Clinical Scorecard: FDA Expands Afrezza to Pediatric Diabetes
At a Glance
Category
Detail
Condition
Type 1 and Type 2 Diabetes in Children and Adolescents
Key Mechanisms
Inhaled mealtime insulin delivered via Technosphere drug-delivery platform.
Target Population
Children and adolescents aged 6 years and older.
Care Setting
Outpatient, including school and sports settings.
Key Highlights
Afrezza is approved for children and adolescents with diabetes.
Administered at the beginning of meals using a portable inhaler.
Supported by phase 3 INHALE-1 trial and over 2 decades of safety and efficacy data.
Recognized in the American Diabetes Association Standards of Care.
Must be used with basal insulin for type 1 diabetes.
Guideline-Based Recommendations
Diagnosis
Assess lung function before treatment initiation and annually.
Management
Not indicated for diabetic ketoacidosis.
Avoid use in patients with chronic lung disease or recent smoking history.
Monitoring & Follow-up
Monitor for hypoglycemia, cough, throat pain, and lung function.
Risks
Risk of acute bronchospasm, decreased lung function, lung cancer, severe allergic reactions, hypokalemia, and heart failure when used with thiazolidinediones.
Patient & Prescribing Data
Children and adolescents aged 6 years and older with type 1 or type 2 diabetes.
Afrezza offers a needle-free mealtime insulin option.
Clinical Best Practices
Assess lung function prior to and during treatment.
Educate patients and caregivers on proper inhaler use.
