- Approval Id
- 93d54b60360dff84
- Drug Name
- TRELEGY ELLIPTA INHALATION POWDER 200 MCG/62.5 MCG/25 MCG
- Product Name
- TRELEGY ELLIPTA INHALATION POWDER 200 MCG/62.5 MCG/25 MCG
- Approval Number
- SIN16914P
- Approval Date
- 2023-12-15
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- POWDER, METERED
- Dosage
- **Dosage and Administration**
Pharmaceutical form: Inhalation powder, pre-dispensed
**Posology**
Administer 1 actuation of Trelegy Ellipta once daily by oral inhalation.
After inhalation, rinse the mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.
Trelegy Ellipta should be used at the same time every day. Do not use Trelegy Ellipta more than 1 time every 24 hours.
**Populations**
**ASTHMA**
Patients should be made aware that Trelegy Ellipta must be used regularly, even when asymptomatic.
If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
Patients should be regularly reassessed by a healthcare professional so that the strength of Trelegy Ellipta they are receiving remains optimal and is only changed on medical advice.
**Adults**
The recommended starting dosage of Trelegy Ellipta for maintenance treatment of asthma is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of Trelegy Ellipta 100/62.5/25 mcg) or fluticasone furoate 200 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of Trelegy Ellipta 200/62.5/25 mcg) once daily, by oral inhalation.
When choosing the starting dosage strength of Trelegy Ellipta, consider the patients’ disease severity; their previous asthma therapy, including the inhaled corticosteroid (ICS) dosage; as well as the patients’ current control of asthma symptoms and risk of future exacerbation.
The maximum recommended dosage is 1 inhalation of Trelegy Ellipta 200/62.5/25 mcg once daily.
For patients who do not respond adequately to Trelegy Ellipta 100/62.5/25 mcg once daily, increasing the dose to Trelegy Ellipta 200/62.5/25 mcg once daily may provide additional improvement in asthma control. For patients who do not respond adequately to Trelegy Ellipta 200/62.5/25 mcg once daily, re-evaluate and consider other therapeutic regimens and additional therapeutic options.
If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be used for immediate relief.
**Children and adolescents**
The safety and efficacy of Trelegy Ellipta have not been established in children or adolescents less than 18 years of age.
**COPD**
**Adults**
The recommended and maximum dose is one inhalation of Trelegy Ellipta 100/62.5/25 micrograms once daily, at the same time each day.
**Children and adolescents**
Use in patients less than 18 years of age is not relevant to the COPD indication for this product.
**ASTHMA and COPD**
**Elderly**
No dosage adjustment is required in patients over 65 years (see _Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**Renal impairment**
No dosage adjustment is required for patients with renal impairment (see _Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**Hepatic impairment**
Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids.
For patients with moderate or severe hepatic impairment the maximum dose is 100/62.5/25 micrograms (see _Warnings and Precautions, Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Route Of Administration
- RESPIRATORY (INHALATION)
- Indication Info
- **Indications**
**ASTHMA**
Trelegy Ellipta is indicated for the maintenance treatment of asthma in patients aged 18 years and older who are not adequately controlled with a combination of a long-acting beta2-agonist and an inhaled corticosteroid.
**COPD**
Trelegy Ellipta is indicated for maintenance treatment to prevent and relieve symptoms associated with moderate to severe chronic obstructive pulmonary disease (COPD) in patients who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (see _Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Contraindications
- **Contraindications**
Trelegy Ellipta is contraindicated in patients with severe milk-protein allergy or who have demonstrated hypersensitivity to fluticasone furoate, umeclidinium, vilanterol or any of the excipients.
- Atc Code
- R03AL08
- Atc Item Name
- vilanterol, umeclidinium bromide and fluticasone furoate
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
- Company Detail Path
- /organization/cac9b4e7bceb9ea7/glaxosmithkline-pte-ltd
