Label: QNASL- beclomethasone dipropionate aerosol, metered

  • NDC Code(s): 59310-210-08, 59310-210-12, 59310-210-13, 59310-210-14
  • Packager: Teva Respiratory, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 02/15

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use QNASL Nasal Aerosol safely and effectively. See full prescribing information for QNASL Nasal Aerosol.
    QNASL™ (beclomethasone dipropionate) Nasal Aerosol
    For Intranasal Use Only
    Initial U.S. Approval: 1976

    RECENT MAJOR CHANGES

    Indications and Usage (1.1) 12/14
    Dosage and Administration, Allergic Rhinitis (2.1) 12/14
    Warnings and Precautions, Local Nasal Effects (5.1) 12/14

    INDICATIONS AND USAGE

    QNASL Nasal Aerosol is a corticosteroid indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years of age and older. (1.1)

    DOSAGE AND ADMINISTRATION

    QNASL Nasal Aerosol is for intranasal use only.

    The recommended dose of QNASL 80 mcg Nasal Aerosol in patients 12 years and older is 320 mcg per day administered as 2 actuations in each nostril once daily (maximum total daily dose of 4 actuations per day). ( 2.1)
    The recommended dose of QNASL 40 mcg Nasal Aerosol in children aged 4 to 11 years of age is 80 mcg per day administered as 1 actuation in each nostril once daily (maximum total daily dose of 2 actuations per day). ( 2.1)

    DOSAGE FORMS AND STRENGTHS

    QNASL Nasal Aerosol is available in two strengths:

    Each actuation of QNASL 40 mcg Nasal Aerosol delivers 40 mcg of beclomethasone dipropionate. ( 3)
    Each actuation of QNASL 80 mcg Nasal Aerosol delivers 80 mcg of beclomethasone dipropionate. ( 3)
    Each strength is supplied in an 8.7 g canister containing 120 actuations; QNASL 40 mcg Nasal Aerosol is also supplied in a 4.9 g canister containing 60 actuations. ( 3)

    CONTRAINDICATIONS

    Patients with a history of hypersensitivity to beclomethasone dipropionate and/or any other QNASL Nasal Aerosol ingredients. (4)

    WARNINGS AND PRECAUTIONS

    Nasal discomfort, epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. ( 5.1)
    Development of glaucoma or posterior subcapsular cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. ( 5.2)
    Hypersensitivity, rash, and urticaria may occur after administration of QNASL Nasal Aerosol. ( 5.3)
    Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. ( 5.4)
    Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue QNASL Nasal Aerosol slowly. ( 5.5)
    Potential reduction in growth velocity in pediatric patients. Monitor growth routinely in pediatric patients receiving QNASL Nasal Aerosol. ( 5.6, 8.4)

    ADVERSE REACTIONS

    The most common adverse reactions (≥ 1% and greater than placebo) in patients 12 years of age and older include nasal discomfort, epistaxis, and headache. (6.1)

    The most common adverse reactions (≥ 2% and greater than placebo) in children 4 to 11 years of age include headache, pyrexia, upper respiratory tract infection, and nasopharyngitis. (6.1)

    To report SUSPECTED ADVERSE REACTIONS, contact Teva Respiratory, LLC at 1-888-482-9522 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

    Revised: 2/2015

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  • FULL PRESCRIBING INFORMATION: CONTENTS*
  • 1 INDICATIONS AND USAGE

    1.1 Treatment of Nasal Symptoms of Allergic Rhinitis

    QNASL Nasal Aerosol is indicated for the treatment of the nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years of age and older.

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  • 2 DOSAGE AND ADMINISTRATION

    Administer QNASL Nasal Aerosol by the intranasal route only. QNASL Nasal Aerosol must be primed prior to initial use by actuating four times. To do this, remove the protective dust cap from the device, hold the device upright between your thumb and forefinger (index finger) (the canister should be on top, pointing down), and spray 4 times into the air, away from your eyes and face. After the initial priming, the dose counter should read 120 for QNASL 40 mcg Nasal Aerosol and QNASL 80 mcg Nasal Aerosol 120-actuation products and 60 for QNASL 40 mcg Nasal Aerosol 60-actuation product. If QNASL Nasal Aerosol is not used for 7 consecutive days it should be primed by spraying 2 times. See accompanying illustrated Patient Information and Instructions for Use leaflet for proper use of QNASL Nasal Aerosol.

    2.1 Allergic Rhinitis

    Adults and Adolescents (12 Years of Age and Older): The recommended dose of QNASL Nasal Aerosol is 320 mcg per day administered as 2 actuations in each nostril (QNASL 80 mcg Nasal Aerosol) once daily (maximum total daily dose of 4 actuations per day).

    Children (4 to 11 Years of Age): The recommended dose of QNASL Nasal Aerosol is 80 mcg per day administered as 1 actuation in each nostril (QNASL 40 mcg Nasal Aerosol) once daily (maximum total daily dose of 2 actuations per day).

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  • 3 DOSAGE FORMS AND STRENGTHS

    QNASL Nasal Aerosol is a nonaqueous nasal spray solution.

    Each actuation of QNASL 40 mcg Nasal Aerosol delivers 40 mcg of beclomethasone dipropionate and each actuation of QNASL 80 mcg Nasal Aerosol delivers 80 mcg of beclomethasone dipropionate. Each strength is supplied in an 8.7 g canister containing 120 actuations; QNASL 40 mcg Nasal Aerosol is also supplied in a 4.9 g canister containing 60 actuations.

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  • 4 CONTRAINDICATIONS

    QNASL Nasal Aerosol is contraindicated in patients with a history of hypersensitivity to beclomethasone dipropionate and/or any other QNASL Nasal Aerosol ingredients [see Warnings and Precautions (5.3)].

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  • 5 WARNINGS AND PRECAUTIONS

    5.1 Local Nasal Effects

    Nasal Discomfort, Epistaxis, and Nasal Ulceration: In clinical trials of 2 to 52 weeks duration, epistaxis and nasal ulcerations were observed more frequently and some epistaxis events were more severe in patients treated with QNASL Nasal Aerosol than those who received placebo. In the 52-week safety trial in patients with perennial allergic rhinitis, nasal erosions were identified in 4 of 415 patients and a nasal ulceration was identified in 1 of 415 patients treated with QNASL Nasal Aerosol. No nasal erosions or ulcerations were reported for patients who received placebo. In clinical trials conducted in pediatric patients ages 4 to 11 years, the local nasal effect was similar to those reported in patients 12 years of age and older. Patients using QNASL Nasal Aerosol over several months or longer should be examined periodically for possible changes in the nasal mucosa. If an adverse reaction (e.g., erosion, ulceration) is noted, discontinue QNASL Nasal Aerosol. [see Adverse Reactions (6.1)].

    Candida Infection: In previous clinical trials with an aqueous formulation of beclomethasone dipropionate administered intranasally, localized infections of the nose and pharynx with Candida albicans had been reported. There were no instances of similar infections observed in clinical trials with QNASL Nasal Aerosol. If such an infection develops, it may require treatment with appropriate local therapy and discontinuation of QNASL Nasal Aerosol treatment. Thus, patients using QNASL Nasal Aerosol over several months or longer should be examined periodically for evidence of Candida infection.

    Nasal Septal Perforation: Instances of nasal septal perforation have been reported in patients following the intranasal application of beclomethasone dipropionate. There were no nasal septal perforations reported during clinical trials in the indicated dose of QNASL 80 mcg Nasal Aerosol administered as 320 mcg once daily in adults and adolescents. There was one report of nasal septal perforation observed in the dose-ranging pediatric clinical trial.

    Impaired Wound Healing: Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use QNASL Nasal Aerosol until healing has occurred.

    5.2 Glaucoma and Cataracts

    Use of intranasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

    Glaucoma and cataract formation was evaluated with ocular assessments that included intraocular pressure measurements and slit lamp examinations in 245 adolescent and adult patients (12 years of age and older) with perennial allergic rhinitis who were treated with QNASL Nasal Aerosol 320 mcg daily (N=197) or placebo (N=48) for up to 52 weeks. In 94% of patients, intraocular pressure (IOP) remained within the normal range (<21 mmHg) during the treatment portion of the trial. There were 10 patients (5%) treated with QNASL Nasal Aerosol and 1 patient (2%) treated with placebo that had intraocular pressure that increased above normal levels (≥21 mmHg) and greater than baseline during the treatment portion of the trial. Two of these occurrences in patients treated with QNASL Nasal Aerosol were reported as adverse reactions, one serious. No instances of cataract formation or other clinically significant ocular incidents were reported in this 52-week safety trial.[see Adverse Reactions (6.1)].

    5.3 Hypersensitivity Reactions Including Anaphylaxis

    Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reported following administration of beclomethasone dipropionate nasally administered and inhalationally administered products. Angioedema, urticaria, and rash have been reported following administration of QNASL Nasal Aerosol. Discontinue QNASL Nasal Aerosol if any such reactions occur [see Contraindications (4)].

    5.4 Immunosuppression

    Persons who are using drugs that suppress the immune system (e.g., corticosteroids) are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is 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 or measles develops, treatment with antiviral agents may be considered.

    Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections.

    5.5 Hypothalamic-Pituitary-Adrenal Axis Effect

    When intranasal steroids are used at higher-than-recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of QNASL Nasal Aerosol should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.

    The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal (e.g., joint and/or muscular pain, lassitude, and depression). Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.

    5.6 Effect on Growth

    Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving QNASL Nasal Aerosol [see Use in Specific Populations (8.4)].

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  • 6 ADVERSE REACTIONS

    Systemic and local corticosteroid use may result in the following:

    Epistaxis, nasal discomfort, nasal ulcerations, Candida albicans infection, and impaired wound healing [see Warnings and Precautions (5.1)]
    Glaucoma and cataracts [see Warnings and Precautions (5.2)]
    Hypercorticism, adrenal suppression, and growth reduction [see Warnings and Precautions (5.5)(5.6), Use in Specific Populations (8.4)]
    Immunosuppression [see Warnings and Precautions (5.4)]

    6.1 Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    Adults and Adolescents 12 Years of Age and Older:

    The safety data described below for adults and adolescents 12 years of age and older with seasonal or perennial allergic rhinitis are based on 4 placebo-controlled clinical trials of 2 to 6 weeks duration evaluating doses of beclomethasone nasal aerosol from 80 to 320 mcg once daily. These short-term trials included a total of 1394 patients with either seasonal or perennial allergic rhinitis. Of these, 575 (378 female and 197 male) received at least one dose of QNASL Nasal Aerosol, 320 mcg once daily and 578 (360 female and 218 male) received placebo. Patient ages ranged from 12 to 82 years and the racial distribution of patients was 81% white, 16% black, and 4% other.

    Short-Term (2–6 Weeks) Trials:Less than 2% of patients in the clinical trials discontinued treatment because of adverse reactions with the rate of withdrawal among patients who received QNASL Nasal Aerosol similar to or lower than the rate among patients who received placebo. Table displays the common adverse reactions (≥ 1% and greater than placebo-treated patients).

     
    Table 1. Adverse Events With ≥ 1% Incidence and Greater than Placebo in QNASL
     
    Nasal Aerosol-Treated Adult and Adolescent Patients with Seasonal or
     
    Perennial Allergic Rhinitis in Controlled Clinical Trials of 2 to 6 Weeks
     
    Duration (Safety Population)

    Adult and Adolescent Patients 12 Years of Age and Older

    QNASL Nasal Aerosol
    320 mcg
    (N = 575)
    n (%)

    Placebo
    (N = 578)
    n (%)

    Nasal Discomfort

    30 (5.2)

    28 (4.8)

    Epistaxis

    11 (1.9)

    7 (1.2)

    Headache

    13 (2.3)

    9 (1.6)

    Nasal ulcerations occurred in 2 patients treated with placebo and in 1 patient treated with QNASL Nasal Aerosol. There were no differences in the incidence of adverse reactions based on gender or race. Clinical trials did not have sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.

    Long-Term 52-Week Safety Trial: In a 52-week placebo-controlled long-term safety trial in patients with PAR, 415 patients (128 males and 287 females, aged 12 to 74 years) were treated with QNASL Nasal Aerosol at a dose of 320 mcg once daily and 111 patients (44 males and 67 females, aged 12 to 67 years) were treated with placebo. Of the 415 patients treated with QNASL Nasal Aerosol, 219 patients were treated for 52 weeks and 196 patients were treated for 30 weeks. While most adverse events were similar in type and rate between the treatment groups, epistaxis occurred more frequently in patients who received QNASL Nasal Aerosol (45 out of 415, 11%) than in patients who received placebo (2 out of 111, 2%). Epistaxis also tended to be more severe in patients treated with QNASL Nasal Aerosol. In 45 reports of epistaxis in patients who received QNASL Nasal Aerosol, 27, 13, and 5 cases were of mild, moderate, and severe intensity, respectively, while the reports of epistaxis in patients who received placebo were of mild (1) and moderate (1) intensity. Seventeen patients treated with QNASL Nasal Aerosol experienced adverse reactions that led to withdrawal from the trial compared to 3 patients treated with placebo. There were 4 nasal erosions and 1 nasal septum ulceration which occurred in patients who received QNASL Nasal Aerosol, and no erosions or ulcerations noted in patients who received placebo. No patient experienced a nasal septum perforation during the trial.

    Pediatric Patients Aged 4 to 11 Years:

    The safety data described below for pediatric patients 4 to 11 years of age with seasonal or perennial allergic rhinitis are based on 3 placebo-controlled clinical trials. These trials were 2 to 12 weeks in duration, evaluated doses of beclomethasone nasal aerosol 80 mcg to 160 mcg once daily and included a total of 1360 patients with either seasonal or perennial allergic rhinitis. Of these, 668 (312 female and 356 male) received at least one dose of QNASL Nasal Aerosol, 80 mcg once daily, 241 (116 female and 125 male) received QNASL Nasal Aerosol 160 mcg once daily, and 451 (203 female and 248 male) received placebo. The racial distribution of patients was 73% white, 20% black, and 6% other. Based on the results from the dose ranging trial, 80 mcg once daily was chosen as the dose in pediatric patients.

    Less than 1.5% of patients in the clinical trials discontinued treatment because of adverse reactions with the rate of withdrawal among patients who received QNASL Nasal Aerosol 80 mcg once daily similar to or lower than the rate among patients who received placebo. Table 2 displays the common adverse reactions (≥ 2% and greater than placebo-treated patients). Additionally, epistaxis was reported at a rate of 4% for both QNASL Nasal Aerosol 80 mcg once daily and placebo treated patients.

    Table 2. Adverse Events With ≥ 2% Incidence and Greater than Placebo in QNASL Nasal

     
    Aerosol-Treated Pediatric Patients with Seasonal or Perennial Allergic Rhinitis in
     
    Controlled Clinical Trials of 2 to 12 weeks Duration (Safety Population)

    Pediatric Patients 4 to 11 Years of Age

    QNASL Nasal Aerosol 80 mcg
    (N=668)

    n (%)

    Placebo (N=451)

    n (%)

    Headache

    23 (3.4)

    15 (3.3)

    Pyrexia

    19 (2.8)

    7 (1.6)

    Upper respiratory tract infection

    17 (2.5)

    8 (1.8)

    Nasopharyngitis

    15 (2.2)

    6 (1.3)

    6.2 Postmarketing Experience

    In addition to adverse reactions reported from clinical trials for QNASL Nasal Aerosol, the following adverse events have been reported during postmarketing use of QNASL Nasal Aerosol or other intranasal and inhaled formulations of beclomethasone dipropionate. 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. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to beclomethasone dipropionate or a combination of these factors.

    QNASL Nasal Aerosol: sneezing, burning sensation

    Intranasal beclomethasone dipropionate: Nasal septal perforation, glaucoma, cataracts, loss of taste and smell, and hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported following intranasal administration of beclomethasone dipropionate.

    Inhaled beclomethasone dipropionate: Hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria, and bronchospasm have been reported following the oral inhalation of beclomethasone dipropionate.

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  • 10 OVERDOSAGE

    Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5)]. There are no data available on the effects of acute or chronic overdosage with QNASL Nasal Aerosol.

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  • 11 DESCRIPTION

    Beclomethasone dipropionate USP, the active component of QNASL Nasal Aerosol, is an anti-inflammatory steroid having the chemical name 9-chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17, 21-dipropionate and the following chemical structure:

    Chemical structure.

    Beclomethasone dipropionate, a di-ester of beclomethasone (a synthetic corticosteroid chemically related to dexamethasone), is a white to almost white, odorless powder with a molecular formula of C28H37ClO7 and a molecular weight of 521.1. It is practically insoluble in water, very soluble in chloroform, and soluble in acetone and in dehydrated alcohol.

    QNASL Nasal Aerosol is a pressurized, nonaqueous solution in a metered-dose aerosol device intended ONLY for intranasal use. It contains a solution of beclomethasone dipropionate in propellant HFA-134a (1,1,1,2-tetrafluoroethane) and dehydrated ethanol. QNASL 40 mcg Nasal Aerosol delivers 40 mcg of beclomethasone dipropionate from the nasal actuator and 50 mcg from the valve. QNASL 80 mcg Nasal Aerosol delivers 80 mcg of beclomethasone dipropionate from the nasal actuator and 100 mcg from the valve. Each strength delivers 59 mg of solution from the valve with each actuation. Each canister of QNASL 40 mcg or 80 mcg Nasal Aerosol, contains 8.7 g of drug and excipients and each provides 120 actuations after priming. Additionally, QNASL 40 mcg Nasal Aerosol contains 4.9 g of drug and excipients and provides 60 actuations after priming.

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  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Beclomethasone dipropionate is a prodrug that is extensively converted to the active metabolite, beclomethasone-17-monopropionate. The precise mechanism through which beclomethasone dipropionate affects rhinitis symptoms is unknown. Corticosteroids have been shown to have multiple anti-inflammatory effects, inhibiting both inflammatory cells (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and the release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines).

    Beclomethasone-17-monopropionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 13 times that of dexamethasone, 6 times that of triamcinolone acetonide, 1.5 times that of budesonide and 25 times that of beclomethasone dipropionate. The clinical significance of these findings is unknown.

    12.2 Pharmacodynamics

    Adrenal Function: The effects of QNASL Nasal Aerosol on the HPA axis were evaluated in two 6-week, randomized, double-blind, parallel-group perennial allergic rhinitis trials – one in adult and adolescent patients 12 to 45 years of age and another in children 6 to 11 years of age. In the first study with adolescent and adult patients aged 12 to 45, QNASL Nasal Aerosol 320 mcg, once daily, was compared with both placebo nasal aerosol and a positive control (a placebo/prednisone group that received prednisone 10 mg orally once daily for the final 7 days of the treatment period). In the second study with pediatric patients aged 6 to 11, QNASL Nasal Aerosol 80 mcg once daily was compared to placebo nasal aerosol. HPA-axis function was assessed by 24-hour serial serum cortisol levels prior to the first dose and after 6 weeks of treatment. Patients were domiciled for the 24-hour serum cortisol assessments. The change from baseline in the 24-hour serum cortisol weighted mean for QNASL Nasal Aerosol and placebo after 6 weeks of treatment were compared.

    In the HPA –axis study in patients 12 to 45 years of age, baseline geometric mean serum cortisol weighted mean values were similar in the QNASL Nasal Aerosol 320 mcg/day and placebo treatment groups (9.04 and 8.45 mcg/dL, respectively). After 6 weeks of treatment, the geometric mean values were 8.18 and 8.01 mcg/dL, respectively, with a change from baseline in 24-hour serum cortisol weighted mean for the QNASL Nasal Aerosol and placebo groups of 0.86 and 0.44, resulting in a difference of 0.42. The geometric mean ratio for QNASL Nasal Aerosol 320 mcg/day to placebo was 0.96 (95% CI: 0.87, 1.06). For comparison, in the positive-control (prednisone) treatment group, the geometric mean ratio for placebo to placebo/prednisone 10 mg/day was 3.17 (95% CI: 2.68, 3.74).

    In the HPA-axis study in patients 6 to 11 years of age, baseline geometric mean serum cortisol weighted mean values were similar in the QNASL Nasal Aerosol 80 mcg/day and placebo treatment groups (5.97 and 6.47 mcg/dL, respectively). After 6 weeks of treatment the geometric mean values were 6.19 and 7.13 mcg/dL, respectively with no decrease from baseline values in both treatment groups. The geometric mean ratio for QNASL Nasal Aerosol 80 mcg/day to placebo was 0.91 (95% CI; 0.81, 1.03).

    12.3 Pharmacokinetics

    Absorption

    Following intranasal administration, most of the beclomethasone dipropionate undergoes extensive conversion to its active metabolite, beclomethasone-17-monopropionate, during absorption. Plasma concentrations of beclomethasone dipropionate and beclomethasone-17-monopropionate have been measured with QNASL Nasal Aerosol in 2 adult and/or adolescent clinical trials and 1 pediatric clinical trial.

    The single-dose pharmacokinetics of QNASL Nasal Aerosol were evaluated in a randomized, open-label, 3-period, crossover trial in healthy adult volunteers. Systemic levels of beclomethasone-17-monopropionate and beclomethasone dipropionate after single-dose intranasal administration of beclomethasone dipropionate at doses of 80 and 320 mcg were compared with the systemic levels of beclomethasone-17-monopropionate and beclomethasone dipropionate after administration of orally inhaled beclomethasone dipropionate HFA at a dose of 320 mcg (QVAR® Inhalation Aerosol). The results of this trial demonstrated that the systemic bioavailability of QNASL Nasal Aerosol 320 mcg was approximately 27.5% (approximately 4-fold lower) of that of orally inhaled beclomethasone dipropionate HFA 320 mcg/day based on the plasma concentrations of beclomethasone-17-monopropionate (AUClast: 1139.7 vs 4140.3 hr*pg/mL; GMR: 0.275; 90% CI for the GMR: 0.214, 0.354). The peak exposure to QNASL Nasal Aerosol 320 mcg/day was approximately 19.5% (approximately 5-fold lower) of that of orally inhaled beclomethasone dipropionate HFA 320 mcg/day as measured by beclomethasone-17-monopropionate (Cmax: 262.7 vs 1343.7 pg/mL; GMR: 0.195; 90% CI for the GMR: 0.158, 0.241).

    Following repeated once-daily administration of QNASL Nasal Aerosol, there was no accumulation or increase in plasma exposure to beclomethasone-17-monopropionate or beclomethasone dipropionate, most likely due to the short plasma half-life relative to the dosing frequency.

    Distribution

    The in vitro protein binding for beclomethasone-17-monopropionate was reported to be 94% to 96% over the concentration range of 1000 to 5000 pg/mL. The volume of distribution at steady state for beclomethasone dipropionate is moderate (20 L) but more extensive for beclomethasone-17-monopropionate (424 L).

    Metabolism

    Beclomethasone dipropionate undergoes extensive first-pass metabolism, forming three metabolites via CYP3A4, beclomethasone-17-monopropionate, beclomethasone-21-monopropionate, and beclomethasone. Beclomethasone-17-monopropionate is the major and most active metabolite.

    Elimination

    The major route of elimination of inhaled beclomethasone dipropionate appears to be via metabolism. More than 90% of inhaled beclomethasone dipropionate is found as beclomethasone-17-monopropionate in the systemic circulation. The mean elimination half-life of beclomethasone-17-monopropionate is 2.8 hours. The terminal elimination half-lives of beclomethasone dipropionate and beclomethasone-17-monopropionate following intranasal dosing with QNASL Nasal Aerosol (320 mcg) were approximately 0.3 hours and 4.5 hours, respectively. Irrespective of the route of administration (injection, oral, or inhalation), beclomethasone dipropionate and its metabolites are mainly excreted in the feces. Less than 10% of the drug and its metabolites are excreted in the urine. It is likely that intranasal beclomethasone dipropionate follows a similar elimination pathway.

    Special Populations

    Formal pharmacokinetic studies using QNASL Nasal Aerosol were not conducted in any special populations.

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  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    The carcinogenicity of beclomethasone dipropionate was evaluated in rats that were exposed for a total of 95 weeks: 13 weeks at inhalation doses up to 0.4 mg/kg and the remaining 82 weeks at combined oral and inhalation doses up to 2.4 mg/kg. In this trial, there was no evidence of carcinogenicity at the highest dose: approximately 70 and 120 times the maximum recommended human daily intranasal dose (MRHDID) in adults and children, respectively, on a mg/m2 basis.

    Beclomethasone dipropionate did not induce gene mutation in bacterial cells or mammalian Chinese hamster ovary (CHO) cells in vitro. No significant clastogenic effect was seen in cultured CHO cells in vitro or in the mouse micronucleus test in vivo.

    In rats, beclomethasone dipropionate caused decreased conception rates at an oral dose of 16 mg/kg (approximately 490 times the MRHDID in adults on a mg/m2 basis). There was no significant effect of beclomethasone dipropionate on fertility in rats at oral doses of 1.6 mg/kg (approximately 50 times the MRHDID in adults on a mg/m2 basis). Inhibition of the estrous cycle in dogs was observed following oral doses of 0.5 mg/kg (approximately 50 times the MRHDID in adults on a mg/m2 basis). No inhibition of the estrous cycle in dogs was seen following 12 months of exposure at an estimated inhalation dose of 0.33 mg/kg (approximately 35 times the MRHDID in adults on a mg/m2 basis).

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  • 14 CLINICAL STUDIES

    14.1 Seasonal and Perennial Allergic Rhinitis

    Adult and Adolescent Patients Aged 12 Years and Older: The efficacy and safety of QNASL Nasal Aerosol have been evaluated in 3 randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials of 2 to 6 weeks duration in adult and adolescent patients 12 years and older with symptoms of seasonal or perennial allergic rhinitis. The 3 clinical trials included one 2-week dose-ranging trial in patients with seasonal allergic rhinitis, one 2-week efficacy trial in patients with seasonal allergic rhinitis, and one 6-week efficacy trial in patients with perennial allergic rhinitis. The trials included a total of 1049 patients (366 males and 683 females). About 81% of patients were Caucasian and 17% African American, the mean age was approximately 38 years. Of these patients 521 received QNASL Nasal Aerosol 320 mcg once daily administered as 2 actuations in each nostril.

    Assessment of efficacy was based on the total nasal symptom score (TNSS). TNSS is calculated as the sum of the patients' scoring of the 4 individual nasal symptoms (rhinorrhea, sneezing, nasal congestion, and nasal itching) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe) as reflective (rTNSS) or instantaneous (iTNSS). rTNSS required the patients to record symptom severity over the previous 12 hours; iTNSS required the patients to record symptom severity over the previous 10 minutes. Morning and evening TNSS scores were averaged over the treatment period and the difference from placebo in the change from baseline rTNSS was the primary efficacy endpoint. The morning iTNSS reflects the TNSS at the end of the 24-hour dosing interval and is an indication of whether the effect was maintained over the 24-hour dosing interval.

    Dose-Ranging Trial: The dose-ranging trial was a 2-week trial that evaluated the efficacy of 3 doses of beclomethasone dipropionate nasal aerosol (80, 160, and 320 mcg, once daily) in patients with seasonal allergic rhinitis. In this trial, only treatment with beclomethasone dipropionate nasal aerosol at the dose of 320 mcg/day resulted in statistically significant improvements compared with placebo in the primary efficacy endpoint, rTNSS (Table 3).

    Table 3. Mean Changes from Baseline in Reflective Total Nasal Symptom Score Over 2
    Weeks in Adult and Adolescent Patients with Seasonal Allergic Rhinitis (ITT
    Population)
    Treatment N Baseline
    (SD)
    LS Mean (SE)
    Change from
    Baseline
    Difference From Placebo
    LS Mean 95% CI

    Beclomethasone dipropionate

    320 mcg/day

    122

    9.17 (1.66)

    -2.22 (0.18)

    -0.63

    -1.13, 0.13

    Beclomethasone dipropionate

    160 mcg/day

    123

    9.24 (1.57)

    -1.87 (0.18)

    -0.29

    -0.78, 0.21

    Beclomethasone dipropionate

    80 mcg/day

    118

    9.33 (1.72)

    -1.88 (0.18)

    -0.29

    -0.80, 0.21

    Placebo

    123

    8.98 (1.47)

    -1.59 (0.18)

    The 320 mcg dose also demonstrated a statistically significant decrease in morning iTNSS than placebo, indicating that the effect was maintained over the 24-hour dosing interval.

    Seasonal and Perennial Allergic Rhinitis Trials: In 2 randomized, double-blind, parallel-group, multicenter, placebo-controlled efficacy trials, once-daily treatment with QNASL Nasal Aerosol for 2 weeks in patients with seasonal allergic rhinitis and for 6 weeks in patients with perennial allergic rhinitis resulted in statistically significant greater decreases from baseline in the rTNSS and morning iTNSS than placebo (Table 4).

    Table 4. Mean Changes From Baseline in Reflective and Instantaneous Total Nasal
    Symptom Scores in Adult and Adolescent Patients with Seasonal or Perennial
    Allergic Rhinitis (ITT Population)
    Treatment N Baseline
    (SD)
    LS Mean (SE)
    Change from
    Baseline
    Difference From Placebo
    LS Mean 95% CI

    Seasonal Allergic Rhinitis

    Reflective Total Nasal Symptom Scores (rTNSS)

    Beclomethasone dipropionate
    320 mcg/day

    167

    9.6 (1.51)

    -2.0 (0.16)

    -0.91

    -1.3, -0.5

    Placebo

    171

    9.5 (1.54)

    -1.0 (0.15)

    Instantaneous Total Nasal Symptom Scores (iTNSS)

    Beclomethasone dipropionate
    320 mcg/day

    167

    9.0 (1.74)

    -1.7 (0.15)

    -0.92

    -1.3, -0.5

    Placebo

    171

    8.7 (1.81)

    -0.8 (0.15)

    Perennial Allergic Rhinitis

    Reflective Total Nasal Symptom Scores (rTNSS)

    Beclomethasone dipropionate
    320 mcg/day

    232

    8.9 (1.70)

    -2.5 (0.14)

    -0.84

    -1.2, -0.5

    Placebo

    234

    9.0 (1.73)

    -1.6 (0.14)

    Instantaneous Total Nasal Symptom Scores (iTNSS)

    Beclomethasone dipropionate
    320 mcg/day

    232

    8.1 (1.98)

    -2.1 (0.13)

    -0.78

    -1.1, -0.4

    Placebo

    234

    8.3 (1.96)

    -1.4 (0.13)

    Pediatric Patients 4 to 11 Years of Age: The efficacy and safety of QNASL Nasal Aerosol have been evaluated in 2 randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials of 2 to 12 weeks duration in pediatric patients 4 to 11 years of age with symptoms of seasonal or perennial allergic rhinitis. The 2 clinical trials included one 2-week dose-ranging trial in patients with seasonal allergic rhinitis (6 - 11 years of age), and one 12-week efficacy trial in patients with perennial allergic rhinitis (4 - 11 years of age). The trials included a total of 1255 patients (680 males and 575 females). About 73% of patients were Caucasian and 20% African American, the mean age was approximately 8 years for one study and 9 years for the second study. Of these patients 596 received QNASL Nasal Aerosol 80 mcg once daily administered as 1 actuation of QNASL 40 mcg Nasal Aerosol in each nostril.

    Assessment of efficacy was based on the total nasal symptom score (TNSS) as described in adult and adolescents efficacy studies.

    Dose-Ranging Seasonal Allergic Rhinitis Trial: The dose-ranging trial was a 2-week trial that evaluated the efficacy of 2 doses of beclomethasone dipropionate nasal aerosol (80 and 160mcg, once daily) in patients with seasonal allergic rhinitis. In this trial, treatment with beclomethasone dipropionate nasal aerosol at the dose of 80 mcg/day resulted in statistically significant improvements compared with placebo in the primary efficacy endpoint, rTNSS (Table 5).

    Table 5. Mean Changes from Baseline in Reflective and Instantaneous Total Nasal

     
    Symptom Scores Over 2 Weeks in Pediatric Patients with Seasonal Allergic
     
    Rhinitis (ITT Population)

    Treatment

    N

    Baseline

    (SD)

    LS Mean (SE)

    Change

    from Baseline

    Difference From Placebo

    LS Mean

    95% CI

    Reflective Total Nasal Symptom Scores (rTNSS)

    Beclomethasone dipropionate 80 mcg/day

    239

    8.9 (1.62)

    -1.9 (0.14)

    -0.71

    -1.1, -0.3

    Beclomethasone dipropionate 160 mcg/day

    241

    9.0 (1.71)

    -2.0 (0.14)

    -0.76

    -1.1, -0.4

    Placebo

    234

    9.0 (1.70)

    -1.2 (0.14)

    -

    -

    -

    Instantaneous Total Nasal Symptom Scores (iTNSS)

    Beclomethasone dipropionate 80 mcg/day

    238

    8.1 (1.99)

    -1.6 (0.13)

    -0.63

    -1.0, -0.3

    Beclomethasone dipropionate 160 mcg/day

    241

    8.1 (2.13)

    -1.7 (0.13)

    -0.73

    -1.1, -0.4

    Placebo

    234

    8.2 (2.10)

    -1.0 (0.13)

    -

    -

    The 80 mcg daily dose also demonstrated a statistically significant decrease in morning iTNSS than placebo, indicating that the effect was maintained over the 24-hour dosing interval. Based on the results from the dose ranging trial, 80 mcg once daily was chosen as the dose for pediatric patients 4-11 years of age.

    Perennial Allergic Rhinitis Trial: In a randomized, double-blind, parallel-group, multicenter, placebo-controlled efficacy trial, treatment with QNASL Nasal Aerosol 80 mcg once daily in patients with perennial allergic rhinitis resulted in statistically significant greater decreases from baseline in the rTNSS (the primary endpoint) and iTNSS than placebo over the first six weeks of treatment (Table 6).

    Table 6. Mean Changes from Baseline in Reflective Total Nasal Symptom Score Over 6 Weeks in

     
    Pediatric Patients 6 to 11 Years of Age with Perennial Allergic Rhinitis (FAS)

    Treatment

    N

    Baseline

    (SD)

    LS Mean (SE)

    Change from

    Baseline

    Difference From Placebo

    LS Mean

    95% CI

    Reflective Total Nasal Symptom Scores (rTNSS)

    Beclomethasone dipropionate 80 mcg/day

    296

    8.6 (1.56)

    -2.26 (0.12)

    -0.66

    -1.08, -0.24

    Placebo

    153

    8.6 (1.60)

    -1.60 (0.17)

    -

    -

    Instantaneous Total Nasal Symptom Scores (iTNSS)

    Beclomethasone dipropionate 80 mcg/day

    296

    7.9 (2.05)

    -1.98 (0.12)

    -0.58

    -0.99, -0.18

    Placebo

    153

    7.8 (2.12)

    -1.39 (0.17)

    -

    -

    FAS=full analysis set

    For pediatric patients 4-11 years of age, improvements in average patient-reported rTNSS and iTNSS were also significantly greater in QNASL Nasal Aerosol 80 mcg per day treated patients compared with placebo.

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  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    QNASL Nasal Aerosol is supplied in 2 strengths and supplied as a pressurized aluminum canister inserted into a blue and white plastic nasal actuator with a built-in dose counter and white dust cap, as follows:

    QNASL 40 mcg Nasal Aerosol, contains 8.7 g of drug and excipients and provides 120 actuations (NDC 59310-206-12) and for the 60-actuation product, 4.9 g of drug and excipients (NDC 59310-206-06). Each actuation delivers 40 mcg of beclomethasone dipropionate from the nasal actuator and 50 mcg from the valve.

    QNASL 80 mcg Nasal Aerosol contains 8.7 g of drug and excipients and provides 120 actuations (NDC 59310-210-12). Each actuation delivers 80 mcg of beclomethasone dipropionate from the nasal actuator and 100 mcg from the valve.

    Each canister of QNASL Nasal Aerosol has a built-in spray counter, which starts at 124 and counts down each time a spray is released for the 120 actuation product and 64 for the 60 actuation product. After the 4 initial priming sprays, the spray counter should read 120 sprays or 60 sprays for the respective products. The correct amount of medication in each intranasal dose cannot be ensured after the counter reads 0; therefore, the device should be discarded when the counter reads 0.

    Do not remove the QNASL Nasal Aerosol canister from the actuator. The QNASL Nasal Aerosol canister should only be used with the QNASL Nasal Aerosol actuator and the actuator should not be used with any other drug product.

    CONTENTS UNDER PRESSURE

    Do not puncture. Do not store near heat or open flame. Do not expose to temperatures higher than 49°C (120°F) as this may cause bursting of the canister. Never throw the device into a fire or an incinerator.

    Store at 25°C (77°F); excursions are permitted between 15° and 30°C (59° and 86°F).

    Keep out of reach of children.

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  • 17 PATIENT COUNSELING INFORMATION

    See FDA-Approved Patient Labeling accompanying the product.

    17.1 Local Nasal Effects

    Inform patients that treatment with QNASL Nasal Aerosol may lead to adverse reactions, including epistaxis, nasal ulceration, and nasal discomfort. Candida infection may also occur with treatment with QNASL Nasal Aerosol. In addition, nasal beclomethasone dipropionate products are known to be associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use QNASL Nasal Aerosol until healing has occurred [see Warnings and Precautions (5.1)].

    17.2 Cataracts and Glaucoma

    Inform patients that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Patients should inform their health care providers if a change in vision is noted while using QNASL Nasal Aerosol [see Warnings and Precautions (5.2)].

    17.3 Hypersensitivity Reactions Including Anaphylaxis

    Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reported following administration of beclomethasone dipropionate nasally administered and inhalationally administered products. Angioedema, urticaria, and rash have been reported following administration of QNASL Nasal Aerosol. If any such reactions occur, patients should discontinue use of QNASL Nasal Aerosol [see Warnings and Precautions (5.3)].

    17.4 Immunosuppression

    Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)].

    17.5 Use Daily for Best Effect

    Patients should use QNASL Nasal Aerosol on a regular, once-daily basis since its effectiveness depends on its regular use. QNASL Nasal Aerosol may not have an immediate effect on rhinitis symptoms. The patient should not increase the prescribed dosage but should contact their physician if symptoms do not improve or if the condition worsens.

    17.6 Keep Spray Out of Eyes or Mouth

    Patients should be informed to avoid spraying QNASL Nasal Aerosol in their eyes or mouth.

    Teva Respiratory logo

    Teva Respiratory, LLC
    Horsham, PA 19044 USA

    ©2014, Teva Respiratory, LLC. All rights reserved.

    QNASL is a registered trademark of Teva Respiratory, LLC.

    Manufactured for Teva Respiratory, LLC
    Horsham, PA 19044
    By: 3M Drug Delivery Systems
    Northridge, CA 91324

     
    PE2768 Rev. 12/2014
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  • PATIENT INFORMATION

    QNASL (kyoo nay' zel)
    (beclomethasone dipropionate)
    Nasal Aerosol

    For Intranasal Use Only

    Read this Patient Information before you start using QNASL Nasal Aerosol and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

    What is QNASL Nasal Aerosol?

    QNASL Nasal Aerosol is a prescription medicine that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older.

    QNASL Nasal Aerosol contains beclomethasone dipropionate, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body that reduce inflammation. When you spray QNASL Nasal Aerosol into your nose, it may help reduce the nasal symptoms of allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, itching, and sneezing.

    It is not known if QNASL Nasal Aerosol is safe and effective in children under 12 years of age.

    Who should not use QNASL Nasal Aerosol?

    Do not use QNASL Nasal Aerosol if you are allergic to beclomethasone dipropionate or any of the ingredients in QNASL Nasal Aerosol. See the end of this Patient Information leaflet for a complete list of ingredients in QNASL Nasal Aerosol.

    What should I tell my healthcare provider before using QNASL Nasal Aerosol?

    Before you use QNASL Nasal Aerosol, tell your healthcare provider if you:

    Have had recent nose problems such as nasal sores, nasal surgery, or a nasal injury
    Have or have had eye problems, such as increased pressure in your eye (glaucoma) or cataracts
    Have tuberculosis or any untreated fungal, bacterial, or viral infections, or eye infections caused by herpes
    Have not had or been vaccinated for chickenpox or measles
    Are pregnant or plan to become pregnant. It is not known if QNASL Nasal Aerosol will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
    Are breastfeeding or plan to breastfeed. It is not known if QNASL Nasal Aerosol passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you are using QNASL Nasal Aerosol

    Tell your healthcare provider about all of the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

    QNASL Nasal Aerosol and other medications may affect each other and cause side effects. QNASL Nasal Aerosol may affect the way other medications work, and other medications may affect the way QNASL Nasal Aerosol works.

    Especially tell your healthcare provider if you take other corticosteroid medicines.

    Ask your healthcare provider for a list of these medicines if you are not sure.

    Know the medications you take. Keep a list of your medications with you to show your healthcare provider and pharmacist when a new medication is prescribed.

    How should I use QNASL Nasal Aerosol?

    Read the Instructions for Use at the end of this leaflet for specific information about the right way to use QNASL Nasal Aerosol
    QNASL Nasal Aerosol is for use in the nose only. Do not spray it in your eyes or mouth
    Use QNASL Nasal Aerosol exactly as your healthcare provider tells you to use it. Do not use more of your medicine or take it more often than your healthcare provider tells you
    QNASL Nasal Aerosol must be primed before you use it for the first time and if you do not use it for 7 or more days in a row. Do not prime your QNASL Nasal Aerosol every day
    Your QNASL Nasal Aerosol has a spray counter which should read 120 sprays after your 4 initial priming sprays
    Do not use your QNASL Nasal Aerosol after the spray counter reads 0. You may not get the right amount of medicine
    The usual dose of QNASL Nasal Aerosol is 2 sprays in each nostril, 1 time a day. You should not use more than a total of 4 sprays per day
    You will get the best results if you keep using QNASL Nasal Aerosol regularly each day. If your symptoms do not improve or get worse, call your healthcare provider

    What are the possible side effects of QNASL Nasal Aerosol?

    QNASL Nasal Aerosol may cause serious side effects, including:

    Nose bleeds or nasal ulcers. Your healthcare provider should check the inside of your nose (nasal mucosa) while you take QNASL Nasal Aerosol for problems. Talk to your healthcare provider if you have nose bleeds or nasal ulcers
    Thrush (candida), a fungal infection in your nose, mouth, or throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat
    Slow wound healing. You should not use QNASL Nasal Aerosol until your nose has healed if you have a sore in your nose, you have had surgery on your nose, or your nose has been injured
    Eye problems such as glaucoma and cataracts. If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use QNASL Nasal Aerosol
    Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency may include:
    o
    Tiredness
    o
    Weakness
    o
    Dizziness
    o
    Nausea
    o
    Vomiting
    Allergic reactions. Serious allergic reactions can happen in people taking QNASL Nasal Aerosol. Stop using QNASL Nasal Aerosol and call your healthcare provider right away or get emergency medical help if you have:
    o
    Shortness of breath or trouble breathing
    o
    Skin rash, redness, or swelling
    o
    Severe itching
    o
    Swelling of your lips, tongue or face
    Immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that may weaken your body's ability to fight infection. Avoid contact with people who have contagious diseases such as chicken pox or measles while you use QNASL Nasal Aerosol. Symptoms of an infection may include:
    o
    Fever
    o
    Pain
    o
    Aches
    o
    Chills
    o
    Feeling tired
    o
    Nausea
    o
    Vomiting
    Slowed growth in children. A child's growth should be checked regularly while using QNASL Nasal Aerosol

    The most common side effects with QNASL Nasal Aerosol include:

    Nasal discomfort
    Nose bleeds
    Headache

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of QNASL Nasal Aerosol. For more information, ask your healthcare provider or pharmacist.

    Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I store QNASL Nasal Aerosol?

    Store QNASL Nasal Aerosol at room temperature 59˚F to 86˚F (15˚C to 30˚C)
    Do not puncture the QNASL Nasal Aerosol canister
    Do not store the QNASL Nasal Aerosol canister near heat or a flame. Temperatures above 120˚F (49˚C) may cause the canister to burst
    Do not throw the QNASL Nasal Aerosol canister into a fire or an incinerator
    Safely throw away medicine that is out of date or no longer needed

    Keep QNASL Nasal Aerosol and all medicines out of the reach of children.

    General information about the safe and effective use of QNASL Nasal Aerosol

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use QNASL Nasal Aerosol for a condition for which it was not prescribed. Do not give QNASL Nasal Aerosol to other people, even if they have the same symptoms that you have. It may harm them.

    This Patient Information summarizes the most important information about QNASL Nasal Aerosol. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about QNASL Nasal Aerosol that is written for health professionals.

    For more information, go to www.QNASL.com or call 1-855-55-QNASL (1-855-557-6275).

    What should I know about allergic rhinitis?

    "Rhinitis" means inflammation of the lining of the nose. Allergic rhinitis is sometimes called "hay fever." Allergic rhinitis can be caused by allergies to pollen, animal dander, house dust mites, mold spores, and other things. If you have allergic rhinitis, your nose becomes stuffy, runny, and itchy. You may also sneeze a lot. You may also have red, itchy, watery eyes or an itchy throat; or blocked, itchy ears.

    What are the ingredients in QNASL Nasal Aerosol?

    Active ingredient: beclomethasone dipropionate

    Inactive ingredient: propellant HFA-134a and ethanol

    INSTRUCTIONS FOR USE

    QNASL (kyoo nay' zel)
    (beclomethasone dipropionate)
    Nasal Aerosol

    Read these Instructions for Use for QNASL Nasal Aerosol before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

    Note: For Use in the Nose Only.

    Do not spray QNASL Nasal Aerosol in your eyes or directly onto your nasal septum (the wall between your 2 nostrils)

    The parts of your QNASL Nasal Aerosol

    The QNASL Nasal Aerosol device comes as a canister that fits into a nasal actuator with a built-in spray counter and protective dust cap. (See Figure A)

    Figure A
    Do not use the QNASL Nasal Aerosol actuator with a canister of medicine from any other inhaler
    Do not use the QNASL Nasal Aerosol canister with an actuator from any other inhaler
    Do not remove the QNASL Nasal Aerosol canister from the actuator

    Priming your QNASL Nasal Aerosol for Use

    Remove your QNASL Nasal Aerosol device from its package
    Your QNASL Nasal Aerosol device must be primed before you use it for the first time or if it has not been used for more than 7 days in a row
    Remove the protective dust cap from the device
    Hold the nasal actuator upright between your thumb and forefinger (index finger). The canister should be on top and the white nasal actuator tip on bottom (See Figure B)
    Figure B
    If you have never used your QNASL Nasal Aerosol device before, spray it 4 times into the air, away from your eyes and face, by pressing down fully on the top of the canister 4 times (See Figure C). Your QNASL Nasal Aerosol device is now ready to use
    Figure C
    After the first time you prime your QNASL Nasal Aerosol device, the spray counter should read 120 (See Figure D)
    Figure D
    Do not prime your QNASL Nasal Aerosol device every day
    If you have used your QNASL Nasal Aerosol device before, but it has not been used in more than 7 days, it must be reprimed. To reprime your QNASL Nasal Aerosol device, spray 2 times into the air, away from your eyes and face, by pressing down fully on the top of the canister 2 times. Your QNASL Nasal Aerosol device is now ready to use

    Using Your QNASL Nasal Aerosol Device

    Step 1: Blow your nose to clear your nostrils.

    Step 2: Remove the protective dust cap from your QNASL Nasal Aerosol device.

    Step 3: Inspect the nasal actuator tip to confirm it is clear of foreign objects.

    Step 4: Hold your QNASL Nasal Aerosol device upright and insert the nasal actuator tip into one nostril (See Figure E).

    Figure E

    Step 5: Point the QNASL Nasal Aerosol device slightly away from the wall between your nostrils (nasal septum) while holding your other nostril closed (See Figure F).

    Figure F

    Step 6: Hold your breath and press down firmly and completely on the canister to release 1 spray (See Figure G). Continue to hold your breath for 5 seconds after releasing the spray and then breathe out slowly through your mouth. Take the QNASL Nasal Aerosol device out of your nostril.

    Figure G

    Step 7: Repeat steps 3-6 for the second spray in the same nostril.

    Step 8: Repeat steps 3-7 for your other nostril.

    Step 9: You should not blow your nose for the next 15 minutes.

    Note: The spray counter will count down each time there is a spray released from your QNASL Nasal Aerosol device.

    Step 10: Clean and store your device. See "Cleaning Your QNASL Nasal Aerosol device."

    Cleaning Your QNASL Nasal Aerosol device

    Wipe the nasal actuator tip with a clean, dry tissue or cloth (See Figure H)
    Do not wash or put any part of the QNASL Nasal Aerosol canister or actuator in water
    Replace the protective dust cap
    Keep your device clean and dry at all times
    Figure H

    How to know when to stop using your QNASL Aerosol device

    The QNASL Nasal Aerosol device has a spray counter, which is there to let you know how many sprays of medicine you have left
    Do not use your QNASL Nasal Aerosol device when 0 is shown in the spray counter window (See Figure I).
    Figure I
    Throw away your QNASL Nasal Aerosol device when the spray counter reaches 0
    Do not throw your QNASL Nasal Aerosol canister into a fire or an incinerator
    Talk with your health care provider before your supply of QNASL Nasal Aerosol runs out to see if you should get a refill

    This PPI and Instructions for Use has been approved by the U.S. Food and Drug Administration.

    Manufactured for: Teva Respiratory, LLC

    Horsham, PA 19044

    By: 3M Drug Delivery Systems

    Northridge, CA 91324

    ©2013 Teva Respiratory, LLC

    All rights reserved.

    QNASL is a registered trademark of Teva Respiratory, LLC

    Rev. 05/13          PE 2670

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  • Package/Label Display Panel

    Qnasl™ 80 mcg (beclomethasone dipropionate) Nasal Aerosol, 120 Metered Sprays Carton

    Qnasl 80 mcg (beclomethasone dipropionate) Nasal Aerosol, 120 Metered Sprays Carton Text

    NDC 59310-210-12

    Qnasl

    (beclomethasone

    diproprionate)

    Nasal Aerosol
    80 mcg per spray

    For Intranasal Use with
    Qnasl Actuator Only

    Rx only

    120 Metered Sprays
    8.7g Net Contents

    TEVA

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  • INGREDIENTS AND APPEARANCE
    QNASL 
    beclomethasone dipropionate aerosol, metered
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59310-210
    Route of Administration NASAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BECLOMETHASONE DIPROPIONATE (UNII: 5B307S63B2) (BECLOMETHASONE - UNII:KGZ1SLC28Z) BECLOMETHASONE DIPROPIONATE 80 ug
    Inactive Ingredients
    Ingredient Name Strength
    NORFLURANE (UNII: DH9E53K1Y8)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59310-210-12 1 in 1 CARTON 04/16/2012
    1 120 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2 NDC:59310-210-14 1 in 1 CARTON 04/13/2012
    2 120 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3 NDC:59310-210-08 1 in 1 CARTON 01/30/2015 01/30/2015
    3 50 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    4 NDC:59310-210-13 1 in 1 CARTON 02/19/2013
    4 50 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA202813 04/13/2012
    Labeler - Teva Respiratory, LLC (176697907)
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