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FDA Date: 4/1/16
Afrezza (insulin human) Inhalation Powder REMS
Goal of the Afrezza (insulin human) Inhalation Powder REMS Program
The goal of the Afrezza REMS is to mitigate the risk of acute bronchospasm associated with Afrezza by:
• Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease
• Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD
• Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease
• Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA
• Communication Plan