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Safety and tolerability of Avamys

In adults

  • In studies with FFNS, it was shown to be well tolerated 1–3
  • As with other INCS, the most common adverse event was epistaxis 34
  • Absolute bioavailability of Avamys is 0.5% vs 33% with budesonide, minimising systemic exposure; rapid clearance via hepatic metabolism 45
  • Long-term use of Avamys did not cause mucosal atrophy (up to 1 year) 6

In children

  • FFNS has no significant effect on HPA axis function in children and adults over 6 years old and 2 weeks of treatment2,3 78
  • 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 9
  • FFNS showed no evidence of mucosal atrophy after 12 months of treatment 6

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.37 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.

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. Fluticasone Furoate Global Data Sheet; version 11, 03 April 2018.
  5. Budesonide Summary of Product Characteristics. Sandoz Limited, July 2017.
  6. 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.
  7. Okubo K, Nakashima M, Miyake N, et al. Comparison of fluticasone furoate and fluticasone propionate for the treatment of Japanese cedar pollinosis. Allergy Asthma Proc 2009;30(1):84–94.
  8. Tripathy I, Levy A, Ratner P, et al. HPA axis safety of fluticasone furoate nasal spray once daily in children with perennial allergic rhinitis. Pediatr Allergy Immunol 2009;20(3):287–294.
  9. Lee LA, Sterling R, Máspero J, et al. Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis. J Allergy Clin Immunol Pract 2014;2(4):421–427.

Avamys is a registered trademark of the GlaxoSmithKline group of companies