Inhaled Insulin

DEA Class; Rx

Common Brand Names; Afrezza

During episodes of hypoglycemia

Chronic lung disease (eg, asthma, COPD), because of the risk of acute bronchospasm

Hypersensitivity to regular human insulin or any inhaled insulin excipients

Nonsevere hypoglycemia (67%)

Cough (25.6-29.4%)

Throat pain or irritation (4.4-5.5%)

Severe hypoglycemia (5.1%)

Headache (3.1-4.7%)

Pulmonary function test decreased (2.8%)

Diarrhea (2.7%)

Bronchitis (2.5%)

Urinary tract infection (2.3%)

Productive cough (2.2%)

Fatigue (2%)

Nausea (2%)

Acute bronchospasm observed in patients with asthma and COPD; before initiating, perform spirometry (FEV1) in all patients; do not use in patients with chronic lung disease

Change insulin regimen under close medical supervision and increase frequency of blood glucose monitoring

Hypoglycemia reported and may be life-threatening; increase frequency of glucose monitoring with changes to insulin dosage, coadministered glucose-lowering medications, meal pattern, and physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness

Assess pulmonary function (eg, spirometry) before initiating, after 6 months of therapy, and annually, even in the absence of pulmonary symptoms

Two cases (2 in 2750 patient-years exposure) of lung cancer reported during clinical trials, both were in patients with history of heavy smoking; 2 additional cases of lung cancer (squamous cell and lung blastoma) occurred in nonsmokers were reported by investigators after clinical trial completion; in patients with active lung cancer, a prior history of lung cancer, or those at risk for lung cancer, consider whether the benefits of use outweigh this potential risk

More patients using inhaled insulin (0.43%) experienced diabetic ketoacidosis in clinical trials compared with comparators (0.14%); monitor and change to alternate route of insulin delivery, if indicated

Hypersensitivity reactions, including severe, life-threatening, generalized allergy, and anaphylaxis can occur with insulin products

Hypokalemia may occur, including life-threatening low serum levels; monitor potassium levels in patients at risk

Monitor for fluid retention and heart failure with concomitant use of thiazolidinediones; consider dosage reduction or discontinuation if heart failure occurs

Limited available data with in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes

There are no data on the presence in human milk, effects on breastfed infant, or on milk production

Inhaled Insulin Human

orally inhaled powder

• Available as single-use cartridges
• 4 units/cartridge
• 8 units/cartridge
• 12 units/cartridge