Most common AEs with AFREZZA (≥2%), excluding hypoglycemia1
Table comparing the incidence of the two most common adverse events—cough and throat pain or irritation—with SC insulin, placebo, and AFREZZA.
These adverse reactions, which exclude hypoglycemia, were not present at baseline, occurred more commonly on AFREZZA than placebo and/or comparator, and occurred in at least 2% of patients treated with AFREZZA in the pool of active-controlled and placebo-controlled trials in patients with T1D or T2D, respectively.1
Mild cough was the most common AE and declined with use2,3
Bar chart showing how mild cough, the most common AE associated with AFREZZA, declined with use. Three percent of patients discontinued due to cough.
3% of patients discontinued due to cough1
Incidence of cough in pooled safety population2,3
Pooled data from 13 phase 2/3 clinical studies in 5,505 patients with T1DM or T2DM treated with AFREZZA®, Technosphere inhalation powder without insulin (TP; placebo), or active-comparator treatment were analyzed for incidences of respiratory treatment-emergent adverse events. Study sample size reduced over time: from 3,017 (AFREZZA) and 2,198 (comparators) at Week 1 to 2,563 (AFREZZA) and 2,034 (comparators) by Week 12.2,3
  • 93.2% of cough episodes were characterized as intermittent or single defined episodes3
No persistent pulmonary safety concerns were identified1
Monitoring lung function is recommended with AFREZZA1
  • Must be conducted before starting patients on AFREZZA, then again at 6 months, and annually thereafter1
  • Patients using AFREZZA have a 1% average decline in lung capacity1,4*
  • In clinical trials lasting up to 2 years, differences presented in the first few months of exposure and were non-progressive5
*The 40-mL average difference between AFREZZA and comparator treated patients represents about 1% decline in total lung capacity.4
Icon of lungs with callout: Upper respiratory infection did not impact the absorption or action of AFREZZA.
Upper respiratory infection did not impact the absorption or action of AFREZZA6
Icon of plate, fork and spoon with plate featuring clock hands.
Free FEV1 test provided when patients start on AFREZZA
  • The FEV1 test is one of the tools that can be used to establish a baseline assessment before initiating AFREZZA; monitor lung function after 6 months of therapy and annually thereafter1
Electronic peak flow meter, or FEV1 test, alongside packaging
Conducting a FEV1 test7
STEP 1
Insert mouthpiece and switch device on
Three-step process for conducting an FEV1 test: Insert mouthpiece and switch on device, instruct patient to exhale 3 times, record best result.
STEP 2
Instruct patient to exhale 3 times
Three-step process for conducting an FEV1 test: Insert mouthpiece and switch on device, instruct patient to exhale 3 times, record best result.
STEP 3
Record best FEV1 result
Three-step process for conducting an FEV1 test: Insert mouthpiece and switch on device, instruct patient to exhale 3 times, record best result.

AE=adverse event; FEV1=forced expiratory volume in 1 second; T1D=type 1 diabetes; T2D=type 2 diabetes.

References: 1. Afrezza (insulin human) Inhalation Powder Prescribing Information. MannKind Corporation. 2. Data on file. MannKind Corporation. 3. McGill JB, Peters A, Buse JB, et al. Comprehensive pulmonary safety review of inhaled Technosphere® insulin in patients with diabetes mellitus. Clin Drug Investig. 2020;40(10):973-983. 4. Stocks J, Quanjer PH. Reference values for residual volume, functional residual capacity and total lung capacity. ATS Workshop on Lung Volume Measurements. Official Statement of The European Respiratory Society. Eur Respir J. 1995;8(3):492-506. 5. Raskin P, Heller S, Honka M, et al. Pulmonary function over 2 years in diabetic patients treated with prandial inhaled Technosphere Insulin or usual antidiabetes treatment: a randomized trial. Diabet Obes Metab. 2012;14(2):163-173. 6. 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(1):e000228. 7. Sonmol PEF. User manual. 2023.

© MannKind Corporation June, 2024. US-AFR-2503

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 for Afrezza® (insulin human) Inhalation Powder

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.