A vampire stands opposite a large wooden stake looking shocked and afraid. His mouth is agape, his eyes are wide, and his hands are raised in a defensive stance. The stake is oversized, solidly built, ornately designed, and has a very sharp whittled end. Standing firm and straight, the stake appears as though it is the personification of ARIKAYCE (amikacin liposome inhalation suspension). A line reads: 'Every vampire has their stake.' A vampire stands opposite a large wooden stake looking shocked and afraid. His mouth is agape, his eyes are wide, and his hands are raised in a defensive stance. The stake is oversized, solidly built, ornately designed, and has a very sharp whittled end. Standing firm and straight, the stake appears as though it is the personification of ARIKAYCE (amikacin liposome inhalation suspension). A line reads: 'Every vampire has their stake.'

Every villain has its weakness.
And now refractory MAC lung disease has ARIKAYCE1

In a Phase 3 trial, ARIKAYCE + background regimen achieved over a 3-fold increase in the percentage of adult patients who experienced culture conversion by Month 6 vs those who received background regimen alone (29.0% [65/224] vs 8.9% [10/112]) (P<0.0001).1,2

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.1

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.1

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.1

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References

  1. ARIKAYCE [package insert]. Bridgewater, NJ: Insmed Incorporated; 2018.
  2. Griffith DE, Eagle G, Thomson R, et al. Amikacin liposome inhalation suspension for treatment-refractory lung disease caused by Mycobacterium avium complex (CONVERT): a prospective, open-label randomized study. Am J Respir Crit Care Med. 2018;198(12):1559-1569.
  3. US Food and Drug Administration. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610498.pdf. Published June 2018. Accessed January 2, 2019.