NYRELLA

5 micrograms of fluticasone furoate per spray/actuation) in each nostril once daily (total daily dose, 110 micrograms). Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril (total daily dose 55 micrograms) may be effective for maintenance.

The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. 5 micrograms of fluticasone furoate per spray/actuation) in each nostril once daily (total daily dose, 55 micrograms). Patients not adequately responding to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) may use two spray actuations in each nostril once daily (total daily dose, 110 micrograms).

Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) is recommended. For full therapeutic benefit regular, scheduled usage is recommended. Onset of action has been observed as early as 8 hours after initial administration.

1). The duration of treatment should be restricted to the period that corresponds to allergenic exposure. Children under 6 years of age The safety and efficacy of Fluticasone furoate in children under the age of 6 years has not been established.

2 but no recommendation on a posology can be made. 2). 2). 2). Method of administration Fluticasone furoate nasal spray is for administration by the intranasal route only. The intranasal device should be shaken before use. The device is primed by pressing the pump for at least six spray actuations (until a fine mist is seen), whilst holding the device upright.

Repriming (approximately 6 sprays until a fine mist is seen) is only necessary if the cap is left off for 5 days or the intranasal device has not been used for 30 days or more. The device should be cleaned after each use and the cap replaced.

Summary of the safety profile The most commonly reported adverse reactions during treatment with fluticasone furoate are epistaxis, nasal ulceration and headache. The most serious undesirable effects are rare reports of hypersensitivity reactions, including anaphylaxis (less than 1 case per 1000 patients).

Tabulated list of adverse reactions There were over 2700 patients treated with fluticasone furoate in safety and efficacy studies for seasonal and perennial allergic rhinitis. Paediatric exposure to fluticasone furoate in safety and efficacy studies in seasonal and perennial allergic rhinitis included 243 patients 12 to <18 years, 790 patients 6 to <12 years and 241 patients 2 to <6 years.

Data from large clinical trials were used to determine the frequency of adverse reactions.

The following convention has been used for the classification of frequencies:

Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10,000 to <1/1000; Very rare <1/10,000; Not known (cannot be estimated from the available data). 4) Respiratory, thoracic and mediastinal disorders Very common *Epistaxis Common Nasal ulceration, dyspnoea** Uncommon Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness.

Very rare Nasal septum perforation Not known Bronchospasm Musculoskeletal and connective tissue disorders (Children) Not known ***Growth retardation (see Clinical experience). Description of selected adverse reactions Epistaxis *Epistaxis was generally mild to moderate in intensity.

In adults and adolescents, the incidence of epistaxis was higher in longer-term use (more than 6 weeks) than in short-term use (up to 6 weeks). 4). Growth retardation has been reported in children receiving nasal corticosteroids. **Dyspnoea cases were reported in more than 1% of patients during clinical trials with fluticasone furoate; similar rates were also observed in placebo groups.

Systemic corticosteroid effects Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.

Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Fluticasone furoate 110 micrograms once daily was not associated with hypothalamic-pituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects. However, the dose of intranasal fluticasone furoate should be reduced to the lowest dose at which effective control of the symptoms of rhinitis is maintained.

As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed concurrently. If there is any reason to believe that adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to fluticasone furoate.

Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

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