QVAR REDIHALER

1 INDICATIONS AND USAGE QVAR REDIHALER 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. ( 1 ) Limitations of Use : Not indicated for the relief of acute bronchospasm. ( 1 )

2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2.1 ) Starting dosage is based on prior asthma therapy and disease severity. ( 2.2 ) Treatment of asthma in patients 4 to 11 years of age: 40 mcg or 80 mcg twice daily. ( 2.2 ) Treatment of asthma in patients 12 years of age and older: 40 mcg, 80 mcg, 160 mcg, or 320 mcg twice daily ( 2.2 ) Discard QVAR REDIHALER inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first. ( 2.1 ) Do not use a spacer or volume holding chamber ( 2.1 ) 2.1 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 [see Patient Counseling Information ( 17 )] . 2.2 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 hour…

5 WARNINGS AND PRECAUTIONS Oropharyngeal candidiasis: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk. ( 5.1 ) Deterioration of asthma and acute episodes: Do not use QVAR REDIHALER for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.2 ) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to QVAR REDIHALER. ( 5.3 ) Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Use with caution in patients with these infections because of the potential for worsening of these infections. ( 5.4 ) Paradoxical bronchospasm: Bronchospasm, with an immediate increase in wheezing, may occur after dosing. Treat bronchospasm immediately with inhaled, short-acting bronchodilator and discontinue QVAR REDIHALER. ( 5.5 ) Hypersensitivity reactions: Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm may occur. Discontinue QVAR REDIHALER if such reactions occur. ( 5.6 ) Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue QVAR REDIHALER slowly. ( 5.7 ) Effects on growth: Monitor growth of pediatric patients. ( 5.8 ) Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. ( 5.9 ) Glaucoma and cataracts: Monitor patients with change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts closely. ( 5.10 ) 5.1 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. 5.2 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. 5.3 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 sup…

4 CONTRAINDICATIONS QVAR REDIHALER is contraindicated in: the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR REDIHALER [see Warnings and Precautions ( 5.6 )] . Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. ( 4 ) Hypersensitivity to any of the ingredients of QVAR REDIHALER. ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Oropharyngeal candidiasis [see Warnings and Precautions ( 5.1 )] Immunosuppression and risk of infections [see Warnings and Precautions ( 5.4 )] Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.7 )] Reduction in bone mineral density [see Warnings and Precautions ( 5.9 )] Growth effects [see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.4 )] Glaucoma and cataracts [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (incidence > 3% and > placebo) include oral candidiasis, upper respiratory tract infection, nasopharyngitis, allergic rhinitis, oropharyngeal pain and sinusitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 (2) 7 (3) 15 (7) 6 (3) 9 (8) 1 (<1) Upper Respiratory Tract Infection 3 (3) 3 (3) 9 (4) 6 (3) 17 (8) 4 (4) 6 (2) Nasopharyngitis 4 (4) 2 (2) 3 (1) 3 (1) 6 (3) 4 (4) 4 (1) Oropharyngeal Pain 2 (2) 2 (2) 1 (<1) 3 (1) 6 (3) 4 (4) 2 (<1) Viral Upper Respiratory Tract Infection 3 (3) 0 1 (<1) 3 (1) 4 (2) 2 (<1) 4 (1) Sinusitis 3 (3) 0 1 (<1) 2 (<1) 1 (<1) 1 (<1) 2 (<1) Rhinitis Allergic 0 3 (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 (2.4) 1 (0.8) 6 (4.8) 5 (4.0) 5 (3.9) Nasopharyngitis 5 (4.0) 11 (8.8) 6 (4.8) 6 (4.8) 4 (3.1) Viral Upper Respiratory Tract Infection 5 (4.0) 5 (4.0) 3 (2.4) 1 (0.8) 4 (3.1) Pharyngitis 4 (3.2) 4 (3.2) 4 (3.2) 4 (3.2) 2 (1.6) Cough 1 (0.8) 3 (2.4) 9 (7.2) 6 (4.8) 4 (3.1) Vomiting 2 (1.6) 2 (1.6) 4 (3.2) 0 2 (1.6) Headache 2 (1.6) 5 (4.0) 0 4 (3.2) 5 (3.9) Pyrexia 1 (0.8) 4 (3.2) 4 (3.2) 3 (2.4) 3 (2.4) *QVAR MDI=QVAR Inhalation Aerosol Other …