Adolescent and Adult Patients: The incidence of common adverse events in Table 2 is based upon 2 placebo-controlled US clinical trials in which 812 adolescent and adult patients (457 females and 355 males) previously treated with as-needed bronchodilators and/or inhaled corticosteroids were treated twice daily for up to 12 weeks with 2 inhalations of FLOVENT HFA 44 mcg Inhalation Aerosol, FLOVENT HFA 110 mcg Inhalation Aerosol, FLOVENT HFA 220 mcg Inhalation Aerosol (dosages of 88, 220, or 440 mcg twice daily) or placebo.

Table 2. Overall Adverse Events With > 3% Incidence in US Controlled Clinical Trials With FLOVENT HFA in Patients ≥ 12 Years of Age With Asthma Previously Receiving Bronchodilators and/or Inhaled Corticosteroids

Table 2 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in any of the groups treated with FLOVENT HFA and were more common than in the placebo group. In considering these data, differences in average duration of exposure should be taken into account.

These adverse events were mostly mild to moderate in severity. Rare cases of immediate and delayed hypersensitivity reactions, including urticaria and rash, have been reported.

Other adverse events that occurred in the groups receiving FLOVENT HFA in these studies with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were:

Ear, Nose, and Throat: Sinusitis/sinus infection, rhinitis, pharyngitis/throat infection, rhinorrhea/post-nasal drip, nasal sinus disorders, laryngitis.

Gastrointestinal: Diarrhea, viral gastrointestinal infections, gastrointestinal signs and symptoms, dyspeptic symptoms, gastrointestinal discomfort and pain, hyposalivation.

Musculoskeletal: Musculoskeletal pain, muscle pain, muscle stiffness/tightness/rigidity.

Neurological: Dizziness, migraines.

Non-Site Specific: Fever, viral infections, pain, chest symptoms.

Skin: Viral skin infections.

Trauma: Muscle injuries, soft tissue injuries, injuries.

Urogenital: Urinary infections.

Fluticasone propionate inhalation aerosol (440 or 880 mcg twice daily) was administered for 16 weeks to patients with asthma requiring oral corticosteroids (Study 3). Adverse events not included in Table 2, but reported by > 3 patients in either group treated with FLOVENT HFA and more commonly than in the placebo group included rhinitis, nausea and vomiting, arthralgia and articular rheumatism, musculoskeletal pain, muscle pain, malaise and fatigue, and sleep disorders.

In 2 long-term studies (26 and 52 weeks), treatment with FLOVENT HFA at dosages up to 440 mcg twice daily was well tolerated. The pattern of adverse events was similar to that observed in the 12-week studies. There were no new and/or unexpected adverse events with long-term treatment.

Pediatric Patients: FLOVENT HFA has been evaluated for safety in 56 pediatric patients aged 4 to 11 years who received 88 mcg twice daily for 4 weeks. Types of adverse events in these pediatric patients were generally similar to those observed in adults and adolescents.

Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of fluticasone propionate. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to fluticasone propionate.

Ear, Nose, and Throat: Aphonia, facial and oropharyngeal edema, including angioedema, and throat soreness and irritation.

Endocrine and Metabolic: Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, osteoporosis, and weight gain.

Eye: Cataracts.

Non-Site Specific: Very rare anaphylactic reaction.

Psychiatry: Agitation, aggression, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

Respiratory: Asthma exacerbation, chest tightness, cough, dyspnea, immediate and delayed bronchospasm, paradoxical bronchospasm, pneumonia, and wheeze.

Skin: Contusions, cutaneous hypersensitivity reactions, ecchymoses, and pruritus.

Eosinophilic Conditions: In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions, with some patients presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone propionate (see PRECAUTIONS: Eosinophilic Conditions).

Inhibitors of Cytochrome P450: Fluticasone propionate is a substrate of cytochrome P450 3A4. A drug interaction study with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Drug Interactions). During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing syndrome and adrenal suppression. Therefore, coadministration of fluticasone propionate and ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.

In a placebo-controlled crossover study in 8 healthy adult volunteers, coadministration of a single dose of orally inhaled fluticasone propionate (1,000 mcg) with multiple doses of ketoconazole (200 mg) to steady state resulted in increased systemic fluticasone propionate exposure, a reduction in plasma cortisol AUC, and no effect on urinary excretion of cortisol. Caution should be exercised when FLOVENT HFA is coadministered with ketoconazole and other known potent cytochrome P450 3A4 inhibitors.

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