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Drug Details

Avamys

• Presentation
  Nasal spray, suspension. White suspension.
• Description
  AVAMYS® 27.5 micrograms/spray nasal spray suspension
• Indications
  Adults, adolescents (12 years and over) and children (6 – 11 years) Avamys is indicated for the treatment of: • the symptoms of allergic rhinitis
• Adult Dosage
  

  Fluticasone furoate nasal spray is for administration by the intranasal route only.

  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.

  Adults and Adolescents (12 years and over)

  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.

   Renal Impaired Patients: No dose adjustment is required in this population.

  Hepatic Impaired Patients: No dose adjustment is required in mild to moderate hepatic impairment. There are no data in patients with severe hepatic impairment .

  The intranasal device should be shaken before use. The device is primed by pressing the mist release button for at least six spray actuations (until a fine mist is seen), whilst holding the device upright. Re-priming (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.

• Child Dosage
  

  Children (6 to 11 years of age)

  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.

  Children under 6 years of age: The experience in children under the age of 6 years is limited. Safety and efficacy in this group has not been well established.

   

• Elderly Dosage
  

  Elderly Patients: No dose adjustment is required in this population

• Contra Indications
  

  Hypersensitivity to the active substance or to any of the excipients of Avamys

• Special Precautions
  

  Fluticasone furoate undergoes extensive first-pass metabolism, therefore the systemic exposure of intranasal fluticasone furoate in patients with severe liver disease is likely to be increased. This may result in a higher frequency of systemic adverse events. Caution is advised when treating these patients.

  Ritonavir

  Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate.

  Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods. These effects vary between patients and different corticosteroids.

  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.

  Growth retardation has been reported in children receiving some nasal corticosteroids at licensed doses. It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring the patient to a paediatric specialist.

  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.

  Avamys contains benzalkonium chloride. It may cause irritation of the nasal mucosa.

• Interactions
  

  Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4.

  Based on data with another glucocorticoid (fluticasone propionate), that is metabolised by CYP3A4, co-administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate.

  Caution is recommended when co-administering fluticasone furoate with potent CYP3A4 inhibitors as an increase in systemic exposure cannot be ruled out. In a drug interaction study of intranasal fluticasone furoate with the potent CYP3A4 inhibitor ketoconazole there were more subjects with measurable fluticasone furoate concentrations in the ketoconazole group (6 of the 20 subjects) compared to placebo (1 out of 20 subjects). This small increase in exposure did not result in a statistically significant difference in 24 hour serum cortisol levels between the two groups.

  The enzyme induction and inhibition data suggest that there is no theoretical basis for anticipating metabolic interactions between fluticasone furoate and the cytochrome P450 mediated metabolism of other compounds at clinically relevant intranasal doses. Therefore, no clinical studies have been conducted to investigate interactions of fluticasone furoate on other drugs.

• Adverse Drug Reactions
  

  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.

  Respiratory, thoracic and mediastinal disorders
  Very common	Epistaxis
  Common	Nasal ulceration

  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). In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between patients receiving fluticasone furoate and patients receiving placebo.