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Fluticasone Furoate (Arnuity Ellipta)

Trade Name : Arnuity Ellipta

GlaxoSmithKline LLC

POWDER

Strength 100 ug/1

FLUTICASONE FUROATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluticasone Furoate (Arnuity Ellipta) which is also known as Arnuity Ellipta and Manufactured by GlaxoSmithKline LLC. It is available in strength of 100 ug/1 per ml. Read more

Fluticasone Furoate (Arnuity Ellipta) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • ARNUITY ELLIPTA is indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older.
  • Important Limitation of Use
  • ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.
  • ARNUITY ELLIPTA is a corticosteroid indicated for once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older. ()
  • Important limitation of use: Not indicated for relief of acute bronchospasm. (, )
  • No data
  • Inhalation powder: Disposable light grey and orange plastic inhaler containing a foil blister strip of powder intended for oral inhalation only. Each blister contains fluticasone furoate 50, 100, or 200u00a0mcg.
  • Inhalation powder: Inhaler containing a foil blister strip of powder formulation for oral inhalation. Each blister contains 50, 100, or 200 mcg of fluticasone furoate. ()
  • The use of ARNUITY ELLIPTA is contraindicated in the following conditions:
  • No data
  • Candida albicans
  • Systemic and local corticosteroid use may result in the following:
  • 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 Adolescent Subjects Aged 12 Years and Older
  • The safety of ARNUITY ELLIPTA was evaluated in 10 double-blind, parallel-group, controlled trials (7 with placebo) of 8 to 76 weeksu2019 duration that enrolled 6,219 subjects with asthma. Doses of fluticasone furoate studied ranged from 25 to 800 mcg.
  • ARNUITY ELLIPTA 100 mcg was studied in 1,663 subjects, and ARNUITY 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 ARNUITY ELLIPTA 100 mcg and ARNUITY ELLIPTA 200 mcg and u22641% 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 ARNUITY ELLIPTA than placebo included hypertension, abscess, breast cancer, traumatic limb amputation, subarachnoid hemorrhage, and intervertebral disc protrusion; all events occurred at rates u22641%.
  • The incidence of adverse reactions associated with ARNUITY ELLIPTA 100 mcg is shown in Table 1 and is based on one 24-week trial (Trial 1) in adult and adolescent subjects with asthma.
  • The incidence of adverse reactions associated with ARNUITY ELLIPTA 200 mcg is shown in Table 2 and is based on one 24-week trial (Trial 3) in adult and adolescent subjects with asthma. This trial did not have a placebo arm.
  • Adverse reactions observed in the other trials were consistent with those described in Tables 1 and 2.
  • Long-term Safety
  • Long-term safety data are based on 2 trials in adult and adolescent subjects with asthma. In one 52-week trial, subjects received fluticasone furoate 100 mcg (n = 201) or fluticasone furoate 200 mcg (n = 202) in combination with a LABA. Subjects had a mean age of 39u00a0years (adolescents made up 16% of the population), 63% were female, and 67% were Caucasian. In addition to the events shown in Table 1 and Table 2, adverse events occurring in u22653% of the subjects treated with fluticasone furoate 100 mcg or fluticasone furoate 200 mcg, in combination with a LABA, included pyrexia, extrasystoles, upper abdominal pain, respiratory tract infection, diarrhea, and allergic rhinitis.
  • In a second 24- to 76-week trial, subjects received fluticasone furoate 100 mcg (n = 1,010). Subjects participating in this trial had a history of 1 or more asthma exacerbations that required treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization for the treatment of asthma within the previous 12 months. Subjects had a mean age of 42 years (adolescents made up 14% of the population), 67% were female, and 73% were Caucasian. In addition to the events shown in Table 1 and Table 2, adverse events occurring in u22653% of subjects treated with fluticasone furoate 100 mcg for up to 76 weeks included allergic rhinitis, nasal congestion, and arthralgia.
  • Pediatric Subjects Aged 5 to 11 Years
  • The safety data for pediatric subjects is based upon one 12-week clinical trial that enrolled 593 subjects with asthma aged 5 to 11 years. Dosages of fluticasone furoate studied were 25, 50, or 100 mcg administered once daily. ARNUITY ELLIPTA 50 mcg was studied in 120 subjects (46 females and 74 males). Adverse reactions (u22653% and greater than placebo) seen in pediatric subjects were similar to those reported in adult and adolescent subjects. Adverse reactions occurring in u22653% of subjects treated with ARNUITY ELLIPTA 50 mcg and greater than placebo were pharyngitis, bronchitis, and viral infection.
  • Most common adverse reactions reported in u22655% of adult and adolescent subjects are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache. ()
  • Most common adverse reactions reported in u22653% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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 ARNUITY ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole).
  • Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid effects. ()
  • Hepatic impairment: Fluticasone furoate systemic exposure may increase in patients with moderate or severe impairment. Monitor for systemic corticosteroid effects. (, )
  • No human overdosage data have been reported for ARNUITY ELLIPTA. The potential for acute toxic corticosteroid effects following overdosage with ARNUITY 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.
  • Single- and repeat-dose trials of fluticasone furoate at doses of 50 to 4,000u00a0mcg have been studied in human subjects. Decreases in mean serum cortisol were observed at dosages of 500u00a0mcg or higher given once daily for 14u00a0days.
  • ARNUITY 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 (6u03b1,11u03b2,16u03b1,17u03b1)-6,9-difluoro-17-{[(fluoro-methyl)thioi just sne]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 CHFOS. It is practically insoluble in water.
  • ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone furoate (50, 100, or 200u00a0mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder mix 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, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg deliver 46, 90, and 182 mcg, respectively, of fluticasone furoate per blister when tested at a flow rate of 60u00a0L/min for 4 seconds.
  • In adult subjects with asthma and a mean FEVof 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2u00a0L/min (range: 71.2 to 133.1u00a0L/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 depend on patient factors, such as inspiratory flow profile.
  • No data
  • Fluticasone furoate produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at inhaled doses up to 9 and 19u00a0mcg/kg/day, respectively (less than the MRHDID on a mcg/m basis).
  • Fluticasone furoate did not induce gene mutation in bacteria or chromosomal damage in a mammalian cell mutation test in mouse lymphoma L5178Y cells inu00a0vitro There was also no evidence of genotoxicity in the inu00a0vivo micronucleus test in rats.
  • No evidence of impairment of fertility was observed in male and female rats at inhaled fluticasone furoate doses up to 29 and 91u00a0mcg/kg/day, respectively (approximately 1 and 4 times, respectively, the MRHDID in adults on a mcg/m basis).
  • The safety and efficacy of ARNUITY ELLIPTA were evaluated in 3,611 adult and adolescent subjects with asthma. The development program included 4 confirmatory trials of 3 and 6 monthsu2019 duration and 3 dose-ranging trials of 8 weeksu2019 duration. The efficacy of ARNUITY ELLIPTA is based primarily on the dose-ranging trials and the confirmatory trials described below. One additional trial evaluated the safety and efficacy of ARNUITY ELLIPTA in 593 subjects aged 5 to 11 years.
  • ARNUITY ELLIPTA 50 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 0173-0888-10).
  • ARNUITY ELLIPTA 100 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 0173-0874-10) or 14 blisters (institutional pack) (NDC 0173-0874-14).
  • ARNUITY ELLIPTA 200 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 0173-0876-10) or 14 blisters (institutional pack) (NDC 0173-0876-14).
  • The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid.
  • Store at room temperature between 68u00b0F and 77u00b0F (20u00b0C and 25u00b0C); excursions permitted from 59u00b0F to 86u00b0F (15u00b0C to 30u00b0C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.
  • ARNUITY ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard ARNUITY ELLIPTA 6 weeks after opening the foil tray or when the counter reads u201c0u201d (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Not for Acute Symptoms
  • Inform patients that ARNUITY ELLIPTA is not meant to relieve acute symptoms of asthma and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta-agonist such as albuterol. Provide patients with such medication and instruct them in how it should be usedn
  • Instruct patients to seek medical attention immediately if they experience any of the following:
  • Advise patients not to increase the dose or frequency of ARNUITY ELLIPTA. The daily dosage of ARNUITY ELLIPTA should not exceed 1 inhalation. If they miss a dose, instruct patients to take their next dose at the same time they normally do.
  • Tell patients they should not stop therapy with ARNUITY ELLIPTA without physician/provider guidance since symptoms may recur after discontinuation.
  • Local Effects
  • Inform patients that localized infections with occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with ARNUITY ELLIPTA, but at times therapy with ARNUITY ELLIPTA may need to be temporarily interrupted under close medical supervision. Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk of thrush.
  • Immunosuppression
  • Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections or ocular herpes simplex.
  • Hypercorticism and Adrenal Suppression
  • Advise patients that ARNUITY ELLIPTA may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to ARNUITY ELLIPTA.
  • Reduction in Bone Mineral Density
  • Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.
  • Reduced Growth Velocity
  • Inform patients that orally inhaled corticosteroids, including ARNUITY ELLIPTA, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route.
  • Glaucoma and Cataracts
  • Advise patients that long-term use of ICS may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations.
  • Hypersensitivity Reactions, Including Anaphylaxis
  • Advise patients that hypersensitivity reactions (e.g., urticaria, flushing, allergic dermatitis, bronchospasm), including anaphylaxis, may occur after administration of ARNUITY ELLIPTA. Instruct patients to discontinue ARNUITY ELLIPTA if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of other powder medications containing lactose; therefore, patients with severe milk protein allergy should not use ARNUITY ELLIPTA.
  • Use Daily for Best Effect
  • Advise patients to use ARNUITY ELLIPTA at regular intervals, since its effectiveness depends on regular use. Maximum benefit may not be achieved for 1 week or longer after starting treatment. If symptoms do not improve after 2 weeks of therapy or if the condition worsens, instruct patients to contact their physicians.
  • Trademarks are owned by or licensed to the GSK group of companies.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92020 GSK group of companies or its licensor.
  • ARN:9PI
  • This Patient Information has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: January 2019
  • This Instructions for Use has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: May 2018
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0888-10
  • ARNUITY ELLIPTAn
  • (fluticasone furoate inhalation powder)
  • 50 mcg
  • Rx Only
  • FOR ORAL INHALATION ONLY
  • Each blister contains 50 mcg of fluticasone furoate and lactose monohydrate.
  • 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters
  • Made in Singapore
  • u00a92018 GSK group of companies or its licensor.
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0874-10
  • ARNUITY ELLIPTAn
  • (fluticasone furoate inhalation powder)
  • 100 mcg
  • Rx Only
  • FOR ORAL INHALATION ONLY
  • Each blister contains 100 mcg of fluticasone furoate and lactose monohydrate.
  • 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters
  • Made in Singapore
  • u00a92017 the GSK group of companies
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0876-10
  • ARNUITYELLIPTAn
  • (fluticasone furoate inhalation powder)
  • 200 mcg
  • Rx Only
  • FOR ORAL INHALATION ONLY
  • Each blister contains 200 mcg of fluticasone furoate and lactose monohydrate.
  • 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters
  • Made in Singapore
  • u00a92017 the GSK group of companies

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