ARNUITY is a maintenance treatment of asthma as preventative therapy in patients aged 12 years and older.
ARNUITY is NOT for the relief of acute bronchospasm.

24-hour efficacy

with ONE inhalation daily

ARNUITY 100 is an ICS proven to deliver continuous lung function improvement for a full 24 hours with ONE inhalation daily.1*

LEARN ABOUT 24-HOUR ARNUITY

*Results of a 12-week, randomized, double-blind trial in 609 subjects with asthma aged 12 years and older (mean: 40 years), symptomatic on low- to mid-dose ICS: Treatment with ARNUITY 100 mcg once daily resulted in statistically significant improvements from baseline in the co-primary endpoints compared with placebo at Week 12—trough FEV1 difference of 136 mL (P=0.002; n=203 and n=193, respectively) and wm FEV1 (0-24 hours) difference of 186 mL (P=0.003; n=106 and n=95, respectively).

FEV1=forced expiratory volume in 1 second; ICS=inhaled corticosteroid; wm=weighted mean.


Important Safety Information

Contraindications

  • ARNUITY is contraindicated for primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
  • ARNUITY is contraindicated in patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone furoate or any of the excipients.

Warnings and Precautions

  • Oropharyngeal candidiasis has occurred in patients treated with ARNUITY. Advise patients to rinse the mouth with water without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis.
  • ARNUITY 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 ARNUITY, 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. Slowly taper the dose of systemic corticosteroids if transferring patients to ARNUITY.
  • Hypercorticism and adrenal suppression may occur with high doses of inhaled corticosteroids, including fluticasone furoate, or at the recommended dose in susceptible individuals. If such effects occur, discontinue ARNUITY slowly.
  • Caution should be exercised when considering the coadministration of ARNUITY with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid adverse effects may occur.
  • If paradoxical bronchospasm occurs, discontinue ARNUITY immediately and institute alternative therapy.
  • Hypersensitivity reactions such as urticaria, flushing, allergic dermatitis, and bronchospasm may occur after administration of ARNUITY. Discontinue ARNUITY 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, 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 adolescent patients.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma following the long-term administration of inhaled corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Adverse Reactions

  • In a 24-week trial, adverse reactions (≥3% and more common than placebo) with ARNUITY 100 mcg (and placebo) were: nasopharyngitis 8% (5%), bronchitis 7% (6%), upper respiratory tract infection 6% (5%), headache 6% (4%), pharyngitis 4% (3%), sinusitis 4% (<1%), toothache 3% (<1%), gastroenteritis viral 3% (0%), oral candidiasis 3% (0%), oropharyngeal candidiasis 3% (0%), oropharyngeal pain 3% (0%).
  • In a separate 24-week trial, adverse reactions (≥3% incidence) with ARNUITY 200 mcg (and 100 mcg) were: nasopharyngitis 13% (12%), headache 13% (10%), bronchitis 7% (12%), influenza 7% (4%), upper respiratory tract infection 6% (2%), sinusitis 4% (7%), oropharyngeal pain 4% (3%), pharyngitis 3% (6%), back pain 3% (3%), dysphonia 3% (2%), oral candidiasis 3% (<1%), procedural pain 3% (<1%), rhinitis 3% (<1%), throat irritation 3% (<1%), abdominal pain 3% (0%), cough 3% (0%).
  • In a 24- to 76-week study, subjects with a history of 1 or more asthma exacerbations within the previous 12 months received fluticasone furoate 100 mcg. In addition to the events reported in the preceding 24-week trials, adverse events occurring in ≥3% of subjects treated with fluticasone furoate 100 mcg for up to 76 weeks included allergic rhinitis, nasal congestion, and arthralgia.

Drug Interactions

  • Caution should be exercised when considering the coadministration of ARNUITY with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid adverse effects may occur.

Use in Specific Populations

  • Use ARNUITY with caution in patients with moderate or severe hepatic impairment. Fluticasone furoate systemic exposure increased by up to 3-fold in subjects with hepatic impairment. Monitor patients for corticosteroid-related side effects.
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