T2D: PROVEN CONTROL

Proven to significantly reduce A1C levels1,2

INSULIN-NAÏVE STUDY: ACHIEVEMENT OF A1C ≤7% WITH AFREZZA1

Data from a 24-week, randomized, double-blind, placebo-controlled, multicenter trial of insulin-naïve adults with T2D (n=353) uncontrolled (A1C >7.5% to 10%) on optimal/maximal tolerated doses of either metformin alone or ≥2 oral agents (OAs). Patients were treated with Afrezza plus OAs or inhaled placebo powder without insulin plus OAs. Baseline A1C levels for Afrezza+OAs and placebo+OAs were 8.25% and 8.27%, respectively. Change from baseline (adjusted mean) A1C levels were -0.82% and -0.42%, respectively.2

  • For insulin-naïve patients currently taking OAs, the addition of Afrezza as mealtime insulin significantly reduced A1C levels from baseline compared with inhaled placebo (–0.82% versus –0.42%; treatment difference, –0.40%; P<0.0001)1,2
  • Significantly more Afrezza-treated subjects reached A1C ≤6.5% compared with placebo-treated subjects (13.6% versus 3.4%; P=0.0021)2
  • Patients on Afrezza had slight weight gain as compared with orals alone (+0.49 kg versus –1.13 kg)2

Proven A1C reduction in patients inadequately controlled3

REAL-WORLD STUDY: CHANGE IN A1C LEVELS OVER TREATMENT COURSE3

Data from a real-world practice setting trial of patients with T2D (n=20) inadequately controlled (A1C 7.5% to 11.5%) after at least 6 months of other diabetes treatments, including OAs and basal insulin. Afrezza treatment was added to each patient’s current therapy, administered before each meal, and titrated per protocol. A1C and blinded CGM measurements were recorded while patients continued to self-monitor blood glucoses daily.3

  • The mean A1C decline with the addition of Afrezza was –1.6%3
  • 90% of patients (18/20) achieved A1C levels of <8%4
  • Afrezza was titrated to a dose of approximately 20 units per meal by the end of the study3

Improvement of TIR3*

REAL-WORLD STUDY: CHANGE IN TIR OVER 12 WEEKS OF TREATMENT WITH AFREZZA3

Data from a real-world practice setting trial of patients with T2D (n=20) inadequately controlled (A1C 7.5% to 11.5%) after at least 6 months of other diabetes treatments, including OAs and basal insulin. Afrezza treatment was added to each patient’s current therapy, administered before each meal, and titrated per protocol. A1C and blinded CGM measurements were recorded while patients continued to self-monitor blood glucoses daily.3

*Relative increase from 42.2% to 65.7% equals 55.7%. Baseline TIR (42.2%) equates to about 10 hours TIR, which increased over 12 weeks to 65.7%, equating to about 16 hours TIR at the end of the study, for an approximate increase of 6 hours TIR per day.3

  • Mean daily blood glucose levels decreased by 41 mg/dL (P<0.0002), which was equivalent to a 20% relative decrease3

Weight neutral profile

WEIGHT CHANGE FROM BASELINE WITH AFREZZA2,5

Data from a 24-week, randomized, double-blind, placebo-controlled, multicenter trial of insulin-naïve adults with T2D (n=353) uncontrolled (A1C >7.5% to 10%) on optimal/maximal-tolerated doses of either metformin alone or ≥2 OAs. Patients were treated with Afrezza plus OAs or inhaled placebo powder without insulin plus OAs. Body weight at baseline was 90.15 kg and 90.79 kg in the Afrezza and placebo groups, respectively.2

Data from a 24-week, randomized, comparative trial of patients (n=305) aged 18 to 80 years with T2D for ≥2 years who were predominantly treated with SC insulin for ≥3 months and had A1C levels of 7.0% to 11.5%. After a 4-week run-in, during which insulin glargine doses were stabilized, patients were randomized to have either Afrezza or SC RAI aspart added to their basal insulin regimen and prandially administered. At baseline, mean A1C levels for Afrezza and SC RAI aspart were 8.9% and 9.0% respectively, and mean change in A1C from baseline after 24 weeks was -1.1% and -1.3% respectively. A treatment difference of 0.26% was not statistically significant, and the predefined equivalency margin was not met. Body weight at baseline was 83.47 kg and 80.79 kg in the Afrezza and SC RAI groups, respectively.5

References: 1. Afrezza (insulin human) Inhalation Powder Prescribing Information. MannKind Corporation. 2. 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 agent. Diabetes Care. 2015;38(12):2274-2281. 3. Levin P, Hoogwerf BJ, Snell-Bergeon J, et al. Ultra rapid-acting inhaled insulin improves glucose control in patients with type 2 diabetes mellitus. Endocr Pract. 2021;27(5):449-454. 4. Data on file. MannKind Corporation. 5. Hoogwerf BJ, Pantalone KM, Basina M, Jones MC, Grant M, Kendall DM. Results of a 24-week trial of Technosphere Insulin versus insulin apart in type 2 diabetes. Endocr Pract. 2021;27(1):38-43.

US-AFR-2131

Important Safety Information  for AFREZZA® (insulin human) Inhalation Powder

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE. Acute bronchospasms has been observed in AFREZZA-treated patients with asthma and COPD. 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
Hide Important Safety Information

Indications and Usage:
Afrezza®(insulin human) Inhalation Powder is a rapid acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus.

Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis, not recommended in patients who smoke or have recently stopped smoking.

Important Safety Information

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE

  • Acute bronchospasms has been observed in AFREZZA-treated patients with asthma and COPD
  • 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.

 

Contraindications
AFREZZA is contraindicated: during episodes of hypoglycemia, in patients with chronic lung disease (such as asthma or chronic obstructive pulmonary disease [COPD]) because of the risk of acute bronchospasm, and in patients with hypersensitivity to regular human insulin or any of the excipients in AFREZZA.

Warnings and Precautions
Acute Bronchospasm: In a study of patients with asthma whose bronchodilators were temporarily withheld for assessment, bronchoconstriction and wheezing following AFREZZA dosing was reported. Before initiating therapy, evaluate all patients with a medical history, physical examination, and spirometry (FEV1) to identify potential underlying lung disease. Do not use in patients with chronic lung disease such as asthma or COPD.

Hypoglycemia or Hyperglycemia with Changes in Insulin Regimen: Glucose monitoring is essential for patients receiving insulin therapy. Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made under close medical supervision and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, dosage modifications of concomitant oral antidiabetic treatment may need to be needed.

Hypoglycemia: Hypoglycemia is the most common adverse reaction associated with insulins, including AFREZZA. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly, and symptoms may differ across patients and change over time in the same patient. Patients and caregivers should be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia.

Decline in Pulmonary Function: AFREZZA causes a decline in lung pulmonary function over time as measured by FEV1. In clinical trials excluding patients with chronic lung disease and 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 first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. In patients who have a decline of ≥20% in FEV1 from baseline, consider discontinuing AFREZZA. 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 observed 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 use outweigh this potential risk.

Diabetic Ketoacidosis (DKA): In clinical trials enrolling patients with type 1 diabetes, diabetic ketoacidosis (DKA) was more common in AFREZZA-treated patients (0.43%; n=13) than in comparator-treated patients (0.14%; n=3). Patients with type 1 diabetes should always use AFREZZA in combination with basal insulin. In patients at risk for DKA, such as those with an acute illness or infection, increase the frequency of glucose monitoring and consider discontinuing AFREZZA and giving insulin using an alternate route of administration.

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 until symptoms and signs resolve.

Hypokalemia: All insulin products, including AFREZZA, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. 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 develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the TZD should be considered.

Drug Interactions
Certain drugs may affect glucose metabolism, increasing the risk of hypoglycemia or deceasing or increasing 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, see Prescribing Information.

Adverse Reactions
The most common adverse reactions associated with AFREZZA are hypoglycemia, cough, and throat pain or irritation.

To report SUSPECTED ADVERSE REACTIONS, contact MannKind Corporation at 1-877-323-8505 or FDA at www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

Please see full Prescribing Information, including BOXED WARNING for AFREZZA.

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