BETHESDA, MD 30 Jun 2014—
and MannKind Corp. on June 27 announced the approval of Afrezza inhalation powder, a new rapid-acting recombinant human insulin formulation.
Afrezza is intended for preprandial use in patients with type 1 or 2 diabetes and is not meant for use as a long-acting insulin, according to the product's labeling (PDF).
In patients with type 1 diabetes, Afrezza must be used in conjunction with a long-acting insulin product. Afrezza is not recommended for use by people who smoke or for the treatment of diabetic ketoacidosis.
A boxed warning in the labeling emphasizes the risks for acute bronchospasm associated with Afrezza and notes that the product is contraindicated during episodes of hypoglycemia and in patients with asthma, chronic obstructive pulmonary disease (COPD), or other chronic lung disease.
Because Afrezza reduces lung function over time, the labeling recommends that lung function be assessed at baseline, after the first six months of therapy, and annually thereafter. All patients before starting treatment with Afrezza should undergo a medical history taking and physical examination to identify whether they may have lung disease.
The labeling warns patients who use Afrezza to report to their healthcare provider any symptoms suggestive of lung cancer that occur after initiating treatment with the inhalational insulin.
An FDA-required medication guide that must be included with each filled prescription emphasizes the risk for acute bronchospasm and other adverse events in patients treated with the inhaled insulin product. A risk evaluation and mitigation strategy, or REMS, has been created to communicate this information to healthcare providers, according to FDA.
Afrezza is supplied in cartridges containing 4 or 8 units of insulin each.
Each dose should be taken at the beginning of a meal, and the dosage must be individualized for each patient.
A chart in the labeling illustrates how many cartridges should be used as a replacement for the patient's usual injected dose of preprandial insulin. Because many factors may affect glycemic control, adjustments should be made to the dose as needed.
The labeling states that blood glucose control should be closely monitored in patients who require large doses of Afrezza, and subcutaneous insulin should be considered as an alternative if the inhaled product does not provide adequate glucose control.
The most frequently reported adverse events associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.
Afrezza cartridges and inhalers are packaged in several configurations, each with two inhalers and 60–180 foil-packaged 4- or 8-unit cartridges.
Unused Afrezza cartridges in their sealed foil packages should be refrigerated at 2–8 °C and may be stored until the labeled expiration date; if left at room temperature, the sealed cartridges must be used within 10 days.
Afreeza inhalers should be discarded 15 days after the first use.