Dosing and management for ARIKAYCE

Down arrow icon

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

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

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 administered1,5:

Once-daily icon

Once daily, around the same time each day

Nebulizer icon

By oral inhalation via the Lamira Nebulizer System only

Additional dosing information2,3,5,6:

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

12 months icon

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 2007 ATS/IDSA Statement recommendations

Refer to the Instructions for Use for full administration information

Download the Instructions for Use
Download arrow icon

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 study reported potential techniques and strategies to help manage upper airway and lower respiratory tract events.4

Study 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 study4
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

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
Download arrow icon
Footnote

In the 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

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

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%).5

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.

Submit via fax (1-800-604-6027) or e-mail (enrollment@arikares.com).

Arikares Support Program icon

Arikares Support Program

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

After I prescribe ARIKAYCE, what will my patient receive?

  1. A Welcome Pack and a call from their Arikares Coordinator to discuss questions and next steps
  2. Their first shipment of ARIKAYCE, arriving in 2 packages: the first containing the 28-day supply of medicine and the second delivering the Lamira Nebulizer System and Getting Started Kit

Patients can receive voluntary device training that can be scheduled with an Arikares Trainer after the ARIKAYCE delivery date is confirmed.

Welcome Pack

Your patients will be sent a Welcome Pack in the mail after enrollment into Arikares that includes important and helpful information about getting started with ARIKAYCE.

Image of the Arikares Welcome Pack unzipped with all of its contents, including various pamphlets and brochures, spread around it.

The Welcome Pack contains:

  1. Welcome Letter
  2. Treatment Journal
  3. Preparing for Your First Shipment of ARIKAYCE
  4. Questionnaire
  5. Medication and Allergy Wallet Cards
  6. Tips for Traveling With Your Medication
  7. Getting to Know Arikares
  8. Create Space for Your Treatment

28-day ARIKAYCE Medication Kit

The first shipment of ARIKAYCE will include a 28-day supply of medicine from a specialty pharmacy. After this initial shipment, patients will continue to receive a 28-day supply of ARIKAYCE each month.

Image of the 28-day ARIKAYCE (amikacin liposome inhalation suspension) Medication Kit box shown open with all materials and kit contents surrounding it.

The 28-day ARIKAYCE Medication Kit contains:

  1. Cooler Return Form
  2. 1 ARIKAYCE Quick Start Guide
  3. 1 Instructions for Use
  4. 1 Full Prescribing Information and Medication Guide
  5. 1 Lamira Nebulizer Handset
  6. 28 once-daily vials of ARIKAYCE (1 vial to be used each day for 28 days)
  7. 4 Lamira Aerosol Heads (1 in each weekly box)

Lamira Nebulizer System and Getting Started Kit

The second shipment will include the Lamira Nebulizer System and Getting Started Kit, and will be sent from the same pharmacy as the first box. Patients will only receive this shipment once.

Image of the Lamira Nebulizer System shipment box shown open with all of its contents around it.

The Lamira Nebulizer System contains:

  1. 1 Instructions for Use
  2. 1 Full Prescribing Information and Medication Guide
  3. 1 Spare Lamira Aerosol Head
  4. 1 Spare Lamira Nebulizer Handset
  5. 1 eBase® Controller
  6. 4 AA Batteries
  7. 1 Connection Cord
  8. 1 A/C Power Supply
  9. 1 Carrying Case
Image of the ARIKAYCE (amikacin liposome inhalation suspension) Getting Started Kit box and all of its contents.

The Getting Started Kit contains:

  1. Timer
  2. Lint-free Drying Mat
  3. 2 oz Dish Soap Sample
  4. Lint-free Towel

ARIKAYCE storage and handling1

Packaging icon
  • 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; 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 (ALIS): results from a patient survey. Open Forum Infect Dis. 2020:ofaa079. doi:10.1093/ofid/ofaa079.
  5. Data on file. Insmed Incorporated. Bridgewater, NJ.
  6. 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.
  7. 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. https://www.atsjournals.org/doi/suppl/10.1164/rccm.201807-1318OC/suppl_file/griffith_data_supplement.pdf. Accessed December 6, 2019.