Short answer: Afrezza, the inhaled insulin sold in the US, is approved for adults and children 6 and older with diabetes. Its boxed warning rules out people with chronic lung disease such as asthma or COPD, and a breathing test is needed before starting, after 6 months and then yearly. The label does not recommend it for people who smoke or quit in the last 6 months, and people with type 1 diabetes must also use a basal insulin.
Afrezza is a rapid-acting human insulin breathed in through its own inhaler at the start of each meal. The label (section 1) approves it to improve blood sugar control in adults and children 6 years and older with diabetes. Its safety and effectiveness have not been established under age 6. After training, the label says patients aged 10 and older may give it themselves if the healthcare provider finds that appropriate.
The NIDDK lists inhaled insulin as rapid-acting: it starts working in 10 to 15 minutes, peaks at about 30 minutes and lasts about 3 hours. Its page still describes inhaled insulin as only for adults; the current label, which is the newer source, includes children from age 6.
The boxed warning is about the lungs. Sudden narrowing of the airways (bronchospasm) has been seen in people with asthma and COPD, so the label contraindicates Afrezza in anyone with chronic lung disease. In a study where people with asthma briefly stopped their inhalers, wheezing and airway narrowing after a dose happened in 29% (5 of 17), compared with none of 13 without asthma, and lung function (FEV1) fell by an average of 400 mL 15 minutes after one dose.
Section 4 also rules out use during a low and in anyone who had a severe allergic reaction to regular human insulin or Afrezza's ingredients. Section 1 says it is not recommended for people who smoke or recently stopped; the Medication Guide defines recently as less than 6 months. It is also not for treating diabetic ketoacidosis.
Before starting, the label calls for a medical history, a physical exam and spirometry (a breathing test that measures FEV1). It repeats spirometry after the first 6 months and every year after that, even without symptoms, and says to consider stopping if FEV1 falls 20% or more from baseline.
| Finding | What the label reports |
|---|---|
| FEV1 over up to 2 years | A small decline, 40 mL more than comparators, seen within 3 months and lasting through treatment |
| Cough, adults with type 2 diabetes | 26% on Afrezza vs 20% on placebo powder and 5% on other treatments |
| Cough, children 6 and older | 21% on Afrezza vs 3% on injected rapid-acting insulin |
| Lung cancer in trials | 2 cases in 2,750 patient-years vs 0 in 2,169 on comparators; both had heavy tobacco use |
Two more lung cancers were reported in non-smokers after the trials ended. The label says the data are not enough to tell whether Afrezza affects lung tumors, and asks prescribers to weigh benefits in people with lung cancer or at risk of it.
Afrezza covers meals only. The label (section 5.6) says people with type 1 diabetes should always use it together with a basal insulin. In type 1 trials, diabetic ketoacidosis happened in 0.43% on Afrezza compared with 0.14% on comparators. During illness or infection, the label suggests more glucose checks and considering giving insulin another way.
Whether Afrezza fits is a prescriber decision built on the breathing tests and history above. Dose Track can log each inhaled dose next to basal injections, and the Afrezza side effects and dosing pages have more from the label.
Read more on Dose Track: Afrezza side effects · Afrezza dosing schedule · Basal insulin · Diabetic ketoacidosis