Updates

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

Inhaler

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A DIFFERENT ANSWER

We know mealtime control isn't easy for today's patients, and that mealtime control is the key to an optimal A1C.6 Afrezza is a one-of-a-kind therapy for improved mealtime control.1

Afrezza is inhaled insulin that enters the bloodstream in less than 1 minute.1,7

The time to first measurable effect is ~12 minutes.1

Icon 1 Fast In Fast Out V3
Icon 2 Management In The Moment
Icon 3 Consider The Patient
Icon 4 Proven Mealtime Control V2

*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

+Based on an estimation of approximately 3 meals per day, for a total of 1095 possible mealtime injections per year.

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A UNIQUE PROFILE

Afrezza has a time-action profile that mimics physiologic insulin.7

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Physiologic Postprandial Insulin Profile 8
Physiologic Postprandial Insulin Profile 8

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Afrezza Postprandial Insulin Profile 1
Afrezza Postprandial Insulin Profile 1

Data from a randomized, controlled, six-treatment, crossover dose-response study compared Afrezza with the rapid-acting insulin analog, lispro, in 30 patients with type 1 diabetes. Mean insulin effect (baseline-corrected glucose infusion rate) profile shown after administration of 4 and 12 Afrezza unit doses in patients with type 1 diabetes. 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. Intrapatient variability in AUC GIR and GIRmax is approximately 28% (95% CI 21-42%) and 27% (95% CI 20-40%), respectively.1

Afrezza has been studied in over 3,000 patients with type 1 and type 2 diabetes1,2

EFFICACY & SAFETY

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CONSIDERING THE PATIENT

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.

Holding The Afrezza Inhaler

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PROVEN CONTROL

IN A TYPE 1 STUDY

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Switching to Afrezza maintained acceptable glucose control.9

Data from an open-label non-inferiority trial compared the change in A1C from baseline to week 24 of prandial Afrezza (n=174) with that of SC rapid-acting insulin (n=170), both with basal insulin, in adult patients (≥18 years) with type 1 diabetes and A1C of 7.5% to 10%.

Afrezza provided less A1C reduction than rapid-acting insulin, and the difference was statistically significant. More subjects in the SC rapid-acting group achieved the A1C target of ≤7%.9

See Efficacy and Safety for more information.

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SUPERIOR CONTROL

IN A TYPE 2 STUDY

Give your patients with type 2 diabetes improved mealtime control.10

Adding Afrezza significantly reduced A1c levels compared to OAs alone.10

Approximately 1/3 of patients achieve A1C ≤7% with Afrezza.10

See Efficacy and Safety for more information.


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Learn about starting your patients on Afrezza

PRESCRIBING AFREZZA


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AfrezzaAssistSM is a one-stop-hub solution which helps your patients get access to Afrezza and stay on therapy. Services include comprehensive reimbursement support and pharmacy fulfillment, as well as product training and support to help improve patient care.

Phone (toll free): 1-844-323-7399 8am-8pm ET, Monday – Friday

Fax: 1-800-561-6174

References

1. Afrezza (insulin human) Inhalation Powder Prescribing Information. MannKind Corporation.

2. Data on file. MannKind Corporation.

3. Akturk HK, Snell-Bergeon JK, Rewers A, et al. Improved postprandial glucose with inhaled Technosphere insulin compared with insulin aspart in patients with type 1 diabetes on multiple daily injections: the STAT study. Diabetes Technol Ther. 2018;20(10):639--647.

4. Peyrot M, Rubin RR, Kruger DF, et al. Correlates of insulin injection omission. Diabetes Care. 2010;33(2):240–245.

5. Lasalle JR, Berria R. Insulin therapy in type 2 diabetes mellitus: a practical approach for primary care physicians and other health care professionals. J Am Osteopath Assoc. 2013;113(3):152–162.

6. 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(3):881-885.

7. Rave K, Heise T, Heinemann L, et al. Inhaled Technosphere insulin in comparison to subcutaneous regular human insulin: time action profile and variability in subjects with type 2 diabetes. J Diabetes Sci Technol. 2008;2(2):205–212.

8. Rossetti P, Porcellati F. Prevention of hypoglycemia while achieving good glycemic control in type 1 diabetes. Diabetes Care. 2008;31(2):S113–S120.

9. 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.

10. Rosenstock J, Franco D, Korpachev V, et al. Inhaled Technosphere insulin versus inhaled Technosphere placebo in insulin-naive subjects with type 2 diabetes inadequately controlled on oral antidiabetes agent. Diabetes Care. 2015;38(12):2274–2281.

11. Oldham PD. Decline of FEV1. Adapted from NHANES III equations. Thorax. 1987;42:161–164.

12. 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.

13. Levin PA, Heinemann L, Boss A, et al. Impact of symptomatic upper respiratory tract infections on insulin absorption and action of Technosphere inhaled insulin. BMJ Open Diabetes Res Care. 2016;4:e000228.

14. Rosenstock J, Lorber DL, Gnudi L, et al. Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomised trial. Lancet. 2010;375(9733):2244–2253.

Important Safety Information

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. 

Important Safety Information

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. 


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.
  • The safety and efficacy of AFREZZA in patients who smoke have not been established. The use of AFREZZA is not recommended in patients who smoke or who have recently stopped smoking (less than 6 months). 

Contraindications
AFREZZA is contraindicated in patients: 

  • During episodes of hypoglycemia
  • With chronic lung disease (such as asthma or chronic obstructive pulmonary disease [COPD]) because of the risk of acute bronchospasm
  • With hypersensitivity to regular human insulin or any of the AFREZZA excipients

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.

Adverse Reactions
The most common adverse reactions associated with AFREZZA (2% or greater incidence) are hypoglycemia, cough, and throat pain or irritation. 

Drug Interactions
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.