ANORO ELLIPTA- umeclidinium bromide and vilanterol trifenatate powder
GlaxoSmithKline LLC
WARNING: ASTHMA-RELATED DEATH
Long-acting beta2 -adrenergic agonists (LABA), such as vilanterol, one of the active ingredients in ANORO? ELLIPTA , increase the risk of asthma-related death. Data from large placebo-controlled US trial that compared the safety of another LABA (salmeterol) with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered class effect of LABA [see Warnings and Precautions
The safety and efficacy of ANORO ELLIPTA in patients with asthma have not been established. ANORO ELLIPTA is not indicated for the treatment of asthma.
INDICATIONS AND USAGE
ANORO ELLIPTA is combination anticholinergic/long-acting beta2 -adrenergic agonist (anticholinergic/LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Important Limitations of Use
ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
2 DOSAGE AND ADMINISTRATION
ANORO ELLIPTA (umeclidinium/vilanterol 62.5 mcg/25 mcg) should be administered as 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 time every 24 hours.
No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment [see Clinical Pharmacology (12.3)].
3 DOSAGE FORMS AND STRENGTHS
Inhalation Powder. Disposable light grey and red plastic inhaler containing foil blister strips of powder intended for oral inhalation only. One strip contains umeclidinium (62.5 mcg per blister), and the other strip contains vilanterol (25 mcg per blister).
4 CONTRAINDICATIONS
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
Excessive Use of ANORO ELLIPTA and Use with Other Long-Acting Beta2 -Agonists
ANORO ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using ANORO ELLIPTA should not use another medicine containing LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason.
ADVERSE REACTIONS
LABA, such as vilanterol, one of the active ingredients in ANORO ELLIPTA, increase the risk of asthma-related death. ANORO ELLIPTA is not indicated for the treatment of asthma
ANORO ELLIPTA is supplied as disposable light grey and red plastic inhaler containing foil strips, each with 30 blisters (or blisters for the institutional pack. One strip contains umeclidinium (62.5 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). blister from each strip is used to create dose. The inhaler is packaged in moisture-protective foil tray with desiccant and peelable lid in the following packs:
NDC 0173-0869-10 30 inhalations (60 blisters)
NDC 0173-0869-06 inhalations (14 blisters), institutional pack
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 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 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.
