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Safety and tolerability of Avamys

In adults:

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In studies with FFNS, it was shown to be well-tolerated 1-3

Running nose

As with other INCS, the most common adverse event was epistaxis 34

Long-term use of Avamys

Long-term use of Avamys did not cause mucosal atrophy (up to 1 year) 5

In children:

Thumbs up

In studies with FFNS, it was shown to be well-tolerated 1-3

Running nose

In paediatric (children aged 2–11 years) clinical studies of up to 12 weeks’ duration, the incidence of epistaxis was similar between Avamys and placebo 4
Avamys is licensed in children that are six and above.

Long-term use of Avamys

Long-term use of Avamys did not cause mucosal atrophy (up to 1 year) 5

Avamys safety information

Avamys is contraindicated in patients with hypersensitivity to any of the ingredients 4

ADVERSE REACTIONS: Epistaxis (the incidence of epistaxis was higher in longer-term use (more than 6 weeks) than in short-term use (up to 6 weeks) in adults and adolescents; in paediatric clinical studies of up to 12 weeks’ duration the incidence of epistaxis was similar between fluticasone furoate and placebo), nasal ulceration and headache 4

A REDUCTION IN GROWTH VELOCITY has been observed in children treated with fluticasone furoate 110 μg daily for 1 year. Therefore, children should be maintained on the lowest dose that delivers adequate symptom control 4

IN SAFETY STUDIES OF ADULTS with perennial allergic rhinitis there was no evidence to suggest that Avamys increases the incidence of adverse ocular effects. 36
As with other intranasal corticosteroids, physicians should be alert to potential systemic steroid effects including ocular changes such as central serous chorioretinopathy 
4

Please refer to the full prescribing information for further details, here.

AE: Adverse event; AR: Allergic rhinitis; FFNS: Fluticasone propionate nasal spray; INCS: Intranasal corticosteroid.

References:

  1. Vasar M, Houle PA, Douglass JA, et al. Fluticasone furoate nasal spray: Effective monotherapy for symptoms of perennial allergic rhinitis in adults/adolescents. Allergy Asthma Proc. 2008;29(3);313-321.
  2. Maspero JF, Walters RD, Wu W, et al. An integrated analysis of the efficacy of fluticasone furoate nasal spray on individual nasal and ocular symptoms of seasonal allergic rhinitis. Allergy Asthma Proc. 2010;31(6):483-492.
  3. Rosenblut A, Bardin PG, Muller B, et al. Long-term safety of fluticasone furoate nasal spray in adults and adolescents with perennial allergic rhinitis. Allergy. 2007:62(9);1071-1077.
  4. Avamys summary of product characteristics
  5. Fokkens WJ, Rinia B, van Drunen CM, et al. No mucosal atrophy and reduced inflammatory cells: active-controlled trial with year-long fluticasone furoate nasal spray. Am J Rhinol Allergy. 2012;26(1):36-44.
  6. La Force C, Journeay GE, Miller SD, et al. Ocular safety of fluticasone furoate nasal spray in patients with perennial allergic rhinitis: a 2-year study. Ann Allergy Asthma lmmunol. 2013;111:45-50.

Avamys is a registered trademark of the GlaxoSmithKline group of companies.