VERAMYST

Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C₂₇H₂₉F₃O₆S. It is practically insoluble in water.

VERAMYST Nasal Spray is an aqueous suspension of micronized fluticasone furoate for topical administration to the nasal mucosa by means of a metering (50 microliters), atomizing spray pump. After initial priming [see Dosage and Administration (2)], each actuation delivers 27.5 mcg of fluticasone furoate in a volume of 50 microliters of nasal spray suspension. VERAMYST Nasal Spray also contains 0.015% w/w benzalkonium chloride, dextrose anhydrous, edetate disodium, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, and purified water. It has a pH of approximately 6.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. The precise mechanism through which fluticasone furoate affects rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. Specific effects of fluticasone furoate demonstrated in in vitro and in vivo models included activation of the glucocorticoid response element, inhibition of pro-inflammatory transcription factors such as NFkB, and inhibition of antigen-induced lung eosinophilia in sensitized rats.

Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate. The clinical relevance of these findings is unknown.

12.2 Pharmacodynamics

Adrenal Function: The effects of VERAMYST Nasal Spray on adrenal function have been evaluated in 4 controlled clinical trials in patients with perennial allergic rhinitis. Two 6-week clinical trials were designed specifically to assess the effect of VERAMYST Nasal Spray on the HPA axis with assessments of both 24-hour urinary cortisol excretion and serum cortisol levels in domiciled patients. In addition, one 52-week safety study and one 12-week safety and efficacy study included assessments of 24-hour urinary cortisol excretion. Details of the studies and results are described below. In all 4 studies, since serum fluticasone determinations were generally below the limit of quantification, compliance was assured by efficacy assessments.

Clinical Trials Specifically Designed to Assess Hypothalamic-Pituitary-Adrenal Axis Effect: In a 6-week randomized, double-blind, parallel-group study in adult and adolescent patients aged 12 years and older with perennial allergic rhinitis, VERAMYST Nasal Spray 110 mcg was compared with both placebo nasal spray and prednisone as a positive-control group that received prednisone 10 mg orally once daily for the final 7 days of the treatment period. Adrenal function was assessed by 24-hour urinary cortisol excretion before and after 6 weeks of treatment and by serial serum cortisol levels. Patients were domiciled for collection of 24-hour urinary cortisol. After 6 weeks of treatment, there was a change from baseline in the mean 24-hour urinary cortisol excretion in the group treated with VERAMYST Nasal Spray (n = 43) of -1.16 mcg/day compared with -3.48 mcg/day in the placebo group (n = 42). The difference from placebo in the group treated with VERAMYST Nasal Spray was 2.32 mcg/day (95% CI: -6.76, 11.39). Urinary cortisol data were not available for the positive-control (prednisone) treatment group. For serum cortisol levels, after 6 weeks of treatment there was a change from baseline in the mean (0-24 hours) of -0.38 and 0.08 mcg/dL for the group treated with VERAMYST Nasal Spray (n = 43) and the placebo group (n = 44), respectively, with a difference between the group treated with VERAMYST Nasal Spray and the placebo group of -0.47 mcg/dL (95% CI: -1.31, 0.37). For comparison, in the positive-control (prednisone, n = 12) treatment group, there was a change in mean serum cortisol (0-24 hours) from baseline of -4.49 mcg/dL with a difference between the prednisone and placebo group of -4.57 mcg/dL (95% CI: -5.83, -3.31).

The second 6-week study conducted in children aged 2 to 11 years was of similar design to the adult study, including adrenal function assessments, but did not include a prednisone positive-control arm. Patients were treated once daily with VERAMYST Nasal Spray 110 mcg or placebo nasal spray. After 6 weeks of treatment, there was a change in the mean 24-hour urinary cortisol excretion in the group treated with VERAMYST Nasal Spray (n = 43) of 0.49 mcg/day compared with 1.92 mcg/day in the placebo group (n = 41), with a difference between the group treated with VERAMYST Nasal Spray and the placebo group of -1.43 mcg/day (95% CI: -5.21, 2.35). For serum cortisol levels, after 6 weeks, there was a change from baseline in mean (0-24 hours) of -0.34 and -0.23 mcg/dL for the group treated with VERAMYST Nasal Spray (n = 48) and for the placebo group (n = 47), respectively, with a difference between the group treated with VERAMYST Nasal Spray and the placebo group of -0.11 mcg/dL (95% CI: -0.88, 0.66).

Additional Hypothalamic-Pituitary-Adrenal Axis Assessments: In the 52-week safety trial in adolescents and adults aged 12 years and older with perennial allergic rhinitis, VERAMYST Nasal Spray 110 mcg (n = 605) was compared with placebo nasal spray (n = 201). Adrenal function was assessed by 24-hour urinary cortisol excretion in a subset of patients who received VERAMYST Nasal Spray (n = 370) or placebo (n = 120) before and after 52 weeks of treatment. After 52 weeks of treatment, the mean change from baseline 24-hour urinary cortisol excretion was 5.84 mcg/day in the group treated with VERAMYST Nasal Spray and 3.34 mcg/day in the placebo group. The difference from placebo in mean change from baseline 24-hour urinary cortisol excretion was 2.50 mcg/day (95% CI: -5.49, 10.49).

In the 12-week safety and efficacy trial in children aged 2 to 11 years with perennial allergic rhinitis, VERAMYST Nasal Spray 55 mcg (n = 185) and VERAMYST Nasal Spray 110 mcg (n = 185) were compared with placebo nasal spray (n = 188). Adrenal function was assessed by measurement of 24-hour urinary free cortisol in a subset of patients who were aged 6 to 11 years (103 to 109 patients per group) before and after 12 weeks of treatment. After 12 weeks of treatment, there was a decrease in mean 24-hour urinary cortisol excretion from baseline in the group treated with VERAMYST Nasal Spray 55 mcg (n = 109) of -2.93 mcg/day and in the group treated with VERAMYST Nasal Spray 110 mcg (n = 103) of -2.07 mcg/day compared with an increase in the placebo group (n = 107) of 0.08 mcg/day. The difference from placebo in mean change from baseline in 24-hour urinary cortisol excretion for the group treated with VERAMYST Nasal Spray 55 mcg was -3.01 mcg/day (95% CI: -6.16, 0.13) and -2.14 mcg/day (95% CI: -5.33, 1.04) for the group treated with VERAMYST Nasal Spray 110 mcg.

When the results of the HPA axis assessments described above are taken as a whole, an effect of intranasal fluticasone furoate on adrenal function cannot be ruled out, especially in pediatric patients.

Cardiac Effects: A QT/QTc study did not demonstrate an effect of fluticasone furoate administration on the QTc interval. The effect of a single dose of 4,000 mcg of orally inhaled fluticasone furoate on the QTc interval was evaluated over 24 hours in 40 healthy male and female subjects in a placebo and positive (a single dose of 400 mg oral moxifloxacin) controlled cross-over study. The QTcF maximal mean change from baseline following fluticasone furoate was similar to that observed with placebo with a treatment difference of 0.788 msec (90% CI: -1.802, 3.378). In contrast, moxifloxacin given as a 400-mg tablet resulted in prolongation of the QTcF maximal mean change from baseline compared with placebo with a treatment difference of 9.929 msec (90% CI: 7.339, 12.520). While a single dose of fluticasone furoate had no effect on the QTc interval, the effects of fluticasone furoate may not be at steady state following single dose. The effect of fluticasone furoate on the QTc interval following multiple dose administration is unknown.

12.3 Pharmacokinetics

Absorption: Following intranasal administration of fluticasone furoate, most of the dose is eventually swallowed and undergoes incomplete absorption and extensive first-pass metabolism in the liver and gut, resulting in negligible systemic exposure. At the highest recommended intranasal dosage of 110 mcg once daily for up to 12 months in adults and up to 12 weeks in children, plasma concentrations of fluticasone furoate are typically not quantifiable despite the use of a sensitive HPLC-MS/MS assay with a lower limit of quantification (LOQ) of 10 pg/mL. However, in a few isolated cases (<0.3%) fluticasone furoate was detected in high concentrations above 500 pg/mL, and in a single case the concentration was as high as 1,430 pg/mL in the 52-week study. There was no relationship between these concentrations and cortisol levels in these subjects. The reasons for these high concentrations are unknown.

Absolute bioavailability was evaluated in 16 male and female subjects following supratherapeutic dosages of fluticasone furoate (880 mcg given intranasally at 8-hour intervals for 10 doses, or 2,640 mcg/day). The average absolute bioavailability was 0.50% (90% CI: 0.34%, 0.74%).

Due to the low bioavailability by the intranasal route, the majority of the pharmacokinetic data was obtained via other routes of administration. Studies using oral solution and intravenous dosing of radiolabeled drug have demonstrated that at least 30% of fluticasone furoate is absorbed and then rapidly cleared from plasma. Oral bioavailability is on average 1.26%, and the majority of the circulating radioactivity is due to inactive metabolites.

Distribution: Following intravenous administration, the mean volume of distribution at steady state is 608 L.

Binding of fluticasone furoate to human plasma proteins is greater than 99%.

Metabolism: In vivo studies have revealed no evidence of cleavage of the furoate moiety to form fluticasone. Fluticasone furoate is cleared (total plasma clearance of 58.7 L/h) from systemic circulation principally by hepatic metabolism via CYP3A4. The principal route of metabolism is hydrolysis of the S-fluoromethyl carbothioate function to form the inactive 17β-carboxylic acid metabolite.

Elimination: Fluticasone furoate and its metabolites are eliminated primarily in the feces, accounting for approximately 101% and 90% of the orally and intravenously administered dose, respectively. Urinary excretion accounted for approximately 1% and 2% of the orally and intravenously administered dose, respectively. The elimination phase half-life averaged 15.1 hours following intravenous administration.

Population Pharmacokinetics: Fluticasone furoate is typically not quantifiable in plasma following intranasal dosing of 110 mcg once daily with the exception of isolated cases of very high plasma levels (see Absorption). Overall, quantifiable levels (>10 pg/mL) were observed in <31% of patients aged 12 years and older and in <16% of children (aged 2 to 11 years) following intranasal dosing of 110 mcg once daily and in <7% of children following intranasal dosing of 55 mcg once daily. There was no evidence to suggest that the presence or absence of detectable levels of fluticasone furoate was related to gender, age, or race.

Hepatic Impairment: Reduced liver function may affect the elimination of corticosteroids. Since fluticasone furoate undergoes extensive first-pass metabolism by the hepatic CYP3A4, the pharmacokinetics of fluticasone furoate may be altered in patients with hepatic impairment. A study of a single 400-mcg dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment (Child-Pugh Class B) resulted in increased C_max (42%) and AUC_(0-∞) (172%), resulting in an approximately 20% reduction in serum cortisol level in patients with hepatic impairment compared with healthy subjects. The systemic exposure would be expected to be higher than that observed had the study been conducted after multiple doses and/or in patients with severe hepatic impairment. Therefore, use VERAMYST Nasal Spray with caution in patients with severe hepatic impairment.

Renal Impairment: Fluticasone furoate is not detectable in urine from healthy subjects following intranasal dosing. Less than 1% of dose-related material is excreted in urine. No dosage adjustment is required in patients with renal impairment.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Fluticasone furoate produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at doses of up to 9 and 19 mcg/kg/day, respectively (less than the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis).

Fluticasone furoate did not induce gene mutation in bacteria or chromosomal damage in a mammalian cell mutation test in mouse lymphoma L5178Y cells in vitro. There was also no evidence of genotoxicity in the in vivo micronucleus test in rats.

No evidence of impairment of fertility was observed in reproductive studies conducted in male and female rats at inhaled fluticasone furoate doses of up to 24 and 91 mcg/kg/day, respectively (approximately 2 and 7 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/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 VERAMYST Nasal Spray was evaluated in 5 randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials of 2 to 4 weeks’ duration in adult and adolescent patients aged 12 years and older with symptoms of seasonal or perennial allergic rhinitis. The 5 clinical trials included one 2-week dose-ranging trial in patients with seasonal allergic rhinitis, three 2-week confirmatory efficacy trials in patients with seasonal allergic rhinitis, and one 4-week efficacy trial in patients with perennial allergic rhinitis. These trials included 1,829 patients (697 males and 1,132 females). About 75% of patients were Caucasian, and the mean age was 36 years. Of these patients, 722 received VERAMYST Nasal Spray 110 mcg once daily administered as 2 sprays in each nostril.

Assessment of efficacy was based on total nasal symptom score (TNSS). TNSS is calculated as the sum of the patients’ scoring of the 4 individual nasal symptoms (rhinorrhea, nasal congestion, sneezing, 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 patients to record symptom severity at the time immediately prior to the next dose. Morning and evening rTNSS 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 (AM 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.

Additional secondary efficacy variables were assessed, including the total ocular symptom score (TOSS) and the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). TOSS is calculated as the sum of the patients’ scoring of the 3 individual ocular symptoms (itching/burning, tearing/watering, and redness) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe) as reflective (rTOSS) or instantaneous scores (iTOSS). To assess efficacy, rTOSS and AM iTOSS were evaluated as described above for the TNSS. Patients’ perceptions of disease-specific quality of life were evaluated through use of the RQLQ, which assesses the impact of allergic rhinitis treatment through 28 items in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional) on a 7-point scale where 0 = no impairment and 6 = maximum impairment. An overall RQLQ score is calculated from the mean of all items in the instrument. An absolute difference of ≥0.5 in mean change from baseline over placebo is considered the minimally important difference (MID) for the RQLQ.

Dose-Ranging Trial: The dose-ranging trial was a 2-week trial that evaluated the efficacy of 4 dosages of fluticasone furoate nasal spray (440, 220, 110, and 55 mcg) in patients with seasonal allergic rhinitis. In this trial, each of the 4 dosages of fluticasone furoate nasal spray demonstrated greater decreases in the rTNSS than placebo, and the difference was statistically significant (Table 3).

Each of the 4 dosages of fluticasone furoate nasal spray also demonstrated greater decreases in the AM iTNSS than placebo, and the difference between each of the 4 fluticasone furoate treatment groups and placebo was statistically significant, indicating that the effect was maintained over the 24-hour dosing interval.

Seasonal Allergic Rhinitis Trials: Three clinical trials were designed to evaluate the efficacy of VERAMYST Nasal Spray 110 mcg once daily compared with placebo in patients with seasonal allergic rhinitis over a 2-week treatment period. In all 3 trials, VERAMYST Nasal Spray 110 mcg demonstrated a greater decrease from baseline in the rTNSS and AM iTNSS than placebo, and the difference from placebo was statistically significant. In terms of ocular symptoms, in all 3 seasonal allergic rhinitis trials, VERAMYST Nasal Spray 110 mcg demonstrated a greater decrease from baseline in the rTOSS than placebo and the difference from placebo was statistically significant. For the RQLQ in all 3 seasonal allergic rhinitis trials, VERAMYST Nasal Spray 110 mcg demonstrated greater decrease from baseline in the overall RQLQ than placebo, and the difference from placebo was statistically significant. The difference in the overall RQLQ score mean change from baseline between the groups treated with VERAMYST Nasal Spray and placebo ranged from -0.60 to -0.70 in the 3 trials, meeting the minimally important difference criterion. Table 4 displays the efficacy results from a representative trial in patients with seasonal allergic rhinitis.

Perennial Allergic Rhinitis Trials: One clinical trial was designed to evaluate the efficacy of VERAMYST Nasal Spray 110 mcg once daily compared with placebo in patients with perennial allergic rhinitis over a 4-week treatment period. VERAMYST Nasal Spray 110 mcg demonstrated a greater decrease from baseline in the rTNSS and AM iTNSS than placebo, and the difference from placebo was statistically significant. Similar to patients with seasonal allergic rhinitis, the improvement of nasal symptoms with VERAMYST Nasal Spray in patients with perennial allergic rhinitis persisted for a full 24 hours, as evaluated by AM iTNSS immediately prior to the next dose. However, unlike the trials in patients with seasonal allergic rhinitis, patients with perennial allergic rhinitis who were treated with VERAMYST Nasal Spray 110 mcg did not demonstrate statistically significant improvement from baseline in rTOSS or in disease-specific quality of life as measured by the RQLQ compared with placebo. In addition, the overall RQLQ score mean change from baseline difference between the group treated with VERAMYST Nasal Spray and the placebo group was -0.23, which did not meet the minimally important difference of ≥0.5. Table 4 displays the efficacy results from the clinical trial in patients with perennial allergic rhinitis.

Onset of action was evaluated by frequent instantaneous TNSS assessments after the first dose in the clinical trials in patients with seasonal allergic rhinitis and perennial allergic rhinitis. Onset of action was generally observed within 24 hours in patients with seasonal allergic rhinitis. In patients with perennial rhinitis, onset of action was observed after 4 days of treatment. Continued improvement in symptoms was observed over approximately 1 and 3 weeks in patients with seasonal or perennial allergic rhinitis, respectively.

Pediatric Patients Aged 2 to 11 Years: The efficacy and safety of VERAMYST Nasal Spray were evaluated in 1,112 children (633 boys and 479 girls), mean age of 8 years with seasonal or perennial allergic rhinitis in 2 controlled clinical trials. The pediatric patients were treated with VERAMYST Nasal Spray 55 or 110 mcg once daily for 2 to 12 weeks (n = 369 for each dose). The trials were similar in design to the trials conducted in adolescents and adults; however, the efficacy determination was made from patient- or parent/guardian-reported TNSS for children aged 6 to <12 years. Children treated with VERAMYST Nasal Spray generally exhibited greater decreases in nasal symptoms than placebo-treated patients. In seasonal allergic rhinitis, the difference in rTNSS was statistically significant only for the 110-mcg dose. In perennial allergic rhinitis, the difference in rTNSS was statistically significant only for the 55-mcg dose. Changes in rTOSS in the seasonal allergic rhinitis trial were not statistically significant compared with placebo for either dose. rTOSS was not assessed in the perennial allergic rhinitis trial. Table 5 displays the efficacy results from the clinical trials in patients with perennial allergic rhinitis and seasonal allergic rhinitis in children aged 6 to <12 years. Efficacy in children aged 2 to <6 years was supported by a numerical decrease in the rTNSS.

16 HOW SUPPLIED/STORAGE AND HANDLING

VERAMYST Nasal Spray, 27.5 mcg per spray, is supplied in a brown glass bottle enclosed in a nasal device with a nozzle and a mist-release button to actuate the spray in a box of 1 (NDC 0173-0753-00) with FDA-Approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of 10 g of white, liquid suspension and will provide 120 metered sprays. After priming [see Dosage and Administration (2)], each spray delivers a fine mist containing 27.5 mcg of fluticasone furoate in 50 microliters of formulation through the nozzle. The contents of the bottle can be viewed through an indicator window. Shake the contents well before each use. The correct amount of medication in each spray cannot be assured before the initial priming and after 120 sprays have been used, even though the bottle is not completely empty. The nasal device should be discarded after 120 sprays have been used.

Store the device in the upright position with the cap in place between 15° and 30°C (59° and 86°F). Do not freeze or refrigerate.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use).

17.1 Local Nasal Effects

Patients should be informed that treatment with VERAMYST Nasal Spray may lead to adverse reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment with VERAMYST Nasal Spray. In addition, nasal corticosteroids are associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use VERAMYST Nasal Spray until healing has occurred [see Warnings and Precautions (5.1)].

17.2 Cataracts and Glaucoma

Patients should be informed that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Patients should inform his/her health care provider if a change in vision is noted while using VERAMYST Nasal Spray [see Warnings and Precautions (5.2)].

17.3 Hypersensitivity Reactions, Including Anaphylaxis

Patients should be aware that hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, may occur after administration of VERAMYST Nasal Spray. If such reactions occur, patients should discontinue use of VERAMYST Nasal Spray [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 Effect on Growth

Parents should be advised that VERAMYST Nasal Spray may slow growth in children. A child taking VERAMYST Nasal Spray should have his/her growth checked regularly [see Warnings and Precautions (5.7) and Pediatric Use (8.4)].

17.6 Use Daily for Best Effect

Patients should use VERAMYST Nasal Spray on a regular once-daily basis for optimal effect. VERAMYST Nasal Spray, like other corticosteroids, does not have an immediate effect on rhinitis symptoms. Although significant improvement is usually achieved within 24 hours in patients with seasonal allergic rhinitis and 4 days in patients with perennial allergic rhinitis, maximum benefit may not be reached for several days. The patient should not increase the prescribed dosage but should contact the physician if symptoms do not improve or if the condition worsens.

17.7 Keep Spray Out of Eyes

Patients should be informed to avoid spraying VERAMYST Nasal Spray in their eyes.

17.8 Potential Drug Interactions

Patients should be advised that coadministration of VERAMYST Nasal Spray and ritonavir is not recommended and to be cautious if coadministrating with ketoconazole.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2012, GlaxoSmithKline. All rights reserved.

VRM:9PI

Patient Information

VERAMYST^® [VAIR-uh-mist]

(fluticasone furoate)

Nasal Spray

For Intranasal Use Only

Read the Patient Information that comes with VERAMYST Nasal Spray carefully before you start using it and each time you get a refill. There may be new information. Keep the leaflet for reference because it gives you a summary of important information about VERAMYST Nasal Spray. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is VERAMYST Nasal Spray?

VERAMYST Nasal Spray is a medicine that treats seasonal and year-round allergy symptoms in adults and children 2 years old and older.

VERAMYST Nasal Spray contains fluticasone furoate, which is a man-made (synthetic) corticosteroid. When you spray VERAMYST Nasal Spray into your nose, it helps reduce the nasal symptoms of allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, nasal itching, and sneezing. VERAMYST Nasal Spray may also help red, itchy, and watery eyes in adults and teenagers with seasonal allergic rhinitis.

Your healthcare provider has prescribed VERAMYST Nasal Spray to treat your symptoms of allergic rhinitis.

It is not known if VERAMYST Nasal Spray is safe and effective in children under 2 years of age.

Who should not use VERAMYST Nasal Spray?

Do not use VERAMYST Nasal Spray if you are allergic to fluticasone furoate or any of the ingredients in VERAMYST Nasal Spray. See the end of this Patient Information leaflet for a complete list of ingredients in VERAMYST Nasal Spray.

What should I tell my healthcare provider before taking VERAMYST Nasal Spray?

Tell your healthcare provider about all of your medical conditions, including if you:

• •have had recent nasal sores, nasal surgery, or nasal injury
• •have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eye)
• •have tuberculosis or any untreated fungal, bacterial, viral infections, or eye infections caused by herpes
• •are exposed to chickenpox or measles.
• •are feeling unwell or have any symptoms that you do not understand.
• •are pregnant or plan to become pregnant. It is not known if VERAMYST Nasal Spray 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 VERAMYST Nasal Spray can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take VERAMYST Nasal Spray.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. VERAMYST Nasal Spray and other medicines may affect each other, causing side effects. Be certain to tell your healthcare provider if you are taking a medicine that contains ritonavir (commonly used to treat HIV infection or AIDS).

How should I use VERAMYST Nasal Spray?

• •This medicine is for use in the nose only. Do not spray it in your eyes or mouth.
• •An adult should help a young child use this medicine.
• •This medicine has been prescribed for you by your healthcare provider. Do not give this medicine to anyone else.
• •Use VERAMYST Nasal Spray exactly as your healthcare provider tells you to. Do not take more of your medicine or take it more often than your healthcare provider tells you. The prescription label will usually tell you how many sprays to take and how often. If it does not or if you are not sure, ask your healthcare provider or pharmacist.
• • For people aged 12 years and older, the usual starting dosage is 2 sprays in each nostril, 1 time a day. After you begin to feel better, your healthcare provider may tell you that 1 spray in each nostril 1 time a day may be enough for you.
• • For children aged 2 to 11 years, the usual starting dosage is 1 spray in each nostril, 1 time a day. Your healthcare provider may tell you to take 2 sprays in each nostril 1 time a day. After you begin to feel better, your healthcare provider may change the dosage to 1 spray in each nostril 1 time a day. An adult should help a young child use this medicine.
• •Do not use VERAMYST Nasal Spray after 120 sprays (plus the initial priming sprays) have been used or after the expiration date, whichever comes first. (The sample bottle contains 30 sprays.) The bottle may not be completely empty. The expiration date is printed as “EXP” on the product label and box. Before you throw away VERAMYST Nasal Spray, talk to your healthcare provider to see if you need a refill of your prescription. If your healthcare provider tells you to continue using VERAMYST Nasal Spray, throw away the empty or expired bottle and use a new bottle of VERAMYST Nasal Spray. Follow the Instructions for Use below.
• •Do not take extra doses or stop taking VERAMYST Nasal Spray without telling your healthcare provider.
• •VERAMYST Nasal Spray may begin to work within 24 hours after you take your first dose. It may take several days before it has its greatest effect. If your symptoms do not improve or get worse, call your healthcare provider.
• •You will get the best results if you keep using VERAMYST Nasal Spray regularly each day without missing a dose. If you miss a dose by several hours, just take your next dose at the usual time. Do not take an extra dose.

What are the possible side effects of VERAMYST Nasal Spray?

VERAMYST Nasal Spray may cause serious side effects, including:

• • thrush (candidiasis), a fungal infection in your mouth and throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
• • hole in the cartilage in the nose (nasal septal perforation). Symptoms of nasal septal perforation may include:
  • ∘crusting in the nose
  • ∘nosebleeds
  • ∘runny nose
  • ∘whistling sound when you breathe
• • slow wound healing. You should not use VERAMYST Nasal Spray until your nose has healed if you have a sore in your nose, have had surgery on your nose, or if 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 these eye problems, you should have regular eye exams while you use VERAMYST Nasal Spray.
• • serious allergic reactions. Serious allergic reactions can happen with VERAMYST Nasal Spray. Stop using VERAMYST Nasal Spray and call your healthcare provider right away if you have any of the following signs of a serious allergic reaction:
• •shortness of breath or trouble breathing
• •skin rash, redness, or swelling
• •severe itching
• •swelling of the 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 infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while you use VERAMYST Nasal Spray. Symptoms of an infection may include:
  • ∘fever
  • ∘pain
  • ∘aches
  • ∘chills
  • ∘feeling tired
  • ∘nausea
  • ∘vomiting
• • adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency may include:
  • ∘tiredness
  • ∘weakness
  • ∘dizziness
  • ∘nausea
  • ∘vomiting
• • slowed or delayed growth in children. A child’s growth should be checked regularly while using VERAMYST Nasal Spray.

The most common side effects of VERAMYST Nasal Spray include:

• • adults and adolescents 12 years of age and older
  • ∘headaches
  • ∘nose bleeds
  • ∘sore throat
  • ∘nose sores
  • ∘back pain
• • children 2 to 12 years of age
  • ∘headaches
  • ∘sore throat
  • ∘nose bleeds
  • ∘fever
  • ∘cough

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

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

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

What should I know about allergic rhinitis?

“Rhinitis” means inflammation of the lining of the nose. It is sometimes called “hay fever.” Allergic rhinitis can be caused by allergies to pollen, animal dander, house dust mite, and mold spores. 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; itchy throat; or blocked, itchy ears.

What are the ingredients in VERAMYST Nasal Spray?

Active ingredient: fluticasone furoate

Inactive ingredients: 0.015% w/w benzalkonium chloride, dextrose anhydrous, edetate disodium, microcrystalline cellulose, carboxymethylcellulose sodium, polysorbate 80, and purified water

Instructions for Use

Read this leaflet carefully before you start to use VERAMYST Nasal Spray. If you have any questions, ask your healthcare provider or pharmacist.

The parts of the VERAMYST Nasal Spray

VERAMYST Nasal Spray comes in a brown glass bottle inside a nasal device. It contains 120 sprays (or 30 sprays if it is a sample) plus the first priming sprays. Be careful not to drop it. If you accidentally drop the device, check it for damage. If the device is damaged, return it to your pharmacist.