2013年3月22日，美国食品药品管理局(FDA)和诺华公司宣布，TOBI Podhaler(妥布霉素吸入干粉)已获准用于发生肺部铜绿假单胞菌(Pa)感染的囊性纤维化(CF)患者。TOBI Podhaler可通过袖珍干粉吸入器将抗生素妥布霉素送入肺内，因而比关联产品TOBI使用更便利，后者通过雾化器给药。
据诺华公司介绍，Pa感染是CF患者肺功能丧失的首要病因。尚不清楚对于年龄＜6岁的患者、肺功能超出特定范围的患者，以及肺部存在洋葱伯克霍尔德菌，TOBI Podhaler是否也安全、有效。
TOBI Podhaler在1个纳入674例年龄≥6岁、合并肺部Pa感染的CF患者的3期临床项目中得到了评估。其中425例患者接受了至少1剂TOBI Podhaler。2项试验对比评估了TOBI Podhaler与安慰剂的疗效，第3项试验则对比评估了TOBI Podhaler与安慰剂的安全性。各项研究均采用获准的剂量112 mg、2次/d(每剂包含4粒28 mg胶囊)，每个疗程包含28天治疗期和随后28 天停药期。疗效评估结果显示，TOBI Podhaler可比安慰剂更有效地改善肺功能。
在临床研究中接受TOBI Podhaler治疗的患者的常见不良反应包括咳嗽、咳血、肺紊乱(肺或CF急性加重)、气促、发热、咽痛、发声困难和头痛。
TOBI Podhaler不需要采用冰箱保存，而且与雾化Pa治疗不同的是，不需要动力源用于驱动给药装置。用于TOBI给药的雾化器必须每天用沸水消毒10分钟，而一次性Podhaler装置仅需在每次使用后用干布擦拭干净、并且每周更换即可。
TOBI Podhaler有望于2013年第二季度在美国上市。 
Indications for TOBI Podhaler:

Management of cystic fibrosis patients with P. aeruginosa.

Adults and Children's Dose:

<6yrs: not recommended. For oral inhalation only. Give in alternate 28-day cycles (28 days on, 28 days off). ≥6yrs: Inhale 4 capsules twice daily, as close to every 12hrs as possible (must be at least 6hrs apart). Give last when using multiple inhalation therapies.

Pharmacological Class:

Aminoglycoside.

Warnings/Precautions:

Safety and efficacy have not been demonstrated in patients <6yrs, in those with FEV1 <25% or >80% predicted, or patients colonized with B. cepacia. Known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. Myasthenia gravis. Parkinson’s disease. Consider performing an audiogram at baseline (esp. at risk of auditory dysfunction). Monitor serum tobramycin levels in auditory or renal dysfunction patients, or if used with other aminoglycosides (or other nephrotoxic or ototoxic drugs) as needed. Discontinue if ototoxicity or nephrotoxicity occurs; may restart when serum tobramycin <2µg/mL. Monitor renal function as needed. Elderly. Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:

Concomitant ethacrynic acid, furosemide, urea, mannitol: not recommended. Diuretics may increase toxicity. Avoid concomitant and/or sequential use with other neurotoxic, nephrotoxic, or ototoxic drugs.

Adverse Reactions:

Cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, headache; hearing loss, tinnitus, nephrotoxicity, bronchospasm.

How Supplied:

Caps—224 (w. Podhaler devices)