A vampire stands above 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). The 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 + standard therapy achieved over a 3-fold increase in the percentage of adult patients who experienced culture conversion by Month 6 vs those who received standard therapy 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. 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. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.1

Guidelines icon

2020 NTM Guidelines STRONGLY RECOMMEND adding ARIKAYCE3

When MAC lung disease patients fail to respond after 6 months of standard therapy, it's time to add 2020 NTM Guideline-recommended ARIKAYCE

ARIKAYCE patient profiles icon

Identify the right patient for ARIKAYCE

Insmed is here to help throughout the patient journey

NTM=nontuberculous mycobacteria.

References

  1. ARIKAYCE [package insert]. Bridgewater, NJ: Insmed Incorporated; 2020.
  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. Daley CL, Iaccarino JM, Lange C, et al. Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline. Clin Infect Dis. 2020;71(4):e1-e36.
  4. Data on file. Insmed Incorporated. Bridgewater, NJ.
  5. Griffith DE, Aksamit T, Brown-Elliott BA, et al; ATS Mycobacterial Diseases Subcommittee. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007;175(4):367-416.
  6. Griffith DE, Eagle G, Thomson R, et al. Amikacin liposome inhalation suspension for treatment-refractory lung disease caused by Mycobacterium avium complex. Online data supplement. Am J Respir Crit Care Med. 2018;198(12)(suppl):E1-E28. Accessed October 16, 2020. https://www.atsjournals.org/doi/suppl/10.1164/rccm.201807-1318OC/suppl_file/griffith_data_supplement.pdf.
  7. US Food and Drug Administration. Published August 2020. Accessed October 16, 2020. https://www.fda.gov/media/113729/download.