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 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.
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.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29f4637b-e204-425b-b89c-7238008d8c10 |
