Afrezza

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Afrezza

Method of action: Drugs Used In Diabets

Treatment option: Diabetes Mellitus

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Afrezza

Quick Facts

Property Description
Active ingredient Insulin human
Form Inhalation powder (dry powder)
Pharmacological class Antidiabetic agent / Ultra rapid-acting insulin
Common use Mealtime blood sugar management
Origin Biosynthetic (Recombinant DNA origin)

What Type of Medicine is Afrezza? (Classification and Purpose)

Afrezza is a prescription drug used to improve glycemic control in adults with diabetes mellitus. It belongs to the antidiabetic agents class, specifically categorized as a rapid-acting inhaled human insulin. Its unique positioning is that of an ultra rapid-acting insulin, defined by its exceptionally fast onset and brief action profile. It functions as a dedicated mealtime (prandial) insulin, providing immediate blood sugar lowering action to counteract the rapid surge of glucose that follows food consumption.

The active ingredient is insulin human, a recombinant protein chemically identical to the insulin naturally produced by the human body. This classification is clinically recognized for its ability to swiftly manage postprandial glucose spikes, a key feature supported by pharmacological studies.

How is Afrezza Different from Other Insulins? (Form and Origin)

The most notable distinction of Afrezza is its dosage form as an inhalation powder, delivered via the oral inhalation route, which contrasts with all subcutaneous injectable insulins. This single-ingredient product utilizes a proprietary carrier system based on the excipient Fumaryl diketopiperazine (FDKP). This dry powder formulation is the foundation of the drug's distinguishing feature: ultra rapid absorption.

Pharmacological studies confirm that this system allows the insulin human to enter the bloodstream faster than other rapid-acting insulin analogues, providing control in the moment. The use of the pulmonary route is intended to closely match the body’s natural insulin release pattern following food consumption, offering a unique approach for adults managing Type 1 or Type 2 diabetes.

Regulatory References

  1. Pharmacokinetics and Pharmacodynamics of Afrezza
  2. Afrezza Pharmacokinetics in Adults

What side effects are possible with Afrezza?

Possible side effects and safety information

The official safety information for this inhaled human insulin is characterized by the metabolic risks common to all insulin products and specific risks related to the inhalation route of administration.


Adverse Reaction Scope

Classification Adverse Reaction System-Organ Class
Very Common Hypoglycemia (low blood sugar) Metabolism and nutrition disorders
Common Cough, Throat pain or irritation Respiratory, thoracic and mediastinal disorders

Serious Adverse Reactions and Safety Constraints

The labeling includes a Boxed Warning regarding the risk of Acute Bronchospasm, a sudden tightening of the airways. As a result, the medicine is contraindicated (absolutely forbidden) in individuals with chronic lung disease, such as asthma or Chronic Obstructive Pulmonary Disease (COPD).

Other serious risks documented by regulatory authorities include episodes of severe hypoglycemia, diabetic ketoacidosis (DKA), severe allergic reactions (including anaphylaxis), and hypokalemia (low blood potassium).


Population-Specific Notes and Monitoring

Regulatory documents specify that the safety and effectiveness have not been established in pediatric patients (under 18 years of age) or in patients who smoke or have recently quit. All patients must undergo a lung function test ( FEV1) before starting therapy, at six months, and annually thereafter, to monitor for a potential decline in pulmonary function associated with long-term use.


Connection to the overall safety profile

This framework establishes a two-part risk profile: the inherent metabolic risk of hypoglycemia, and distinct, mandatory respiratory constraints. The strict contraindication for chronic lung disease and the requirement for continuous pulmonary function monitoring define the critical boundaries for the drug's approved regulatory use.

Overdose and Emergency Response

The official overdose profile for insulin human inhalation powder is defined by the acute pharmacological effect of an insulin excess, leading to hypoglycemia (low blood glucose). This outcome can result from an excess of insulin relative to food intake or energy expenditure.

Domain Official Regulatory Statement
Documented Overdose Presentations Symptoms of low blood sugar include confusion, drowsiness, tremor, sweating, headache, anxiety, and tachycardia (fast heartbeat).
Severe/Life-Threatening Outcomes Overdose leading to severe hypoglycemia is classified as life-threatening, with the potential for seizures, unconsciousness, and permanent brain damage or death.
Mandated Emergency Actions Immediate medical attention or emergency services must be contacted for severe symptoms, such as convulsions or loss of consciousness.
Supportive Management No specific antidote is known. Management focuses on symptomatic and supportive treatment, including the administration of glucose (oral or parenteral) and the use of glucagon injection for unconscious patients. Extended observation and hospital monitoring are required after recovery from severe hypoglycemia to prevent recurrence.

Increased frequency of blood glucose monitoring is noted as necessary for patients with renal or hepatic impairment due to the increased risk of hypoglycemia. The regulatory guidance mandates that a glucagon kit be available for use by household members in the event of severe hypoglycemia.

Therapeutic Uses of Afrezza

Afrezza is generally considered a prescription therapeutic agent used to help improve glycemic control in adults diagnosed with diabetes mellitus, encompassing both Type 1 and Type 2. It is classified as a dedicated mealtime insulin, which may provide support for mealtime glucose control during the period of increased glucose from food intake. Its therapeutic uses are relevant for addressing two symptom axes of diabetes: postprandial hyperglycemia (blood sugar spikes that follow meals) and addressing the chronic indicator elevated A1C.

This specialized mealtime intervention is applied in clinical contexts where carbohydrate consumption may be associated with episodic blood sugar excursions where supportive symptom management is appropriate. The medication assists with maintaining functional stability during these symptomatic periods and supports patients during episodes of heightened discomfort. This intervention supports patients with the management of their prescribed target blood glucose goals and contributes to easing the overall symptom load associated with the chronic disease.

Quick Fact: Relief for Post-Meal Spikes
Symptom Targeted Postprandial hyperglycemia
Clinical Context Routine daily mealtime therapy
Patient Benefit Helps mitigate blood sugar excursions

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Afrezza

Afrezza's official eligibility is strictly defined by age, pulmonary health, and specific medical conditions. It is approved only for adult patients (age ge 18 years) with Type 1 (used with basal insulin) or Type 2 diabetes. Safety and effectiveness are not established for pediatric patients (under 18).


Contraindications and Restrictions

The medicine is contraindicated and must not be used in patients with chronic lung disease, including asthma or COPD, due to the risk of acute bronchospasm. It is also contraindicated during episodes of acute hypoglycemia or in patients with known hypersensitivity to human insulin or its excipients.

Afrezza is not recommended for the treatment of Diabetic Ketoacidosis (DKA) or for patients who smoke or have recently quit smoking, as safety and efficacy have not been established in smokers. Use requires specific monitoring and caution in patients with hepatic or renal impairment, as the drug's effects have not been fully studied in these groups. The official label requires all patients to have a lung function assessment ( FEV1) prior to initiating therapy and periodically thereafter.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes officially documented interaction patterns for Afrezza (insulin human inhalation powder) as defined in regulatory labeling. The primary structure involves pharmacodynamic interactions that alter the drug's core activity.

Documented Pharmacodynamic Interactions

Co-administration with several medicinal product categories is documented to affect blood glucose control. Drugs such as ACE Inhibitors, MAO Inhibitors, and Salicylates may increase the blood glucose lowering effect of Afrezza, raising the risk of hypoglycemia. Conversely, drugs such as Corticosteroids, Sympathomimetics, Diuretics, and Thyroid Hormones may decrease the blood glucose lowering effect.

Certain anti-adrenergic drugs, including Beta-blockers, may mask the signs and symptoms of hypoglycemia, requiring close monitoring. A critical safety interaction is documented with Thiazolidinediones (TZDs), where co-use may cause fluid retention, leading to or exacerbating heart failure.

Restrictions and Substance Interactions

Official restrictions include the contraindication of use in patients with chronic lung disease (e.g., asthma or COPD) due to the risk of acute bronchospasm. The label also documents that alcohol consumption may cause severe low blood sugar. Use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking.

Mechanism of Action

Afrezza functions as an inhaled human insulin that is formulated as a powder for pulmonary delivery. Upon inhalation, the insulin particles rapidly dissolve in the moisture lining the alveoli of the lungs. This pulmonary route facilitates exceptionally rapid absorption into the systemic circulation due to the vast surface area and rich capillary network of the lung parenchyma.

The circulating insulin polypeptide then acts on its primary biological target, the insulin receptor (IR), which is a tetrameric tyrosine kinase receptor expressed ubiquitously on the cell surfaces of tissues such as muscle, adipose, and liver. Insulin binding to the alpha-subunits of the IR triggers a conformational change, activating the beta-subunit's intrinsic tyrosine kinase activity. This activation initiates a downstream intracellular phosphorylation cascade.

Key substrates, notably the Insulin Receptor Substrates (IRS) proteins, are phosphorylated, leading to the activation of two major pathways: the phosphatidylinositol 3-kinase (PI3K)/Akt pathway and the Mitogen-Activated Protein Kinase (MAPK) pathway. Activation of the PI3K/Akt pathway promotes the translocation of the glucose transporter 4 (GLUT4) vesicles from the cytoplasm to the plasma membrane of muscle and adipose cells. This insertion of GLUT4 channels mediates the facilitated uptake of glucose from the extracellular space into the cells. Simultaneously, in the liver, insulin acts to inhibit gluconeogenesis and glycogenolysis. The coordinated effects across these tissues result in a system-level modulation of plasma glucose homeostasis.

Dosage and Administration Information

How to Use Afrezza (Insulin Human) Inhalation Powder — Administration Guidelines

Afrezza is administered via oral inhalation using the prescribed Afrezza Inhaler only. It is a rapid-acting, mealtime (prandial) insulin for use in adult patients with diabetes mellitus. In patients with Type 1 diabetes, Afrezza must be used in combination with a long-acting (basal) insulin.

Dosage and Timing

Dosing is strictly individualized based on the patient's metabolic needs and blood glucose monitoring results. The powder is administered at the beginning of each meal. The product is available in single-use cartridges of 4 units, 8 units, and 12 units. Doses exceeding the contents of a single cartridge require the use of multiple cartridges combined.

Procedural Steps

  1. Preparation: Before use, the cartridge(s) and inhaler must be at room temperature for 10 minutes.
  2. Loading: Open the inhaler by lifting the white mouthpiece, place the appropriate cartridge (cup down) inside, and then close the mouthpiece. After loading, the inhaler must be kept level to avoid loss of the drug powder.
  3. Inhalation: Hold the inhaler away from your mouth and exhale fully. Place the mouthpiece in your mouth, forming a seal with your lips. Inhale deeply through the inhaler, then remove the inhaler from your mouth and hold your breath for as long as comfortable.
  4. Post-Dose: Open the inhaler, remove the used cartridge, and discard it after a single inhalation. Repeat steps 2 and 3 if the dose requires multiple cartridges. The Afrezza Inhaler must be discarded and replaced after 15 days of use.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Afrezza

Evidence for Use in Adults with Type 1 Diabetes

Research examined the use of inhaled human insulin in adult patients with Type 1 Diabetes, a condition characterized by fluctuating or episodic manifestations of high blood sugar. The primary evidence base comes from Randomized Controlled Trials (RCTs). These studies monitored outcomes related to systemic or functional imbalance like the overall chronic indicator Glycated Hemoglobin (A1C), as well as Postprandial Glucose (PPG) concentrations.

A1C change over the study period was observed alongside patient groups receiving subcutaneous rapid-acting insulins. Furthermore, studies reported observations of post-meal blood sugar patterns when compared to subcutaneous rapid-acting insulins. Research examined patterns related to the frequency of low blood sugar, or hypoglycemia, when evaluated alongside the active comparator over the study duration.

Evidence for Use in Adults with Type 2 Diabetes

The research base for Afrezza in adult patients with Type 2 Diabetes includes Phase 3 Randomized Controlled Trials (RCTs). These studies were evaluated in patients managing their diabetes using oral medications, with or without basal insulin. The research explored how the addition of inhaled human insulin was associated with changes in overall glycemic control, specifically measuring A1C.

Trials reported measurements of A1C change from baseline for the group receiving inhaled insulin and for the group receiving a placebo (an inactive substance). These findings contribute to the broader evidence landscape for managing Type 2 Diabetes.

Studies on Onset and Duration of Action

Pharmacokinetic/Pharmacodynamic (PK/PD) studies examined the time it takes for the insulin to reach its maximum concentration in the blood (T max) and how long its blood-sugar-lowering activity lasts. Findings describe patterns where serum insulin concentration reached its peak at a time point that was monitored in comparison to subcutaneous rapid-acting insulins.

What Remains Uncertain in the Research Base

Research describes the lack of extensive, long-term data (i.e., multiple years) that monitors the clinical outcomes of long-term use. Comparative evidence is lacking for certain scenarios, particularly against all available subcutaneous rapid-acting insulin analogs. Subgroup findings are uncertain, meaning research provides context but not individual predictions regarding specific, less-studied demographics.

Key Studies & References

  1. AFREZZA (insulin human) Inhalation Powder Prescribing Information (DailyMed)
  2. Efficacy and Safety of Technosphere® Insulin Compared With Insulin Aspart in Type 1 Diabetes: A Phase 3 Study (Affinity-1/Pivotal T1D Trial)
  3. Safety and Efficacy of Inhaled Insulin Technosphere in Patients with Type 2 Diabetes: A Randomized, Controlled Study (Affinity-2/Pivotal T2D Trial)
  4. Pharmacokinetic and Glucodynamic Profile of Inhaled Technosphere Insulin (Afrezza) Compared With Subcutaneous Insulin Aspart

Frequently Asked Questions (FAQ)

Common questions about Afrezza (FAQ)


Q: Can Afrezza cause long-term problems with my lungs?

A: Official documents note that Afrezza causes a decline in a measure of lung function, called FEV1, over time. Because of this, patients are monitored periodically for pulmonary function. The effects of using the medication for treatment duration longer than two years have not been established in research studies.


Q: Does smoking affect how Afrezza works?

A: According to the official product information, the safety and effectiveness of Afrezza have not been established in patients who smoke. For this reason, use is not recommended in patients who currently smoke or who have recently stopped smoking.


Q: Can children or teenagers use Afrezza?

A: Afrezza is approved only for use in adult patients. The safety and effectiveness of the medicine have not been established in pediatric patients, who are those under 18 years of age.


Q: What kind of research has been done on Afrezza for managing blood sugar?

A: Studies have examined how Afrezza helps to manage blood sugar in adults with Type 1 and Type 2 diabetes. The research primarily tracks changes in chronic blood sugar indicators, such as Glycated Hemoglobin (or A1C), and patterns of post-meal glucose concentrations.


Q: Do you need a specific type of prescription to get Afrezza?

A: Regulatory documents require that all patients have a lung function test (a measure called FEV1) before starting therapy. This test must be repeated after six months and annually thereafter to monitor lung function.


Q: Does Afrezza have any risk of causing low blood sugar (hypoglycemia)?

A: Hypoglycemia, or low blood sugar, is listed as a very common adverse reaction associated with Afrezza. This risk is common to all insulin products. Severe hypoglycemia is noted as a serious risk in the official safety information.


Q: Do I need to change my diet when starting Afrezza?

A: Official administration guidelines indicate that a change in diet is one factor that may require a modification to a patient's dosage. The impact of changes in meal patterns can be reviewed with a healthcare provider.


Q: How often should blood sugar be checked when starting Afrezza?

A: While specific frequency is individualized, official documents indicate that an increased frequency of blood glucose monitoring is noted when switching insulin regimens or during changes in physical activity, diet, or illness.


Q: Is Afrezza suitable for managing high blood sugar that is not related to a meal?

A: Afrezza is classified as a rapid-acting, mealtime (prandial) insulin indicated to improve glycemic control related to food consumption. It is not recommended for the treatment of diabetic ketoacidosis (DKA), which is a serious, non-meal-related complication.


Q: Can I use Afrezza if I have kidney or liver problems?

A: Clinical studies have not fully examined the use of Afrezza in patients with kidney (renal) or liver (hepatic) impairment. The administration section notes that patients in these populations may require more frequent blood glucose monitoring and potentially lower dosages.


Q: Can Afrezza be taken if I have a respiratory infection like the flu or common cold?

A: Official documents advise that the presence of an acute illness, such as fever or infection, is a factor to be communicated to a healthcare provider. An illness may increase stress on the body and change the amount of diabetes medicine needed.


Q: What happens if I accidentally swallow the Afrezza powder?

A: The official Instructions for Use state that patients should not put the cartridges in their mouth and not swallow them. If mishandling occurs before inhalation, the guidelines advise removing and discarding the cartridge.


Q: How should I dispose of used Afrezza cartridges and the inhaler?

A: The official guidelines state to discard used cartridges right away and to keep all medication stored out of the reach of children. The reusable inhaler must also be discarded and replaced after 15 days of use, according to the manufacturer's instructions.


Q: Does Afrezza require a separate glucose monitor?

A: While the label does not specify a device, all insulin therapy requires blood glucose monitoring. The official label mandates increased frequency of monitoring when starting Afrezza or during dose adjustments.


Q: Does Afrezza interact with common over-the-counter medications?

A: Official guidance advises against using over-the-counter medicines that contain alcohol while using Afrezza. General regulatory guidance notes that it is important to communicate all medicines, including those available without a prescription, to a healthcare provider.


Q: Do the effects of Afrezza vary based on my meal size or composition?

A: Official administration guidelines state that dosage modifications may be needed with changes in meal patterns. This includes the macronutrient content (such as carbohydrates or fats) or the timing of food intake.

How should Afrezza be stored and disposed of?

How to Store and Dispose of Afrezza

Storage Conditions

Unopened Afrezza cartridges must be stored in the refrigerator between 36 F to 46 F (2 C to 8 C). The product must never be frozen.

If unopened blister cards or strips are stored at room temperature, they must be used within 10 days. Once the foil is punctured, the cartridges should be used within 3 days.

Handling and Stability

Keep new cartridges in the original foil packaging until immediately before use. Do not put an unrefrigerated strip back into the refrigerator. Before use, allow the cartridge and inhaler to reach room temperature for 10 minutes. The reusable inhaler must be discarded and replaced after 15 days of use.

Disposal and Safety

Discard used cartridges right away; never leave unused cartridges in the inhaler. Keep Afrezza and all medications stored out of the reach of children.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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