- Approval Id
- 4635697cd78c5d98
- Drug Name
- TRELEGY ELLIPTA INHALATION POWDER 100 MCG/62.5 MCG/25 MCG
- Product Name
- TRELEGY ELLIPTA INHALATION POWDER 100 MCG/62.5 MCG/25 MCG
- Approval Number
- SIN15806P
- Approval Date
- 2019-09-12
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- POWDER, METERED
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>Pharmaceutical form: Inhalation powder, pre-dispensed</p>
<p><strong>Posology</strong></p>
<p>Administer 1 actuation of Trelegy Ellipta once daily by oral inhalation.</p>
<p>After inhalation, rinse the mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.</p>
<p>Trelegy Ellipta should be used at the same time every day. Do not use Trelegy Ellipta more than 1 time every 24 hours.</p>
<p><strong>Populations</strong></p>
<p><strong>ASTHMA</strong></p>
<p>Patients should be made aware that Trelegy Ellipta must be used regularly, even when asymptomatic.</p>
<p>If symptoms arise in the period between doses, an inhaled, short-acting beta<sub>2</sub>-agonist should be taken for immediate relief.</p>
<p>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.</p>
<p><strong>Adults</strong><br>
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.</p>
<p>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.</p>
<p>The maximum recommended dosage is 1 inhalation of Trelegy Ellipta 200/62.5/25 mcg once daily.</p>
<p>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.</p>
<p>If asthma symptoms arise in the period between doses, an inhaled, short-acting beta<sub>2</sub>-agonist (rescue medicine, e.g., albuterol) should be used for immediate relief.</p>
<p><strong>Children and adolescents</strong></p>
<p>The safety and efficacy of Trelegy Ellipta have not been established in children or adolescents less than 18 years of age.</p>
<p><strong>COPD</strong></p>
<p><strong>Adults</strong></p>
<p>The recommended and maximum dose is one inhalation of Trelegy Ellipta 100/62.5/25 micrograms once daily, at the same time each day.</p>
<p><strong>Children and adolescents</strong></p>
<p>Use in patients less than 18 years of age is not relevant to the COPD indication for this product.</p>
<p><strong>ASTHMA and COPD</strong></p>
<p><strong>Elderly</strong></p>
<p>No dosage adjustment is required in patients over 65 years (see <em>Pharmacokinetics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Renal impairment</strong></p>
<p>No dosage adjustment is required for patients with renal impairment (see <em>Pharmacokinetics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Hepatic impairment</strong></p>
<p>Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids.</p>
<p>For patients with moderate or severe hepatic impairment the maximum dose is 100/62.5/25 micrograms (see <em>Warnings and Precautions, Pharmacokinetics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- RESPIRATORY (INHALATION)
- Indication Info
- <p><strong>Indications</strong></p>
<p><strong>ASTHMA</strong></p>
<p>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.</p>
<p><strong>COPD</strong></p>
<p>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 <em>Clinical Studies</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>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.</p>
- Atc Code
- R03AL08
- Atc Item Name
- vilanterol, umeclidinium bromide and fluticasone furoate
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
- Company Detail Path
- /organization/glaxosmithkline-pte-ltd
