SAFETY—LUNG FUNCTION

Monitor lung function periodically with Afrezza®1

About the forced expiratory volume in 1 second (FEV1) test

  • Must be conducted before starting patients on Afrezza, then again at 6 months, and annually thereafter1
  • Establishes a baseline assessment of lung function1
  • Identifies patients who experience a decline in lung function over time1

Conducting a FEV1 test

Step 1

Insert mouthpiece and switch device on

Step 2

Instruct patient to exhale 3 times

Step 3

Record best FEV1 result

The FEV1 test is one of the tools that can be used to help establish a baseline assessment, and monitor lung function after 6 months of therapy, and annually thereafter1

Complimentary FEV1  devices

  • For healthcare professionals, MannKind will ship 1 complimentary FEV1 device and 10 tubes directly to your office
  • For patients with diabetes, MannKind will ship 1 complimentary device and instructions directly to their residence for convenient at-home testing

CHANGE IN FEV1 WITH AFREZZA VS ANTI-DIABETES TREATMENTS IN T1D AND T2D1

Data for mean change in FEV1 from baseline (BL) among Afrezza-treated patients (n=1,532) versus comparator-treated patients (n=1,542) from clinical trials excluding patients with chronic lung disease and lasting up to 2 years. The observed changes in FEV1 were similar in patients with T1D and T2D.1

  • In healthy individuals, total lung capacity is about 4,000-6,000 mL2
    • The 40-mL average difference between Afrezza- and comparator-treated patients represents about a 1% decline of total lung capacity1,2
    • In clinical trials lasting up to 2 years, differences manifested in the first few months of exposure and were non-progressive3,4
  • FEV1 decreases at a rate of 25-40 mL/year with normal aging after age 30,5 whereas people with diabetes experience an additional decline in FEV1 of approximately 25 mL/year6
  • A decline in FEV1 of ≥15% occurred in 6% of Afrezza-treated subjects compared to 3% of comparator-treated subjects1
  • Absorption of Afrezza was not impacted by upper respiratory infection7

References: 1. Afrezza (insulin human) Inhalation Powder Prescribing Information. MannKind Corporation. 2. 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. 3. Data on file. MannKind Corporation. 4. Raskin P, Heller S, Honka M, Chang P-C, Boss AH, Richardson PC, 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. 5. Thomas ET, Guppy M, Straus SE, Bell KJL, Glasziou P, Rate of normal lung function decline in ageing adults: a systematic review of prospective cohort studies. BMJ Open. 2019;9(6):e028150. 6. Lange P, Groth S, Mortensen J, et al. Diabetes mellitus and ventilatory capacity: a five year follow-up study. Eur Respir J. 1990;3(3):288-292. 7. 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.

US-AFR-1671

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.

AFREZZA, and the Afrezza logo, MANNKIND, BLUHALE, BLUHALE PRO, TECHNOSPHERE, AFREZZAASSIST and AfrezzaAssit and logo are registered trademarks of MannKind. © MannKind Corporation 2024.
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