WHEN 6 MONTHS OF STANDARD THERAPY FAILS IN ADULTS WITH MAC LUNG DISEASE, Adding ARIKAYCE can change what comes next1,2
ARIKAYCE helped patients with MAC lung disease get converted and stay converted when 6 months of standard therapy failed1,3,4
LIMITED POPULATION: ARIKAYCE® is 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. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.
This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Limitation of Use: ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.
*The CONVERT trial is referred to as “Trial 1” in the full Prescribing Information.
MAC=Mycobacterium avium complex.
Learn about patients who may be appropriate for adding ARIKAYCE to their standard therapy.
In the CONVERT* trial, treatment with ARIKAYCE + standard therapy resulted in culture conversion results that lasted.1
Learn about resources for you and your patients for prescribing and getting started with ARIKAYCE.