Safety Information for Afrezza®,
including Boxed WARNING
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
•Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza®
IMPORTANT SAFETY INFORMATION FOR AFREZZA® (INSULIN HUMAN) INHALATION POWDER
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.CONTRAINDICATIONS Afrezza® is contraindicated in patients with the following:
•During episodes of hypoglycemia.•Chronic lung disease, such as asthma or chronic obstructive pulmonary disease (COPD), because of the risk of acute bronchospasm.•Hypersensitivity to regular human insulin or any of the Afrezza® excipients.WARNINGS AND PRECAUTIONS Afrezza® is contraindicated in patients with chronic lung disease such as asthma or COPD. Prior to initiating therapy, patients should be eva luated 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.
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 is the most common adverse reaction of insulin therapy, including Afrezza®, and may be serious and life-threatening. Patients and caregivers must be educated on mitigating the risks associated with hypoglycemia.
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. Therefore, pulmonary function should be assessed with spirometry at baseline, after the initial 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. More frequent lung function assessment should be considered in patients with pulmonary symptoms, e.g., wheezing, bronchospasm, breathing difficulties, or cough.
In Afrezza® 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. 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.
Increase the frequency of glucose monitoring and consider an alternate route of administration of insulin in patients at risk for diabetic ketoacidosis (DKA). In clinical trials enrolling subjects with type 1 diabetes, DKA was more common in subjects receiving Af |
