FLEXIBLE DOSING

Mealtime control is possible with individualized dosing1

TYPICAL DOSING AT MEALTIME

In clinical trials, most patients received 12-24 Afrezza® insulin units per meal at the end of the study2,3

DOSING CONSIDERATIONS

Clinical trials have shown it may take ~1.5x the amount of Afrezza to achieve a comparable glucose-lowering effect to injected insulin2,4

EFFECTIVE DOSING

Like all insulin therapy, monitor therapeutic effect of Afrezza and adjust dosing as needed to achieve optimal glycemic control1

INSULIN DOSE CONVERSION TABLE AND ANTICIPATED DOSE AFTER TITRATION1,4

*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 meal1

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 above1
  • 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 day1
  • Convert each estimated mealtime-injected dose to an appropriate Afrezza dose using the table above1
  • Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose1

Mealtime dose adjustment:

  • Adjust the dosage of Afrezza based on the individual’s metabolic needs, blood glucose monitoring results, and glycemic control goal1
  • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function, or during acute illness1
  • 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 insulin1

CONSIDER correction doses of Afrezza at 1 and/or 2 hours post-meal IF NEEDED4

2-hour correction used only if blood glucose is ≥201 mg/dL and has not decreased by ≥50 mg/dL between 1 and 2 hours.

Data from the STAT study 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. Two-hour correction dose was used only if blood glucose was ≥201 mg/dL and did not decrease by ≥50 mg/dL between 1 and 2 hours.4

CONVENIENT PACKAGING

Afrezza mealtime control is possible with individualized dosing1

TITRATION BOXES OFFER FLEXIBILITY FOR GETTING PATIENTS STARTED ON AFREZZA

Afrezza is an ultra rapid-acting inhaled insulin used at the beginning of a meal with an oral inhaler and 1 or more single-use cartridges. Afrezza comes in 4-, 8-, and 12-unit color-coded cartridges. Patients can mix and match cartridges for their prescribed dose. For example, two 12-unit cartridges provide a dose of 24 units of Afrezza.

Prescribe additional boxes as needed to control glucose levels. Afrezza should be dosed based on the patient’s metabolic needs.

DOSING WITH AFREZZA

This video helps patients understand how inhaled Afrezza doses are different than injected insulin. It also introduces the Dosing Worksheet and how to dose with Afrezza cartridges.

dosing with afrezza

References: 1. Afrezza (insulin human) Inhalation Powder Prescribing Information. MannKind Corporation. 2. 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. 3. 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. 4. 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.

US-AFR-1672

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.

Important Safety Information

Indications and Usage:

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

Limitations of Use: Patients with type 1 diabetes must use with a long-acting insulin, not recommended for the treatment of diabetic ketoacidosis, not recommended in patients who smoke.

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.

 

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 AFREZZA excipients.

Warnings and Precautions
Acute Bronchospasm: Acute bronchospasm has been observed following AFREZZA dosing in patients with asthma and COPD. Prior to initiating therapy, evaluate patients with a medical history, physical examination, and spirometry (FEV1) to identify potential underlying lung disease. Do not use in patients with COPD.

Change in Insulin Regimen: Monitor blood glucose in all patients treated with insulin. Modify insulin regimen and dose cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment.

Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin therapy, including AFREZZA, and may be serious and life-threatening. Educate patients and caregivers on recognizing symptoms and mitigating the risks associated with hypoglycemia.

Decline in Pulmonary Function: AFREZZA has been shown to cause a decrease in lung function as measured by FEV1. In clinical trials 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 initial 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 reported in patients exposed to AFREZZA while no cases were reported for the comparators. 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 outweigh the risks.

Diabetic Ketoacidosis (DKA): In clinical trials enrolling subjects with type 1 diabetes, diabetic ketoacidosis (DKA) was more common in subjects receiving AFREZZA (0.43%; n=13) than in subjects receiving comparators (0.14%; n=3). Increase the frequency of glucose monitoring and consider an alternate route of administration of insulin in patients at risk for DKA.

Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue AFREZZA, monitor, and treat if indicated.

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 occurs, consider dose reduction or discontinuation of TZD.

Drug Interactions
Certain drugs may affect glucose metabolism, increasing the risk of hypoglycemia or decreasing 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 include hypoglycemia, cough, and throat pain or irritation.

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

AFREZZA, MANNKIND, and the Afrezza and MannKind logos are registered trademarks, and AFREZZAASSIST, AfrezzaAssist and logo are mark applications, all owned by MannKind Corporation. © MannKind Corporation 2021. This site is intended for use by US healthcare professionals only.

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