ARNUITY and FLOVENT HFA are maintenance treatments of asthma as preventative therapy. ARNUITY is for patients aged 5 years and older.
FLOVENT HFA is for patients aged 4 years and older. ARNUITY and FLOVENT HFA are NOT indicated for relief of acute bronchospasm.

From the makers of FLOVENT HFA (fluticasone propionate), the #1 most prescribed ICS*

Discover 24-hour ARNUITY, the only once‑daily ICS in the ELLIPTA Inhaler

*Source: IMS Health NPA. US TRx Data. Danbury, CT; March 2011 - August 2018.

ARNUITY ELLIPTA and FLOVENT HFA (44 mcg):

A Comparison of Select Characteristics

Only one inhalation daily

Once-daily dosing day or night

No priming or shaking required

Easy-to-use1 ELLIPTA inhaler

Breath actuated. No hand-breath coordination required.

Have patients on twice-daily FLOVENT?

Consider once-daily ARNUITY in the ELLIPTA inhaler for your appropriate patients aged 5 years and older.

Learn More About ARNUITY

Important Safety Information for ARNUITY and FLOVENT HFA

CONTRAINDICATIONS

  • ARNUITY and FLOVENT HFA are 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.
  • ARNUITY and FLOVENT HFA are contraindicated in patients who have demonstrated hypersensitivity to any of the ingredients of ARNUITY or FLOVENT HFA.

WARNINGS AND PRECAUTIONS

  • Oropharyngeal candidiasis has occurred in patients treated with ARNUITY or FLOVENT HFA. Advise patients to rinse the mouth with water without swallowing following inhalation.
  • ARNUITY and FLOVENT HFA are NOT rescue medicines 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 inhaled corticosteroids 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 or FLOVENT HFA.
  • Hypercorticism and adrenal suppression may occur with higher than the recommended dose or at the regular dosage of inhaled corticosteroids in susceptible individuals. If such changes occur, appropriate therapy should be considered.
  • Caution should be exercised when considering the coadministration of ARNUITY or FLOVENT HFA with long-term 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 or FLOVENT HFA immediately and institute alternative therapy.
  • Hypersensitivity reactions such as urticaria, flushing, allergic dermatitis, and bronchospasm may occur after administration of ARNUITY or FLOVENT HFA. Discontinue ARNUITY or FLOVENT HFA if such reactions occur.
  • Decreases in bone mineral density 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 (eg, 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 children and adolescents.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the long-term administration of inhaled corticosteroids; therefore, monitoring is warranted.
  • When prescribing FLOVENT HFA, be alert to systemic eosinophilic conditions, such as Churg-Strauss syndrome.

ADVERSE REACTIONS WITH ARNUITY

  • 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.

ADVERSE REACTIONS WITH FLOVENT HFA

  • 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%).

USE IN SPECIFIC POPULATIONS

  • Use ARNUITY or FLOVENT HFA 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. Impairment of liver function may lead to accumulation of fluticasone propionate or fluticasone furoate in plasma. Therefore, monitor patients for corticosteroid-related side effects.
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Please see full Prescribing Information, including Patient Information, for FLOVENT HFA.

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

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References

View all references

1003776R0 June 2018

References

  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 September 2018.
  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. http://www.nhlbi.nih.gov/­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.
1005066R0 May 2018