FDA Approves Inhaled Insulin
In late June, MannKind Corp. announced the FDA approved their product, an inhaled form of insulin, known as Afrezza.
The medication is intended to be taken before a meal, and is approved only for use in people with Type I or Type II diabetes. The dose is personalized to each patient’s individualized requirements. The medicine is not meant to replace long-acting insulin.
The medication is supplied in inhalers that contain either four or eight units of insulin each. Labeling provides a chart to show patients how many cartridges replace the patient’s typical injected pre-meal insulin dose. As various factors affect blood sugar control, dose adjustments should be made on an as needed basis.
In those with Type I diabetes, Afrezza has to be used alongside a long-acting insulin option. Smokers and those who suffer from diabetic ketoacidosis should not use this medication.
Use of this product increases the risks for acute bronchospasm, and therefore it should not be used in patients who suffer from chronic obstructive pulmonary disease (COPD), asthma, or another form of chronic lung disease. It should not be used during hypoglycemic episodes.
Over time, Afrezza reduces lung function. As such, lung function needs to be assessed at the beginning of treatment, then again after six months of therapy. Beyond that, lung function should be assessed on a yearly basis. Before starting treatment, all patients should have a physical exam and examine their medical history to determine whether or not they may have lung disease. Patients who begin treatment with Afrezza should talk to their doctor if they experience any symptoms that suggest lung cancer.
The FDA requires a medication guide be included with all filled prescriptions. This medication guide mentions the increased risk for acute bronchospasm and other adverse events reported in patients who use the inhaled insulin. According to the FDA, a risk evaluation and mitigation strategy has been developed to communicate the information with doctors and other healthcare professionals. Pharmacists should ensure that their patients understand all of the risks involved.
Blood sugar levels should be closely monitored in patients who need high doses of Afrezza. Injectable insulin should be used as an alternative if inhaled insulin does not provide the adequate blood sugar control.
Clinical trials show the most common side effects associated with using Afrezza include: hypoglycemia, throat irritation or pain, and cough.
Cartridges and inhalers are available in multiple configurations, each with two inhalers, and anywhere from 60 to 180 packages of cartridges contain four or eight units of insulin. Unused cartridges can be stored in the refrigerator until the expiration date, or they may be left at room temperature. If left unrefrigerated, the unused cartridges must be used within 10 days. Inhalers must be thrown out 15 days after the first use.