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RESOURCES FOR YOU AND YOUR PATIENTS

Help patients get started and stay on Afrezza

Downloadable resources for your practice

Sample Letter of Medical Necessity
Download (General Template)
Download (T2D Insulin-Naive)
Prior Authorization & Appeal Checklist
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Sample Letter of Appeal
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Product Reference Guide
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HCP Getting Started Guide
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Downloadable resources for you and your patients

Access Options for Afrezza

Outlines options for accessing Afrezza.

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Getting Started Guide

This guide has everything patients need to know about Afrezza and how to use it.

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Download Spanish Version
How to Use Afrezza

Teaches the 4 steps necessary for proper inhalation technique.

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Dosing & Titration Worksheet

Fill out this dosing regimen with your patient so they can always keep track of their doses per meal.

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Storage & Handling Guide

Discusses proper care of the Afrezza inhaler and cartridges.

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Virtual training center

welcome to afrezzaassist
Welcome to AfrezzaAssist

Our Patient Support Guides are here to provide personalized answers and assistance for every step of the Afrezza journey.

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filling your afrezza® prescription
Filling Your Afrezza Prescription

Teaches how to navigate insurance coverage, savings options, and additional programs in order to get and pay for Afrezza.

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how to use afrezza
How to Use Afrezza

Reviews what patients will find in their Afrezza box and demonstrates the four easy steps to properly inhaling Afrezza.

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dosing with afrezza
Dosing With Afrezza

Helps patients understand how inhaled Afrezza doses are different than injected insulin. Introduces the Dosing Worksheet and how to dose with Afrezza cartridges.

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storage and handling
Storage and Handling

Discusses how to keep Afrezza safe and secure with these proper storing, cleaning, and handling tips.

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filling your afrezza® prescription
Afrezza Formulation and Delivery

Learn more information about the Technosphere Technology used for Afrezza.

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US-AFR-1673

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
Hide 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.

Important Safety Information

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 and the Afrezza logo, MANNKIND, BLUHALE, TECHNOSPHERE and AFREZZAASSIST are registered trademarks, READY. SET. INHALE., the Racing Car design and BLUHALE PRO are marks, all owned by MannKind Corporation. © MannKind Corporation 2022. This site is intended for use by US healthcare professionals only.

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