Safety Monitoring

Prescribing information for the Exubera system recommends all patients have baseline spirometry testing, a follow-up 6 months after initiation of

Figure 9 FEV1 with Exubera® inhaled insulin therapy after (A) 12 weeks and (B) 2 years. *-0.009 (95% CI -0.014 to 0.023); f0.014 (95% CI -0.021 to 0.049). Abbreviations: FEVi, forced expiratory volume in 1 s; OA, oral agents.

treatment, and yearly follow-up thereafter. Exubera is not recommended for patients with baseline FEV1 or DLCO <70% predicted. In patients who experience a >20% decrease in FEV1, tests should be repeated. If this finding is confirmed, then treatment should be discontinued. Treatment should also be stopped in the rare case of acute bronchospasm (22).

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