适应症
TOBI Podhaler 适用于治疗铜绿假单胞菌囊性纤维化患者。

用法用量
TOBI Podhaler胶囊不得吞咽，因为无法在肺部获得预期效果。TOBI Podhaler胶囊的内容物仅用于口服吸入，只能与Podhaler装置一起使用。对于6岁及以上的成人和儿科患者，TOBI Podhaler的推荐剂量是使用Podhaler装置吸入四粒28毫克TOBI Podhaler胶囊的内容物，每天两次，持续28天。TOBI Podhaler每天两次，交替给药28天。治疗 28 天后，患者应在接下来的 28 天内停止 TOBI Podhaler 治疗，然后在接下来的 28 天开启和 28 天关闭周期内恢复治疗。TOBI Podhaler胶囊应始终储存在泡罩中，每个胶囊只能在使用前立即取出。对于服用几种不同吸入药物和/或进行胸部物理治疗的患者，治疗顺序应遵循医生的建议。建议TOBI Podhaler最后服用。

不良反应
TOBI Podhaler已在425名暴露于至少一剂TOBI Podhaler的囊性纤维化患者中的安全性进行了评估，其中包括273名在三个周期（6个月）治疗中暴露的患者。每个周期包括28天的治疗（每天两次施用112mg）和28天的治疗。血清肌酐≥2mg/dL和血尿素氮（BUN）≥40mg/dL的患者被排除在临床研究之外。该人群中有218名男性和207名女性，反映了美国的囊性纤维化人群，绝大多数患者是白种人。221岁≥20例，121<13至20岁≥83例，6至<13岁≥239例。有<>例筛查FEV的患者1% 预测 ≥50%，156 例筛查 FEV 患者1% 预测 <50%，30 例患者 FEV 缺失1%预测。主要安全性人群反映了研究1的患者，这是一项开放标签研究，比较TOBI Podhaler与TOBI（妥布霉素吸入溶液，USP）在三个周期内，每次4周，然后停止治疗4周。随机化，按计划的3：2比例，导致308名患者接受TOBI Podhaler治疗，209名患者接受TOBI治疗。对于TOBI Podhaler组和TOBI组，每个周期的平均药物暴露时间为28至29天。两只手臂的平均年龄在25至26岁之间。平均基线有限碳排放值1两组的预测百分比为53%。

Information on the long-term efficacy and safety of TOBI Podhaler is limited. There is no information in patients with limited pulmonary reserve (FEV1 <25% predicted). Decreased susceptibility of Pseudomonas aeruginosa to tobramycin has been seen with use of TOBI Podhaler. The relationship between in vitro susceptibility test results and clinical outcome with TOBI Podhaler therapy is not clear. Occurrence of decreased susceptibility on treatment should be monitored, and treatment with an alternative therapy should be considered if clinical worsening is observed.TOBI Podhaler may not be tolerated by all patients. Patients should be instructed to consider alternative therapy if they are unable to tolerate TOBI Podhaler. Patients should be advised to complete a full 28-day course of TOBI Podhaler, even if they are feeling better. After 28 days of therapy, patients should stop TOBI Podhaler therapy for the next 28 days, and then resume therapy for the next 28-day on and 28-day off cycle.Patients should be advised that if they have been prescribed a 7-day pack of TOBI Podhaler either immediately before or during a 28-day treatment with TOBI Podhaler, then they must count each day of use toward the 28 day on-treatment part of their cycle. Patients should only take a total of 28 consecutive days of treatment during a cycle.Similarly, patients should be advised that if they have been prescribed a 1-day pack of TOBI Podhaler either immediately before or during a 28-day treatment with TOBI Podhaler, then they must count each day of use toward the 28 day on-treatment part of their cycle. Patients should only take a total of 28 consecutive days of treatment during a cycle.