VERAMYST- fluticasone furoate spray, metered
GlaxoSmithKline LLC
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.
Titrate an individual patient to the minimum effective dosage to reduce the possibility of side effects.
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. 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, dosage reduction to 55 mcg once daily is recommended.
3 DOSAGE FORMS AND STRENGTHS
VERAMYST Nasal Spray is a nasal spray suspension. Each spray (50 microliters) delivers 27.5 mcg of fluticasone furoate.
DESCRIPTION
Fluticasone furoate, the active component of VERAMYST Nasal Spray, is a synthetic fluorinated corticosteroid having the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate
Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27 H29 F3 O6 S. 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.
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
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Local Nasal Effects
Inform patients 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. Advise patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma to not use VERAMYST Nasal Spray until healing has occurred [see Warnings and Precautions (5.1)].
Cataracts and Glaucoma
Inform patients that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Instruct patients to inform their healthcare providers if a change in vision is noted while using VERAMYST Nasal Spray [see Warnings and Precautions (5.2)].
Hypersensitivity Reactions, including Anaphylaxis
Inform patients that hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, may occur after administration of VERAMYST Nasal Spray. Instruct patients to discontinue use of VERAMYST Nasal Spray if such reactions occur [see Warnings and Precautions (5.3)].
Immunosuppression
Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their healthcare providers without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)].
Effect on Growth
Advise parents 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), Use in Specific Populations (8.4)].
Use Daily for Best Effect
Instruct patients to 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. Instruct the patient to not increase the prescribed dosage but contact the healthcare provider if symptoms do not improve or if the condition worsens.
Keep Spray Out of Eyes
Inform patients to avoid spraying VERAMYST Nasal Spray in their eyes.
Potential Drug Interactions
Advise patients that coadministration of VERAMYST Nasal Spray and ritonavir is not recommended and to be cautious if coadministering with ketoconazole.
VERAMYST is a registered trademark of the GSK group of companies.
GlaxoSmithKline
Research Triangle Park, NC 27709
�2016 the GSK group of companies. All rights reserved.
