3 KEY ISSUES AFFECTING INHALED MEDICATION DELIVERY

MEET THE REDIHALER DEVICE

THE QVAR PARTICLE

Learn about dosing

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® (beclomethasone dipropionate HFA) Inhalation Aerosol 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 Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.

References: 1. Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J. 2002;19(2):246-251. 2. 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. 3. 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. 4. Fink JB, Rubin BK. Problems with inhaler use: a call for improved clinician and patient education. Respir Care. 2005;50(10):1360-1374. 5. Guilbert TX, 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. 6. Jarvis S, Ind PW, Shiner RJ. Inhaled therapy in elderly COPD patients; time for re-evaluation? Age Ageing. 2007;36(2):213-218. 7. 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. 8. Lavorini F. The challenge of delivering therapeutic aerosols to asthma patients. ISRN Allergy. 2013;102418. doi:10.1155/2013/102418. 9. Flovent Diskus Prescribing Information. Research Triangle Park, NC; GlaxoSmithKline; July 2017. 10. Pulmicort Flexhaler Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2016. 11. ProAir RespiClick Prescribing Information. Horsham, PA: Teva Respiratory, LLC. 12. ArmonAir RespiClick Prescribing Information. Frazer, PA: Teva Respiratory, LLC. 13. AirDuo RespiClick Prescribing Information. Frazer, PA: Teva Respiratory, LLC. 14. Asmanex Twisthaler Prescribing Information. Whitehouse Station, NJ; Merck & Co., Inc. September 2014. 15. 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. 16. Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002;109(2)(suppl):S447-S460. 17. 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. 18. Zeidler M, Corren J. Hydrofluoroalkane formulations of inhaled corticosteroids for the treatment of asthma. Treat Respir Med. 2004;3(1):35-44. 19. 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. 20. Pickering H, Pitcairn GR, Hirst PH, et al. Regional lung deposition of a technetium 99m-labeled formulation of mometasone furoate administered by hydrofluoroalkane 227 metered-dose inhaler. Clin Ther. 2000;22(12):1483-1493. 21. Leach C, Colice GL, Luskin A. Particle size of inhaled corticosteroids: does it matter? J Allergy Clin Immunol. 2009;124(6)(suppl):S88-S93. 22. QVAR RediHaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC. 23. QVAR Prescribing Information. Frazer, PA: Teva Respiratory, LLC. 24. 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. 25. 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. 26. 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 Institute of Health, National Heart, Lung, and Blood Institute; August 2007. 27. 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 Pulmonary Medicine. 2016;16(80):1-10. 28. Tamura G, Sakae H, Fujino S. In vitro evaluation of dry powder inhaler devices of corticosteroid preparations. Allergol Int. 2012;61:149-154. 29. Berger R, Berger WE. Particle size and small airway effects of mometasone furoate delivered by dry powder inhaler. Allergy Asthma Proc. 2013;34:1-7. 30. Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhaler. Respir Med. 2000;94(suppl B):S3-S9. 31. Drollmann A, Nave R, Steinijans VW, Baumgärtner E, Bethke TD. Equivalent pharmacokinetics of the active metabolite of ciclesonide with and without use of the AeroChamber Plus™ spacer for inhalation. Clin Pharmacokinet. 2006;45(7):729-736. 32. Dolovich M, Labiris R. Imaging drug delivery and drug responses in the lung. Proc Am Thorac Soc. 2004;1:329-337. 33. Newman S, Salmon A, Nave R, Drollmann A. High lung deposition of 99mTc-labeled ciclesonide administered via HFA-MDI to patients with asthma. Respir Med. 2006;100(3):375-384. 34. Hirst PH, Pitcairn GR, Richards JC, Rohatagi S, Gilllen MS, Newman SP. Deposition and pharmacokinetics of an HFA formulation of triamcinolone acetonide delivered by pressurized metered dose inhaler. J Aerosol Med. 2001;14(2):155-165. 35. Small CJ, Gillespie M. Pharmacokinetics of beclomethasone dipropionate delivered by breath-actuated inhaler and metered-dose inhaler in healthy subjects [published online ahead of print September 22, 2017]. J Aerosol Med Pulm Drug Deliv. doi:10.1089/jamp.2017.1397.

If you would like to contact Teva Respiratory headquarters, you may call: 1-888-482-9522.


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® (beclomethasone dipropionate HFA) Inhalation Aerosol 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 Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.