in the U.S.: 1988-1994 and 1999-2012. Diabetes Care. 2016; Mar; 39(3): e33-e35.
4. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients. Diabetes Care. 2003:26:881-885.
7. Data on file.
9. Cassidy J, Amin N, Marino M. et al. Insulin lung deposition and clearance following Technosphere® insulin inhalation powder administration. Pharm Res. doi: 10.1007/s11095-011-0443-4.
10. Levin PA, Heinemann L, Boss A, Rosenblit PD. Impact of symptomatic upper respiratory tract infections on insulin absorption and action of Technosphere inhaled insulin. BMJ Open Diabetes Res Care. 2016: 4: e000228.
12. Rossetti P. Porcellati F. Both GB. Fanelli CG. Prevention of hypoglycemia while achieving good glycemic control in type 1 diabetes: the role of insulin analogs. Diabetes Care. 2008: Feb:31 Suppl 2:SL13-120. doi: 10.2337/dc08-s227.
13. Potochka E. Hovorka R, Baughman R, et al Characterization of metabolism parameters following Technosphere® insulin and insulin Lispro. Poster #1561-P presented at: American Diabetes Association. 70th Scientific Session; 2010; Orlando, FL.
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.