# 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 guidance, and recommended box configurations.

## Patient resources

- [AFREZZA Patient Training Resources](https://afrezzahcp.com/patient-training-resources/): Patient Navigator enrollment, training videos for proper inhalation technique and storage and handling, and downloadable patient resources including the Getting Started Guide.
- [AFREZZA Training Start Sheet](https://afrezzahcp.com/afrezza-start-sheet/): Digital Start Sheet for enrolling adult patients in AFREZZA inhalation training.

## Access and support

- [Access and Support Through MannKind Cares®](https://afrezzahcp.com/access-support/): Enrollment options (online, fax, phone, eRx), prior authorization support, Pediatric Cash Pay Bridge Program ($35 or less per month for patients ages 6 to 23, effective June 1 2026 through December 31 2026), Commercial/Medicare Part D approved program ($35/month), and Cash Pay Option ($99/box).
- [Request AFREZZA Information](https://afrezzahcp.com/request-information/): Request AFREZZA samples, demonstration kits, FEV1 kits for HCP office or single-patient use, BluHale PRO inhalation training device, or schedule time with a MannKind field representative.

## Regulatory documents

- [Full Prescribing Information (PDF)](https://afrezzahcp.com/wp-content/uploads/pdfs/prescribing-information.pdf): Complete FDA-approved prescribing information including BOXED WARNING, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specific populations, clinical pharmacology, and clinical studies.
- [Medication Guide (PDF)](https://afrezzahcp.com/wp-content/uploads/pdfs/medication-guide.pdf): Patient Medication Guide approved by the FDA.

## Patient education resources

- [AFREZZA Patient Brochure – English (PDF)](https://afrezzahcp.com/wp-content/uploads/pdfs/AFREZZA_Patient_Brochure_English_2026.pdf): Patient-facing overview of AFREZZA, how it works, what to expect, and getting started.
- [AFREZZA Patient Brochure – Spanish (PDF)](https://afrezzahcp.com/wp-content/uploads/pdfs/AFREZZA_Patient_Brochure_Spanish_2026.pdf): Spanish-language patient brochure.
- [AFREZZA Getting Started Guide – English (PDF)](https://afrezzahcp.com/wp-content/uploads/pdfs/AFREZZA_Getting_Started_Guide_Patient_English_2026.pdf): Step-by-step patient guide for initiating AFREZZA therapy.
- [AFREZZA Getting Started Guide – Spanish (PDF)](https://afrezzahcp.com/wp-content/uploads/pdfs/AFREZZA_Getting_Started_Guide_Patient_Spanish_2026.pdf): Spanish-language getting started guide.
- [AFREZZA Dosing Worksheet (PDF)](https://afrezzahcp.com/wp-content/uploads/pdfs/AFREZZA_Dosing_Worksheet_Patient_English_2026.pdf): Dosing and titration worksheet for patients and clinicians.
- [AFREZZA Training Start Sheet (PDF)](https://afrezzahcp.com/wp-content/uploads/pdfs/AFREZZA_Training_Start_Sheet_HCP_Patient_English_2026.pdf): HCP-completed start sheet for enrolling patients in AFREZZA inhalation training.

## Important safety information

WARNING: Risk of acute bronchospasm in patients with chronic lung disease. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD because of the risk of acute bronchospasm in these patients. Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients. AFREZZA causes a small but greater decline in FEV1 compared with comparators (mean difference, 40 mL over 2 years in clinical trials). In patients with a FEV1 decline of greater than or equal to 20% from baseline, discontinuation should be considered. The most common adverse reactions associated with AFREZZA are hypoglycemia, cough, and throat pain or irritation.

Please see Full Prescribing Information, including BOXED WARNING at https://afrezzahcp.com/wp-content/uploads/pdfs/prescribing-information.pdf