Fluticasone/Vilanterol
Combination product
Pronunciation: floo-TIK-a-soen and vye-LAN-ter-ol
What it isInhaled corticosteroid plus long-acting beta-2 agonist; asthma and COPD maintenance.
Why this one24-hour vilanterol allows once-daily dosing, simpler than twice-daily budesonide/formoterol or fluticasone/salmeterol.
What limits itICS/LABA dual therapy is no longer favored in COPD; steroid adds thrush, dysphonia and pneumonia.
Pearls
- Rinse mouth after each dose.
- Only the 100/25 mcg strength is approved for COPD.
- Not a rescue inhaler; reliever (MART) use unproven.
Braids
Components (2)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| COPD, maintenance | Adults | 100/25 mcg 1 actuation QD | 1 actuation QD | 100/25 mcg 1 actuation QD |
| Asthma, maintenance | Adults >=18 y | 100/25 or 200/25 mcg 1 actuation QD — strength by severity/prior ICS dose | 1 actuation QD | 200/25 mcg 1 actuation QD |
| Asthma, maintenance | 12-17 y | 100/25 mcg 1 actuation QD | 1 actuation QD | 100/25 mcg 1 actuation QD |
| Asthma, maintenance | 5-11 y | 50/25 mcg 1 actuation QD | 1 actuation QD | 50/25 mcg 1 actuation QD |
Renal No adjustment needed
Hepatic Use with caution in moderate/severe impairment — fluticasone furoate exposure up to 3-fold; monitor for corticosteroid effects (effect in <18 y not evaluated)
Max 1 actuation per 24 h; onset (100-mL FEV1 gain) median ~15 min in asthma
Instructions
- Oral inhalation only, same time every day; never more than 1 inhalation per 24 h
- Rinse mouth with water without swallowing after each dose
- Adults with asthma: if inadequate response on 100/25 QD, may increase to 200/25 QD; if inadequate on 200/25, re-evaluate regimen
- Use inhaled SABA (e.g., albuterol) for symptoms between doses
Available strengths
- powder 0.05/0.025, 0.1/0.025, 0.2/0.025 mg/inh
Contraindications
- Primary treatment of status asthmaticus or acute COPD/asthma episodes requiring intensive measures
- Severe hypersensitivity to milk proteins
Cautions
- LABA monotherapy increases serious asthma-related events; never add another LABA
- Do not initiate in acutely deteriorating asthma/COPD; not for acute symptoms
- Oropharyngeal candidiasis — rinse mouth after use
- Increased pneumonia risk in COPD
- Immunosuppression: worsening infections; severe chickenpox/measles risk
- Adrenal suppression; taper systemic corticosteroids on transfer
- Paradoxical bronchospasm — discontinue if it occurs
- Caution in cardiovascular disorders (beta-adrenergic stimulation)
- Bone mineral density decrease; monitor growth in pediatric patients
- Glaucoma/cataracts with long-term ICS
- Hypokalemia, hyperglycemia; caution in convulsive disorders, thyrotoxicosis, diabetes, ketoacidosis
Adverse reactions
- COPD (>=3%): nasopharyngitis, URTI, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, pyrexia
- Asthma (>=2%): nasopharyngitis, oral candidiasis, headache, influenza, URTI, bronchitis, sinusitis, oropharyngeal pain, dysphonia, cough
Pregnancy Insufficient human data; no fetal structural abnormalities in animal inhalation studies at multiples of MRHDID
Lactation No human milk data; low concentrations of other ICS detected in milk; weigh breastfeeding benefit vs need
Cost
Clinical profile
Defining liabilityPneumonia and steroid/adrenergic systemic adverse effects
Part D rank #198.
Self-check
- At what age does fluticasone/vilanterol’s asthma maintenance indication begin?
Age 5. - What COPD role is listed for fluticasone/vilanterol?
Maintenance.
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