A Portable Nebulizer Option for Patients With COPD

OCTOBER 11, 2018
This article was sponsored by Sunovion Pharmaceuticals Inc.




 
Education and training on proper inhalation device technique is essential in helping to achieve treatment goals in the management of chronic obstructive pulmonary disease (COPD).1 More than two-thirds of patients with COPD make at least 1 administration error while using an inhalation device.1 Device-specific challenges that may impact proper inhalation technique may include required setup and maintenance; dosing feedback availability; and administration time.2-4 Counseling patients on proper medication administration may help patients with device-specific challenges.5

Initial and ongoing training by the pharmacist on the use of inhalation devices is intended to have an impact on patient technique and overall treatment goals. As part of the COPD treatment services needed for patients, pharmacists are encouraged to follow up with each patient throughout the course of treatment to continuously recheck device use.1 Pharmacists are well-positioned to address device-specific challenges and to educate patients on the correct use of inhalation devices, including nebulized devices.1 This opportunity for pharmacists to educate and train patients on appropriate COPD device use is important with COPD medications that have been newly prescribed.

LONHALA® MAGNAIR® (glycopyrrolate) Inhalation Solution6
LONHALA MAGNAIR (glycopyrrolate) inhalation solution is indicated for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. LONHALA MAGNAIR should not be used as rescue therapy for the treatment of acute episodes of bronchospasm. Please see the accompanying Important Safety Information at the end of this article.

Dosage & Administration6
The recommended dose of LONHALA MAGNAIR is the inhalation of the contents of a single 1-mL LONHALA vial, which contains 25 mcg of glycopyrrolate, twice daily using MAGNAIR. LONHALA MAGNAIR should be administered at the same times (morning and evening) every day. Patients should be instructed on the appropriate use of LONHALA MAGNAIR. More frequent administration or a greater number of inhalations (more than 1 vial twice daily) of LONHALA MAGNAIR is not recommended. Dosage adjustment is not required for geriatric patients, patients with hepatic impairment, or patients with mild-to-moderate renal impairment. For complete administration steps, see Manufacturer's Instructions for Use located at . 

Features of the MAGNAIR® Nebulizer System
LONHALA MAGNAIR is the first and only nebulized long-acting muscarinic receptor antagonist (LAMA) therapy in a closed-system device featuring eFlow® technology.7
  •  Portable & battery-operated: The small, lightweight, and compact design of the MAGNAIR Nebulizer System allows it to fit in a discreet carrying bag. It can be used with 4 AA batteries or an AC adapter. The MAGNAIR Nebulizer System handset (2.4 x 4.7 inches) and controller (1.6 x 4.6 inches) are small. With batteries included, MAGNAIR weighs 10.2 ounces.8
  • 2- to 3-minute administration: Administration takes 2 to 3 minutes, with proper assembly and cleaning. Improper cleaning and maintenance may increase administration time. Pharmacists can direct patients to the Manufacturer's Instructions for Use accompanying MAGNAIR for detailed information on appropriate maintenance and cleaning. It is important for patients to understand how to correctly administer LONHALA vials using MAGNAIR. Instruct patients that LONHALA vials should only be administered via MAGNAIR, and MAGNAIR should not be used for administering any other medications.6-8
  • Virtually silent administration: LONHALA MAGNAIR features a virtually silent administration that allows patients to administer medication without noticeable noise.7,9
  • Audiovisual feedback mechanism: MAGNAIR features an audiovisual feedback mechanism. Patients will hear 2 beeps and the green LED light will turn off when the device has completed its administration cycle.8
  • Laser-drilled aerosol head: The MAGNAIR aerosol head features a vibrating, perforated membrane with laser-drilled holes that, with proper assembly and cleaning, is designed to deliver consistently sized particles at 3.7 µm mass median aerodynamic diameter. This membrane is designed for use only with MAGNAIR.7,8
  • Regular tidal breathing: Patients breathe naturally through the mouthpiece when taking treatment. Instruct patients to not cover the blue flap with their lips, to breathe naturally through the mouthpiece for the duration of the administration period, and to not inject or swallow the LONHALA solution.6,8
Practical Considerations
How LONHALA MAGNAIR is Supplied6
Patients may present with 2 separate prescriptions: 1 for the Starter Kit and/or 1 for the Refill Kit (TABLE). Inform patients who have received the LONHALA MAGNAIR Starter Kit that a Refill Kit will be provided to them on a monthly basis and educate them on the contents within. Instruct patients to throw away the old handset parts after using 60 vials of LONHALA and use the replacement handset parts with the next 60 vials of LONHALA from the monthly Refill Kit.



Coverage
Unlike traditional nebulizers, the MAGNAIR device is not categorized as durable medical equipment by CMS and is not reimbursed under Medicare Part B. LONHALA MAGNAIR is covered by Medicare Part D, because LONHALA, the drug, and MAGNAIR, the device, were approved under the same new drug application, and so they are both treated as a drug and reimbursed under Part D (no guarantee of coverage).

Sunovion Answers
Sunovion Answers is a patient support service for Sunovion products, including LONHALA MAGNAIR. It is designed to provide personalized assistance for patients, as well as for their caregivers and healthcare providers. Sunovion Answers is available for patients throughout treatment, providing additional services including savings, co-pay, and reimbursement support; training in product use; and additional resources.

Patient Training & Education
Some patients will receive 1-on-1 training when they pick up their Starter Kit at a participating pharmacy, or they will receive training over the phone. Patients who do not use a participating pharmacy should be advised to Sunovion Answers to ensure that they receive the proper training. As part of this comprehensive support program, participating pharmacies or Sunovion Answers make follow-up calls to patients 5 to 7 days after they pick up the Starter Kit, and then approximately 21 days after every fill. Pharmacists can advise patients on the comprehensive treatment support offered through Sunovion Answers to ensure that patients receive the proper training and follow-up with LONHALA MAGNAIR treatment.

Summary
Pharmacists have an important role in counseling patients on the appropriate administration of COPD medications, including LONHALA MAGNAIR. Patients should be counseled on the device features of LONHALA MAGNAIR, such as its 2- to 3-minute administration time, virtually silent administration, portability, and audiovisual feedback mechanism. In addition to providing appropriate training on use of the device and of the contents of the Starter and Refill Kits, pharmacists should be prepared to counsel patients on additional areas of support, including coverage information and the comprehensive patient support service, Sunovion Answers, offered to patients receiving treatment with LONHALA MAGNAIR.


References
  1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: 2018 report. GOLD website. goldcopd.org/wp-content/uploads/2017/11/GOLD-2018-v6.0-FINAL-revised-20-Nov_WMS. 2018:1-123. 
  2. Koehorst-ter Huurne K, Movig K, van der Valk P, van der Palen J, Brusse-Keizer M. The influence of type of inhalation device on adherence of COPD patients to inhaled medication. Expert Opin Drug Deliv. 2016;13(4):469-475. doi: 10.1517/17425247.2016.1130695.
  3. Lavorini F, Magnan A, Dubus JC, et al. Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD. Respir Med. 2008;102(4):593-604. doi: 10.1016/j.rmed.2007.11.003.
  4. Taffet EG, Donohue JF, Altman PR. Considerations for managing chronic obstructive pulmonary disease in the elderly. Clin Interv Aging. 2014;9:23-30. doi: 10.2147/CIA.S52999.
  5. Crompton GK, Barnes PJ, Broeders M, et al. The need to improve inhalation technique in Europe: a report from the Aerosol Drug Management Improvement Team. Respir Med. 2006;100(9):1479-1494. doi: 10.1016/j.rmed.2006.01.008.
  6. LONHALA MAGNAIR (glycopyrrolate) Inhalation Solution [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; 2018.
  7. Pham S, Ferguson GT, Kerwin E, Goodin T, Wheeler A, Bauer A. In vitro characterization of the eFlow closed system nebulizer with glycopyrrolate inhalation solution. J Aerosol Med Pulm Drug Deliv. 2018;31(3):162-169. doi: 10.1089/jamp.2017.1384.
  8. LONHALA MAGNAIR (glycopyrrolate) Inhalation Solution [instructions for use]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; 2017.
  9. Data on file. eLete Loudness measurement. Test Report 4669, 2017. PARI Pharma GmbH.

Important Safety Information for LONHALA® MAGNAIR® (glycopyrrolate) Inhalation Solution
INDICATION
LONHALA® MAGNAIR® (glycopyrrolate) is an anticholinergic indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

IMPORTANT SAFETY INFORMATION
LONHALA MAGNAIR is contraindicated in patients with a hypersensitivity to glycopyrrolate or to any of the ingredients.

LONHALA MAGNAIR should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta­2-agonist.

As with other inhaled medicines, LONHALA MAGNAIR can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs following dosing with LONHALA MAGNAIR, it should be treated immediately with an inhaled, short-acting bronchodilator; LONHALA MAGNAIR should be discontinued immediately and alternative therapy instituted.

Immediate hypersensitivity reactions have been reported with LONHALA MAGNAIR. If signs occur, discontinue LONHALA MAGNAIR immediately and institute alternative therapy.

LONHALA MAGNAIR should be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) and of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Patients should be instructed to consult a physician immediately should any of these signs or symptoms develop.

The most common adverse events reported in ≥2% of patients taking LONHALA MAGNAIR, and occurring more frequently than in patients taking placebo, were dyspnea (4.9% vs 3.0%) and urinary tract infection (2.1% vs 1.4%).

LONHALA solution is for oral inhalation only and should not be injected or swallowed. LONHALA vials should only be administered with MAGNAIR.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

For more information, please see full  and for LONHALA MAGNAIR at .
 

LONHALA is a registered trademark and is a trademark of Sunovion Pharmacueuticals Inc. MAGNAIR is a registered trademark of PARI Pharma GmBH,
used under license, eFlow and eLete are registered trademarks of PARA Pharma SUNOVION and are registered trademarks of Sumitomo Dainippon
Pharma Co., Ltd. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainppon Pharma Co., Ltd. © 2018 Sunovion Pharmacueticals Inc. 

All rights reserved. LON341-18