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ARNUITY is an inhaled corticosteroid (ICS) indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older. ARNUITY is NOT indicated for the relief of acute bronchospasm.

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Important Safety Information


ARNUITY is contraindicated in the following conditions:

  • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
  • Severe hypersensitivity to milk proteins or 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 after inhalation.
  • ARNUITY is NOT a rescue medicine and should NOT be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
  • 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.
  • Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to ARNUITY.
  • Hypercorticism and adrenal suppression may occur with higher than the recommended dose or at the regular dosage of ICS in susceptible individuals. If such changes occur, appropriate therapy should be considered.
  • Caution should be exercised when considering the coadministration of ARNUITY with ketoconazole and other known strong CYP3A4 inhibitors (eg, 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 have been observed with long-term administration of products containing ICS. 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 (eg, anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care prior to initiating ARNUITY and periodically thereafter.
  • ICS, 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 ICS that effectively controls their asthma. Monitor growth of children and adolescents.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the long-term administration of ICS, including ARNUITY. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ARNUITY long term.

Adverse Reactions

  • Most common adverse reactions (≥5% of subjects ≥12 years of age) reported in a 24-week trial with ARNUITY 100 mcg (and placebo) were: nasopharyngitis 8% (5%), bronchitis 7% (6%), upper respiratory tract infection 6% (5%), headache 6% (4%).
  • Most common adverse reactions (≥5% of subjects ≥12 years of age) reported in a separate 24-week trial 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%).
  • In a 12-week trial, adverse reactions (≥3% and greater than placebo) seen in subjects aged 5 to 11 years were similar to those reported in adult and adolescent subjects. Adverse reactions occurring in ≥3% of subjects treated with ARNUITY 50 mcg and greater than placebo were pharyngitis, bronchitis, and viral infection.
  • 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.

Use In Specific Populations

  • Use ARNUITY with caution in patients with moderate or severe hepatic impairment, as fluticasone furoate systemic exposure may increase by up to 3-fold. Monitor for corticosteroid-related side effects.

Please see full Prescribing Information, including Patient Information, for ARNUITY.



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FLFWCNT190027 August 2019


  1. Data on file, GSK.
  2. Bleecker ER, Lötvall J, O'Byrne PM, et al. Fluticasone furoate–vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial. J Allergy Clin Immunol Pract. 2014;2(5):553-561.
  3. O’Byrne PM, Bleecker ER, Bateman ED, et al. Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma. Eur Respir J. 2014;43(3):773-782.
  4. Lötvall J, Bleecker ER, Busse WW, et al. Efficacy and safety of fluticasone furoate 100 μg once-daily in patients with persistent asthma: a 24-week placebo and active-controlled randomised trial. Respir Med. 2014;108(1):41-49.
  5. Managed Markets Insight & Technology, LLC, Database as of April 2019.
  6. Salter M, Biggadike K, Matthews JL, et al. Pharmacological properties of the enhanced-affinity glucocorticoid fluticasone furoate in vitro and in an in vivo model of respiratory inflammatory disease. Am J Physiol Lung Cell Mol Physiol. 2007;293(3):L660-L667.
  7. National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma. Full report 2007.­files/docs/guidelines/asthgdln.pdf. Updated August 28, 2007. Accessed May 23, 2018.
  8. Oliver AJ, Covar RA, Goldfrad CH, et al. Randomized trial of once-daily fluticasone furoate in children with inadequately controlled asthma. J Pediatr. 2016;178:246-253.e2.
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