umeclidinium bromide and vilanterol trifenatate (Anoro Ellipta)

US NDC LINE: 0173-0869

Trade Name: Anoro Ellipta

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: GlaxoSmithKline LLC

Presentation: POWDER

Strength: 62.5; 25 ug/1; ug/1

Storage and handling

UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

  • No data
  • No data
  • ANORO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
  • Important Limitations of Use
  • ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and efficacy of ANORO ELLIPTA in asthma have not been established.
  • ANORO ELLIPTA is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta-adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ()
  • Important limitations of use: Not indicated for relief of acute bronchospasm or for the treatment of asthma. (, )
  • ANORO ELLIPTA (umeclidinium/vilanterol 62.5 mcg/25 mcg) should be administered as 1 inhalation once daily by the orally inhaled route only.
  • ANORO ELLIPTA should be used at the same time every day. Do not use ANORO ELLIPTA more than 1 time every 24 hours.
  • No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment .
  • Inhalation powder: Disposable light grey and red plastic inhaler containing 2 foil blister strips of powder intended for oral inhalation only. One strip contains umeclidinium (62.5u00a0mcg per blister), and the other strip contains vilanterol (25u00a0mcg per blister).
  • Inhalation powder: Inhaler containing 2 foil blister strips of powder formulation for oral inhalation. One strip contains umeclidinium 62.5u00a0mcg per blister and the other contains vilanterol 25u00a0mcg per blister. ()
  • The use of ANORO ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients .
  • Use of a long-acting beta-adrenergic agonist (LABA) without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma n n- Arrayn- . ANORO ELLIPTA is not indicated for the treatment of asthma.
  • No data
  • The following adverse reactions are described in greater detail in other sections:
  • Most common adverse reactions (incidence u22651% and more common than placebo) are pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or .
  • No data
  • No data
  • No case of overdose has been reported with ANORO ELLIPTA.
  • ANORO ELLIPTA contains both umeclidinium and vilanterol; therefore, the risks associated with overdosage for the individual components described below apply to ANORO ELLIPTA. Treatment of overdosage consists of discontinuation of ANORO ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage.
  • ANORO ELLIPTA is an inhalation powder drug product for delivery of a combination of umeclidinium (an anticholinergic) and vilanterol (a LABA) to patients by oral inhalation.
  • Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure:
  • Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is CHNOu2022Br (as a quaternary ammonium bromide compound). It is slightly soluble in water.
  • Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1)-2-[(6-{2-[(2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure:
  • Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is CHClNOu2022CHO. It is practically insoluble in water.
  • ANORO ELLIPTA is a light grey and red plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder mix of micronized umeclidinium bromide (74.2u00a0mcg equivalent to 62.5u00a0mcg of umeclidinium), magnesium stearate (75u00a0mcg), and lactose monohydrate (to 12.5u00a0mg), and each blister on the other strip contains a white powder mix of micronized vilanterol trifenatate (40u00a0mcg equivalent to 25u00a0mcg of vilanterol), magnesium stearate (125u00a0mcg), and lactose monohydrate (to 12.5u00a0mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece.
  • Under standardized in vitro test conditions, ANORO ELLIPTA delivers 55u00a0mcg of umeclidinium and 22 mcg of vilanterol per dose when tested at a flow rate of 60u00a0L/min for 4u00a0seconds.
  • In adult subjects with obstructive lung disease and severely compromised lung function (COPD with FEV/FVC <70% and FEV <30% predicted or FEV <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5u00a0L/min (range: 43.5 to 81.0u00a0L/min).
  • The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.
  • No data
  • ANORO ELLIPTA
  • No studies of carcinogenicity, mutagenicity, or impairment of fertility were conducted with ANORO ELLIPTA; however, studies are available for the individual components, umeclidinium and vilanterol, as described below.
  • Umeclidinium
  • Umeclidinium produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at inhaled doses up to 137 and 295/200 mcg/kg/day (male/female), respectively (approximately 20 and 25/20 times the MRHDID in adults on an AUC basis, respectively).
  • Umeclidinium tested negative in the following genotoxicity assays: the in vitro Ames assay, in vitro mouse lymphoma assay, and in vivo rat bone marrow micronucleus assay.
  • No evidence of impairment of fertility was observed in male and female rats at subcutaneous doses up to 180 mcg/kg/day and at inhaled doses up to 294 mcg/kg/day, respectively (approximately 100 and 50 times, respectively, the MRHDID in adults on an AUC basis).
  • Vilanterol
  • In a 2-year carcinogenicity study in mice, vilanterol caused a statistically significant increase in ovarian tubulostromal adenomas in females at an inhalation dose of 29,500 mcg/kg/day (approximately 7,800 times the MRHDID in adults on an AUC basis). No increase in tumors was seen at an inhalation dose of 615 mcg/kg/day (approximately 210 times the MRHDID in adults on an AUC basis).
  • In a 2-year carcinogenicity study in rats, vilanterol caused statistically significant increases in mesovarian leiomyomas in females and shortening of the latency of pituitary tumors at inhalation doses greater than or equal to 84.4 mcg/kg/day (greater than or equal to approximately 20 times the MRHDID in adults on an AUC basis). No tumors were seen at an inhalation dose of 10.5u00a0mcg/kg/day (approximately equivalent to the MRHDID in adults on an AUC basis).
  • These tumor findings in rodents are similar to those reported previously for other beta-adrenergic agonist drugs. The relevance of these findings to human use is unknown.
  • Vilanterol tested negative in the following genotoxicity assays: the in vitro Ames assay, in vivo rat bone marrow micronucleus assay, in vivo rat unscheduled DNA synthesis (UDS) assay, and in vitro Syrian hamster embryo (SHE) cell assay. Vilanterol tested equivocal in the in vitro mouse lymphoma assay.
  • No evidence of impairment of fertility was observed in male and female rats at inhaled vilanterol doses up to 31,500 and 37,100u00a0mcg/kg/day, respectively (both approximately 5,490 times the MRHDID based on AUC).
  • The safety and efficacy of ANORO ELLIPTA were evaluated in a clinical development program that included 6 dose-ranging trials, 4 lung function trials of 6 monthsu2019 duration (2 placebo controlled and 2 active controlled), two 12-week crossover trials, and a 12-month longu2011term safety trial. The efficacy of ANORO ELLIPTA is based primarily on the dose-ranging trials in 1,908 subjects with COPD or asthma and the 2 placebo-controlled confirmatory trials, with additional support from the 2 active-controlled and 2 crossover trials in 5,388 subjects with COPD, including chronic bronchitis and/or emphysema . Evidence of efficacy for ANORO ELLIPTA on COPD exacerbations was established by the efficacy of the umeclidinium component as part of a fixed-dose combination with an ICS/LABA, as assessed in a 12-month trial in 10,355 subjects .
  • ANORO ELLIPTA is supplied as a disposable light grey and red plastic inhaler containing 2 foil strips, each with 30 blisters (or 7 blisters for the institutional pack). One strip contains umeclidinium (62.5u00a0mcg per blister), and the other strip contains vilanterol (25u00a0mcg per blister). A blister from each strip is used to create 1 dose. The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:
  • NDC 0173-0869-10u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 inhalations (60 blisters)
  • NDC 0173-0869-06u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a07 inhalations (14 blisters), institutional pack
  • 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.
  • ANORO ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard ANORO ELLIPTA 6u00a0weeks 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).
  • Serious Asthma-Related Events
  • ANORO ELLIPTA is not indicated for the treatment of asthma. Inform patients that LABA, such as vilanterol (one of the active ingredients in ANORO ELLIPTA), when used alone (without ICS) for asthma increase the risk of asthma-related hospitalization or asthma-related death.
  • Not for Acute Symptoms
  • Inform patients that ANORO ELLIPTA is not meant to relieve acute symptoms of COPD 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 medicine and instruct them in how it should be used.
  • Instruct patients to seek medical attention immediately if they experience any of the following:
  • Tell patients they should not stop therapy with ANORO ELLIPTA without healthcare provider guidance since symptoms may recur after discontinuation.
  • Do Not Use Additional Long-acting Beta-agonists
  • Instruct patients not to use other medicines containing a LABA. Patients should not use more than the recommended once-daily dose of ANORO ELLIPTA.
  • Instruct patients who have been taking inhaled, short-acting beta-agonists on a regular basis to discontinue the regular use of these products and use them only for the symptomatic relief of acute symptoms.
  • Paradoxical Bronchospasm
  • As with other inhaled medicines, ANORO ELLIPTA can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue ANORO ELLIPTA and contact their healthcare provider right away.
  • Risks Associated with Beta-agonist Therapy
  • Inform patients of adverse effects associated with beta-agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.
  • Worsening of Narrow-Angle Glaucoma
  • Instruct patients to be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a healthcare provider immediately if any of these signs or symptoms develop.
  • Worsening of Urinary Retention
  • Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination). Instruct patients to consult a healthcare provider immediately if any of these signs or symptoms develop.
  • Trademarks are owned by or licensed to the GSK group of companies.ANORO ELLIPTA was developed in collaboration with Innoviva.
  • GlaxoSmithKlineResearch Triangle Park, NC 27709
  • u00a92019 GSK group of companies or its licensor.
  • ANR:9PI
  • No data
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0869-10
  • ANORO
  • (n
  • Rx Only
  • 62.5 mcg/25 mcg
  • FOR ORAL INHALATION ONLY
  • Each blister on one strip contains 62.5 mcg of umeclidinium, magnesium stearate, and lactose monohydrate. Each blister on the other strip contains 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.
  • 1 ELLIPTA Inhaler containing 30 doses (60 blisters total)
  • u00a92019 GSK group of companies or its licensor.

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of umeclidinium bromide and vilanterol trifenatate (Anoro Ellipta) which is also known as Anoro Ellipta and Manufactured by GlaxoSmithKline LLC. It is available in strength of 62.5; 25 ug/1; ug/1 per ml.

umeclidinium bromide and vilanterol trifenatate (Anoro 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.

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