Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase

You may not qualify if:

• Administration of any investigational drug within 8 weeks prior to Screening.
• Emergency room visit or hospitalization for CF or respiratory-related illness within the 4 weeks prior to Screening.
• History of alcohol, medication, or illicit drug abuse within the 1 year prior to Screening.
• History of lung transplantation.
• Female of childbearing potential who is lactating or is not practicing an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD).
• Positive pregnancy test. All women of childbearing potential will be tested.
• Use of any anti-pseudomonal antibiotics (IV antibiotics, all inhalation antibiotics, oral fluoroquinolones) within the 28 days prior to Screening.
• Initiation of chronic therapy (i.e. TOBI®, high-dose ibuprofen, rhDNase, macrolide antibiotics) within the 28 days prior to Screening.
• History of sputum or throat swab culture yielding Burkholderia cepacia within 2 years of Screening.
• History of mycobacterial and/or Aspergillus infection requiring treatment within 2 years prior to Screening, and/or history of allergic bronchopulmonary aspergillosis (ABPA).
• History of biliary cirrhosis with portal hypertension, or splenomegaly (refer to study manual).
• GGT, AST, or ALT ≥ 3 times the upper limit of normal at Screening visit.
• ANC ≤ 1000 performed at Screening visit.
• Serum creatinine \> 1.5 times normal performed at Screening visit.
• History of daily, continuous oxygen supplementation or requirement for more than 2 L/min at night.
• +2 more criteria