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The right dose for maximum clinical benefits
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DOSING FOR
MEALTIME
In clinical trials:
By the end of the study, the range of average dose per meal was 12-16 units1-4*
DOSING FOR MEALTIME
In clinical trials: By the end of the study, the range of average dose per meal was 12-16 uits1-4*
*For insulin-naïve individuals, start on 4 units of AFREZZA® at each meal.1
It may take 1.5-2x the amount of AFREZZA to achieve a comparable effect to SC RAI1,3
Insulin Dose Conversion & Anticipated Dose After Titration1,5
†Calculation based on the 1.5-times conversion rate from injectable insulin units.
Reaching an effective dose is critical to maximizing the clinical benefits of AFREZZA
Starting mealtime dose for insulin-naïve individuals:
  • Start on 4 units of AFREZZA at each meal5
Starting mealtime dose for individuals using SC prandial insulin:
  • Determine the appropriate AFREZZA dose for each meal by converting from the injected dose using the table above5
  • For example, if the patient is currently using 6 units of SC prandial insulin then consider starting with 8 AFREZZA units with each meal
Starting mealtime dose for individuals using SC pre-mixed insulin:
  • Estimate the mealtime-injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the 3 meals of the day5
  • Convert each estimated mealtime-injected dose to an appropriate AFREZZA dose using the table above5
  • Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose5
Mealtime Correction Doses at 1 and/or 2 hours postmeal1
‡2-hour correction used only if BG is ≥201 mg/dL and has not decreased by ≥50 mg/dL between 1 and 2 hours.
Data from the STAT study of patients with T1D with A1C levels 6.5% to 10%. Individuals were randomized to treatment with titrated AFREZZA (n=22) or titrated SC RAI aspart (n=34) and included in the final analysis. All were required to wear a real-time CGM throughout the trial. Patients in the AFREZZA group were advised to take supplemental inhalations at 1 and 2 hours after meals if indicated based on PPG values.1
Mealtime dose adjustment:
  • Adjust the dosage of AFREZZA based on the individual’s metabolic needs, blood glucose monitoring results, and glycemic control goal5
  • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (ie, macronutrient content or timing of food intake), changes in renal or hepatic function, or during acute illness5
  • Carefully monitor blood glucose control in patients requiring high doses of AFREZZA. If, in these patients, blood glucose control is not achieved with increased AFREZZA doses, consider use of SC mealtime insulin5
Mealtime control with individualized dosing
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  • Patients can mix and match cartridges for their prescribed dose5
  • Like all insulin therapy, monitor therapeutic effect of AFREZZA and adjust dosing as needed to achieve optimal glycemic control5
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Download AFREZZA Product Reference Guide
Important prescription information to include when writing a script

§Examples shown are the most commonly prescribed boxes. Prescribe additional boxes as needed to control glucose levels. AFREZZA should be dosed based on the patient’s metabolic needs.

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Calculate AFREZZA unit dosing
Utilize our online calculator to determine AFREZZA starting dose and ordering prescription information.
adobe acrobat download> </div> <div class=Download AFREZZA Dosing Worksheet
AFREZZA Dosing Calculator can help you to calculate an appropriate AFREZZA starting dose for each patient with diabetes currently on injected subcutaneous (SC) insulin or naïve to insulin based on currently approved labeling. Please note this calculator does not substitute or overwrite medical judgment.

Step 1: Diabetes Patient

Step 2: Input Current Dosage of Injected SC Insulin

units
units
units
units

Afrezza Starting Dose

Starting Afrezza Dose per Meal

Breakfast

X units

Lunch

X units

Dinner

X units

Snacks*

X units

Calculated Dose per Day*

units

Suggested SKU (NDC) Code to Fill 30-Day Supply

NDC# XXXX-XXXX-XX

# of boxes = 

Afrezza X, X & X unit cartridges,

contains X cartridges

[XX] X, X and X unit cartridges

(XXXX Total Afrezza Units)

Suggested Directions for Use:

Inhale Y-Z units by mouth with meals and additional units as needed for glucose control. Max total daily dose X units.**

Dispense X box of NDC XXXXX-XXXX-XX that has Afrezza X, X and X unit cartridges – XXX total cartridges (1 month supply).

Clinical trials have shown it may take ~1.5x the amount of Afrezza to achieve a comparable glucose-lowering effect to injected insulin.1, 2

*Adjust total based on snacks

**Based on rounding off to the nearest Afrezza SKU box

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Afrezza Starting Dose

Starting Afrezza Dose per Meal

Breakfast

4 units

Lunch

4 units

Dinner

4 units

Snacks*

4 units

Calculated Dose per Day*

units

Suggested SKU (NDC) Code to Fill 30-Day Supply

NDC# 47918-0874-90

# of boxes = 2

Afrezza 4-unit cartridges,

contains 90 cartridges

[90] 4-unit cartridges

(360 Total Afrezza Units)

Suggested Directions for Use:

Inhale 4-units by mouth at mealtime and additional units as needed for glucose control. Max total daily dose 24 units.**

Dispense 2 boxes of NDC 47918-0874-90 that has Afrezza 4 unit cartridges – 90 total cartridges (1 month supply).

Clinical trials have shown it may take ~1.5x the amount of Afrezza to achieve a comparable glucose-lowering effect to injected insulin.1, 2

*Adjust total based on snacks

**Based on rounding off to the nearest Afrezza SKU box

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Like all insulin therapy, monitor therapeutic effect of Afrezza and adjust dosing for the patient to achieve optimal glycemic control.

By using this resource, you agree to the following: This Dosing Calculator is being provided "AS IS" and is intended for use only by qualified healthcare providers. All calculations should be confirmed before use. MannKind makes no claims as to the accuracy of the information contained herein. Neither MannKind, nor any other party involved in the preparation or publication of this site, shall be liable to you or others for any decisions made or actions taken by you or others in reliance on this information.

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. 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.

References: 1. 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. 2. Levin P, Hoogwerf BJ, Snell-Bergeon J, Vigers T, Pyle L, Bromberger L. Ultra rapid-acting inhaled insulin improves glucose control in patients with type 2 diabetes mellitus. Endocr Pract. 2021;27(5):449-454 3. 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. 4. 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 agents. Diabetes Care. 2015;38(12):2274-2281. 5. Afrezza (insulin human) Inhalation Powder Prescribing Information. MannKind Corporation.

© MannKind Corporation June. 2024, US-AFR-2504

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.

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 bronchospasm 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 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 decreasing 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.