Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

1 inhalation (fluticasone/umeclidinium/vilanterol 100 mcg-62.5 mcg-25 mcg) orally once a day
Maximum dose: 1 inhalation every 24 hours

Comments:

• More frequent administration or a greater number of inhalations than the recommended dose should not be used, as adverse effects are more likely to occur with higher doses.
• Use with caution when transferring from systemically active corticosteroid therapy.
• Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to this drug.

• Long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
• Reduce exacerbations of COPD in patients with a history of exacerbations.

Usual Adult Dose for Asthma - Maintenance

1 inhalation (fluticasone/umeclidinium/vilanterol 100 mcg-62.5 mcg-25 mcg or 200 mcg-62.5 mcg-25 mcg) orally once a day
Maximum dose: 1 inhalation (fluticasone/umeclidinium/vilanterol 200 mcg-62.5 mcg-25 mcg) every 24 hours

Comments:

• When choosing starting dose, consider disease severity, previous asthma therapy (including inhaled corticosteroid use), current symptom control and risk of future exacerbations.
• Patients with inadequate response to fluticasone/umeclidinium/vilanterol 100 mcg-62.5 mcg-25 mcg may gain additional improvement with fluticasone/umeclidinium/vilanterol 200 mcg-62.5 mcg-25 mcg.
• Consider reevaluation and other therapies if response to fluticasone/umeclidinium/vilanterol 200 mcg-62.5 mcg-25 mcg is inadequate.
• If asthma symptoms arise between doses, use and inhaled short-acting beta-2 agonist (e.g. albuterol) for immediate relief.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: Safety has not been evaluated.

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS:

• Hypersensitivity to any of the ingredients
• Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required
• Severe hypersensitivity to milk proteins

Dialysis

Data not available

Other Comments

Administration advice:

• For oral inhalation only.
• Use at the same time every day.
• After each inhalation, rinse mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis.
• The inhaler is not reusable. Do not attempt to take the inhaler apart.
• Discard 6 weeks after opening the foil tray or when the counter reads zero, whichever comes first.
• The manufacturer's product information should be consulted for instruction on how to use the inhaler device.

• Store at room temperature between 68F and 77F (20C and 25C).
• Store in the unopened protective foil tray in a dry place away from direct heat or sunlight, and only open when ready to use.

• Consult a healthcare provider immediately if 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) develop.
• Consult a healthcare provider immediately if any signs or symptoms of urinary retention (e.g., difficulty passing urine, painful urination) develop.
• Patients should not use other medicines containing a long-acting beta2 agonists (LABA).
• Patients should carry a warning card indicating their need of supplementary systemic corticosteroids during periods of stress or a severe COPD exacerbation.

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