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AFREZZA® for US Healthcare Professionals

AFREZZA® (insulin human) Inhalation Powder is the only FDA-approved ultra rapid-acting inhaled mealtime insulin, indicated to improve glycemic control in children, adolescents, and adults 6 years of age and older with type 1 or type 2 diabetes. AFREZZA is delivered as a dry powder through a small breath-activated inhaler with an onset of action of approximately 12 minutes. This site is intended for U.S. Healthcare Professionals only.

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# AFREZZA® for US Healthcare Professionals

> AFREZZA® (insulin human) Inhalation Powder is the only FDA-approved ultra rapid-acting inhaled mealtime insulin, indicated to improve glycemic control in children, adolescents, and adults 6 years of age and older with type 1 or type 2 diabetes. AFREZZA is delivered as a dry powder through a small breath-activated inhaler with an onset of action of approximately 12 minutes. This site is intended for U.S. Healthcare Professionals only.

Manufactured by MannKind Corporation. This site contains the full Prescribing Information including BOXED WARNING, clinical efficacy and safety data from registrational and post-approval trials, dosing and prescribing information, patient training resources, and access and affordability program information through MannKind Cares®.

## Clinical efficacy

- [AFFINITY Trial Efficacy in Adults](https://afrezzahcp.com/efficacy/affinity-trials/): Registrational trial data from AFFINITY-1 (vs MDI) and AFFINITY-2 (vs placebo). A1C reductions, hypoglycemia outcomes (31% Level 1 and 38% Level 2 relative decrease vs RAA), and weight-neutrality data across adult T1D and T2D populations.
- [INHALE-3 Trial: AFREZZA vs Injectables and Pumps](https://afrezzahcp.com/efficacy/inhale-3-trial/): Adult T1D trial comparing AFREZZA with Usual Care (MDI or AID). 30% of AFREZZA participants achieved A1C <7% vs 17% on Usual Care. 24% achieved TIR >70%. Mean weight gain 0.1 kg AFREZZA vs 1.4 kg Usual Care over 17 weeks.
- [INHALE-1 Pediatric Trial](https://afrezzahcp.com/efficacy/inhale-1-trial/): Phase 3 trial in patients ages 6 years and older with T1D. Numerically similar A1C change to rapid-acting analog. DTSQ treatment satisfaction score 4.99/6. Includes meal-challenge postprandial glucose data.

## Safety

- [AFREZZA Adult Safety](https://afrezzahcp.com/safety/adult/): Adverse reactions (cough 29% T1D, 26% T2D), 3% discontinuation due to cough, ~1% lung capacity decline over 2 years, FEV1 monitoring requirements (baseline, 6 months, annually thereafter), and FEV1 test guidance.
- [AFREZZA Pediatric Safety from INHALE-1](https://afrezzahcp.com/safety/children/): Pediatric safety profile from the INHALE-1 trial. Cough 21% (vs 3% RAA), no significant FEV1 difference at 56 weeks, no hypoglycemia difference, stable BMI.

## Pharmacology

- [AFREZZA Closely Mimics Physiologic Insulin](https://afrezzahcp.com/mimics-physiologic-insulin/): Time-action and PK/PD data. ~12-minute onset of action compared with 15-20 minutes for SC rapid-acting analogs. Shorter duration of action more closely mimics physiologic postprandial insulin secretion.

## Dosing and prescribing

- [AFREZZA Dosing and Prescribing](https://afrezzahcp.com/dosing-prescribing/): SC RAA conversion (multiply by 2X, round down to nearest cartridge size 4/8/12 units), insulin-naïve starting dose (4 units per meal), NDC codes (47918-0880-18 for 4&8 unit box, 47918-0898-18 for 8&12 unit box, 47918-0874-90 for 4-unit single box), titration g
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