Afrezza is an inhaled rapid-acting insulin used at mealtimes. In May 2026, MannKind announced FDA approval for children and adolescents aged 6 years and older with diabetes.
Quick summary
Afrezza is not a replacement for basal insulin and is not used to treat diabetic ketoacidosis. Families should ask about lung screening, asthma or COPD history, hypoglycemia risk, dosing, backup insulin plans, and whether the child is a good candidate.
Key takeaways
- The pediatric approval applies to children and adolescents aged 6 years and older, according to the company announcement and updated label.
- Afrezza is a mealtime insulin option, not a full insulin plan by itself.
- The prescribing information includes important lung-related warnings and contraindications.
- Any insulin change for a child should be planned with the diabetes team.
What changed
The approval expanded Afrezza from adult use to pediatric use in children and adolescents aged 6 and older with type 1 or type 2 diabetes. It gives some families another mealtime insulin option, but it does not make injections, pumps, basal insulin, glucose monitoring, or education unnecessary.
What families should check
Ask whether spirometry or lung assessment is needed before starting. Afrezza is contraindicated in people with chronic lung disease such as asthma or COPD. Families should also ask how to dose meals, what to do if a dose is missed, how to manage sick days, and when injected insulin is still needed.
Safety questions
Like other insulins, Afrezza can cause hypoglycemia. The label also notes cough and lung-function monitoring. It is not for diabetic ketoacidosis. Children using any insulin need a clear plan for lows, highs, ketones, school, sports, and backup supplies.
How to read the news
This approval means Afrezza is an option for eligible pediatric patients, not that it is best for every child. Families should balance convenience, inhaler technique, lung history, cost, coverage, dosing precision, and the child’s routine.
What to ask your care team
- Is my child eligible based on age, diabetes type, lung history, and current insulin plan?
- Do we need lung testing before and during treatment?
- What basal insulin, backup insulin, ketone, and sick-day plan should we keep?
- How should school staff handle Afrezza, lows, glucagon, and emergencies?
Practical takeaway
Afrezza may be another mealtime insulin option for some children, but it should be started only with a pediatric diabetes team and a written safety plan.
Safety note
Seek urgent help for severe low blood sugar, seizure, unconsciousness, ketones, vomiting, rapid breathing, severe shortness of breath, wheezing, or glucose that remains dangerously high or low despite the care plan. This information is general education and is not a substitute for medical care.
Source summary
- MannKind: FDA approval announcement. Company announcement of FDA approval for children and adolescents aged 6 and older. Source
- FDA label: Afrezza prescribing information. Updated prescribing information with indications, warnings, contraindications, and pediatric information. Source
- ClinicalTrials.gov: INHALE-1. Trial record for the pediatric Afrezza study. Source
- ADA Standards of Care. Professional diabetes care guidance context. Source