Dosing and management for ARIKAYCE

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ARIKAYCE is indicated for use as part of a combination antibacterial drug regimen1

Combination icon showing the prescription of standard therapy plus ARIKAYCE (amikacin liposome inhalation suspension) delivered through a nebulizer.

ARIKAYCE is indicated in combination with standard therapy for the treatment of refractory MAC lung disease for adults who have limited or no alternative treatment options.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

ARIKAYCE is a once-daily inhalation that can take about 14 minutes to administer1,2

ARIKAYCE is supplied as a sterile, white, milky, aqueous, liposome suspension for oral inhalation in a unit-dose glass vial containing amikacin 590 mg/8.4 mL (equivalent to amikacin sulfate 623 mg/8.4 mL).1

The recommended dose of ARIKAYCE in adults is the once-daily oral inhalation of the contents of one 590 mg/8.4 mL ARIKAYCE vial using the Lamira Nebulizer System.1

ARIKAYCE should be administered as part of a multidrug antibacterial regimen1,5:

Once-daily icon

Once daily, around the same time each day

Nebulizer icon

By oral inhalation via the Lamira Nebulizer System only

Additional dosing information2:

14 minutes icon

Administered for approximately 14 minutes. Treatment time may vary and could take up to 20 minutes

Home administration icon

Flexibility to administer at home or anywhere with a clean, flat, stable surface

Refer to the Instructions for Use for full administration information

Download the Instructions for Use
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Watch a step-by-step video on how to use ARIKAYCE

ARIKAYCE (amikacin liposome inhalation suspension) Quick Start Guide booklet icon

Download the ARIKAYCE Quick Start Guide

An on-the-go overview of instructions for patients who were just prescribed ARIKAYCE.

ARIKAYCE was specifically designed to be administered with the Lamira Nebulizer System only3

The recommended dose of ARIKAYCE in adults is the once-daily inhalation of the contents of one ARIKAYCE vial using the Lamira Nebulizer System.1

Lamira Nebulizer System image

Clinical management strategies for select respiratory adverse events

Ongoing monitoring can help alert physicians to the development of adverse events (AEs) that can be common with multidrug MAC lung disease treatment regimens.6 One survey reported potential techniques and strategies to help manage upper airway and lower respiratory tract events.4,6

Survey limitations and disclosures

  • This information is not included in the ARIKAYCE full Prescribing Information
  • The data is from a telephone survey of 26 patients prescribed ARIKAYCE conducted during a 2-month period at 2 academic medical centers in the United States4
  • Writing assistance was provided to the authors through funding from Insmed Incorporated. Insmed was not involved with the conceptualization, development, conduct, or analyses of the survey4
Increased coughing icon

Increased coughing:

Management strategies included4

  • Bronchodilator use
  • Changing ARIKAYCE administration to the evening
  • Brief interruptions of ARIKAYCE
  • Antitussive agents
  • Lozenges
  • Warm water or glycerin gargle post-dosing
  • Soothing fluid intake
Dysphonia icon

Dysphonia:

Management strategies included4

  • Changing ARIKAYCE administration to the evening
  • Brief interruptions of ARIKAYCE
  • Antitussive agents
  • Lozenges
  • Warm water or glycerin gargle post-dosing
  • Soothing fluid intake
Dyspnea icon

Dyspnea:

Management strategies included4

  • Bronchodilator use
  • Brief interruptions of ARIKAYCE
  • Limiting physical activity
  • Increasing supplemental oxygen, if already administering
Increased sputum production icon

Increased sputum production:

Management strategies included4

  • Airway clearance (eg, specific breathing techniques, chest percussion, and positive expiratory pressure therapy)

Reminder:

It's important to educate patients that increased sputum production may be a form of airway clearance in itself.4

Footnote

In the CONVERT study, the brief interruptions of ARIKAYCE lasted up to a maximum of 14 days. Patients may require varying lengths of interruption, which should be determined by the clinician's judgment.4,5

Advice from a top expert

Infectious Disease Specialist, Wendi K Drummond, DO MPH, shares recommendations for managing and monitoring ARIKAYCE patients.

Managing Patients' Expectations

Patient custom care icon

Management strategies should be customized to individual patients according to their specific needs. Use your clinical judgment when evaluating which strategy to use, including temporarily interrupting or discontinuing ARIKAYCE treatment, if necessary. Educating both patients and their extended care team may aid in early recognition and management of respiratory AEs that could help contribute to a successful treatment outcome.4,6

Download the ARIKAYCE counseling guide

A sheet to help discuss a custom ARIKAYCE treatment plan with your patients.

Download
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Using a bronchodilator is recommended for patients with preexisting respiratory conditions1,5

Pretreatment with a bronchodilator (short-acting selective ß2 agonists) is recommended for patients with a history of hyperreactive airway disease, COPD, asthma, or bronchospasm.1

As expected in this patient population with underlying respiratory comorbidities, bronchodilator use was common in the CONVERT trial, especially selective ß2-adrenoreceptor agonists (47.6%), which were utilized in a higher proportion of patients in the ARIKAYCE + standard therapy arm (52.2%) compared to the standard therapy alone arm (38.4%).5

Instruct patients to first use the bronchodilator, following the instructions, before using ARIKAYCE.1

AE=adverse event; MAC=Mycobacterium avium complex.

References

  1. ARIKAYCE [package insert]. Bridgewater, NJ: Insmed Incorporated; 2020.
  2. Lamira Nebulizer System instructions for use. Midlothian, VA: PARI Respiratory Equipment, Inc; 2018.
  3. 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.
  4. Swenson C, Lapinel NC, Ali J. Clinical management of respiratory adverse events associated with amikacin liposome inhalation suspension: results from a patient survey. Open Forum Infect Dis. 2020:7(4). doi:10.1093/ofid/ofaa079.
  5. Data on file. Insmed Incorporated. Bridgewater, NJ.
  6. 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.
  7. 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.
  8. 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.