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Indication

Avamys nasal spray is indicated for the treatment of the symptoms of allergic rhinitis 1

For adults and adolescents from 12 years of age:

The recommended starting dose is two spray actuations (27.5 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.

For children aged 6 to 11 years:

The recommended starting dose is one spray actuation (27.5 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. However, it may take several days of treatment to achieve maximum benefit, and the patient should be informed that their symptoms will improve with continuous regular use (see section 5.1). The duration of treatment should be restricted to the period that corresponds to allergenic exposure.

Efficacy

Avamys is effective for all major nasal and ocular symptoms
associated with seasonal AR* 2

Nose
Nasal symptoms
Eye
Ocular symptoms

Effective reduction in the nasal and ocular symptoms of perennial AR from baseline3

PAR symptoms graph

Most AEs were of mild to moderate intensity and comparable to placebo. The most common AEs reported were: epistaxis, headache, nasopharyngitis, laryngopharyngeal pain.

Targeted action with Avamys

FF has the highest glucocorticoid receptor affinity and the strongest tissue binding compared to other INCS3-5

Glucocorticoid receptor affinity 5(in human lung tissue in vitro)

Receptor affinity graph
Target
Longer tissue retention

* Integrated analysis performed on data from 4 randomised, double-blind, placebo-controlled, parallel-group, multicentre trials, which were
designed to evaluate the efficacy and safety of FFNS for 14 days in 1141 adult and adolescent seasonal AR patients. The primary efficacy
measure for each study was the mean change from baseline over the entire treatment period in daily rTNSS.
† Global, randomised, double-blind, placebo-controlled, 6-week study evaluating the efficacy and tolerability of intranasal fluticasone furoate
in patients ≥12 years of age (n=302) with perennial AR. The primary efficacy measure was mean change from baseline over the 6-week
treatment period in daily reflective TNSS.
‡ Compared to fluticasone propionate, budesonide, mometasone furoate, and ciclesonide.
FFNS: Fluticasone furoate nasal spray; INCS: Intranasal corticosteroid; MFNS: Mometasone furoate nasal spray; rTNSS: Reflective total nasal symptom score; rTOSS: Reflective total ocular symptom score; TNSS: Total nasal symptom score.

References:

  1. Avamys SPC available on www.medicines.ie last accessed April 2019
  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. 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.
  4. Baumann D, Bachert C, Högger P. Dissolution in nasal fluid, retention and anti-inflammatory activity of fluticasone furoate in human nasal tissue ex vivo. Clin Exp Allergy. 2009;39(10):1540-1550.
  5. Valotis A, Hogger P. Human receptor kinetics and lung tissue retention of the enhanced-affinity glucocorticoid fluticasone furoate. Respir Res. 2007;8(1):54.

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971 medsafety@hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Avamys is a registered trademark of the GlaxoSmithKline group of companies