Afrezza inhaled insulin recently approved

Afrezza is an inhaled, ultra-rapid acting mealtime insulin therapy designed to improve glycemic control in adults with Type 1 and Type 2 diabetes. In patients with type 1 diabetes, it must be used with a long-acting insulin.  Afrezza is a drug-device combination product, consisting of an inhalation powder in a single dose cartridge & a small inhaler. Each cartridge can deliver a dose of 4 units or 8units; For doses exceeding 8 units, inhalations from multiple cartridges are necessary.  It is administered at the start of a meal with onset of action 12 to 15 minutes later. Peak action is usually seen about 90 minutes after dosing & the effects last about 160minutes. The insulin contained in Afrezza is regular human insulin.

Adverse affects seen in trials: Acute bronchospasm has been observed in patients with asthma and COPD. Lung Cancer: increased cases were seen in clinical trials; however, data was insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors. Others include: hypoglycemia, Diabetic Ketoacidosis, cough, throat pain or irritation, headache, fatigue, nausea urinary tract infection, weight gain. Before starting Afrezza, a medical history, physical exam and spirometry (FEV1) tests should be performed in all patients to identify potential lung disease. Long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established. Afrezza causes a decline in lung function over time as measured by FEV1. Pulmonary function should be assessed at baseline, after the first 6 months of therapy, and annually thereafter, even in the absence of pulmonary symptoms.

Additional info: insulin exposed to temperatures higher than 98.6°F (37°C) should be discarded. Store unopened product in refrigerator. If a foil packet is not refrigerated, the contents must be used within 10 days. Inhaler may be stored refrigerated, but should be at room temperature before using. Before use, cartridges should be at room temperature for 10 minutes.



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