Afrezza® 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.
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.
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.
Afrezza® is contraindicated in patients with chronic lung disease such as asthma or COPD. Prior to initiating therapy, patients should be evaluated 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® reported 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 Afrezza® (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.
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.
The most common adverse reactions associated with Afrezza® include hypoglycemia, cough (including productive cough), throat pain or irritation, headache, diarrhea, fatigue and nausea.
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*Offer is not valid for patients if their prescriptions are paid in part or in full by any state or federally funded programs, including, but not limited to, Medicare or Medicaid, Medigap, VA, DOD or TriCare. Offer is not valid where prohibited by law. Sanofi US reserves the right to rescind, revoke, or amend this offer without notice. Maximum benefit is $150 per prescription depending on your out-of-pocket costs for the duration of the program. Eligibility criteria: Only patients who reside in the United States, Puerto Rico, Guam or the U.S. Virgin Islands can participate in this program. If you have any questions about this program, please call 866-991-2840, or if you have questions about Afrezza®, talk to your healthcare professional.