about qvar redihaler

THE ROLE OF

PARTICLE SIZE IN ASTHMA TREATMENT

  • Inflammation associated with asthma occurs in all areas of the lung1,2
  • Medication that targets the large and small airways is vital for achieving asthma control1,2
    • Lung and oropharyngeal deposition can vary by drug formulation and particle size2-4
  • A small-particle ICS targets the large and small airways of the lung5,6

ICS=inhaled corticosteroid.

Diagram showing distinction between large and small airways

QVAR RediHaler is formulated with small particles that

target both the large and small airways, where chronic inflammation exists5-7

Graphic showing varying particle sizes and the particle size for QVAR RediHaler

The relationship of particle size to clinical efficacy is unknown.

HFA=hydrofluoroalkane.

Chart not drawn to scale.

*Particle size measures are mass median aerodynamic diameter (MMAD).

In studies with QVAR, the majority of medication was deposited

in the lungs, not the oropharynx3,8,9

The relationship of lung deposition to clinical efficacy is unknown. While deposition studies have not been conducted with QVAR RediHaler, data from QVAR, which is bioequivalent to QVAR RediHaler, show that the majority of medication is deposited in the lungs, not the oropharynx.3,10

Lung regions as isolated for imaging

Based on an open-label study in 7 patients with mild asthma designed to determine the lung deposition and distribution of radiolabeled HFA-BDP from 2 devices, using coordination and discoordinated techniques in the press and breathe (P&B) inhaler. The distribution shown here is for the P&B on-time group, who were trained to actuate 0.32 seconds after start of inspiration.11

QVAR RediHaler is the

first and only breath-actuated aerosol ICS12

For your adult and pediatric patients ages 4 and up12

<60 L/min is considered to be a low inspiratory flow rate.

QVAR RediHaler 80 mcg and 40 mcg inhalers and packages
 

QVAR RediHaler

Innovation

QVAR RediHaler is a breath-actuated device that eliminates the need for hand–breath coordination and is designed to be used without a spacer.12§
Pressurized metered-dose inhaler

Hand–breath coordination with pMDIs can be a struggle

  • Many patients lack the proper hand–breath coordination required to use their press-and-breathe inhalers correctly14,15
  • Poor hand–breath coordination can adversely impact dose delivery14,16,17
    • This may result in a subtherapeutic amount of medicine reaching the lungs
  • In a prospective study, up to 67% of patients in a sub-set (n=193) who were using MDIs had poor hand–breath coordination15
Inhaler spacer

Spacers are not always a solution

  • An observational study found no evidence that prescribed spacer devices are associated with improved asthma outcomes for extrafine- or fine-particle ICSs administered by pMDIs18
    • This study of patients ages 12 to 80 years compared the deposition of drug molecules for extrafine- and fine-particle ICSs with and without a spacer. There were 4 cohorts in the study: extrafine-particle ICSs with a spacer (n=1840) and without a spacer (n=1840), and fine-particle ICSs with a spacer (n=412) and without a spacer (n=412)18
  • In a survey (n=53), 85% of patients prescribed spacers did not use them19

§Do not use with a spacer.

pMDI=pressurized metered-dose inhaler.

An innovative device

with 3 basic steps for operation12

Read complete Instructions for Use in full Prescribing Information

1. OPEN
How to use QVAR RediHaler step 1
  • Open the white cap
  • Breathe out fully

Remember: Do not open the cap until you are ready to take your inhalation and never breathe out into the inhaler mouthpiece.

2. INHALE
How to use QVAR RediHaler step 2
  • Place the mouthpiece in your mouth and close your lips around it so you form a good seal
  • Inhale deeply to release the medicine
  • Remove inhaler, hold breath for 5 to 10 seconds, then, breathe out slowly, away from the inhaler

Remember: Hold inhaler upright as you take your inhalation and do not cover the vents on top.

3. CLOSE
How to use QVAR RediHaler step 3
  • Close the white cap after inhaling to prepare your next inhalation

Remember: If your healthcare provider has told you to take more than 1 inhalation per dose, make sure the white cap is closed and repeat steps 1-3. After taking your prescribed number of inhalations, rinse your mouth with water without swallowing to help reduce the risk of a fungal infection (thrush) in your mouth.

IMPORTANT: Always close the cap after use. This primes the device for the next dose.

UNDERSTANDING

inspiratory flow rate

To trigger asthma medication release, breath-actuated devices are dependent on inspiratory flow, which varies among patients20,21

  • With some common breath-actuated devices, the inspiratory flow rate required for activation ranges from 20 L/min to 88 L/min22
  • Failure to achieve the required inspiratory flow rate may reduce dose consistency and delivery20
    • This may compromise medication deposition

The average inspiratory flow rate for tidal breathing (breathing at rest) of young children (6 months to 4 years of age) is 8 to 16 L/min23

Graphic showing tidal breathing range of 8 to 16 L/min for young children

The average inspiratory flow rate for tidal breathing of adults is 13 to 18 L/min23

Graphic showing tidal breathing range of 13 to 18 L/min for adults
 

QVAR RediHaler Actuates with a

low inspiratory flow rate of 20 L/min12,13*

Inspiratory flow rate required to actuate QVAR RediHaler

Graphic showing QVAR RediHaler inspiratory flow rate of 20 L/min

The propellant hydrofluoroalkane in QVAR RediHaler assists in dose delivery by propelling medication out of the device after a patient takes an inhalation12

*<60 L/min is considered to be a low inspiratory flow rate.

Important Safety Information

  • Contraindications: QVAR RediHaler is contraindicated in:
    • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
    • Patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR RediHaler
  • Localized infections: Infections with Candida albicans have occurred in the mouth and pharynx in some patients receiving QVAR RediHaler. Advise rinsing of mouth with water without swallowing after use. If oropharyngeal candidiasis develops, QVAR RediHaler may need to be temporarily interrupted under close medical supervision
  • Deterioration of asthma and acute episodes: Do not use QVAR RediHaler for the relief of acute symptoms. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with QVAR RediHaler
  • Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed in patients who are transferred from systemically active corticosteroids to QVAR RediHaler because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to QVAR RediHaler
  • Immunosuppression: Patients who are on drugs that suppress the immune system, such as corticosteroids, are more susceptible to infections than healthy individuals and should avoid exposure to chicken pox or measles. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex
  • Paradoxical Bronchospasm: Inhaled corticosteroids may produce inhalation-induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If this occurs with QVAR RediHaler, it should be treated immediately with an inhaled, short-acting bronchodilator. Treatment with QVAR RediHaler should be discontinued and alternate therapy instituted
  • Hypersensitivity reactions: Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm, may occur after administration of QVAR RediHaler. Discontinue QVAR RediHaler if such reactions occur
  • Hypercorticism and Adrenal Suppression: It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher than recommended doses. If such changes occur, reduce the QVAR RediHaler dose slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms
  • Effects on Growth: Orally inhaled corticosteroids, including QVAR RediHaler, may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving QVAR RediHaler. To minimize the systemic effects, titrate to the lowest dosage that effectively controls symptoms
  • Reduction in Bone Mineral Density (BMD): Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care
  • Eye Disorders: Glaucoma, increased intraocular pressure, blurred vision and cataracts have been reported following the long-term administration of inhaled corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts
  • Adverse Reactions: Most common adverse reactions (incidence ≥3% and >placebo) include oral candidiasis, upper respiratory tract infection, nasopharyngitis, allergic rhinitis, oropharyngeal pain and sinusitis.

Indication

QVAR RediHaler is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age or older.

Important Limitation of Use: QVAR RediHaler is NOT indicated for the relief of acute bronchospasm.

Please see full Prescribing Information.

References: 1. Gelfand EW, Kraft M. The importance and features of the distal airways in children and adults. J Allergy Clin Immunol. 2009;124(6 Suppl):S84-S87. 2. Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002;109(2 Suppl): S447-S460. 3. Leach CL, Kuehl PJ, Chand R, Ketai L, Norenberg JP, McDonald JD. Characterization of respiratory deposition of fluticasone-salmeterol hydrofluoroalkane-134a and hydrofluoroalkane-134a beclomethasone in asthmatic patients. Ann Allergy Asthma Immunol. 2012;108(3):195-200. 4. Zeidler M, Corren J. Hydrofluoroalkane formulations of inhaled corticosteroids for the treatment of asthma. Treat Respir Med. 2004;3(1):35-44. 5. Data on file (R&D Investigation Report: Assessment of Aerodynamic Particle Size Distribution of BDP BAI and QVAR MDI). Frazer, PA: Teva Respiratory, LLC. November 2017. 6. van der Molen T, Postma DS, Martin RJ, et al. Effectiveness of initiating extrafine-particle versus fine-particle inhaled corticosteroids as asthma therapy in the Netherlands. BMC Pulm Med. 2016;16(80):1-10. 7. National Asthma Education and Prevention Program (NAEPP). Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma–Full Report 2007. Bethesda, MD: US Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute; August 2007. 8. Leach CL, Davidson PJ, Boudreau RJ. Improved airway targeting with the CFC-free HFA–beclomethasone metered-dose inhaler compared with CFC–beclomethasone. Eur Respir J. 1998;12(6):1346-1353. 9. Dolovich M, Labiris R. Imaging drug delivery and drug responses in the lung. Proc Am Thorac Soc. 2004;1:329-337. 10. Small CJ, Gillespie M. Pharmacokinetics of beclomethasone dipropionate delivered by breath-actuated inhaler and metered-dose inhaler in healthy subjects. J Aerosol Med Pulm Drug Deliv. 2018;31(3):182-190. 11. Leach CL, Davidson PJ, Hasselquist BE, Boudreau RJ. Influence of particle size and patient dosing technique on lung deposition of HFA-beclomethasone from a metered dose inhaler. J Aerosol Med. 2005;18(4):379-385. 12. QVAR RediHaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC. 13. Sharma G, Mahler DA, Mayorga VM, Deering KL, Harshaw Q, Ganapathy V. Prevalence of low peak inspiratory flow rate at discharge in patients hospitalized for COPD exacerbation. Chronic Obstr Pulm Dis. 2017;4(3):217-224. 14. Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J. 2002;19(2):246-251. 15. Khassawneh BY, Al-Ali MK, Alzoubi KH, et al. Handling of inhaler devices in actual pulmonary practice: metered-dose inhaler versus dry powder inhalers. Respir Care. 2008;53(3):324-328. 16. Wilkes W, Fink J, Dhand R. Selecting an accessory device with a metered-dose inhaler: variable influence of accessory devices on fine particle dose, throat deposition, and drug delivery with asynchronous actuation from a metered-dose inhaler. J Aerosol Med. 2001;14(3):351-360. 17. Fink JB, Rubin BK. Problems with inhaler use: a call for improved clinician and patient education. Respir Care. 2005;50(10):1360-1374. 18. Guilbert TW, Colice G, Grigg J, et al. Real-life outcomes for patients with asthma prescribed spacers for use with either extrafine- or fine-particle inhaled corticosteroids. J Allergy Clin Immunol Pract. 2017;5(4):1040-1049. 19. Jarvis S, Ind PW, Shiner RJ. Inhaled therapy in elderly COPD patients; time for re-evaluation? Age Ageing. 2007;36(2):213-218. 20. Dal Negro RW. Dry powder inhalers and the right things to remember: a concept review. Multidiscip Respir Med. 2015;10(1):13. doi:10.1186/s40248-015-0012-5. 21. Lavorini F. The challenge of delivering therapeutic aerosols to asthma patients. ISRN Allergy. 2013;102418. doi:10.1155/2013/102418. 22. Data on file (Breath actuated devices and inspiratory flow rates). Frazer, PA: Teva Respiratory, LLC. April 2019. 23. Haidl P, Heindl S, Siemon K, Bernacka M, Cloes RM. Inhalation device requirements for patients’ inhalation maneuvers. Respir Med. 2016;118:65-75.