Viltica-U25 mcg+100 mcg+62.5 mcg

This triple combination inhaler, delivering an inhaled corticosteroid (fluticasone furoate), a long-acting muscarinic antagonist (umeclidinium), and a long-acting beta-2 agonist (vilanterol), is indicated for:

• Maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, in adults
• Maintenance treatment of asthma in adults whose disease is not adequately controlled on a combination of an inhaled corticosteroid and a long-acting beta-2 agonist, or who otherwise require all three components

Important limitation of use: This medicine is not indicated for the relief of acute bronchospasm or acute exacerbations of COPD or asthma, and is not appropriate as the primary treatment of status asthmaticus or other acute episodes requiring intensive measures. A separate fast-acting, short-acting bronchodilator must always be available for sudden symptoms.

Contains fluticasone furoate, umeclidinium bromide, and vilanterol trifenatate as active ingredients, delivered as a dry powder for oral inhalation via a single inhaler device (commonly the Ellipta-type device), in two strengths: 100 mcg/62.5 mcg/25 mcg (the only strength indicated for COPD, and one of two strengths available for asthma) and 200 mcg/62.5 mcg/25 mcg (fluticasone furoate/umeclidinium/vilanterol, for asthma only).

This is a once-daily "triple therapy" inhaler that combines three complementary medicines in a single device: fluticasone furoate, an inhaled corticosteroid that reduces airway inflammation; umeclidinium, a long-acting anticholinergic bronchodilator; and vilanterol, a long-acting beta-2 agonist bronchodilator. Together, these address both the inflammatory and the airway-narrowing components of COPD and, in appropriately selected patients, asthma, in a single, convenient once-daily inhalation. It is a maintenance medicine only, not intended for relief of sudden breathing difficulty, and carries the class-wide boxed warning associated with long-acting beta-2 agonists regarding increased risk of asthma-related death when not used together with an inhaled corticosteroid - a risk this specific triple combination addresses by always including the corticosteroid component.

Therapeutic Class: Triple Combination Bronchodilator/Corticosteroid (ICS + LAMA + LABA)

All three components act locally within the lungs after inhalation via the dry powder inhaler device, with systemic absorption occurring to varying degrees for each component; fluticasone furoate has low oral bioavailability, reducing systemic corticosteroid exposure relative to some older inhaled steroids. All three components have durations of action supporting once-daily dosing. Moderate to severe hepatic impairment can increase systemic exposure to the fluticasone furoate component up to three-fold, requiring monitoring for corticosteroid-related side effects in this population.

• For oral inhalation only, using the specific inhaler device provided
• Take once daily, at approximately the same time each day, generally in the morning
• Rinse the mouth with water without swallowing after each use, to help reduce the risk of oral thrush (candidiasis) from the inhaled corticosteroid component
• Keep a separate fast-acting rescue inhaler available at all times for sudden symptoms
• Do not use to treat an acute asthma or COPD attack that has already started

The following should be assessed by a healthcare professional before combining with this medicine:

• Monoamine oxidase inhibitors, tricyclic antidepressants, or other QT-prolonging medicines: use this inhaler with extreme caution, or avoid, in patients on these medicines or within 2 weeks of stopping them, since they may potentiate the cardiovascular effects of the vilanterol component.
• Beta-blockers: may block the pulmonary effect of vilanterol and could produce severe bronchospasm; use with caution, and consider a cardioselective beta-blocker if one is needed.
• Non-potassium-sparing diuretics: combined use may worsen ECG changes and/or low blood potassium associated with these diuretics; use with caution.
• Other anticholinergic-containing medicines: avoid combining with other anticholinergic drugs, given the risk of additive anticholinergic side effects from the umeclidinium component.
• Strong CYP3A4 inhibitors (such as ketoconazole or ritonavir): may increase systemic exposure to the fluticasone furoate component; use with caution.

Common side effects

• Nasopharyngitis, upper respiratory tract infection
• Headache
• Bronchitis
• Pharyngitis, sinusitis
• Cough
• Back pain
• Oral candidiasis (thrush)

Serious side effects (require prompt medical attention)

• Increased risk of asthma-related death with LABA use: long-acting beta-2 agonists like vilanterol, when used alone, increase this risk; this triple combination includes an inhaled corticosteroid specifically to mitigate this risk, and should never be paired with an additional standalone LABA product.
• Immediate hypersensitivity reactions: rash, hives, swelling of the face or throat, difficulty breathing - discontinue immediately if these occur.
• Paradoxical bronchospasm: sudden worsening of wheezing or breathing difficulty immediately after use - discontinue and treat with an alternative fast-acting bronchodilator.
• Cardiovascular effects: increased heart rate, palpitations, elevated blood pressure - particularly relevant in patients with cardiovascular disease.
• Anticholinergic effects from umeclidinium: worsening of narrow-angle glaucoma (eye pain, blurred vision, halos around lights) or urinary retention, particularly in patients with prostatic hyperplasia or bladder outlet obstruction.
• Signs of pneumonia, which may be more common in COPD patients using inhaled corticosteroids.
• Reduced bone mineral density and other systemic corticosteroid effects with long-term, high-dose use.

Pregnancy

Data on this specific triple combination in human pregnancy are limited; use during pregnancy should only occur if a doctor determines the potential benefit outweighs the potential risk, given that poorly controlled asthma or COPD itself carries risk to both mother and baby.

Breastfeeding

It is not known whether the components of this inhaler pass into human milk in clinically significant amounts; use during breastfeeding should be discussed with a healthcare professional, weighing the benefits of breastfeeding against the mother's clinical need for treatment.

• Not for acute symptoms: do not use to relieve sudden breathing difficulty or treat an acute COPD/asthma attack; keep a separate fast-acting rescue inhaler available at all times.
• LABA safety: while combining a LABA with an inhaled corticosteroid (as in this product) does not carry the same increased asthma-death risk as LABA monotherapy, do not add a separate standalone LABA-containing product to this regimen.
• Local and systemic corticosteroid effects: monitor for oral thrush (rinse mouth after each use), and, with prolonged use, be aware of the potential for reduced bone density, adrenal suppression, and effects on growth (relevant mainly in younger patients, though this product is not indicated in children).
• Narrow-angle glaucoma and urinary retention: use with caution in patients with these conditions or with prostatic hyperplasia/bladder outlet obstruction, given umeclidinium's anticholinergic activity.
• Hepatic impairment: use with caution in moderate to severe impairment, given increased systemic fluticasone furoate exposure and associated corticosteroid-related side-effect risk.
• Not indicated for use in children and adolescents (17 years and younger).

Overdose is likely to result in exaggerated known effects from each of the three components, including excessive beta-agonist stimulation (tachycardia, tremor, headache), anticholinergic effects (dry mouth, urinary retention, blurred vision), and, with sustained excessive use, systemic corticosteroid effects. Suspected significant overdose requires prompt medical evaluation, particularly for cardiac monitoring given the vilanterol component; treatment is generally supportive, provided in a medical facility.

Store the inhaler at room temperature, in the sealed tray until ready for use, and discard 6 weeks after opening the tray or when the dose counter reads zero, whichever comes first, per the specific product's instructions. Keep out of reach of children.

• Hepatic impairment: Use with caution in moderate to severe impairment, given increased fluticasone furoate systemic exposure (up to 3-fold); monitor for corticosteroid-related side effects.
• Renal impairment: No specific dose adjustment is generally required.
• Elderly: Used with the same dosing approach as younger adults, with attention to overall cardiovascular and anticholinergic risk factors.
• Children and adolescents (17 years and younger): Not indicated; safety and effectiveness have not been established in this age group.

This inhaler is used as ongoing, long-term maintenance therapy for COPD or asthma, for as long as it provides symptom benefit and is well tolerated, as part of the patient's overall disease management plan, with regular review by the treating doctor.

Drug Class: Inhaled corticosteroid (fluticasone furoate) + long-acting muscarinic antagonist (umeclidinium) + long-acting beta-2 agonist (vilanterol)

Fluticasone furoate reduces airway inflammation by binding to glucocorticoid receptors, suppressing the release of inflammatory mediators involved in COPD and asthma. Umeclidinium blocks muscarinic acetylcholine receptors in airway smooth muscle, preventing the bronchoconstricting effect of acetylcholine and helping keep the airways open. Vilanterol stimulates beta-2 adrenergic receptors in airway smooth muscle, causing the muscles around the airways to relax. Together, these three complementary mechanisms - reducing inflammation, blocking one bronchoconstricting pathway, and directly relaxing airway muscle - provide more comprehensive control of COPD and asthma symptoms than a single- or dual-component inhaler.

This triple combination inhaler is not indicated for use in children and adolescents 17 years of age and younger; safety and effectiveness have not been established in this age group.