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Trelegy Ellipta 100mcg/62.5mcg/25mcg Inhaler
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Indications & Clinical Uses
- Trelegy Ellipta 100/62.5/25 mcg combines an inhaled corticosteroid (fluticasone furoate), a long-acting muscarinic antagonist (umeclidinium) and a long-acting beta2-agonist (vilanterol) in a single once-daily dry-powder inhaler.
- In the United States it is approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and for the maintenance treatment of asthma in patients aged 18 years and older, where a separate 200/62.5/25 mcg strength is also available for asthma only.
- In the European Union, Trelegy Ellipta is likewise approved for COPD and for asthma in adults inadequately controlled on an inhaled corticosteroid/long-acting beta-agonist combination.
- It is not a reliever inhaler and must not be used to treat sudden breathlessness or an asthma or COPD attack; a fast-acting rescue inhaler should always be carried separately.
- GSK markets it worldwide under the same brand name, and patients use it themselves at home, once daily, at the same time each day.
Side Effects
- Trelegy Ellipta has no boxed warning.
- Very common effects include headache and, less commonly, oral thrush (candidiasis) from the inhaled steroid component; other common effects include upper respiratory infections, bronchitis, pneumonia, back pain, joint pain, sinusitis, sore throat, cough and constipation.
- Long-acting beta-agonists such as vilanterol can very rarely worsen asthma control or, extremely rarely, contribute to asthma-related death, so asthma should never be treated with Trelegy Ellipta alone, without an inhaled corticosteroid component and regular review.
- Umeclidinium can cause a fast or irregular heartbeat, blurred vision, eye pain, or worsening of narrow-angle glaucoma and difficulty passing urine, particularly in men with prostate enlargement.
- Paradoxical bronchospasm - sudden worsening of wheeze right after inhaling - needs the dose stopped and urgent medical review.
- Rinse your mouth with water after each dose and spit it out, without swallowing, to reduce the risk of oral thrush and hoarseness.
Precautions & Warnings
- Trelegy Ellipta must not be used to relieve sudden breathlessness; keep a fast-acting reliever inhaler on hand for that.
- It is contraindicated in people with a severe allergy to milk proteins, because the powder contains lactose, and in known hypersensitivity to any component.
- Use with caution in significant cardiovascular disease, seizure disorders, thyrotoxicosis, uncontrolled diabetes, narrow-angle glaucoma and urinary retention (because of the umeclidinium component), and in active or untreated respiratory infections, where inhaled corticosteroids need caution.
- Long-term use of inhaled corticosteroids can reduce bone density and, rarely, affect adrenal or growth-hormone function; monitor accordingly, especially in adolescents and long-term users.
- There is no specific pregnancy contraindication, but it should be used in pregnancy or breastfeeding only if the expected benefit outweighs any risk, on medical advice.
- Rinse the mouth after use.
- Store the inhaler at 20°C to 25°C, keep it dry, and throw it away six weeks after opening the foil tray or when the dose counter reads zero, whichever comes first.
Avoid Interactions
- Effects that may be increased: strong CYP3A4 inhibitors, such as ketoconazole, ritonavir and other HIV protease inhibitors, raise fluticasone furoate levels and the risk of systemic corticosteroid side effects, including adrenal suppression - such combinations should be avoided unless the benefit clearly outweighs the risk.
- Other medicines that prolong the QT interval, and non-potassium-sparing diuretics, may add to vilanterol's effects on the heart and potassium levels.
- Beta-blockers, including eye drops, can block the drug's bronchodilating effect and should generally be avoided in respiratory disease.
- Monoamine oxidase inhibitors and tricyclic antidepressants increase the risk of heart-rhythm effects when combined with vilanterol.
- Other inhaled anticholinergic medicines should not be used alongside Trelegy Ellipta, because their effects add together and raise anticholinergic side-effect risk.
- Tell your healthcare provider about all other medicines and supplements you take, particularly for heart problems, depression, HIV or fungal infections, before starting Trelegy Ellipta.
References
Frequently Asked Questions
Trelegy Ellipta combines fluticasone furoate, umeclidinium and vilanterol in one inhaler for daily maintenance treatment of COPD, and of asthma in adults 18 and over. It reduces flare-ups and improves breathing over time. It is not a rescue inhaler and will not stop a sudden attack.
Trelegy Ellipta is inhaled once daily, at the same time each day, straight from the Ellipta device - no shaking or priming needed. Rinse your mouth with water and spit it out afterwards to lower the risk of oral thrush. Always keep a separate fast-acting reliever inhaler for sudden symptoms.
Trelegy Ellipta has no boxed warning. Common side effects include headache, oral thrush, throat irritation, and respiratory or urinary infections. Long-acting beta-agonists can rarely worsen asthma; get urgent help for sudden wheeze after inhaling, a fast or irregular heartbeat, or eye pain.
Avoid strong antifungal or HIV medicines such as ketoconazole and ritonavir with Trelegy Ellipta, as they raise steroid side-effect risk. Avoid other inhaled anticholinergic medicines and beta-blockers, including eye drops, which can block its effect. Tell your doctor about heart, prostate or glaucoma problems first.
Store Trelegy Ellipta at 20°C to 25°C, away from moisture, with the cap closed between doses. Keep it in its sealed tray until first use, write the opening date on the label, and throw it away 6 weeks after opening the tray or when the counter reads zero.
No. Trelegy Ellipta is approved only for adults - for COPD maintenance, and for asthma from age 18. It is not studied or approved for children or teenagers, and should never be used to treat a sudden asthma or COPD attack in anyone, regardless of age.
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