Qvar Drug Information

Generic name: BECLOMETHASONE DIPROPIONATE HFA

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Uses of Qvar

is indicated in the maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. Limitations of Use: QVAR REDIHALER is not indicated for the relief of acute bronchospasm. QVAR REDIHALER is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older.

Limitations of Use : Not indicated for the relief of acute bronchospasm.

Dosage & Administration of Qvar

General Overview

Administration Administer QVAR REDIHALER by oral inhalation. After inhalation, rinse mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. Consistent dose delivery is achieved, whether using the 40‑ or 80‑mcg strengths, due to proportionality of the 2 products (i.e., 2 actuations of 40‑mcg strength should provide a dose comparable to 1 actuation of the 80‑mcg strength). Inhaler Instructions Patients should be instructed on the proper use of their inhaler.

Do not use QVAR REDIHALER with a spacer or volume holding chamber. Shaking the inhaler prior to use is not necessary. Do not shake the inhaler with the cap open to avoid possible actuation of the device.

Priming QVAR REDIHALER does not require priming. Cleaning Keep the inhaler clean and dry at all times. Never wash or put any part of the inhaler in water.

Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. Dose Counter QVAR REDIHALER has a dose counter attached to the actuator.

When the patient receives the inhaler, the number 120 will be displayed. The dose counter will count down each time a spray is released. When the dose counter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill.

When the dose counter reaches 0, the background will change to solid red. Discard QVAR REDIHALER inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first .

Recommended Dosage Adults and Adolescents 12 years of age and older

The recommended starting dosage for patients 12 years of age and older who are not on an inhaled corticosteroid is 40 to 80 mcg twice daily by oral inhalation, approximately 12 hours apart. The starting dosage is based on previous asthma therapy and disease severity, including consideration of the patients’ current control of asthma symptoms and risk of future exacerbation. For patients switching to QVAR REDIHALER from another inhaled corticosteroid product, select the appropriate starting dosage strength of QVAR REDIHALER based on the strength of the previous inhaled corticosteroid product and disease severity: 40, 80, 160 or 320 mcg twice daily.

For patients who do not respond adequately to the initial dosage after 2 weeks of therapy, increasing the dosage may provide additional asthma control. The maximum recommended dosage for patients 12 years of age and older is 320 mcg twice daily. Pediatric Patients 4 to 11 years The recommended starting dosage for patients aged 4 to 11 years of age is 40 mcg twice daily by oral inhalation, approximately 12 hours apart.

The starting dosage is based on previous asthma therapy and disease severity, including consideration of the patients’ current control of asthma symptoms and risk of future exacerbation. For patients who do not respond adequately to QVAR REDIHALER 40 mcg after 2 weeks of therapy, increasing the dosage to QVAR REDIHALER 80 mcg twice daily may provide additional asthma control. The maximum recommended dosage for patients 4 to 11 years of age is 80 mcg twice daily.

General Dosing Recommendations The onset and degree of symptom relief will vary in individual patients. Improvement in asthma symptoms can occur within 24 hours of the beginning of treatment and should be expected within the first or second week, but maximum benefit should not be expected until 3 to 4 weeks of therapy. Improvement in pulmonary function is usually apparent within 1 to 4 weeks after the start of therapy.

If a dosage regimen of QVAR REDIHALER fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options (e.g., replacing the current strength of QVAR REDIHALER with a higher strength, or adding additional controller therapies) should be considered. As with any inhaled corticosteroid, physicians are advised to titrate the dose of QVAR REDIHALER downward over time to the lowest level that maintains proper asthma control. This is particularly important in children since a controlled study has shown that beclomethasone dipropionate has the potential to affect growth in children.

The maximum number of inhalations should not exceed 8 per day.

Side Effects of Qvar

Clinical Trials Experience

A total of 1858 subjects participated in the QVAR REDIHALER clinical development program. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults and Adolescent Patients 12 years of Age and Older: The adverse reaction information presented in Table 1 is derived from 3 double-blind, placebo-controlled clinical trials in which 1230 patients (751 female and 479 male adults previously treated with as‑needed bronchodilators and/or inhaled corticosteroids) were treated with QVAR REDIHALER (doses of 40, 80, 160, or 320 mcg twice daily) or QVAR (beclomethasone dipropionate HFA) Inhalation Aerosol (QVAR MDI; doses of 160 or 320 mcg twice daily) or placebo.

In considering these data, difference in average duration of exposure and clinical trial design should be taken into account. Table 1: Adverse Reactions Experienced by at Least 3% of Adult and Adolescent Patients in the QVAR REDIHALER or QVAR MDI Groups and Greater Than Placebo by Treatment and Daily Dose Preferred Term Number (%) of patients QVAR REDIHALER QVAR MDI Placebo 80 mcg N=90 160 mcg N=92 320 mcg N=214 640 mcg N=211 320 mcg N=212 640 mcg N=107 N=304 Oral Candidiasis 0 2 7 15 6 9 1 (<1) Upper Respiratory Tract Infection 3 3 9 6 17 4 6 Nasopharyngitis 4 2 3 3 6 4 4 Oropharyngeal Pain 2 2 1 (<1) 3 6 4 2 (<1) Viral Upper Respiratory Tract Infection 3 0 1 (<1) 3 4 2 (<1) 4 Sinusitis 3 0 1 (<1) 2 (<1) 1 (<1) 1 (<1) 2 (<1) Rhinitis Allergic 0 3 0 2 (<1) 0 1 (<1) 0 *QVAR MDI=QVAR Inhalation Aerosol 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. Pediatric Patients 4 to 11 Years of Age: The adverse reaction information presented in Table 2 concerning QVAR REDIHALER and QVAR MDI is derived from one 12‑week placebo-controlled study in pediatric patients 4 to 11 years of age with persistent asthma.

Table 2: Adverse Reactions Experienced by at Least 3% of Patients 4 to 11 Years of Age in the QVAR REDIHALER or QVAR MDI Groups and Greater Than Placebo by Treatment and Daily Dose Preferred Term Number (%) of patients QVAR REDIHALER QVAR MDI Placebo 80 mcg N=126 160 mcg N=125 80 mcg N=125 160 mcg N=125 N=127 Upper Respiratory Tract Infection 3 1 6 5 5 Nasopharyngitis 5 11 6 6 4 Viral Upper Respiratory Tract Infection 5 5 3 1 4 Pharyngitis 4 4 4 4 2 Cough 1 3 9 6 4 Vomiting 2 2 4 0 2 Headache 2 5 0 4 5 Pyrexia 1 4 4 3 3 *QVAR MDI=QVAR Inhalation Aerosol 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.

Postmarketing Experience

In addition to the adverse reactions reported from clinical trials with QVAR REDIHALER, the following adverse reactions have been identified during post-approval use of QVAR MDI and other inhaled corticosteroids. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Local Effects: Localized infections with Candida albicans have occurred in patients treated with beclomethasone dipropionate or other orally inhaled corticosteroids . Psychiatric and Behavioral Changes: Aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation have been reported (primarily in children). Eye Disorders: Blurred vision, central serous chorioretinopathy (CSC).

Warnings & Cautions for Qvar

Oropharyngeal Candidiasis Localized infections with Candida albicans have occurred in the mouth

and pharynx in some patients receiving QVAR REDIHALER. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with QVAR REDIHALER therapy, but at times therapy with QVAR REDIHALER may need to be temporarily interrupted under close medical supervision. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

Deterioration of Asthma and Acute Episodes

QVAR REDIHALER is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short‑acting beta 2 ‑agonist, not QVAR REDIHALER, should be used to relieve acute symptoms such as shortness of breath. 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. During such episodes, patients may require therapy with oral corticosteroids.

Transferring Patients from Systemic Corticosteroid Therapy

HPA Suppression/Adrenal Insufficiency 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. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic‑pituitary‑adrenal (HPA) function. Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn.

During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infections (particularly gastroenteritis) or other conditions with severe electrolyte loss. Although QVAR REDIHALER may provide control of asthmatic symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid that is necessary for coping with these emergencies. During periods of stress or a severe asthmatic attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physician for further instruction.

These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic steroids during periods of stress or a severe asthma attack. Patients requiring oral or other systemic corticosteroids should be weaned slowly from oral or other systemic corticosteroid use after transferring to QVAR REDIHALER. Lung function (FEV 1 or PEF), beta‑agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral or other systemic corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Unmasking of Allergic Conditions Previously Suppressed by Systemic Corticosteroids Transfer of patients from systemic corticosteroid therapy to QVAR REDIHALER may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions. Corticosteroid Withdrawal Symptoms During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.

Immunosuppression and Risk of Infections Persons who are on drugs which suppress

the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune patients on corticosteroids. In such patients who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure.

It is not known how the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection, and nor is the contribution of the underlying disease and/or prior corticosteroid treatment known. If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

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 inhalation induced bronchospasm occurs following dosing 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.

Immediate 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

QVAR REDIHALER will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since beclomethasone dipropionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of QVAR REDIHALER in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with QVAR REDIHALER should be observed carefully for any evidence of systemic corticosteroid effects.

Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when beclomethasone dipropionate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of QVAR REDIHALER should be reduced 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. Monitor the growth of pediatric patients receiving QVAR REDIHALER routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including QVAR REDIHALER, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms .

Reduction in Bone Mineral Density Decreases in bone mineral density (BMD) have

been observed with long‑term administration of products containing inhaled corticosteroids. The clinical significance of small changes in BMD with regard to long‑term outcomes, such as fracture, is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids) should be monitored and treated with established standards of care. 5.10 Glaucoma and Cataracts Glaucoma, increased intraocular pressure, blurred vision and cataracts have been reported following the use of 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 while using QVAR REDIHALER.

Contraindications for Qvar

is contraindicated in: the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required . in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR REDIHALER . Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to any of the ingredients of QVAR REDIHALER.

Clinical Studies of Qvar

Trials in the Maintenance Treatment of Asthma Adult and Adolescent Patients 12

Years of Age and Older Two confirmatory clinical trials were conducted comparing QVAR REDIHALER with placebo in adult and adolescent patients with persistent asthma (Trial 1 and Trial 2). Trial 1 (NCT02040779): This randomized, double-blind, parallel-group, placebo-controlled, 12-week, efficacy and safety trial compared QVAR REDIHALER 40 and 80 mcg given as 1 inhalation twice daily with placebo in adult and adolescent patients with persistent symptomatic asthma despite low-dose inhaled corticosteroid or non-corticosteroid asthma therapy. Patients aged 12 years and older who met the entry criteria including FEV 1 40-85 percent of predicted normal, reversible bronchoconstriction of 15% with short-acting inhaled beta-agonist entered a 14-21 day run-in period. 270 patients (104 previously treated with inhaled corticosteroids) who met all the randomization criteria including asthma symptoms and rescue medication use were discontinued from asthma maintenance medication and randomized equally to treatment with QVAR REDIHALER 80 mcg/day, QVAR REDIHALER 160 mcg/day or placebo. Baseline FEV 1 values were similar across treatments.

The primary endpoint for this trial was the standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV 1 ) area under the effect curve from time zero to 12 weeks. Patients in both treatment groups had significantly greater improvements in trough FEV 1 compared to placebo (QVAR REDIHALER 80 mcg/day, LS mean change of 0.124 L and QVAR REDIHALER 160 mcg/day, LS mean change of 0.116 L over 12 weeks) (Table 3). In addition, the mean change from baseline is displayed in Figure 1. Both doses of QVAR REDIHALER were effective in improving asthma control with significantly greater improvements in FEV 1 and morning PEF when compared to placebo. Reduction in asthma symptoms was also supportive of the efficacy of QVAR REDIHALER. Figure 1: A 12‑Week Clinical Trial in Patients with Asthma: Mean Change in FEV 1 Trial 2 (NCT02513160): This randomized, double-blind, parallel-group, placebo-controlled, 6-week, efficacy and safety trial compared QVAR REDIHALER 40 and 80 mcg given as 4 inhalations twice daily and placebo in adult and adolescent patients with persistent symptomatic asthma despite treatment with non-corticosteroid, inhaled corticosteroids (with or without a long acting beta agonist ), or combination asthma therapy.

The study also included a reference treatment group, QVAR ® Inhalation Aerosol (QVAR MDI) 40 mcg, 4 inhalations twice daily. Patients aged 12 years and older who met the entry criteria including FEV 1 50-90% predicted normal, reversible bronchoconstriction of at least 10% with short-acting inhaled beta-agonist discontinued baseline asthma treatment and entered a 2-4 week run-in period. 425 patients (257 previously treated with ICS with or without LABA) who met all the randomization criteria including FEV 1 of 40-85% predicted and 15% reversibility with short-acting inhaled beta-agonist, and asthma symptoms were randomized equally to QVAR REDIHALER 320 mcg/day, QVAR REDIHALER 640 mcg/day, QVAR MDI 320 mcg/day or placebo. Baseline FEV 1 values were similar across treatments.

Similar results were demonstrated with QVAR MDI. Figure 2: A 6‑Week Dose Response Clinical Trial in Patients with Inhaled Corticosteroid-Dependent Asthma: Mean Change in FEV 1 as Percent of Predicted Side-by-side comparison of the primary analysis of standardized baseline-adjusted trough morning FEV 1 from time zero to the end of the treatment period for both studies is shown below in Table 3. Table 3: Primary Analysis of Standardized Baseline-Adjusted Trough Morning FEV 1 (L) AUEC from Time Zero to the End of the Treatment Period 12-week Study and 6-week Dose Response Study 12 weeks; FAS 6 weeks; mITT Analysis set Parameter Statistic Placebo (N=90) QVAR REDIHALER 80 mcg/day (N=88) QVAR REDIHALER 160 mcg/day (N=92) Placebo (N=107) QVAR REDIHALER 320 mcg/day (N=108) QVAR REDIHALER 640 mcg/day (N=105) QVAR MDI * 320 mcg/day (N=105) Difference from placebo Difference of Least Square mean — 0.124 0.116 — 0.144 0.150 0.148 95% CI — 0.054, 0.193 0.048, 0.185 — 0.0807, 0.2066 0.0868, 0.2132 0.0847, 0.2114 *QVAR MDI=QVAR Inhalation Aerosol Pediatric Patients 4 to 11 Years of Age This randomized, double-blind, parallel-group, placebo controlled, 12-week, global efficacy and safety trial (NCT02040766) compared QVAR REDIHALER 40 or 80 mcg, QVAR MDI 40 or 80 mcg or placebo given as 1 inhalation twice daily in pediatric patients aged 4 through 11 years old with persistent symptomatic asthma despite treatment with non-corticosteroid or low dose inhaled corticosteroid (with or without a long acting beta agonist ). Patients aged 4 to 5 years who were technically unable to complete spirometry participated in the safety population. Patients who met the entry criteria including FEV 1 40-90% predicted normal and reversible bronchoconstriction of at least 12% with short acting inhaled beta agonist entered a 14-21 day run in period. Patients who met the randomization criteria including asthma symptoms and rescue medication use discontinued asthma therapy and were randomized equally across treatment groups.

Five hundred sixty-eight pediatric patients with symptomatic asthma of which 410 had previously been treated with low dose inhaled corticosteroids with or without a LABA were randomized to receive either 40 mcg or 80 mcg twice daily of QVAR REDIHALER, QVAR MDI or placebo. The primary endpoint was the change from baseline in trough percent predicted FEV 1 AUEC (0-12 weeks). While the primary endpoint, was not statistically significant, change in weekly average of daily morning peak expiratory flow (PEF, L/min) over the 12 week treatment period was 11.3 and 8.5 for the 80 mcg/day and 160 mcg/day doses of QVAR REDIHALER, respectively, at nominal significance. Similar results were seen with evening PEF. Figure 1 Figure 2

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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