DRUGS & SUPPLEMENTS

QvarSpray

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QvarSpray uses


1 INDICATIONS AND USAGE

QvarSpray 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 Treatment of Nasal Symptoms of Allergic Rhinitis

QvarSpray® 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.

2 DOSAGE AND ADMINISTRATION

Administer QvarSpray Nasal Aerosol by the intranasal route only. QvarSpray 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 (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 QvarSpray 40 mcg Nasal Aerosol and QvarSpray 80 mcg Nasal Aerosol 120-actuation products and 60 for QvarSpray 40 mcg Nasal Aerosol 60-actuation product. If QvarSpray 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 QvarSpray Nasal Aerosol.

QvarSpray Nasal Aerosol is for intranasal use only.

  • The recommended dose of QvarSpray 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 QvarSpray 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 )

2.1 Allergic Rhinitis

Adults and Adolescents (12 Years of Age and Older): The recommended dose of QvarSpray 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 QvarSpray 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

QvarSpray Nasal Aerosol is a nonaqueous nasal spray solution.

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

QvarSpray Nasal Aerosol is available in two strengths:

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

4 CONTRAINDICATIONS

QvarSpray Nasal Aerosol is contraindicated in patients with a history of hypersensitivity to QvarSpray and/or any other QvarSpray Nasal Aerosol ingredients .

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

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5 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.
  • Eye Disorders. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts. ( 5.2 )
  • Hypersensitivity, rash, and urticaria may occur after administration of QvarSpray 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 QvarSpray Nasal Aerosol slowly. ( 5.5 )
  • Potential reduction in growth velocity in pediatric patients. Monitor growth routinely in pediatric patients receiving QvarSpray Nasal Aerosol. ( 5.6, 8.4 )

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 QvarSpray 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 QvarSpray 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 QvarSpray 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 QvarSpray Nasal Aerosol .

Candida Infection: In previous clinical trials with an aqueous formulation of QvarSpray 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 QvarSpray Nasal Aerosol. If such an infection develops, it may require treatment with appropriate local therapy and discontinuation of QvarSpray Nasal Aerosol treatment. Thus, patients using QvarSpray 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 QvarSpray. There were no nasal septal perforations reported during clinical trials in the indicated dose of QvarSpray 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 QvarSpray Nasal Aerosol until healing has occurred.

5.2 Eye Disorders

Use of intranasal and inhaled corticosteroids may result in the development of increased intraocular pressure, blurred vision, glaucoma and/or cataracts. 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.

Glaucoma and cataract formation was evaluated with ocular assessments that included intraocular pressure measurements and slit lamp examinations in 245 adolescent and adult patients with perennial allergic rhinitis who were treated with QvarSpray 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 QvarSpray 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 QvarSpray 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 .

5.3 Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reported following administration of QvarSpray nasally administered and inhalationally administered products. Angioedema, urticaria, and rash have been reported following administration of QvarSpray Nasal Aerosol. Discontinue QvarSpray Nasal Aerosol if any such reactions occur .

5.4 Immunosuppression

Persons who are using drugs that 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 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. 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 QvarSpray 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 QvarSpray Nasal Aerosol .

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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
  • Eye Disorders
  • Hypercorticism, adrenal suppression, and growth reduction [see Warnings and Precautions (5.5) (5.6) , Use in Specific Populations (8.4)]
  • Immunosuppression

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.

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 QvarSpray 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 QvarSpray Nasal Aerosol similar to or lower than the rate among patients who received placebo. Table 1 displays the common adverse reactions (≥ 1% and greater than placebo-treated patients).

  • Table 1. Adverse Events With ≥ 1% Incidence and Greater than Placebo in QvarSpray
  • 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


QvarSpray 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 QvarSpray 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 QvarSpray 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 QvarSpray 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 QvarSpray 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 QvarSpray Nasal Aerosol. In 45 reports of epistaxis in patients who received QvarSpray 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 QvarSpray 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 QvarSpray 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 QvarSpray Nasal Aerosol, 80 mcg once daily, 241 (116 female and 125 male) received QvarSpray 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 QvarSpray 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 QvarSpray Nasal Aerosol 80 mcg once daily and placebo treated patients.


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


QvarSpray 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 QvarSpray Nasal Aerosol, the following adverse events have been reported during postmarketing use of QvarSpray Nasal Aerosol or other intranasal and inhaled formulations of QvarSpray. 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 QvarSpray or a combination of these factors.

QvarSpray Nasal Aerosol: sneezing, burning sensation

Intranasal QvarSpray: Nasal septal perforation, blurred vision, glaucoma, cataracts, central serous chorioretinopathy (CSC), loss of taste and smell, and hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported following intranasal administration of QvarSpray.

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

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7 DRUG INTERACTIONS

No drug interaction studies have been performed with QvarSpray Nasal Aerosol.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled clinical trials in pregnant women treated with QvarSpray Nasal Aerosol. QvarSpray was teratogenic and embryocidal in the mouse and rabbit although these effects were not observed in rats. QvarSpray Nasal Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans.

QvarSpray administered subcutaneously was teratogenic and embryocidal in the mouse and rabbit at doses approximately twice the maximum recommended human daily intranasal dose in adults (on a mg/m2 basis at maternal doses of 0.1 and 0.025 mg/kg/day in mice and rabbits, respectively). No teratogenicity or embryocidal effects were seen in rats at approximately 460 times MRHDID (in adults on a mg/m2 basis at a maternal inhalation dose of 15 mg/kg/day).

Non-teratogenic Effects: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.

8.3 Nursing Mothers

It is not known whether QvarSpray is excreted in human breast milk. However, other corticosteroids have been detected in human breast milk and thus caution should be exercised when QvarSpray Nasal Aerosol is administered to a nursing mother.

8.4 Pediatric Use

The safety and effectiveness of QvarSpray Nasal Aerosol in children 4 years and older have been established . The safety and effectiveness of QvarSpray Nasal Aerosol in children younger than 4 years of age have not been established. Controlled pediatric clinical trials with QvarSpray Nasal Aerosol included 909 children 4 to 11 years of age and 188 adolescent patients 12 to 17 years of age .

Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA-axis function. The long-term effects of reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch-up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including QvarSpray Nasal Aerosol, should be monitored routinely (e.g., via stadiometry).

A 12-month, randomized, controlled clinical trial evaluated the effects of QVAR®, an orally inhaled HFA QvarSpray product, without spacer versus chlorofluorocarbon-propelled (CFC) QvarSpray with large volume spacer on growth in children with asthma ages 5 to 11 years. A total of 520 patients were enrolled, of whom 394 received HFA-beclomethasone dipropionate (100 to 400 mcg/day ex-valve) and 126 received CFC-beclomethasone dipropionate (200 to 800 mcg/day ex-valve). When comparing results at month 12 to baseline, the mean growth velocity in children treated with HFA-beclomethasone dipropionate was approximately 0.5 cm/year less than that noted with children treated with CFC-beclomethasone dipropionate via large volume spacer. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives.

The potential for QvarSpray Nasal Aerosol to cause reduction in growth velocity in susceptible patients or when given at higher than recommended dosages cannot be ruled out.

8.5 Geriatric Use

Clinical trials of QvarSpray Nasal Aerosol did not include sufficient numbers of subjects aged 65 years and older to determine whether they responded differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, administration to elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

10 OVERDOSAGE

Chronic overdosage may result in signs/symptoms of hypercorticism . There are no data available on the effects of acute or chronic overdosage with QvarSpray Nasal Aerosol.

11 DESCRIPTION

QvarSpray USP, the active component of QvarSpray 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:

QvarSpray, 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.

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

Chemical structure.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

QvarSpray is a prodrug that is extensively converted to the active metabolite, beclomethasone-17-monopropionate. The precise mechanism through which QvarSpray affects rhinitis symptoms is unknown. Corticosteroids have been shown to have multiple anti-inflammatory effects, inhibiting both inflammatory cells 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 QvarSpray. The clinical significance of these findings is unknown.

12.2 Pharmacodynamics

Adrenal Function: The effects of QvarSpray 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, QvarSpray 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, QvarSpray 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 QvarSpray 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 QvarSpray 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 QvarSpray Nasal Aerosol and placebo groups of 0.86 and 0.44, resulting in a difference of 0.42. The geometric mean ratio for QvarSpray 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 QvarSpray 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 QvarSpray 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 QvarSpray undergoes extensive conversion to its active metabolite, beclomethasone-17-monopropionate, during absorption. Plasma concentrations of QvarSpray and beclomethasone-17-monopropionate have been measured with QvarSpray Nasal Aerosol in 2 adult and/or adolescent clinical trials and 1 pediatric clinical trial.

The single-dose pharmacokinetics of QvarSpray Nasal Aerosol were evaluated in a randomized, open-label, 3-period, crossover trial in healthy adult volunteers. Systemic levels of beclomethasone-17-monopropionate and QvarSpray after single-dose intranasal administration of QvarSpray at doses of 80 and 320 mcg were compared with the systemic levels of beclomethasone-17-monopropionate and QvarSpray after administration of orally inhaled QvarSpray HFA at a dose of 320 mcg (QVAR® Inhalation Aerosol). The results of this trial demonstrated that the systemic bioavailability of QvarSpray Nasal Aerosol 320 mcg was approximately 27.5% (approximately 4-fold lower) of that of orally inhaled QvarSpray 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 QvarSpray Nasal Aerosol 320 mcg/day was approximately 19.5% (approximately 5-fold lower) of that of orally inhaled QvarSpray 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 QvarSpray Nasal Aerosol, there was no accumulation or increase in plasma exposure to beclomethasone-17-monopropionate or QvarSpray, 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 QvarSpray is moderate (20 L) but more extensive for beclomethasone-17-monopropionate (424 L).

Metabolism

QvarSpray 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 QvarSpray appears to be via metabolism. More than 90% of inhaled QvarSpray 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 QvarSpray and beclomethasone-17-monopropionate following intranasal dosing with QvarSpray Nasal Aerosol (320 mcg) were approximately 0.3 hours and 4.5 hours, respectively. Irrespective of the route of administration (injection, oral, or inhalation), QvarSpray 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 QvarSpray follows a similar elimination pathway.

Special Populations

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

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenicity of QvarSpray 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.

QvarSpray 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, QvarSpray 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 QvarSpray 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).

14 CLINICAL STUDIES

14.1 Seasonal and Perennial Allergic Rhinitis

Adult and Adolescent Patients Aged 12 Years and Older: The efficacy and safety of QvarSpray 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 QvarSpray 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 QvarSpray nasal aerosol (80, 160, and 320 mcg, once daily) in patients with seasonal allergic rhinitis. In this trial, only treatment with QvarSpray 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

QvarSpray

320 mcg/day


122


9.17 (1.66)


-2.22 (0.18)


-0.63


-1.13, 0.13


QvarSpray

160 mcg/day


123


9.24 (1.57)


-1.87 (0.18)


-0.29


-0.78, 0.21


QvarSpray

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 QvarSpray 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)


QvarSpray

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)


QvarSpray

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)


QvarSpray

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)


QvarSpray

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 QvarSpray 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 QvarSpray Nasal Aerosol 80 mcg once daily administered as 1 actuation of QvarSpray 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 QvarSpray nasal aerosol (80 and 160mcg, once daily) in patients with seasonal allergic rhinitis. In this trial, treatment with QvarSpray 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)


QvarSpray 80 mcg/day


239


8.9 (1.62)


-1.9 (0.14)


-0.71


-1.1, -0.3


QvarSpray 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)


QvarSpray 80 mcg/day


238


8.1 (1.99)


-1.6 (0.13)


-0.63


-1.0, -0.3


QvarSpray 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 QvarSpray 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)


QvarSpray 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)


QvarSpray 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 QvarSpray Nasal Aerosol 80 mcg per day treated patients compared with placebo.

16 HOW SUPPLIED/STORAGE AND HANDLING

QvarSpray 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:

QvarSpray 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 QvarSpray from the nasal actuator and 50 mcg from the valve.

QvarSpray 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 QvarSpray from the nasal actuator and 100 mcg from the valve.

Each canister of QvarSpray 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 QvarSpray Nasal Aerosol canister from the actuator. The QvarSpray Nasal Aerosol canister should only be used with the QvarSpray 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.

17 PATIENT COUNSELING INFORMATION

17.1 Local Nasal Effects

Inform patients that treatment with QvarSpray Nasal Aerosol may lead to adverse reactions, including epistaxis, nasal ulceration, and nasal discomfort. Candida infection may also occur with treatment with QvarSpray Nasal Aerosol. In addition, nasal QvarSpray 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 QvarSpray Nasal Aerosol until healing has occurred .

17.2 Eye Disorders

Inform patients that blurred vision, 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 QvarSpray Nasal Aerosol .

17.3 Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reported following administration of QvarSpray nasally administered and inhalationally administered products. Angioedema, urticaria, and rash have been reported following administration of QvarSpray Nasal Aerosol. If any such reactions occur, patients should discontinue use of QvarSpray Nasal Aerosol .

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 .

17.5 Use Daily for Best Effect

Patients should use QvarSpray Nasal Aerosol on a regular, once-daily basis since its effectiveness depends on its regular use. QvarSpray 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 QvarSpray Nasal Aerosol in their eyes or mouth.

Teva Respiratory, LLC

Frazer, PA 19355 USA

©2017, Teva Respiratory, LLC. All rights reserved.

QvarSpray® is a registered trademark of Teva Respiratory, LLC.

Manufactured for Teva Respiratory, LLC

Frazer, PA 19355

By: 3M Drug Delivery Systems

Northridge, CA 91324

United States Patent Nos. 7,780,038

PE3533 Rev. 07/2017

Teva Respiratory logo


PATIENT INFORMATION

QvarSpray

(beclomethasone dipropionate)

Nasal Aerosol

  • QvarSpray Nasal Aerosol is available in 2 different strengths:
    • QvarSpray Nasal Aerosol 40 mcg is only for use in children 4 years to 11 years of age and should be given under the supervision of a parent, guardian or caregiver.
  • QvarSpray Nasal Aerosol 80 mcg is only for use in adolescents and adults 12 years of age and older.

What is QvarSpray Nasal Aerosol?

QvarSpray Nasal Aerosol is a prescription medicine that treats seasonal nasal and year-round nasal allergy symptoms in children 4 years of age and older and adults.

QvarSpray Nasal Aerosol contains QvarSpray, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body that reduce inflammation. When QvarSpray Nasal Aerosol is sprayed into the 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 QvarSpray Nasal Aerosol is safe and effective in children under 4 years of age.


Who should not use QvarSpray Nasal Aerosol?

Do not use QvarSpray Nasal Aerosol if you or your child is allergic to QvarSpray or any of the ingredients in QvarSpray Nasal Aerosol. See the end of this leaflet for a complete list of ingredients in QvarSpray Nasal Aerosol.


What should you tell your or your child’s healthcare provider before using QvarSpray Nasal Aerosol?

Before using QvarSpray Nasal Aerosol, tell the healthcare provider about all of your medical conditions, including if you or your

Child:

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

Tell the healthcare provider about all of the medicines you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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

Especially tell the healthcare provider if you or your child takes other corticosteroid medicines.

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


How should you or your child use QvarSpray Nasal Aerosol?

  • QvarSpray Nasal Aerosol 40 mcg is only for use in children 4 years to 11 years of age and should be given under the supervision of a parent, guardian or caregiver.
  • QvarSpray Nasal Aerosol 80 mcg is only for use in adolescents and adults 12 years of age and older.
  • Read the step-by-step Instructions for Use at the end of this leaflet for specific information about the right way to use QvarSpray Nasal Aerosol.
  • QvarSpray Nasal Aerosol is for use in the nose only. Do not spray it in your eyes or mouthand do not let your child spray it in their eyes or mouth.
  • Use QvarSpray Nasal Aerosol exactly as the healthcare provider tells you or your child to use it. Do not use more of your medicine or take it more often or let your child use more of the medicine or take it more often than the healthcare provider tells you.
  • QvarSpray Nasal Aerosol must be primed before it is used for the first time and if you or your child does not use it for 7 or more days in a row. Do not prime the QvarSpray Nasal Aerosol every day.
  • QvarSpray Nasal Aerosol 40 mcg comes in 120 sprays or 60 sprays. QvarSpray Nasal Aerosol 80 mcg comes in 120 sprays only:
  • The 120-actuation product has a spray counter which should read 124 sprays before priming and 120 sprays after priming.
  • The 60-actuation product has a spray counter which should read 64 sprays before priming and 60 sprays after priming.
  • Do not use the QvarSpray Nasal Aerosol after the spray counter reads 0. You or your child may not get the right amount of medicine.
  • The usual dose of QvarSpray Nasal Aerosol:
    • 40 mcg is 1 spray in each nostril, 1 time a day for children who are 4 years to 11 years of age. Your child should not use more than a total of 2 sprays per day.
    • 80 mcg is 2 sprays in each nostril, 1 time a day for adolescents and adults 12 years of age and older. You should not use more than a total of 4 sprays per day.

You and your child will get the best results if they keep using QvarSpray Nasal Aerosol regularly each day. If you or your child’s symptoms do not improve or get worse, call the healthcare provider.


What are the possible side effects of QvarSpray Nasal Aerosol?

QvarSpray Nasal Aerosol may cause serious side effects, including:

  • nose bleeds or nasal ulcers. The healthcare provider should check the inside of you or your child’s nose (nasal mucosa) while taking QvarSpray Nasal Aerosol for problems. Talk to the healthcare provider if the nose bleeds or has nasal ulcers.
  • fungal infections (thrush) in the nose, mouth, or throat. Tell the healthcare provider if you or your child has any redness or white colored patches in the mouth or throat.
  • slow wound healing. You or your child should not use QvarSpray Nasal Aerosol until the nose has healed if there was a sore in the nose, had surgery on the nose, or the nose has been injured.
  • eye problems. If you or your child has had glaucoma, cataracts or blurred vision in the past, you or your child should have regular eye exams while using QvarSpray Nasal Aerosol.
  • serious allergic reactions. Stop using QvarSpray Nasal Aerosol and call the healthcare provider right away or get emergency medical help right away if you or your child get any of the following signs and symptoms of a serious allergic reaction:

    ○ hives ○ swelling of your lips, tongue or face ○ rash ○ breathing problems

  • immune system effects and a higher chance for infections. Tell your or your child’s healthcare provider about any signs or symptoms of infection such as:

    ○ fever ○ pain ○ body aches ○ chills

    ○ feeling tired ○ nausea ○ vomiting

  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency can happen in people who take higher doses of QvarSpray than recommended over a long period of time. Symptoms of adrenal insufficiency may include:

    ○ tiredness ○ weakness ○ dizziness ○ nausea ○ vomiting

  • slowed growth in children. Children should have their growth checked regularly while using QvarSpray Nasal Aerosol.

The most common side effects with QvarSpray Nasal Aerosol 40 mcg in children who are 4 years to 11 years of age include:

  • Epistaxis (nose bleeding)
  • headache
  • fever
  • upper respiratory tract infection
  • pain or swelling of your nose or throat (Nasopharyngitis)

The most common side effects with QvarSpray Nasal Aerosol 80 mcg in adolescents and adults 12 years of age and older include:

  • nasal discomfort
  • nose bleeds (epistaxis)
  • headache

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

These are not all the possible side effects of QvarSpray Nasal Aerosol. For more information, ask the 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 QvarSpray Nasal Aerosol?

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

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


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

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

You can ask your pharmacist or healthcare provider for information about QvarSpray Nasal Aerosol that is written for health professionals.


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 your child has allergic rhinitis, their nose becomes stuffy, runny, and itchy. He/she may also sneeze a lot. Your child may also have red, itchy, watery eyes or an itchy throat; or blocked, itchy ears.


What are the ingredients in QvarSpray Nasal Aerosol?

Active ingredient: QvarSpray

Inactive ingredient: propellant HFA-134a and ethanol


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


PLEASE SEE REVERSE SIDE FOR INSTRUCTIONS FOR USE.

INSTRUCTIONS FOR USE

QvarSpray (kyoo nay' zel) 80 mcg

(beclomethasone dipropionate)

Nasal Aerosol

Read these Instructions for Use for QvarSpray 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 QvarSpray Nasal Aerosol in your eyes, mouth or directly onto your nasal septum (the wall between your 2 nostrils).

The parts of your QvarSpray Nasal Aerosol

The QvarSpray Nasal Aerosol device comes as a canister that fits into a nasal actuator with a built-in spray counter and protective dust cap. .

  • Do not use the QvarSpray Nasal Aerosol actuator with a canister of medicine from any other inhaler.
  • Do not use the QvarSpray Nasal Aerosol canister with an actuator from any other inhaler.
  • Do not remove the QvarSpray Nasal Aerosol canister from the actuator.

Priming your QvarSpray Nasal Aerosol for Use

Your QvarSpray 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 your QvarSpray Nasal Aerosol device from its package.
  • Remove the protective dust cap from the device by pulling it straight off.
  • 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 .
  • If you have never used your QvarSpray 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 .

  • After the first time you prime your QvarSpray Nasal Aerosol device, the spray counter should read 120 .


  • Your QvarSpray Nasal Aerosol device is now ready to use.
  • Do not prime your QvarSpray Nasal Aerosol device every day.
  • If you have used your QvarSpray Nasal Aerosol device before, but it has not been used in more than 7 days, it must be reprimed. To reprime your QvarSpray 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 QvarSpray Nasal Aerosol device is now ready to use.

Using Your QvarSpray Nasal Aerosol Device

Step 1: Blow your nose to clear your nostrils.

Step 2: Remove the protective dust cap from your QvarSpray Nasal Aerosol device by pulling it straight off.

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

Step 4: Hold your QvarSpray Nasal Aerosol device upright and insert the nasal actuator tip into one nostril .

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


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


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 QvarSpray Nasal Aerosol device.

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

Cleaning Your QvarSpray Nasal Aerosol device

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


How to know when to stop using your QvarSpray Aerosol device

  • The QvarSpray 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 QvarSpray Nasal Aerosol device when 0 is shown in the spray counter window .


  • Throw away your QvarSpray Nasal Aerosol device when the spray counter reaches 0.
  • Do not throw your QvarSpray Nasal Aerosol canister into a fire or an incinerator.
  • Talk with your healthcare provider before your QvarSpray Nasal Aerosol medicine runs out to see if you should get a refill.

Manufactured for: Teva Respiratory, LLC

Frazer, PA 19355

By: 3M Drug Delivery Systems

Northridge, CA 91324

©2017 Teva Respiratory, LLC

All rights reserved.

QvarSpray is a registered trademark of Teva Respiratory, LLC

Rev. 07/2017 PE 3534

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

Figure A Figure B Figure C Figure D Figure E Figure F Figure G Figure H Figure I

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

NDC 59310-210-12

QvarSpray

(beclomethasone

diproprionate)

Nasal Aerosol

80 mcg per spray

For Intranasal Use with

QvarSpray Actuator Only

Rx only

120 Metered Sprays

8.7g Net Contents

TEVA

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

QvarSpray pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


QvarSpray available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


QvarSpray destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


QvarSpray Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


QvarSpray pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."QNASL (BECLOMETHASONE DIPROPIONATE) AEROSOL, METERED [TEVA RESPIRATORY, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."BECLOMETHASONE DIPROPIONATE MONOHYDRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "BECLOMETHASONE DIPROPIONATE". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming QvarSpray?

Depending on the reaction of the QvarSpray after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider QvarSpray not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is QvarSpray addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on QvarSpray, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of QvarSpray consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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