AFREZZA® Dosing and Prescribing

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Simplify mealtime insulin with AFREZZA®

Having a treatment option that fits more easily into daily life may help support adherence. AFREZZA has been used in adults for over a decade and offers a consistent dosing approach for patients transitioning from SC RAA.1-6

AFREZZA inhaler graphic with average dose context callout: 12 to 20 units per meal for adult and pediatric patients in clinical trials. AFREZZA inhaler graphic with average dose context callout: 12 to 20 units per meal for adult and pediatric patients in clinical trials.

Calculate a starting dose

1. Select patient type

Starting dose conversion5,7,8

  • Multiply the SC RAA units by 2X
  • Round AFREZZA units down to the closest cartridge size
  • Starting doses are available in 4, 8, 12, and 16 units

2. Enter current SC RAA units

Breakfast

Lunch

Dinner

Snacks

Starting dose conversion5,7,8

  • Multiply the SC RAA units by 2X
  • Round AFREZZA units down to the closest cartridge size
  • Starting doses are available in 4, 8, 12, and 16 units

Titration

  • Like all insulin therapy, monitor the therapeutic effect of AFREZZA and adjust dosing, as needed, to achieve optimal glycemic control1
  • The basal/bolus ratio was ~50%/50% prior to initiating AFREZZA and ~30%/70% after titrating AFREZZA in the pediatric and adult clinical studies9,10

The average dose of AFREZZA per meal was 12 to 20 units for adult and pediatric patients in clinical trials.5, 11-14

DOWNLOAD THE AFREZZA DOSING WORKSHEET

Available AFREZZA boxes7

AFREZZA boxes are available with single-unit cartridges and combinations.7

AFREZZA 4-unit and 8-unit combination box graphic, NDC 47918-0880-18: 90 4-unit cartridges plus 90 8-unit cartridges, 180 total cartridges, 1080 total insulin units, 36 max daily units. AFREZZA 4-unit and 8-unit combination box graphic, NDC 47918-0880-18: 90 4-unit cartridges plus 90 8-unit cartridges, 180 total cartridges, 1080 total insulin units, 36 max daily units.
AFREZZA 8-unit and 12-unit combination box graphic, NDC 47918-0898-18: 90 8-unit cartridges plus 90 12-unit cartridges, 180 total cartridges, 1800 total insulin units, 60 max daily units. AFREZZA 8-unit and 12-unit combination box graphic, NDC 47918-0898-18: 90 8-unit cartridges plus 90 12-unit cartridges, 180 total cartridges, 1800 total insulin units, 60 max daily units.

Other box options7

Single boxes

  • 4-unit cartridges (12 max daily units)
  • 8-unit cartridges (24 max daily units)
  • 12-unit cartridges (36 max daily units)

Combination box

  • 4-, 8-, and 12-unit cartridges (48 max daily units)

How is AFREZZA dosed in children and adolescents transitioning from injected mealtime insulin?

AFREZZA dosing for children and adolescents follows the same conversion principles used in adults transitioning from SC ultra rapid-acting analogs. The usual injected mealtime insulin dose is rounded to the nearest whole number, multiplied by 2, and then rounded down to the nearest available AFREZZA cartridge dose.5,7,8,15

• AFREZZA cartridges are available in 4-, 8-, and 12-unit doses, allowing clinicians to titrate mealtime insulin based on glucose response5,7,8,15

A1C, glycated hemoglobin; BG, blood glucose; CGM, continuous glucose monitoring; Max, maximum; NDC, National Drug Code; SC, subcutaneous; SC RAA, subcutaneous rapid-acting analog; T1D, type 1 diabetes.

References: 1. Bode BW, McGill JB, Lorber DL, Gross JL, Chang PC, Bregman DB. Inhaled Technosphere insulin compared with injected prandial insulin in type 1 diabetes: a randomized 24-week trial. Diabetes Care. 2015;38(12):2266-2273. 2. Hoogwerf BJ, Pantalone KM, Basina M, et al. Results of a 24-week trial of Technosphere insulin versus insulin aspart in type 2 diabetes. Endocr Pract. 2021;27(1):38-43. 3. Beck RW, Bailey RJ, Akturk HK, et al; INHALE-3 Study Group. A 13-week single-arm evaluation of inhaled Technosphere insulin plus insulin degludec for adults with type 1 diabetes. Diabetes Technol Ther. 2025;27(3):161-169. 4. Beck RW, Bailey RJ, Klein KR, et al; INHALE-3 Study Group. Inhaled Technosphere insulin plus insulin degludec for adults with type 1 diabetes: the INHALE-3 extension study. Diabetes Technol Ther. 2025;27(3):170-178. 5. Hirsch IB, Beck RW, Marak MC, et al; INHALE-3 Study Group. A randomized trial comparing inhaled insulin plus basal insulin versus usual care in adults with type 1 diabetes. Diabetes Care. 2025;48(3):353–360. 6. Haller MJ, Kanapka L, Monzavi R, et al; INHALE-1 Study Group. INHALE-1: a multicenter randomized trial of inhaled Technosphere insulin in children with type 1 diabetes. Diabetes Care. 2026;49(1):179-187. 7. AFREZZA. Prescribing information. MannKind Corporation; 2026. 8. Kaiserman KB, Christiansen M, Bhavsar S, et al. Reduction in postprandial peak glucose with increased Technosphere insulin dosage. J Diabetes Sci Technol. 2024;18(2):397-401. 9. Rittenberry J, Sylvan J, Mycue L-E, Griparic L, Kaiserman K. Inhaled insulin dosing in a randomized trial in adults with type 1 diabetes. AACE Endocrinol Diabetes. Published online 2026. doi:10.1016/j.aed.2025.12.020 10. Kaiserman K, Mycue L-E. Inhaled Technosphere insulin (TI) dosing in youth with T1D. Poster presented at: Advanced Technologies & Treatment for Diabetes; March 11-14, 2026; Barcelona, Spain. 11. Data on file (AFREZZA bolus dosing). MannKind Corporation. 12. Data on file (Calculation for Dosing). MannKind Corporation. 13. Beck RW, Bailey RJ, Klein KR, et al; INHALE-3 Study Group. Inhaled Technosphere insulin plus insulin degludec for adults with type 1 diabetes: the INHALE-3 extension study. Diabetes Technol Ther. 2025;27(3):170-178. 14. 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. 15. AFREZZA. Instructions for Use. MannKind Corporation.

© MannKind Corporation May 2026. US-AFR-2899

Indications and Usage:

Afrezza® (insulin human) Inhalation Powder is a rapid acting inhaled human insulin indicated to improve glycemic control in adult and pediatric patients 6 years of age and older 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 bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (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.

Indications and Usage:

Afrezza® (insulin human) Inhalation Powder is a rapid acting inhaled human insulin indicated to improve glycemic control in adult and pediatric patients 6 years of age and older 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 bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (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 COPD) because of the risk of acute bronchospasm, and in patients with previous severe hypersensitivity reaction to any regular human insulin product or any of the inactive ingredients in AFREZZA. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with AFREZZA.

Warnings and Precautions

Acute Bronchospasm in Patients with Chronic Lung Disease: 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: Changes in an insulin regimen (e.g., insulin strength, manufacturer, injection site or type, or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. If clinically indicated, make any necessary changes to a patient's insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. For patients with type 2 diabetes dosage modification of concomitant oral antidiabetic treatment may 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. Advise patients to recognize and manage hypoglycemia and self-monitor glucose. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of glucose monitoring is recommended.

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 concomitantly 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. 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 PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. 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.

Adverse Reactions

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

Drug Interactions

Certain drugs may affect glucose metabolism, increasing the risk of hypoglycemia, or decreasing or increasing the blood glucose lowering effect of AFREZZA. Dosage modification 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.

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.