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For US healthcare professionals only.

ARNUITY is an inhaled corticosteroid 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.

While the precise mechanism of ARNUITY in treating asthma is unknown, the active ingredient in ARNUITY, fluticasone furoate (FF), is a corticosteroid with anti-inflammatory activity. Inflammation is an important component in the pathogenesis of asthma. FF exerts its activity as an intact molecule, and not as a prodrug or salt of fluticasone. Following repeat-dose inhaled administration, the plasma elimination half-life of FF averaged 24 hours.

For additional information, see Pharmacology page.
For patients with asthma, ARNUITY is a maintenance treatment that can be used as preventative therapy in patients aged 5 years and older. ARNUITY is NOT indicated for the relief of acute bronchospasm. In clinical studies, ARNUITY ELLIPTA has been proven to provide 24-hour efficacy with one inhalation daily.2
To order, visit our ARNUITY samples and savings offers page. You can also click the “Request Samples” button at the top of the page or visit GSK Source. Log in to the GSK Samples and Savings Request Portal and then register. After registration, if you are a licensed practitioner in a relevant specialty, you can select the ARNUITY samples and savings offers you would like to receive. Once you submit your request, you should receive your samples and savings offers within a week.
Log in to the GSK Samples and Savings Request Portal. After you register and submit your request for ARNUITY savings offers, you’ll receive patient coupons in the mail. You can distribute these coupons to your eligible patients and request more coupons once a month. Patients may also request coupons at arnuity.com.
Patients who are Medicare eligible, or who are enrolled in any federal healthcare program, or who are Medicare eligible and enrolled in an employer-sponsored group waiver health plan or government prescription drug benefit program for retirees, or who are enrolled in any similar federal or state programs, including state pharmaceutical assistance programs, are NOT eligible. For coupon eligibility purposes, all those 65 or older are considered Medicare eligible.
ARNUITY ELLIPTA is available in 3 strengths — 50 mcg, 100 mcg, and 200 mcg - taken as a once-daily dose. ARNUITY ELLIPTA should be administered as one inhalation once daily at the same time every day. For more information on dosing recommendations based on the patient's age, visit our Dosing and Administration page.

ARNUITY 50 mcg is indicated for pediatric patients aged 5 to 11 years.

Consider ARNUITY 50 for your appropriate pediatric patients...

  • who have inadequately controlled asthma
  • who need 24-hour efficacy from a once-daily inhalation
  • whose parents want a convenient, once-daily option their child can take at the same time each day or night
Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate. The clinical relevance of these in vitro findings is unknown.

The fluticasone steroid backbone is common to both fluticasone furoate and fluticasone propionate. Fluticasone furoate contains a 17α-furoate ester; fluticasone propionate contains a propionate ester. For more information about fluticasone furoate, visit our Pharmacology page.
ARNUITY 50 mcg once daily is the only approved dosage for pediatric patients aged 5 to 11 years.

For patients aged 12 years and older, ARNUITY ELLIPTA 200 mcg is the highest recommended daily dose.

Patients should not use ARNUITY more than once every 24 hours. If symptoms arise between doses, an inhaled, short-acting beta2-agonist (SABA) should be used for immediate relief. See full dosing information.
No, ARNUITY contains lactose, which can lead to hypersensitivity reactions. ARNUITY is contraindicated in patients with known hypersensitivity to milk proteins.

The safety data for ARNUITY 50 mcg for pediatric patients is based upon a 12-week clinical trial that enrolled 593 subjects with asthma aged 5-11 years. ARNUITY ELLIPTA 50 mcg was studied in 120 subjects.

Adverse reactions (≥3% and greater than placebo) seen in pediatric subjects were similar to those reported in adult and adolescent subjects. Adverse reactions occurring in ≥3% of subjects treated with ARNUITY ELLIPTA 50 mcg and greater than placebo were:

  • Pharyngitis
  • Bronchitis
  • Viral infection

According to the results from a 24-week trial in adolescent and adult subjects with asthma, adverse reactions with ARNUITY ELLIPTA 100 mcg included:

  • Nasopharyngitis
  • Bronchitis
  • Upper respiratory tract infection
  • Headache
  • Pharyngitis
  • Sinusitis
  • Toothache
  • Gastroenteritis viral
  • Oral candidiasis
  • Oropharyngeal candidiasis
  • Oropharyngeal pain

These results were ≥3% incidence and more common than placebo. Visit our Adverse Reactions page to learn more.

According to the results from a 24-week trial in adolescent and adult subjects with asthma, adverse reactions with ARNUITY ELLIPTA 200 mcg included:

  • Nasopharyngitis
  • Headache
  • Bronchitis
  • Influenza
  • Upper respiratory tract infection
  • Sinusitis
  • Oropharyngeal pain
  • Pharyngitis
  • Back pain
  • Dysphonia
  • Oral candidiasis
  • Procedural pain
  • Rhinitis
  • Throat irritation
  • Abdominal pain
  • Cough

These results were ≥3% incidence and more common than ARNUITY ELLIPTA 100 mcg. Visit our Adverse Reactions page to learn more.

ARNUITY ELLIPTA offers broad formulary coverage nationally as of November 2018, according to the Managed Markets Insight & Technology, LLC, Database. Specifically, 80% of commercial patient lives and 88% of Medicare Part D patient lives have favorable coverage nationally. Visit our Medicare Part D Coverage page to see additional information. Individual access may vary by geography and plan benefit design. Formulary status is subject to change.
Favorable coverage is formulary access without restrictions, which means reimbursement from a health plan with no accompanying step edits or prior authorizations.

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 ingredients.

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 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.
  • 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 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 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 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 (eg, anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care prior to initiating ARNUITY and periodically thereafter.
  • 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.

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

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References

View all references

1003862R0 July 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 November 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