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.

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FLOVENT HFA was approved in 2004 for patients aged 12 years and older and in 2006 for patients aged 4-11 years.

EXPANDCOLLAPSE

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.

Please see full Prescribing Information, including Patient Information, for FLOVENT HFA.

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