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  • Avamys
    / GSK

    Active Ingredient
    Fluticasone (as furoate) 27.5 mcg/dose

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Nasal Spray

    120 sprays

    not in the basket chart 84222 9341


    Administer this Nasal Spray by the intranasal route only. Prime 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 the 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 the Nasal Spray well before each use.
    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.
    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.
    Hepatic Impairment: Use AVAMYS Nasal Spray with caution in patients with moderate or severe hepatic impairment.
    Renal Impairment: No dosage adjustment is required in patients with renal impairment.


    Treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.


    Hypersensitivity to the active substance or to any of its excipients.

    Special Precautions

    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 AVAMYS Nasal Spray than those who received placebo . (see side effects)
    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 AVAMYS 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 AVAMYS Nasal Spray. Therefore, patients using AVAMYS 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: Postmarketing cases of nasal septal perforation have been reported in patients following the intranasal application of AVAMYS Nasal Spray (see side effects).
    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 AVAMYS Nasal Spray until healing has occurred.
    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 AVAMYS 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 AVAMYS 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 this Nasal Spray 110 mcg once daily and 1 patient treated with placebo) had cataracts identified during the study that were not present at baseline.
    See prescribing information for full details.

    Side Effects

    Systemic and local corticosteroid use may result in the following:
    – Epistaxis, ulcerations, Candida albicans infection, impaired wound healing, and nasal septal perforation.
    – Cataracts and glaucoma
    – Immunosuppression
    – Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction.
    See prescribing information for full details.

    Drug interactions

    Fluticasone furoate is cleared by extensive first-pass metabolism mediated by CYP 3A4. In a drug interaction study of intranasal fluticasone furoate and the CYP 3A4 inhibitor ketoconazole given as a 200-mg once-daily dose for 7 days, 6 of 20 subjects receiving fluticasone furoate and ketoconazole had measurable but low levels of fluticasone furoate compared with 1 of 20 receiving fluticasone furoate and placebo. Based on this study and the low systemic exposure, there was a 5% reduction in 24-hour serum cortisol levels with ketoconazole compared with placebo. The data from this study should be carefully interpreted because the study was conducted with ketoconazole 200 mg once daily rather than 400 mg, which is the maximum recommended dosage. Therefore, caution is required with the co-administration of AVAMYS Nasal Spray and ketoconazole or other potent CYP 3A4 inhibitors.
    Based on data with another glucocorticoid, fluticasone propionate, metabolized by CYP 3A4, co-administration of AVAMYS Nasal Spray with the potent CYP 3A4 inhibitor ritonavir is not recommended because of the risk of systemic effects secondary to increased exposure to fluticasone furoate. High exposure to corticosteroids increases the potential for systemic side effects, such as cortisol suppression.
    Enzyme induction and inhibition data suggest that fluticasone furoate is unlikely to significantly alter the cytochrome P450-mediated metabolism of other compounds at clinically relevant intranasal dosages.

    Pregnancy and Lactation

    Pregnancy: Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This product should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
    Nonteratogenic Effects: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.
    Nursing Mothers: It is not known whether fluticasone furoate is excreted in human breast milk. However, other corticosteroids have been detected in human milk. Since there are no data from controlled trials on the use of intranasal fluticasone furoate by nursing mothers, caution should be exercised when administered to a nursing woman.
    See prescribing information for full details.


    Chronic overdose may result in signs/symptoms of hypercorticism. There are no data on the effects of acute or chronic overdose with this product. Because of low systemic bioavailability and an absence of acute drug-related systemic findings in clinical studies (with dosages of up to 440 mcg/day for 2 weeks [4 times the maximum recommended daily dose]), overdose is unlikely to require any therapy other than observation.
    Intranasal administration of up to 2,640 mcg/day (24 times the recommended adult dose) of fluticasone furoate was administered to healthy human volunteers for 3 days. Single- and repeat-dose studies with orally inhaled fluticasone furoate doses of 50 to 4,000 mcg have shown decreased mean serum cortisol at doses of 500 mcg or higher. The oral median lethal dose in mice and rats was >2,000 mg/kg (approximately 74,000 and 147,000 times, respectively, the maximum recommended daily intranasal dose in adults and 52,000 and 105,000 times, respectively, the maximum recommended daily intranasal dose in children, on a mcg/m2 basis).
    Acute overdose with the intranasal dosage form is unlikely since 1 bottle of AVAMYS Nasal Spray contains approximately 3 mg of fluticasone furoate, and the bioavailability of fluticasone furoate is <1% for 2.64 mg/day given intranasally and 1% for 2 mg/day given as an oral solution.

    Glaxo Operations UK Ltd