Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

Fluticasone 100 mcg-vilanterol 25 mcg (1 inhalation) orally once a day
Maximum dose: 1 inhalation in 24 hours

Comments:

• This drug is not indicated for the relief of acute bronchospasm.
• Only fluticasone 100 mcg-vilanterol 25 mcg is indicated for the treatment of COPD.
• If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.

Uses: Long term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema; to reduce exacerbations in patients with COPD

Usual Adult Dose for Chronic Obstructive Pulmonary Disease

Fluticasone 100 mcg-vilanterol 25 mcg (1 inhalation) orally once a day
Maximum dose: 1 inhalation in 24 hours

Comments:

• This drug is not indicated for the relief of acute bronchospasm.
• Only fluticasone 100 mcg-vilanterol 25 mcg is indicated for the treatment of COPD.
• If shortness of breath occurs in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.

Uses: Long term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema; to reduce exacerbations in patients with COPD

Usual Adult Dose for Asthma - Maintenance

Initial dose: 1 inhalation of fluticasone 100 mcg-vilanterol 25 mcg or fluticasone 200 mcg-vilanterol 25 mcg orally once a day
Maximum dose: 1 inhalation of fluticasone 200 mcg-vilanterol 25 mcg in 24 hours

Comments:

• This drug should not be used in asthma patients adequately controlled on low or medium dose inhaled corticosteroids.
• If asthma symptoms arise in the period between doses, use an inhaled, short-acting beta2-agonist for immediate relief.
• The starting dosage is based on patients' asthma severity: For patients previously treated with low to mid dose corticosteroid, fluticasone 100 mcg-vilanterol 25 mcg should be considered; for patients previously treated with mid to high dose corticosteroid, fluticasone 200 mcg-vilanterol 25 mcg should be considered.

Use: In patients not adequately controlled on a long-term asthma medication, such as an inhaled corticosteroid, or when the severity of the disease clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

• Once asthma control is achieved and maintained, assess the patient at regular intervals and step down or discontinue therapy with this drug if possible without losing control of asthma; maintain the patient on a long-term inhaled corticosteroid.
• If there is no adequately response with fluticasone 100 mcg-vilanterol 25 mcg, dose can be increased to fluticasone 200 mcg-vilanterol 25 mcg for additional improvement in asthma control.
• If a previously effective dosage fails to provide adequate improvement in asthma control, reevaluate the therapy and consider additional therapeutic options (e.g., increase the strength of this drug, adding additional inhaled corticosteroid, initiating oral corticosteroids).

Precautions

US BOXED WARNING:
Asthma Related Death:

• Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, one of the active ingredients in this drug, increase the risk of asthma-related death. Data from a 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 a class effect of LABA. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids (ICS) or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients.
• When treating patients with asthma, physicians should only prescribe this drug for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue this drug) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use this drug for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Use at same time each day.
• For oral inhalation only.
• After each inhalation, rinse mouth with water and spit out to help reduce the risk of oropharyngeal candidiasis.
• 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.
• This drug should not be used with additional LABA.

Storage requirements:

• Store in the unopened protective foil tray in a dry place away from direct heat or sunlight, and only open when ready to use.
• Throw away 6 weeks after opening the foil tray or when the counter reads zero, whichever comes first

Reconstitution/preparation techniques: The manufacturer's product information should be consulted.

General:

• Limitation of use: This drug is not indicated for the relief of acute bronchospasm.
• This drug should not be initiated in acutely deteriorating COPD or asthma; should not be used to treat acute symptoms.

Monitoring:

• Ocular: Regular eye examinations are recommended
• Gastrointestinal: Infections of the mouth and pharynx
• Metabolic: Hypokalemia and hyperglycemia

Patient advice:

• Write the date the tray is opened on the label of the inhaler.
• Contact physician if symptoms get worse, more inhalation of the rescue inhaler than usual is needed, fever, chills, change in sputum color, increased breathing problems develop, or if exposed to chickenpox or measles.
• Therapy with this drug should not be stopped without physician advice since symptoms may recur after discontinuation.
• Carry a warning card indicating the need for supplementary systemic corticosteroids during periods of stress or severe COPD exacerbation.

Frequently asked questions

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