rezza® (0.43%; n=13) than in subjects receiving comparators (0.14%; n=3).
As with all insulins, Afrezza® use can lead to life-threatening hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Afrezza®, monitor and treat if indicated.
Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) and insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dose reduction or discontinuation of TZD must be considered.
DRUG INTERACTIONS 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. The signs and symptoms of hypoglycemia may be reduced when taking Afrezza® concomitantly with beta-blockers, clonidine, guanethidine, and reserpine.
ADVERSE REACTIONS The most common adverse reactions associated with Afrezza® include hypoglycemia, cough (including productive cough), throat pain or irritation, and headache.
RISK eva lUATION AND MITIGATION STRATEGY
Access the REMS website to learn more about the Afrezza® REMS program.
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.
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