Trelegy Ellipta
Combination product
Pronunciation: floo-TIK-a-soen and yoo-me-kli-DIN-ee-um and vye-LAN-ter-ol (trel-ee-jee-ee-LIP-ta)
Combination of Fluticasone and Umeclidinium and Vilanterol.
Each component keeps its own pharmacology page; the combination itself adds no new mechanism.
Trio
Components (3)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| COPD, maintenance | Adults | 1 actuation QD of 100/62.5/25 mcg (only strength indicated for COPD) | 1 actuation QD | 1 actuation QD — max 1 per 24 h |
| Asthma, maintenance | Adults >=18 y (not indicated <18 y) | 1 actuation QD of 100/62.5/25 or 200/62.5/25 mcg — strength by severity/prior ICS dose | 1 actuation QD | 200/62.5/25 mcg 1 actuation QD |
Renal No adjustment needed
Hepatic No adjustment for moderate impairment; use with caution in moderate/severe — fluticasone furoate exposure up to 3-fold; monitor for corticosteroid effects
Max 1 actuation per 24 h
Instructions
- Oral inhalation only, same time every day; never more than 1 actuation per 24 h
- Rinse mouth with water without swallowing after each dose
- Asthma: if inadequate response on 100/62.5/25, may increase to 200/62.5/25 QD; if inadequate on 200/62.5/25, re-evaluate regimen
- Use inhaled SABA (e.g., albuterol) for symptoms between doses
Available strengths
- powder 0.1/0.0625/0.025, 0.2/0.0625/0.025 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 COPD/asthma; 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
- Glaucoma/cataracts; worsening narrow-angle glaucoma (anticholinergic)
- Worsening urinary retention (prostatic hyperplasia, bladder-neck obstruction)
- Hypokalemia, hyperglycemia; caution in convulsive disorders, thyrotoxicosis, diabetes, ketoacidosis
Adverse reactions
- COPD (>=1%): URTI, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, UTI, diarrhea, gastroenteritis, oropharyngeal pain, cough, dysphonia
- Asthma (>=2%): pharyngitis/nasopharyngitis, upper respiratory tract infection/viral URTI, bronchitis, respiratory tract infection/viral respiratory tract infection, sinusitis/acute sinusitis, urinary tract infection, rhinitis, influenza, headache, back pain
- Postmarketing: palpitations, blurred vision/eye pain/glaucoma/raised IOP, hypersensitivity incl. anaphylaxis/angioedema/rash/urticaria, hyperglycemia, muscle spasms, tremor, anxiety, dysuria and urinary retention
Pregnancy Insufficient human data; no fetal structural abnormalities in animal inhalation studies at multiples of MRHDID
Lactation No information on fluticasone furoate, umeclidinium or vilanterol in human milk, on the breastfed child, or on milk production; umeclidinium was detected in the plasma of pups of dosed lactating rats - weigh the benefits of breastfeeding against the mother's clinical need
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 0.1/0.0625/0.025 mg/inh | powder | per unit | — | $11.12/ea | not offered |
| 0.2/0.0625/0.025 mg/inh | powder | per unit | — | $11.18/ea | not offered |
Part D rank #79.