Chemical formula: C₂₇H₂₉F₃O₆S Molecular mass: 538.576 g/mol PubChem compound: 9854489
Fluticasone furoate interacts in the following cases:
Caution is recommended when co-administering fluticasone furoate with potent CYP3A inhibitors including cobicistat-containing products as an increase in the risk of systemic side effects is expected. Coadministration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects. 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.
Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate.
There are no adequate data from the use of fluticasone furoate in pregnant women. In animal studies glucocorticoids have been shown to induce malformations including cleft palate and intra-uterine growth retardation. This is not likely to be relevant for humans given recommended nasal doses which results in minimal systemic exposure. Fluticasone furoate should be used in pregnancy only if the benefits to the mother outweigh the potential risks to the foetus or child.
It is unknown whether nasal administered fluticasone furoate is excreted in human breast milk.
Administration of fluticasone furoate to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
There are no fertility data in humans.
Fluticasone furoate has no or negligible influence on the ability to drive and use machines.
The most commonly reported adverse reactions during treatment with fluticasone furoate are epistaxis, nasal ulceration and headache. The most serious undesirable effects are rare reports of hypersensitivity reactions, including anaphylaxis (less than 1 case per 1000 patients).
There were over 2700 patients treated with fluticasone furoate in safety and efficacy studies for seasonal and perennial allergic rhinitis. Paediatric exposure to fluticasone furoate in safety and efficacy studies in seasonal and perennial allergic rhinitis included 243 patients 12 to <18 years, 790 patients 6 to <12 years and 241 patients 2 to <6 years.
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.
| Immune system disorders | |
| Rare | Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria. |
| Nervous system disorders | |
| Common | Headache. |
| Eye disorders | |
| Not known | Transient ocular changes (see Clinical experience), vision blurred |
| Respiratory, thoracic and mediastinal disorders | |
| Very common | Epistaxis* |
| Common | Nasal ulceration, dyspnoea** |
| Uncommon | Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness. |
| Very rare | Nasal septum perforation |
| Not known | Bronchospasm |
| Musculoskeletal and connective tissue disorders (Children) | |
| Not known | Growth retardation (see Clinical experience).*** |
* 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).
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods. Growth retardation has been reported in children receiving nasal corticosteroids.
** Dyspnoea cases were reported in more than 1% of patients during clinical trials with fluticasone furoate; similar rates were also observed in placebo groups.
The safety in children under 6 years has not been well established. Frequency, type and severity of adverse reactions observed in the paediatric population are similar to those in the adult population.
* 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.
** In a one-year clinical study assessing growth in pre-pubescent children receiving 110 micrograms of fluticasone furoate once daily, an average treatment difference of -0.27 cm per year in growth velocity was observed compared to placebo.
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