This site is intended for US healthcare professionals only.

For US healthcare professionals only.

FLOVENT HFA is a maintenance treatment of asthma as preventative therapy in patients aged 4 years and older. FLOVENT HFA is NOT indicated for relief of acute bronchospasm.

Clinical Trials Experience

The incidence of common adverse reactions in the table below is based upon two placebo-controlled U.S. clinical trials in which 812 adult and adolescent subjects (457 females and 355 males) previously treated with as-needed bronchodilators and/or inhaled corticosteroids were treated twice daily for up to 12 weeks.

Adverse Reactions with FLOVENT HFA with >3% Incidence and More Common than Placebo in Subjects Aged 12 Years and Older with Asthma

ADVERSE EVENT FLOVENT HFA
88 mcg
Twice Daily
(n = 203)
%
FLOVENT HFA
220 mcg
Twice Daily
(n = 204)
%
FLOVENT HFA
440 mcg
Twice Daily
(n = 202)
%
Placebo
(n = 203)
%
EAR, NOSE &, AND THROAT
Upper respiratory tract infection 18 16 16 14
Throat irritation 8 8 10 5
Upper respiratory inflammation 2 5 5 1
Sinusitis/sinus infection 6 7 4 3
Hoarseness/dysphonia 2 3 6 <1
GASTROINTESTINAL
Candidiasis mouth/throat and non–site specific 4 2 5 <1
LOWER RESPIRATORY
Cough 4 6 4 5
Bronchitis 2 2 6 5
NEUROLOGICAL
Headache 11 7 5 6

The table above 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. Less than 2% of subjects discontinued from the trials because of adverse reactions. The average duration of exposure was 73 to 76 days in the active treatment groups compared with 60 days in the placebo group.

Additional Adverse Reactions

Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT HFA compared with subjects treated with placebo include the following: rhinitis, rhinorrhea/post-nasal drip, nasal sinus disorders, laryngitis, diarrhea, viral gastrointestinal infections, dyspeptic symptoms, gastrointestinal discomfort and pain, hyposalivation, musculoskeletal pain, muscle pain, muscle stiffness/tightness/rigidity, dizziness, migraines, fever, viral infections, pain, chest symptoms, viral skin infections, muscle injuries, soft tissue injuries, urinary infections.

In a third study, fluticasone propionate inhalation aerosol (440 or 880 mcg twice daily) was administered for 16 weeks to 168 subjects with asthma requiring oral corticosteroids. Adverse reactions not included above, but reported by more than 3 subjects in either group treated with FLOVENT HFA and more commonly than in the placebo group included nausea and vomiting, arthralgia and articular rheumatism, and malaise and fatigue.

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

Pediatric Subjects Aged 4 to 11 Years

FLOVENT HFA has been evaluated for safety in 56 pediatric subjects who received 88 mcg twice daily for 4 weeks. Types of adverse reactions in these pediatric subjects were generally similar to those observed in adults and adolescents.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of fluticasone propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

  • Ear, Nose, and Throat
    Aphonia, facial and oropharyngeal edema, and throat soreness and irritation.
  • Endocrine and Metabolic
    Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, osteoporosis, and weight gain.
  • Eye
    Cataracts.
  • Gastrointestinal Disorders
    Dental caries and tooth discoloration.
  • Immune System Disorders
    Immediate and delayed hypersensitivity reactions, including urticaria, anaphylaxis, rash, and angioedema and bronchospasm, have been reported.
  • Infections and Infestations
    Esophageal candidiasis.
  • 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.

Important Safety Information

Contraindications

  • FLOVENT HFA is contraindicated for primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Important Safety Information

Contraindications

  • FLOVENT HFA is contraindicated for primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

  • FLOVENT HFA is contraindicated in patients with hypersensitivity to any of the ingredients of FLOVENT HFA.

Warnings and Precautions

  • Oropharyngeal candidiasis has been observed in clinical studies in patients treated with FLOVENT HFA. Advise patients to rinse the mouth with water without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis.
  • FLOVENT HFA should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta2-agonist, not FLOVENT HFA, should be used to relieve acute symptoms such as shortness of breath.
  • Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections.
  • Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to FLOVENT HFA.
  • Hypercorticism and adrenal suppression may occur with high doses of inhaled corticosteroids, including fluticasone propionate, or at the recommended dose in susceptible individuals. If such effects occur, discontinue FLOVENT HFA slowly.
  • Immediate hypersensitivity reactions may occur after administration of FLOVENT HFA. Discontinue FLOVENT HFA if such reactions occur.
  • Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care.
  • Inhaled corticosteroids, as well as poorly controlled asthma, may cause a reduction in growth velocity, and the long-term effect on final adult height is unknown. Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of pediatric patients.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma following the long‐term administration of inhaled corticosteroids, including FLOVENT HFA. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
  • If paradoxical bronchospasm occurs, discontinue FLOVENT HFA immediately and institute alternative therapy.
  • The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with FLOVENT HFA is not recommended because increased systemic corticosteroid adverse effects may occur.
  • Be alert to systemic eosinophilic conditions, such as Churg-Strauss syndrome.

Adverse Reactions

  • Most common adverse reactions (incidence >3%) in patients taking FLOVENT HFA 88 mcg twice daily, FLOVENT HFA 220 mcg twice daily, FLOVENT HFA 440 mcg twice daily, and placebo, respectively, were upper respiratory tract infection (18%, 16%, 16%, 14%), throat irritation (8%, 8%, 10%, 5%), upper respiratory inflammation (2%, 5%, 5%, 1%), sinusitis/sinus infection (6%, 7%, 4%, 3%), hoarseness/dysphonia (2%, 3%, 6%, <1%), candidiasis mouth/throat and non-site specific (4%, 2%, 5%, <1%), cough (4%, 6%, 4%, 5%), bronchitis (2%, 2%, 6%, 5%), and headache (11%, 7%, 5%, 6%).

Drug Interactions

  • The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with FLOVENT HFA is not recommended because increased systemic corticosteroid adverse effects may occur.

Use In Specific Populations

  • Fluticasone propionate is predominantly cleared by hepatic metabolism. Impairment of liver function may lead to accumulation of fluticasone propionate in plasma. Therefore, patients with hepatic disease should be closely monitored.
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