Indications and Usage
AFREZZA® (insulin human) Inhalation Powder is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.
Limitations of Use
- AFREZZA is not a substitute for long-acting insulin. AFREZZA must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus.
- AFREZZA is not recommended for the treatment of diabetic ketoacidosis.
- The safety and efficacy of AFREZZA in patients who smoke has not been established. The use of AFREZZA is not recommended in patients who smoke or who have recently stopped smoking (less than 6 months).
Important Safety Information
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
- Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA.
- AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD.
- Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.
Access the AFREZZA Risk Evaluation and Mitigation Strategy (REMS) program at www.afrezzarems.com.
AFREZZA is contraindicated in patients:
- During episodes of hypoglycemia.
- With chronic lung disease (such as asthma or chronic obstructive pulmonary disease [(COPD)] because of the risk of acute bronchospasm.
- With hypersensitivity to regular human insulin or any of the AFREZZA excipients.
Warnings and Precautions
Acute Bronchospasm: Prior to initiating therapy, evaluate patients with a medical history, physical examination and spirometry (FEV1) to identify potential underlying lung disease. Acute bronchospasm has been observed following AFREZZA dosing in patients with asthma and patients with COPD. The long-term safety and efficacy of AFREZZA in patients with chronic lung disease has not been established.
Change in Insulin Regimen: Monitor blood glucose in all patients treated with insulin. Modify insulin regimen and dose cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment.
Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin therapy, including AFREZZA, and may be serious and life-threatening. Educate patients and caregivers on mitigating the risks associated with hypoglycemia.
Decline in Pulmonary Function: AFREZZA has been shown to cause a decrease in lung function as measured by FEV1. In clinical trials lasting up to 2 years, AFREZZA treated patients experienced a small (40 mL) but greater FEV1 decline than comparator treated patients. Assess pulmonary function with spirometry at baseline, after the initial 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. Consider more frequent lung function assessment in patients with pulmonary symptoms, e.g., wheezing, bronchospasm, breathing difficulties, or persistent or recurring cough. If symptoms persist, discontinue AFREZZA.
Lung Cancer: In clinical trials, 2 cases of lung cancer were reported in patients exposed to AFREZZA while no cases were reported for the comparators. Two additional cases of lung cancer (squamous cell) were reported in non-smokers exposed to AFREZZA after the trial completion. These data are insufficient to determine whether AFREZZA has an effect on lung or respiratory tract tumors. In patients with active lung cancer, a prior history of lung cancer, or in patients at risk of lung cancer, consider whether the benefits of AFREZZA outweigh the risks.
Diabetic Ketoacidosis (DKA): Increase the frequency of glucose monitoring and consider an alternate route of administration of insulin in patients at risk for DKA.
Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue AFREZZA, monitor and treat if indicated.
Hypokalemia: Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of TZDs and insulin. Observe these patients for signs and symptoms of heart failure. If heart failure occurs, consider dose reduction or discontinuation of TZD.
Certain drugs may affect glucose metabolism, increasing the risk of hypoglycemia or decreasing the blood glucose lowering effect of AFREZZA. Dose adjustment and increased frequency of blood glucose monitoring may be required. Co-administration of beta-blockers, clonidine, guanethidine, and reserpine with AFREZZA may reduce the signs and symptoms of hypoglycemia.
The most common adverse reactions associated with AFREZZA include hypoglycemia, cough, and throat pain or irritation.