Inhaled Insulin Product Approved

In June, the FDA approved the inhaled insulin product created by MannKind Corp, Afrezza Inhalation Powder, for preprandial use in patients who have type 1 or 2 diabetes.

Afrezza is a fast-acting recombinant human insulin formulation; it isn’t meant for long-term use by diabetic patients.

In fact, those individuals with type 1 diabetes must use Afrezza in conjunction with another long-acting insulin product. People who smoke or who have diabetic ketoacidosis should not use Afrezza.

What’s more, acute bronchospasm is associated with Afrezza. The drug also is contraindicated during hypoglycemia episodes as well as in patients with COPD, asthma or other chronic lung disease.

The drug’s box label also recommends that patients’ lung function go through assessment at baseline, as well as after the first six months of use and each year afterwards. All individuals who start using Afrezza should also have a thorough physical examination and have their medical history taken in order to make sure they don’t have lung disease. In addition, the labeling recommends that patients using Afrezza report any symptoms related to lung cancer to their physician that occur after starting to use the drug.

The medication comes in cartridges, with each containing four or eight units of insulin. Patients taking the drug should take their individualized dose at the beginning of each meal. A chart on the product’s labeling shows how many cartridges the patient should use as replacement for the person’s usual injected dose of preprandial insulin.

The product’s packaging also states the importance of closely monitoring the blood glucose control of individuals requiring large doses of Afrezza. In addition, if Afrezza doesn’t provide adequate glucose control, the labeling recommends looking to subcutaneous insulin as an alternative.

As for adverse effects associated with Afrezza, the most frequently reported in clinical trials included hypoglycemia, throat pain/irritation and cough.

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