ARIKAYCE (amikacin)
SELF ADMINISTRATION- INHALATION SUSPENSION
Indications for Prior Authorization:
- Indicated in adults who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy
Patients must meet the following criteria for the indication(s) above:
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Patient is 18 years of age or older, AND
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Diagnosis of Mycobacterium avium complex (MAC) lung disease confirmed by chart note documentation, AND
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Prescribed by or in consultation with an infectious disease specialist or pulmonologist, AND
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Failure (confirmed by a positive sputum culture) of at least a 6-month trial of a multidrug background regimen therapy at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced, AND
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Arikayce® should be used with background multidrug regimen (including a macrolide [azithromycin or clarithromycin], ethambutol, and a rifamycin [rifampin or rifabutin])
Dosing:
- Inhale 1 vial (590mg/8.4mL) once daily
- For oral inhalation use only
- Use Arikayce® vials only with the Lamira Nebulizer System
- Consider pre-treatment with inhaled bronchodilator in patients with a history of hyperreactive airway disease
Approval:
- 1 year
Last review date: December 9, 2019