Prescription Drug Information: Veramyst

VERAMYST — fluticasone furoate spray, metered
Physicians Total Care, Inc.

1 INDICATIONS AND USAGE

1.1 Treatment of Allergic Rhinitis

VERAMYST® (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.

2 DOSAGE AND ADMINISTRATION

Administer VERAMYST Nasal Spray by the intranasal route only. Prime VERAMYST Nasal Spray before using for the first time by shaking the contents well and releasing 6 sprays into the air away from the face. When VERAMYST Nasal Spray has not been used for more than 30 days or if the cap has been left off the bottle for 5 days or longer, prime the pump again until a fine mist appears. Shake VERAMYST Nasal Spray well before each use.

2.1 Adults and Adolescents Aged 12 Years and Older

The recommended starting dosage is 110 mcg once daily administered as 2 sprays (27.5 mcg/spray) in each nostril. Titrate an individual patient to the minimum effective dosage to reduce the possibility of side effects. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage to 55 mcg (1 spray in each nostril) once daily may be effective in maintaining control of allergic rhinitis symptoms.

2.2 Children Aged 2 to 11 Years

The recommended starting dosage in children is 55 mcg once daily administered as 1 spray (27.5 mcg/spray) in each nostril. Children not adequately responding to 55 mcg may use 110 mcg (2 sprays in each nostril) once daily. Once symptoms have been controlled, the dosage may be decreased to 55 mcg once daily.

3 DOSAGE FORMS AND STRENGTHS

VERAMYST Nasal Spray is a nasal spray suspension. Each spray (50 microliters) delivers 27.5 mcg of fluticasone furoate.

4 CONTRAINDICATIONS

VERAMYST Nasal Spray is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3)] .

5 WARNINGS AND PRECAUTIONS

5.1 Local Nasal Effects

Epistaxis and Nasal Ulceration

In clinical studies 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 VERAMYST Nasal Spray than those who received placebo [see Adverse Reactions (6)].

Candida Infection

Evidence of localized infections of the nose with Candida albicans was seen on nasal exams in 7 of 2,745 patients treated with VERAMYST Nasal Spray during clinical trials and was reported as an adverse event in 3 patients. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of VERAMYST Nasal Spray. Therefore, patients using VERAMYST Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.

Nasal Septal Perforation

Instances of nasal septal perforation have been reported in patients following the intranasal application of corticosteroids. There were no instances of nasal septal perforation observed in clinical studies with VERAMYST Nasal Spray.

Impaired Wound Healing

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use VERAMYST Nasal Spray until healing has occurred.

5.2 Glaucoma and Cataracts

Nasal 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 intraocular pressure measurements and slit lamp examinations in 1 controlled 12-month study in 806 adolescent and adult patients aged 12 years and older and in 1 controlled 12-week study in 558 children aged 2 to 11 years. The patients had perennial allergic rhinitis and were treated with either VERAMYST Nasal Spray (110 mcg once daily in adult and adolescent patients and 55 or 110 mcg once daily in pediatric patients) or placebo. Intraocular pressure remained within the normal range (<21 mmHg) in ≥98% of the patients in any treatment group in both studies. However, in the 12-month study in adolescents and adults, 12 patients, all treated with VERAMYST Nasal Spray 110 mcg once daily, had intraocular pressure measurements that increased above normal levels (≥21 mmHg). In the same study, 7 patients (6 treated with VERAMYST Nasal Spray 110 mcg once daily and 1 patient treated with placebo) had cataracts identified during the study that were not present at baseline.

5.3 Hypersensitivity Reactions, Including Anaphylaxis

Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, may occur after administration of VERAMYST Nasal Spray. Discontinue VERAMYST Nasal Spray if such reactions occur [see Contraindications (4)].

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 have not 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 Effects

Hypercorticism and Adrenal Suppression

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 VERAMYST Nasal Spray 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 those 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 Use of Cytochrome P450 3A4 Inhibitors

Co-administration with ritonavir is not recommended because of the risk of systemic effects secondary to increased exposure to fluticasone furoate. Use caution with the co-administration of VERAMYST Nasal Spray and other potent cytochrome P450 (CYP) 3A4 inhibitors, such as ketoconazole [see Drug Interactions (7)].

5.7 Effect on Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving VERAMYST Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including VERAMYST Nasal Spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].

6 ADVERSE REACTIONS

Systemic and local corticosteroid use may result in the following:

  • Epistaxis, ulcerations, Candida albicans infection, impaired wound healing [see Warnings and Precautions (5.1)]
  • Cataracts and glaucoma [see Warnings and Precautions (5.2)]
  • Immunosuppression [see Warnings and Precautions (5.4)]
  • Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]

6.1 Clinical Trials Experience

The safety data described below reflect exposure to VERAMYST Nasal Spray in 1,563 patients with seasonal or perennial allergic rhinitis in 9 controlled clinical trials of 2 to 12 weeks’ duration. The data from adults and adolescents are based upon 6 clinical trials in which 768 patients with seasonal or perennial allergic rhinitis (473 females and 295 males aged 12 years and older) were treated with VERAMYST Nasal Spray 110 mcg once daily for 2 to 6 weeks. The racial distribution of adult and adolescent patients receiving VERAMYST Nasal Spray was 82% white, 5% black, and 13% other. The data from pediatric patients are based upon 3 clinical trials in which 795 children with seasonal or perennial rhinitis (352 females and 443 males aged 2 to 11 years) were treated with VERAMYST Nasal Spray 55 or 110 mcg once daily for 2 to 12 weeks. The racial distribution of pediatric patients receiving VERAMYST Nasal Spray was 75% white, 11% black, and 14% other.

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 Aged 12 Years and Older

Overall adverse reactions were reported with approximately the same frequency by patients treated with VERAMYST Nasal Spray and those receiving placebo. Less than 3% of patients in clinical trials discontinued treatment because of adverse reactions. The rate of withdrawal among patients receiving VERAMYST Nasal Spray was similar or lower than the rate among patients receiving placebo.

Table 1 displays the common adverse reactions (>1% in any patient group receiving VERAMYST Nasal Spray) that occurred more frequently in patients aged 12 years and older treated with VERAMYST Nasal Spray compared with placebo-treated patients.

Table 1. Adverse Reactions With >1% Incidence in Controlled Clinical Trials of 2 to 6 Weeks’ Duration With VERAMYST Nasal Spray in Adult and Adolescent Patients With Seasonal or Perennial Allergic Rhinitis

Adverse Event

Adult and Adolescent Patients

Aged 12 Years and Older

Vehicle Placebo

(n = 774)

VERAMYST Nasal Spray

110 mcg Once Daily

(n = 768)

Headache

54 (7%)

72 (9%)

Epistaxis

32 (4%)

45 (6%)

Pharyngolaryngeal pain

8 (1%)

15 (2%)

Nasal ulceration

3 (<1%)

11 (1%)

Back pain

7 (<1%)

9 (1%)

There were no differences in the incidence of adverse reactions based on gender or race. Clinical trials did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger subjects.

Pediatric Patients Aged 2 to 11 Years

In the 3 clinical trials in pediatric patients aged 2 to <12 years, overall adverse reactions were reported with approximately the same frequency by patients treated with VERAMYST Nasal Spray and those receiving placebo. Table 2 displays the common adverse reactions (>3% in any patient group receiving VERAMYST Nasal Spray), that occurred more frequently in patients aged 2 to 11 years treated with VERAMYST Nasal Spray compared with placebo-treated patients.

Table 2. Adverse Reactions With >3% Incidence in Controlled Clinical Trials of 2 to 12 Weeks’ Duration With VERAMYST Nasal Spray in Pediatric Patients With Seasonal or Perennial Allergic Rhinitis

Adverse Event

Pediatric Patients Aged 2 to <12 Years

Vehicle Placebo

(n = 429)

VERAMYST Nasal Spray

55 mcg Once Daily

(n = 369)

VERAMYST Nasal Spray

110 mcg Once Daily

(n = 426)

Headache

31 (7%)

28 (8%)

33 (8%)

Nasopharyngitis

21 (5%)

20 (5%)

21 (5%)

Epistaxis

19 (4%)

17 (5%)

17 (4%)

Pyrexia

7 (2%)

17 (5%)

19 (4%)

Pharyngolaryngeal pain

14 (3%)

16 (4%)

12 (3%)

Cough

12 (3%)

12 (3%)

16 (4%)

There were no differences in the incidence of adverse reactions based on gender or race. Pyrexia occurred more frequently in children aged 2 to <6 years compared with children aged 6 to <12 years.

Long-Term (52-Week) Safety Trial

In a 52-week, placebo-controlled, long-term safety trial, 605 patients (307 females and 298 males aged 12 years and older) with perennial allergic rhinitis were treated with VERAMYST Nasal Spray 110 mcg once daily for 12 months and 201 were treated with placebo nasal spray. While most adverse reactions were similar in type and rate between the treatment groups, epistaxis occurred more frequently in patients who received VERAMYST Nasal Spray (123/605, 20%) than in patients who received placebo (17/201, 8%). Epistaxis tended to be more severe in patients treated with VERAMYST Nasal Spray. All 17 reports of epistaxis that occurred in patients who received placebo were of mild intensity, while 83, 39, and 1 of the total 123 epistaxis events in patients treated with VERAMYST Nasal Spray were of mild, moderate, and severe intensity, respectively. No patient experienced a nasal septal perforation during this trial.

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