VERAMYST® (fluticasone furoate) Nasal Spray

----------------------------INDICATIONS AND USAGE---------------------
VERAMYST Nasal Spray is a corticosteroid indicated for treatment of symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years. (1.1)
-----------------------DOSAGE AND ADMINISTRATION----------------
For intranasal use only. Usual starting dosages:
• Adults and adolescents ≥12 years: 110 mcg (2 sprays per nostril) once daily. (2.1)
• Children 2-11 years: 55 mcg (1 spray per nostril) once daily. (2.2)
• Priming Information: Prime VERAMYST Nasal Spray before using for the first time, when not used for more than 30 days, or if the cap has been left off the bottle for 5 days or longer. (2)
---------------------DOSAGE FORMS AND STRENGTHS--------------
Nasal spray: 27.5 mcg of fluticasone furoate in each 50-microliter spray. (3)
Supplied in 10-g bottle containing 120 sprays. (16)
-------------------------------CONTRAINDICATIONS------------------------
None. (4)
-----------------------WARNINGS AND PRECAUTIONS-----------------
• Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. (5.1)
• Development of glaucoma or posterior subcapsular cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. (5.2)
• 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. (5.3)
• Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue VERAMYST Nasal Spray slowly. (5.4)
• Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving VERAMYST Nasal Spray. (5.6, 8.4)
------------------------------ADVERSE REACTIONS-----------------------
The most common adverse reactions (>1% incidence) included headache, epistaxis, pharyngolaryngeal pain, nasal ulceration, back pain, pyrexia, and cough. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
-------------------------------DRUG INTERACTIONS------------------------
Potent inhibitors of cytochrome P450 3A4 (CYP3A4) may increase exposure to fluticasone furoate.
• Co-administration of ritonavir is not recommended. (5.5, 7)
• Use caution with co-administration of other potent CYP3A4 inhibitors, such as ketoconazole. (5.5, 7)
-----------------------USE IN SPECIFIC POPULATIONS----------------
Hepatic impairment may increase exposure to fluticasone furoate. Use with caution in patients with severe hepatic impairment. (8.6)

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

FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Treatment of Allergic Rhinitis
2 DOSAGE AND ADMINISTRATION
2.1 Adults and Adolescents 12 Years of Age and Older
2.2 Children 2 to 11 Years of Age
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Local Nasal Effects
5.2 Glaucoma and Cataracts
5.3 Immunosuppression
5.4 Hypothalamic-Pituitary-Adrenal Axis Effects
5.5 Use of CYP3A4 Inhibitors
5.6 Effect on Growth
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Seasonal and Perennial Allergic Rhinitis
16 HOW SUPPLIED/STORAGE AND HANDING
17 PATIENT COUNSELING INFORMATION
17.1 Local Nasal Effects
17.2 Cataracts and Glaucoma
17.3 Immunosuppression
17.4 Use Daily for Best Effect
17.5 Keep Spray Out of Eyes
17.6 Potential Drug Interactions
*Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Treatment of Allergic Rhinitis
VERAMYST Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients 2 years of age 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 test 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 12 Years of Age 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 2 to 11 Years of Age
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
None.