Usual Adult Dose for Diabetes Type 2

Insulin-naive:
Initial dose: 4 units via oral inhalation at the beginning of each meal
Maintenance dose: Adjust dose based on individual's metabolic needs, glucose monitoring results, and glycemic goals

Switching from Subcutaneous Mealtime Insulin:
Dose conversion as follows:
4 units inhaled insulin replaces up to 4 units of subcutaneous mealtime insulin
8 units inhaled insulin replaces 5 to 8 units of subcutaneous mealtime insulin
12 units inhaled insulin replaces 9 to 12 units of subcutaneous mealtime insulin
16 units inhaled insulin replaces 13 to 16 units of subcutaneous mealtime insulin
20 units inhaled insulin replaces 17 to 20 units of subcutaneous mealtime insulin
24 units inhaled insulin replaces 21 to 24 units of subcutaneous mealtime insulin

Switching from Subcutaneous Pre-mixed insulin:

• Estimate mealtime injected dose by dividing the total daily injected pre-mixed insulin dose by one-half (half will be the total daily mealtime dose; half will be the daily basal dose)
• Divide the total daily mealtime dose equally among the 3 meals of the day; use dose conversion table above
• Give the other half the total daily injected dose as injected basal insulin

• Dose adjustments may be needed with changes in physical activity, meal patterns, or during acute illness.
• Use a single inhalation per cartridge; doses exceeding 8 units will require multiple cartridges.
• Monitor blood glucose, especially in patients requiring high doses; if blood glucose control is not achieved with increasing doses, consider subcutaneous mealtime insulin.

Usual Adult Dose for Diabetes Type 1

Insulin-naive:
Initial dose: 4 units via oral inhalation at the beginning of each meal
Maintenance dose: Adjust dose based on individual's metabolic needs, glucose monitoring results, and glycemic goals

Switching from Subcutaneous Mealtime Insulin:
Dose conversion as follows:
4 units inhaled insulin replaces up to 4 units of subcutaneous mealtime insulin
8 units inhaled insulin replaces 5 to 8 units of subcutaneous mealtime insulin
12 units inhaled insulin replaces 9 to 12 units of subcutaneous mealtime insulin
16 units inhaled insulin replaces 13 to 16 units of subcutaneous mealtime insulin
20 units inhaled insulin replaces 17 to 20 units of subcutaneous mealtime insulin
24 units inhaled insulin replaces 21 to 24 units of subcutaneous mealtime insulin

Switching from Subcutaneous Pre-mixed insulin:

• Estimate mealtime injected dose by dividing the total daily injected pre-mixed insulin dose by one-half (half will be the total daily mealtime dose; half will be the daily basal dose)
• Divide the total daily mealtime dose equally among the 3 meals of the day; use dose conversion table above
• Give the other half the total daily injected dose as injected basal insulin

• Dose adjustments may be needed with changes in physical activity, meal patterns, or during acute illness.
• Use a single inhalation per cartridge; doses exceeding 8 units will require multiple cartridges.
• Monitor blood glucose, especially in patients requiring high doses; if blood glucose control is not achieved with increasing doses, consider subcutaneous mealtime insulin.

Renal Dose Adjustments

Use with caution. Frequent glucose monitoring and dose adjustment may be necessary.

Liver Dose Adjustments

Use with caution. Frequent glucose monitoring and dose adjustment may be necessary.

Precautions

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Afrezza. It includes a communication plan. For additional information: www.fda.gov/REMS

US BOXED WARNINGS:

• Acute bronchospasm has been observed in patients with asthma and COPD.
• Contraindicated in patients with chronic lung disease.
• Prior to initiating treatment, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential underlying lung disease in all patients.

Dialysis

Data not available

Other Comments

Administration Advice:

• See patient instructions for use for complete administration instructions with illustrations
• For oral inhalation; use only with Afrezza(R) inhaler
• Use a single inhalation per cartridge; doses exceeding 12 units will require a single inhalations from multiple cartridges
• Administer at the beginning of a meal
• Inhaler must be kept level (white mouthpiece on top, purple base on bottom) after cartridge is inserted; if inhaler is turned upside down, shaken, or dropped, drug loss may occur and cartridge should be replaced before use.
• Replace inhaler every 15 days.

• Inhaler may be stored refrigerated, but should be at room temperature before use; cartridges and inhaler should be at room temperature for 10 minutes prior to use.
• Cartridges should be stored in sealed foil packages in refrigerator until ready to use; blister cards and strips should not be put back in the refrigerator after being at room temperature.
• Unopened foil package, blister card, and strips stored at room temperature should be used within 10 days.
• Opened strips should be used within 3 days.

• Inhaled insulin is not a substitute for long-acting insulin; it should be used in combination with long-acting insulin in patients with type 1 diabetes mellitus.
• Inhaled insulin is not recommended for the treatment of diabetic ketoacidosis.
• The safety and efficacy of inhaled insulin in patients who smoke has not been established; inhaled insulin is not recommended in patients who smoke or who have recently stopped smoking.

• Assess pulmonary function (FEV1) prior to initiating, at 6 months, and annually; may increase monitoring as needed.
• Routine self-monitoring of blood glucose (SMBG) and regular HbA1c testing is recommended; more frequent blood glucose monitoring is recommended during periods of stress, changes in insulin regimen, and with changes to concomitant medications.
• Monitor potassium levels in patients at risk for hypokalemia.
• Monitor for fluid retention and symptoms of heart failure in patients receiving concomitant peroxisome proliferator-activated receptor (PPAR )-agonists.

• Patients should report any respiratory difficulty to their healthcare provider.
• Patients should understand the importance of diet, exercise, and blood glucose monitoring in the management of diabetes; they should be able to recognize and treat high and low blood glucose levels.
• Patients should seek medical advice promptly during periods of stress as their insulin requirements may change.
• Patients who are pregnant or planning to become pregnant should speak with their healthcare provider.
• Patients should understand that episodes of hypoglycemia can impair concentration and reaction time and impair their ability to drive or perform other hazardous tasks; consider blood glucose monitoring prior to engaging in these tasks.