EFFICACY PROFILE

QVAR RediHaler demonstrates early and sustained improvements in lung function

Improvements seen as early as Week 21

QVAR RediHaler 80 mcg/day and 160 mcg/day significantly improved FEV1 over 12 weeks by 0.124 L and 0.116 L (P=0.0005 and P=0.001), respectively, versus placebo1,2

Chart showing mean change in lung function using QVAR RediHaler 80 mcg/day and 160 mcg/day 
                 over 12 weeks vs placebo Chart showing mean change in lung function using QVAR RediHaler 80 mcg/day and 160 mcg/day 
                 over 12 weeks vs placebo

STUDY DESIGN: Randomized, double-blind, placebo-controlled, parallel-group, 12-week clinical study of 270 patients 12 years of age and older with symptomatic asthma, 104 of whom had previously been treated with an inhaled corticosteroid (ICS). Patients were randomized to receive either 40 mcg or 80 mcg of QVAR RediHaler twice daily or placebo. Primary endpoint was change in FEV1 from baseline through 12 weeks.2

QVAR RediHaler improves lung function

QVAR RediHaler 320 mcg/day and 640 mcg/day significantly improved FEV1 over 6 weeks by 0.144 L and 0.150 L (P<0.0001), respectively, versus placebo2,3

Chart showing mean change in lung function using QVAR RediHaler 320 mcg/day and 640 mcg/day 
                 over 6 weeks vs placebo Chart showing mean change in lung function using QVAR RediHaler 320 mcg/day and 640 mcg/day 
                 over 6 weeks vs placebo

STUDY DESIGN: Randomized, double-blind, placebo-controlled, parallel-group, 6-week clinical study of 425 patients 12 years of age and older with symptomatic asthma, 257 of whom had previously been treated with an inhaled corticosteroid (ICS) with or without a long-acting bronchodilator. Patients were randomized to receive either 160 mcg or 320 mcg of QVAR RediHaler twice daily, QVAR twice daily, or placebo. Primary endpoint was change in FEV1 from baseline through 6 weeks.2

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SAFETY PROFILE

Safety profiles for QVAR RediHaler and QVAR

Adult and adolescent safety profile

Adverse reactions experienced by ≥3% of adult and adolescent patients 12 years of age and older in the QVAR RediHaler or QVAR groups and greater than placebo by treatment and daily dose2

Other adverse reactions that occurred in clinical trials using QVAR RediHaler with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were back pain, headache, pain, nausea, and cough.2

Table showing adverse reactions of QVAR 
                  RediHaler vs QVAR pMDI and placebo in adolescent and adult patients Table showing adverse reactions of QVAR 
                  RediHaler vs QVAR pMDI and placebo in adolescent and adult patients

Pediatric safety profile

Adverse reactions experienced by ≥3% of pediatric patients 4 to 11 years of age in the QVAR RediHaler or QVAR groups and greater than placebo by treatment and daily dose2

Other adverse reactions that occurred in clinical trials using QVAR RediHaler with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were influenza, gastroenteritis viral, ear infection, oral candidiasis, diarrhea, and myalgia.2

Blue particle person
Table showing adverse reactions of QVAR RediHaler vs QVAR pMDI and placebo in pediatric patients Table showing adverse reactions of QVAR RediHaler vs QVAR pMDI and placebo in pediatric patients

FEV1=forced expiratory volume in one second.

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. Hampel FC Jr, Carr W, Gillespie M, Small CJ. Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) via a breath-actuated inhaler for persistent asthma. Allergy Asthma Proc. 2017;38(6):419-430. 2. QVAR RediHaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC. 3. Data on file (Clinical Study Report: A randomized, double-blind, placebo-controlled, parallel-group, 6-week clinical study to assess the efficacy and safety of beclomethasone dipropionate delivered via breath-actuated inhaler (BAI) at 320 or 640 mcg/day in adolescent and adult patients 12 years of age and older with persistent asthma. Study BDB-AS-30039). Frazer, PA: Teva Respiratory, LLC; August 2016.

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.