ConexiantFDA Expands Afrezza to Pediatric Diabetes

📋 Regulatory Action / Label Change

The FDA has approved inhaled mealtime insulin (Afrezza) for children and adolescents aged 6 and older with type 1 or type 2 diabetes. The label expansion introduces a needle-free mealtime dosing option for pediatric patients, supported by the phase 3 INHALE-1 trial.

Professional Impact

• Afrezza requires basal insulin co-administration in type 1 diabetes; it is not a standalone regimen
• Contraindicated in chronic lung disease (asthma, COPD) due to acute bronchospasm risk; pulmonary function must be assessed at baseline, 6 months, and annually
• Not indicated for patients who currently smoke or stopped within 6 months; not approved under age 6
• Warnings include decreased lung function, lung cancer signal, DKA, hypokalemia, and heart failure risk with concomitant thiazolidinedione use

Action Items

• Review pulmonary history before considering Afrezza in any pediatric patient
• Establish spirometry baseline and annual monitoring protocol per label requirements
• Document smoking status — active or recent smokers are excluded
• Verify basal insulin is in place for all type 1 pediatric patients prior to prescribing