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Fluticasone Furoate

FDA Drug Information • Also known as: Arnuity Ellipta, Flonase Sensimist Allergy Relief, Fluticasone Furoate Ellipta

Brand Names
Arnuity Ellipta, Flonase Sensimist Allergy Relief, Fluticasone Furoate Ellipta
Dosage Form
POWDER
Product Type
BULK INGREDIENT

Description

11 DESCRIPTION Fluticasone Furoate ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure: Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C 27 H 29 F 3 O 6 S. It is practically insoluble in water. Fluticasone Furoate ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Fluticasone Furoate ELLIPTA 50 mcg, Fluticasone Furoate ELLIPTA 100 mcg, and Fluticasone Furoate ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV 1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will...

What Is Fluticasone Furoate Used For?

1 INDICATIONS AND USAGE Fluticasone Furoate ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use Fluticasone Furoate ELLIPTA is NOT indicated for the relief of acute bronchospasm. Fluticasone Furoate ELLIPTA is an inhaled corticosteroid indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. ( 1 ) Limitations of Use: Not indicated for relief of acute bronchospasm. ( 1 , 5.2 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION

  • For oral inhalation only. ( 2.1 )
  • Maintenance treatment of asthma in adult and pediatric patients aged 12 years and older: The starting dosage, 1 actuation of Fluticasone Furoate ELLIPTA 100 mcg or Fluticasone Furoate ELLIPTA 200 mcg once daily, is based on prior asthma therapy and disease severity. ( 2.2 )
  • Maintenance treatment of asthma in pediatric patients aged 5 to 11 years: 1 actuation of Fluticasone Furoate ELLIPTA 50 mcg once daily. ( 2.2 ) 2.1 Administration
  • Administer 1 actuation of Fluticasone Furoate ELLIPTA once daily by oral inhalation.
  • After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.
  • Fluticasone Furoate ELLIPTA should be used at the same time every day. Do not use Fluticasone Furoate ELLIPTA more than 1 time every 24 hours.
  • The maximum benefit may not be achieved for up to 2 weeks or longer after starting treatment. Individual patients may experience a variable time to onset and degree of symptom relief. No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with mild hepatic impairment [see Clinical Pharmacology ( 12.3 )] . 2.2 Recommended Dosage Adult and Pediatric Patients Aged 12 Years and Older The recommended starting dosage for adult and pediatric patients aged 12 years and older not on an inhaled corticosteroid (ICS) is fluticasone furoate 100 mcg (1 actuation of Fluticasone Furoate ELLIPTA 100 mcg) once daily by oral inhalation.
  • For other adult and pediatric patients aged 12 years and older, the recommended starting dosage should be based on previous asthma drug therapy and disease severity.
  • For adult and pediatric patients aged 12 years and older who do not respond to Fluticasone Furoate ELLIPTA 100 mcg after 2 weeks of therapy, replacement with Fluticasone Furoate ELLIPTA 200 mcg may provide additional asthma control.
  • The maximum recommended dosage in adult and pediatric patients aged 12 years and older is Fluticasone Furoate ELLIPTA 200 mcg once daily.
  • If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist (rescue medicine, e.g., albuterol) should be used for immediate relief.
  • If a previously effective dosage regimen of Fluticasone Furoate ELLIPTA fails to provide adequate improvement in asthma control, the therapeutic regimen should be re-evaluated and additional therapeutic options (e.g., replacing the current strength of Fluticasone Furoate ELLIPTA with a higher strength, initiating an ICS and long-acting beta 2 -agonist [LABA] combination product, initiating oral corticosteroids) should be considered.
  • After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to help reduce the possibility of adverse reactions. Pediatric Patients Aged 5 to 11 Years The recommended dosage for pediatric patients aged 5 to 11 years is fluticasone furoate 50 mcg (1...

    • Side Effects (Adverse Reactions)

    6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following:

  • Oropharyngeal Candidiasis [see Warnings and Precautions ( 5.1 )]
  • Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.3 )]
  • Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )]
  • Reduction in BMD [see Warnings and Precautions ( 5.9 )]
  • Growth Effects in Pediatrics [see Warnings and Precautions ( 5.10 )]
  • Glaucoma and Cataracts [see Warnings and Precautions ( 5.11 )] Most common adverse reactions reported in ≥5% of adult and pediatric subjects aged 12 years and older are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache. ( 6.1 ) Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult and Pediatric Subjects Aged 12 Years and Older The safety of fluticasone furoate ELLIPTA was evaluated in 10 double-blind, parallel-group, controlled trials (7 with placebo) of 8 to 76 weeks’ duration that enrolled 6,219 subjects with asthma. Doses of fluticasone furoate studied ranged from 25 to 800 mcg. Fluticasone furoate ELLIPTA 100 mcg was studied in 1,663 subjects, and fluticasone furoate ELLIPTA 200 mcg was studied in 608 subjects. Subject ages ranged from 12 to 84 years, 65% were female, and 75% were Caucasian. In these trials, the proportion of subjects who discontinued study treatment early due to adverse reactions was 2% for subjects treated with both fluticasone furoate ELLIPTA 100 mcg and fluticasone furoate ELLIPTA 200 mcg and ≤1% for placebo-treated subjects. Serious adverse events, whether considered drug-related or not by the investigators, that occurred in more than 1 subject and in a greater percentage of subjects treated with fluticasone furoate ELLIPTA than placebo included hypertension, abscess, breast cancer, traumatic limb amputation, subarachnoid hemorrhage, and intervertebral disc protrusion; all events occurred at rates ≤1%. The incidence of adverse reactions associated with fluticasone furoate ELLIPTA 100 mcg is shown in Table 1 and is based on one 24-week trial (Trial 1) in adult and pediatric subjects aged 12 years and older with asthma. Table 1. Adverse Reactions with Fluticasone Furoate ELLIPTA 100 mcg with ≥3% Incidence and More Common than Placebo (Trial 1, Intent-to-Treat Population) Adverse Reaction Fluticasone Furoate ELLIPTA 100 mcg (n = 114) % Placebo (n = 115) % 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 The incidence of adverse reactions associated with fluticasone furoate ELLIPTA 200 mcg is shown in Table 2 and is based on one 24-week trial (Trial 3) in adult and pediatric subjects aged 12 years and older with asthma. This trial did not have a placebo arm. Table 2. Adverse Reactions with Fluticasone Furoate ELLIPTA 200 mcg with ≥3% Incidence (Trial 3, Safety Population) Adverse Reaction Fluticasone Furoate ELLIPTA 200 mcg (n = 119) % Fluticasone Furoate ELLIPTA 100 mcg (n = 119) % 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 Adverse reactions observed in the other trials were consistent with...

    • Drug Interactions

    7 DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid effects. ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone furoate is a substrate of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate. Caution should be exercised when considering the coadministration of Fluticasone Furoate ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.6 ), Clinical Pharmacology ( 12.3 )] .

    Contraindications

    4 CONTRAINDICATIONS Fluticasone Furoate ELLIPTA is contraindicated in the following conditions:

  • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] .
  • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate or any of the excipients [see Warnings and Precautions ( 5.8 ), Description ( 11 )] .
  • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ( 4 )
  • Severe hypersensitivity to milk proteins ( 4 )
  • Demonstrated hypersensitivity to any ingredients. ( 4 )

    • Pregnancy and Breastfeeding

    8.1 Pregnancy Risk Summary There are insufficient data on the use of Fluticasone Furoate ELLIPTA in pregnant women to inform a drug‑associated risk (see Clinical Considerations ). In animal reproduction studies, fluticasone furoate administered by inhalation to rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. The highest fluticasone furoate doses in the rat and rabbit studies were 4 times and 1 time, respectively, the maximum recommended human daily inhalation dose (MRHDID) (see Data .) . The estimated risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre‑eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. Data Animal Data: Fluticasone Furoate : In 2 separate embryofetal developmental studies, pregnant rats and rabbits received fluticasone furoate during the period of organogenesis at doses up to approximately 4 and 1 times, respectively, the MRHDID (on a mcg/m 2 basis at maternal inhalation doses up to 91 and 8 mcg/kg/day, respectively). No evidence of structural abnormalities in fetuses was observed in either species. In a perinatal and postnatal developmental study in rats, dams received fluticasone furoate during late gestation and lactation periods at doses up to approximately 1 time the MRHDID (on a mcg/m 2 basis at maternal inhalation doses up to 27 mcg/kg/day). No evidence of effects on offspring development was observed.

    Overdosage

    10 OVERDOSAGE No human overdosage data have been reported for Fluticasone Furoate ELLIPTA. The potential for acute toxic corticosteroid effects following overdosage with Fluticasone Furoate ELLIPTA is low. Because of low systemic bioavailability (13.9%) and an absence of acute drug-related systemic findings in clinical trials, overdosage of fluticasone furoate is unlikely to require any treatment other than observation. If used at excessive doses for prolonged periods, systemic effects such as hypercorticism may occur [see Warnings and Precautions ( 5.5 )] . Single- and repeat-dose trials of fluticasone furoate at doses of 50 to 4,000 mcg have been studied in human subjects. Decreases in mean serum cortisol were observed at dosages of 500 mcg or higher given once daily for 14 days.

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING Fluticasone Furoate ELLIPTA 50 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 66993-166-97). Fluticasone Furoate ELLIPTA 100 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 66993-167-97). Fluticasone Furoate ELLIPTA 200 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 66993-168-97). The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid. Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children. Fluticasone Furoate ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard Fluticasone Furoate ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.