Dosing and administration for ARIKAYCE

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

ARIKAYCE is indicated in combination with a background regimen 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 dosage is once-daily oral inhalation of the contents of one 590 mg/8.4 mL ARIKAYCE vial.1

ARIKAYCE should be administered1,4:

Once-daily icon

Once daily, around the same time each day

Nebulizer icon

By oral inhalation via the Lamira Nebulizer System only

Additional dosing information2-5:

14 minutes icon

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

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

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Patients who achieved culture conversion in the CONVERT* trial continued on their treatment regimen for 12 months from the first month of culture conversion, consistent with the ATS/IDSA Statement recommendations

Refer to the Instructions for Use for full administration information.

Watch a step-by-step video on how to use 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

Using a bronchodilator is recommended for patients with preexisting respiratory conditions1,4

Pretreatment with a bronchodilator (short-acting selective ß2 agonists) should be considered for patients with known 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 + background regimen arm (52.2%) compared to the background regimen alone arm (38.4%).4

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

Prescribing ARIKAYCE

Prescribing ARIKAYCE enrollment form icon

Download the Arikares Enrollment Form

Download and complete the Arikares Enrollment Form to prescribe ARIKAYCE. The form can also be used to enroll your patients in the Arikares Support Program.

Arikares Support Program icon

Arikares Support Program

The Arikares Support Program is here to assist and guide patients throughout the course of their therapy.

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Receiving ARIKAYCE treatment

At the start of treatment, patients will receive 2 shipments from a specialty pharmacy. They include a 28-day supply of ARIKAYCE and a one-time shipment of the Lamira Nebulizer System. After these initial shipments, patients will only receive monthly shipments of a 28-day supply of ARIKAYCE.4,6

ARIKAYCE storage and handling1

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  • Store ARIKAYCE vials refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. Once expired, discard any unused drug
  • ARIKAYCE can be stored at room temperature up to 77°F (25°C) for up to 4 weeks. Once at room temperature, any unused drug must be discarded at the end of 4 weeks
  • Prior to opening, the ARIKAYCE vial should be shaken well for at least 10 to 15 seconds until the contents appear uniform and well mixed
Footnote

*The CONVERT trial is referred to as “Trial 1” in the ARIKAYCE full Prescribing Information.

ATS=American Thoracic Society; IDSA=Infectious Diseases Society of America.

References

  1. ARIKAYCE [package insert]. Bridgewater, NJ: Insmed Incorporated; 2018.
  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. Data on file. Insmed Incorporated. Bridgewater, NJ.
  5. Griffith DE, Aksamit T, Brown-Elliott BA, et al; for the 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. ARIKAYCE [instructions for use]. Bridgewater, NJ: Insmed Incorporated; 2018.