INTENDED FOR UK AND IRELAND HEALTHCARE PROFESSIONALS Patient InformationHomePrescribing information

The first inhaled quinolone for
the management of chronic
Pseudomonas aeruginosa pulmonary
infection in adults with cystic fibrosis 1

Awaken the lungs
About Quinsair
Quinsair and Mode of Action
  • Quinsair (levofloxacin nebuliser solution) is the first inhaled quinolone antibiotic offering a different option to manage chronic Pseudomonas aeruginosa pulmonary infection in adults with CF.1
  • Quinsair is an effective twice-daily treatment in ready to use ampoules providing a simple to administer treatment option for your patients.1,2
  • Quinsair does not need to be refrigerated,1 making it easy to store.
  • Chronic Pseudomonas aeruginosa pulmonary infections in adults remain a key treatment challenge in CF and respiratory related problems are still the main cause of mortality for people with CF.3
  • There was a need for an additional inhaled antibiotic option from a different pharmacological class and Quinsair fulfils this need by offering an additional choice of inhaled antibiotic.4
Quinsair has a different mechanism of action against Pseudomonas aeruginosa vs other inhaled antibiotic options1,5-9
  • Quinsair offers CF healthcare professionals increased opportunity and flexibility to optimise inhaled antibiotic treatment to preserve lung health for their adult CF patients.4

References:

  1. Quinsair. Summary of Product Characteristics. Chiesi Limited.
  2. Elborn JS et al. A phase 3, open-label, randomized trial to evaulate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. J Cyst Fibros 2015;14:507–14.
  3. UK Cystic Fibrosis Registry Annual Data Report 2019. Published August 2020.
  4. Quinsair. European Medicines Agency. Assessment Report 2014; EMA/CHMP/676680/2014 (EMEA/H/C/002789/0000); 1–106.
  5. Cayston. Summary of Product Characteristics. Gilead Sciences Limited.
  6. Colomycin. Summary of Product Characteristics, Teva Limited.
  7. Bramitob. Summary of Product Characteristics, Chiesi Limited.
  8. Tobi. Summary of Product Characteristics, Mylan Limited.
  9. Gumustas M et al. Effect of polymer-based nanoparticles on the assay of antimicrobial drug delivery systems.
    In: Multifunctional system for combined delivery, biosensing and diagnostics. Grumezescu AM (Ed), William Andrew, 2017.
Dosing and Storage
  • Quinsair is a 28 day treatment, followed by 28 days off treatment. A 240 mg dose (one ampoule) is taken twice a day and it takes approximately 5 minutes to nebulise each dose.1
See how Quinsair compares to aztreonam lysine:1,2
Quinsair Aztreonam lysine
Ready to use
No refrigeration required
Posology 2 x daily 3 x daily
Patient age ≥ 18 years ≥ 6 years
Package 4 ampoules per foil, 14 x foils 84 vials of active ingredient, 88 solvent ampoules
Container Plastic ampoules Glass vials, plastic ampoules
No protection from light
Shelf Life 3 years Solvent: 3 years   Powder vial: 4 years
Shelf life out of fridge N/A 28 days
Pre-treatment with a bronchodilator Optional Required

References:

  1. Quinsair. Summary of Product Characteristics. Chiesi Limited.
  2. Cayston. Summary of Product Characteristics. Gilead Sciences Limited.
Nebuliser Handset

A Zirela®* nebuliser handset comes in each box of Quinsair.1

  • Quinsair is delivered through the Zirela®* nebuliser handset and eBase controller** which is small, quiet and portable and has an inhalation time of about 5 minutes.1-4
  • The Zirela® nebuliser handset is specifically designed for use with Quinsair and provides efficient drug delivery with less than 2% remaining in the reservoir.1†
  • The Zirela® nebuliser handset has a different sized reservoir and aerosol head than other nebuliser handsets.
  • Other nebuliser handsets and aerosol heads may look similar to the Zirela® nebuliser handset, but they must not be used with Quinsair as this could result in sub-optimal dosing.1
  • Both the aerosol chamber and the aerosol head of the Zirela® nebuliser handset are labelled ‘Zirela®’,3 so they can be differentiated from other nebuliser handsets.
  1. Quinsair is designed to be administered using the Zirela® nebuliser handset and operated with an eBase controller. Further information on the nebuliser and controller can be found at www.pari.com. Zirela® is a registered trademark of PARI Pharma GmbH, Germany.
  2. The e-Base controller is not provided within the Quinsair box.
  3. Total drug delivered: 236.1 mg from 240 mg ampoule.

References:

  1. Quinsair. Summary of Product Characteristics. Chiesi Limited.
  2. Quinsair. Patient Information Leaflet. Chiesi Limited.
  3. Pari Zirela nebuliser handset. Instructions for use. Available at www.pari.com (accessed October 2020).
  4. Pari eFlow rapid with eBase controller. Product Information. Available at www.pari.com (accessed October 2020).
KEY DATA
Phase III efficacy and safety study (24 weeks) – Elborn et al. 2015
A phase 3, open-label, randomized trial to evaulate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. J Cyst Fibros 2015;14:507–14.1
Study aim To evaluate the efficacy and safety of Quinsair (LIS) compared with tobramycin inhaled solution (TIS) over three treatment cycles in stable cystic fibrosis patients ≥ 12 years with chronic Pseudomonas aeruginosa infection (Note: Quinsair is indicated in adults aged 18 years old and over)
Study design Phase III, non-inferiority, randomised (2:1), multi-national, open-label, active comparator
Primary endpoint Relative change in FEV1 % predicted from baseline to Day 28
Secondary endpoints include: Time to exacerbation, time to additional anti-pseudomonal antibiotic use and patient-reported quality of life
  • In the study Quinsair met the primary endpoint of non-inferiority in relative change in FEV1 % predicted from baseline to day 28. The least squares mean between-group difference (LIS minus TIS) in FEV1 was 1.86% [95% CI −0.66 to 4.39%]1
Mean changes from baseline in FEV1 % predicted over 3 x 28-day on treatment, 28-day off treatment cycles (secondary endpoint)
Time to exacerbation – Quinsair vs TIS (secondary endpoint)
Quinsair significantly reduced exacerbation related hospitalisations vs TIS (exploratory endpoint)

Quinsair is licensed in adults 18 years old and over

TIS, tobramycin inhaled solution

Study Overview
Study MPEX 2091 (n=282)
Study period 168 days
Study drug Quinsair (inhaled)
Comparator TIS (inhaled)
Pulmonary function Primary endpoint: Quinsair demonstrated non-inferiority vs TIS after 28 days on treatment

Quinsair consistently increased FEV1 % predicted from baseline after each treatment cycle; TIS only increased FEV1 % predicted above baseline after first cycle

A pre-planned analysis of categorical change in FEV1% predicted from baseline to day 28 showed improvement for 70% of patients receiving Quinsair compared to 53% of patients receiving TIS (p=0.02) [Secondary endpoint]

Exacerbation 45% increase in time to first exacerbation (p=0.15); 131 days (Quinsair) vs 90.5 days (TIS)

Significant reduction (10.5% p=0.04) in exacerbation-related hospitalisations vs TIS

Additional antibiotic use Significantly lengthens the median time to first additional anti-pseudomonal antibiotic use; 141 days (Quinsair) vs 110 days (TIS), p=0.04

FEV1, forced expiratory volume in 1 second; TIS, tobramycin inhaled solution

Reference:

  1. Elborn JS et al. A phase 3, open-label, randomized trial to evaulate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. J Cyst Fibros 2015;14:507–14.
Phase III efficacy and safety study extension (48 weeks) – Elborn et al. 2016
Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. J Cyst Fibros 2016;15:634-640.1
Study design Open-label, non-randomised, single-arm extension study. Patients in the tobramycin inhaled solution (TIS) group who continued the trial were switched to Quinsair (LIS)
Primary endpoint Relative change in FEV1% predicted from baseline to Day 28
Secondary endpoints Time to exacerbation, time to additional anti-pseudomonal antibiotic use and patient-reported quality of life
Relative changes in FEV1 % predicted from RCT baseline to day 336 (secondary endpoint)

Adapted from Elborn JS et al. 2016

Quinsair is licensed in adults 18 years old and over.

FEV1, forced expiratory volume in 1 second; LS, least squares; LIS, levofloxacin inhaled solution; RCT, randomised controlled trial; SE, standard error; TIS, tobramycin inhaled solution

Time to first exacerbation among extension enrollees (secondary endpoint)

Quinsair is licensed in adults 18 years old and over.

TIS, tobramycin inhaled solution
Adapted from Elborn JS, et al. 2016 (supplementary data)

Change in CFQ-R respiratory domain from baseline (secondary endpoint)

Quinsair is licensed in adults 18 years old and over.

CFQ-R, cystic fibrosis questionnaire-revised; SE, standard error; TIS, tobramycin inhaled solution
Adapted from Elborn JS, et al. 2016 (supplementary data)

Study Overview
Study MPEX 209 (Extension)1 (n=88)
Study period 48 weeks: core study 24 weeks, followed by 24 week extension (day 168 – 336)
Study drug Quinsair (inhaled)
Comparator TIS (inhaled)
Pulmonary function Relative change in percent predicted FEV1 (primary endpoint) showed similar mean increases in LIS/LIS patients during cycles 1-3 of the RCT and cycles 4 and 5 of the extension, but this was not apparent during cycle 6
Exacerbation The median time to the first exacerbation (from RCT baseline) was 99.5 days for Tobramycin/Quinsair and 153.5 days for Quinsair/Quinsair
Quality of life In the Quinsair/Quinsair group there was a sustained improvement in CFQ-R respiratory domain compared with RCT baseline. Patients switching from TIS to Quinsair experienced a similar symptomatic benefit (CFQ-R) for the first cycle. For the second and third cycles, the benefit of Quinsair to the TIS/Quinsair patients was less

CFQ-R, cystic fibrosis questionnaire-revised; FEV1, forced expiratory volume in 1 second; RCT, randomised controlled trial; TIS, tobramycin inhaled solution

Reference:

  1. Elborn JS et al. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. J Cyst Fibros 2016;15:634-640.
Post hoc analysis of Phase III efficacy and safety study (24 weeks) – Fischer et al. 2016
Pulmonary exacerbations and changes in lung function in CF adult patients with P. aeruginosa treated with inhaled levofloxacin or tobramycin. Pediatric Pulmonol 2016;51(S45):359.1

Quinsair (referred to as LIS; Levofloxacin inhalation solution in the data) was evaluated in a randomised, active controlled, non-inferiority open-label study (Elborn et al. 2015) versus tobramycin inhalation solution (TIS) over three 28-day on/off cycles in cystic fibrosis (CF) patients ≥12 years of age.

Data on the ≥18 year (the licensed population) patient subgroup were studied, the post-hoc analysis of adults measured:

  • Changes in Absolute FEV1 % predicted from baseline over the 3 cycles
  • Difference in time to Pulmonary Exacerbation as defined by first antibiotic treatment and antibiotic treatment in the presence of symptoms.

Baseline demographics were comparable between the two groups, with the exception of a higher proportion of patients randomised to Quinsair, having more than 3 pulmonary exacerbations.

Change in absolute FEV1 % predicted over the three cycles in adults

LS mean differences in absolute FEV1 change from baseline at the end of each treatment period for Quinsair (LIS) minus TIS:
+1.0% predicted [95% Cl: -0.2, 2.3] at Day 28 (no statistical significance)
+1.9% predicted [0.4, 3.4] at Day 84 (P=0.014)
+1.6% predicted [0.01, 3.1] at Day 140 (P=0.048)

FEV1, forced expiratory volume in 1 second; TIS, tobramycin inhaled solution; LS, least squares; LIS, levofloxacin inhaled solution

Quinsair significantly lengthened time to exacerbation vs TIS in adults >18 (P=0.023)

ABx, antipseudomonal antibiotic; PEx, pulmonary exacerbation; LIS, levofloxacin inhalation solution; TIS, tobramycin inhalation solution

Time to pulmonary exacerbation defined by antipseudomonal antibiotic in the presence of 1 of 4 worse respiratory symptoms was compared between treatment groups using Cox proportional hazards with terms for treatment, region and baseline FEV1 % predicted (<55%, ≥55%)

Reference:

  1. Fischer R et al. Pulmonary exacerbations and changes in lung function in CF adult patients with P. aeruginosa treated with inhaled levofloxacin or tobramycin. Pediatric Pulmonol 2016;51(S45):359.
In vitro data – King P, et al. 2010
In vitro pharmacodynamics of levofloxacin and other aerosolized antibiotics under multiple conditions relevant to chronic pulmonary infection. in cystic fibrosis. Antimicrob Agents Chemother 2010;54(1):143-148.1

Levofloxacin is the active drug in Quinsair2

Unlinke tobramycin, levofloxacin’s bactericidal activity in vitro is not reduced in CF sputum1

Levofloxacin is a fluoroquinolone antibiotic with potent activity in vitro against key pathogens found in CF patients, including Pseudomonas aeruginosa1,2

Levofloxacin has greater antimicrobial activity in vitro than tobramycin and aztreonam lysine against Pseudomonas aeruginosa in biofilms1

Rapid and sustained killing of 11 of the 12 isolates by all concentrations of levofloxacin were observed in vitro within the first 30 minutes1

Bactericidal activities of high concentration of levofloxacin, tobramycin and aztreonam against P. aeruginosa isolates from CF patients1

Isolates killed within 30 minutes

Adapted from : King P, et al. Antimicrob Agents Chemother 2010; 54(1):143-148

MIC, Minimum Inhibitory Concentration

References:

  1. King P et al. In vitro pharmacodynamics of levofloxacin and other aerosolized antibiotics under multiple conditions relevant to chronic pulmonary infection. in cystic fibrosis. Antimicrob Agents Chemother 2010;54(1):143–148.
  2. Quinsair Summary of Product Characteristics, Chiesi Limited.
Starting Quinsair
What is in a box of Quinsair?
  • 56 doses of Quinsair 240 mg for 28 days’ treatment, packaged in 14 foils with 4 ready-to-use plastic ampoules in each 1
  • Zirela®* nebuliser handset, inside outer packaging in its own box 1

*Quinsair is designed to be administered using the Zirela® nebuliser handset and operated with an eBase controller. Further information on the nebuliser and controller can be found at www.pari.com. Zirela® is a registered trademark of PARI Pharma GmbH, Germany

Reference:

  1. Quinsair. Summary of Product Characteristics. Chiesi Limited.
Day to day use of Quinsair
  • Quinsair should be taken twice daily for 28 days, followed by 28 days off-treatment.1
  • It can be useful to work out in advance how taking Quinsair will fit in with your patient’s morning and evening routines, as this could aid adherence.
  • Only the Zirela®* nebuliser handset should be used to take Quinsair (other handsets may result in sub-optimal dosing).1
  • Quinsair does not need to be stored in a fridge.1
  • Quinsair ampoules are ready-to-use, with no reconstitution required.1
  • A dose of Quinsair should take approximately 5 minutes to nebulise through the Zirela® nebuliser handset.1
  • To see how to assemble, dismantle, clean, and disinfect the handset, watch the instructional videos on our resources page

*Quinsair is designed to be administered using the Zirela® nebuliser handset and operated with an eBase controller. Further information on the nebuliser and controller can be found at www.pari.com. Zirela® is a registered trademark of PARI Pharma GmbH, Germany

Reference:

  1. Quinsair. Summary of Product Characteristics. Chiesi Limited.
Test dosing with Quinsair
  • The license for Quinsair does not require a supervised test dose.
  • We recognise many CF Centres do prefer to challenge test their patients when starting a different inhaled antibiotic.
  • Many patients now have equipment at home available to take their own measurements, for example spirometers for FEV1 and scales to assist with calculating their BMI.
  • With the aim of keeping patients out of hospital as much as possible, it may be practical to take some measurements at home before and after they visit the CF centre.
  • To help patients starting Quinsair, we have instructional videos showing how to put together the Zirela®* nebuliser handset, how to take Quinsair and take apart and clean the Zirela® nebuliser handset.
  • And in the UK we also offer Chiesi funded homecare delivery for Quinsair, with a choice of 3 providers, so patients can get their Quinsair delivered to them at home.

Contact your Chiesi CF Hospital Specialist for more information and support

*Quinsair is designed to be administered using the Zirela® nebuliser handset and operated with an eBase controller. Further information on the nebuliser and controller can be found at www.pari.com. Zirela® is a registered trademark of PARI Pharma GmbH, Germany

Managing taste disturbance with Quinsair
  • Quinsair was formulated to minimise the bitter taste of levofloxacin whilst retaining its effectiveness.1
  • Taste disturbance, or dysgeusia, has been reported by some patients taking Quinsair.2
  • Phase III studies demonstrated that the incidence of dysgeusia had minimal impact on adherence in the majority of patients and the incidence reported reduced over time.3,4
  • Quinsair is a different inhaled antibiotic,2 so patients may not be used to the taste at first and it might take a while for them to get used to it.
  • When starting Quinsair it is important to manage the possibility of taste disturbance with patients.
  • It may be useful to take measures to mitigate a bitter taste, based on existing clinical practice for other medicines which don’t taste nice.

References:

  1. Quinsair. European Medicines Agency. Assessment Report 2014; EMA/CHMP/676680/2014 (EMEA/H/C/002789/0000); 1–106.
  2. Quinsair. Summary of Product Characteristics. Chiesi Limited.
  3. Elborn JS et al. A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. J Cyst Fibros 2015;14:507–14.
  4. Elborn JS et al. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. J Cyst Fibros 2016;15:634–40.
Tolerability with Quinsair
  • Quinsair offers a well-established tolerability profile, which is similar overall to Tobramycin Inhalation Solution.1
  • Bronchospasm is uncommon with Quinsair.2
  • If acute symptomatic bronchospasm occurs after taking Quinsair, patients may benefit from the use of a short-acting bronchodilator at least 15 minutes to 4 hours prior to subsequent doses.2
  • To see a full list of Quinsair adverse events, please see the UK Summary of Product Characteristics or the Ireland Summary of Product Characteristics.

References:

  1. Elborn JS et al. A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. J Cyst Fibros 2015;14:507–14.
  2. Quinsair. Summary of Product Characteristics. Chiesi Limited.
RESOURCES
Materials

In this section you will find Quinsair videos, along with materials which can be downloaded.

  •  
    Quinsair Key Takeaways Booklet (UK)
    This booklet gives a summary of need to know information about Quinsair including its practical benefits and its efficacy vs Tobramycin Inhaled Solution, for UK CF Healthcare Professionals.
  •  
    Quinsair Key Takeaways Booklet (Ireland)
    This booklet gives a summary of need to know information about Quinsair including its practical benefits and its efficacy vs Tobramycin Inhaled Solution, for CF Healthcare Professionals in the Republic of Ireland.
  •  
    Quinsair Comparison with Aztreonam Lysine (UK)
    This resource gives a summary comparison of Quinsair and Aztreonam Lysine for UK CF Healthcare Professionals.
  •  
    Quinsair Comparison with Aztreonam Lysine (Ireland)
    This resource gives a summary comparison of Quinsair and Aztreonam Lysine for CF Healthcare Professionals in the Republic of Ireland.

If you would like to provide the information below to your patients, please direct them to the Quinsair patient section of this website.

  •  
    Quinsair Patient Support Leaflet
    This leaflet provides patients prescribed Quinsair with a summary of information about the product and how it should be used.
  •  
    Quinsair Nebuliser Handset Patient Information
    This material shows the importance of using the correct nebuliser handset for Quinsair and how to tell the difference between the Zirela® handset provided with Quinsair, and a similar looking nebuliser handset.
Video guides
  • Watch the videos to learn about the correct inhalation technique for when you use Quinsair.

PREPARING YOUR NEBULISER SYSTEM

USING YOUR NEBULISER SYSTEM

LOOKING AFTER YOUR NEBULISER SYSTEM

  1. Quinsair Summary of Product Characteristics. Chiesi Limited.

IE-QUI-2000038 | Dec 2020

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