TRELEGY ELLIPTA 62.5 MCG

What is TRELEGY ELLIPTA?

TRELEGY ELLIPTA 62.5 MCG contains UMECLIDINIUM (UMECLIDINIUM BROMIDE) : 62.5 MCG FLUTICASONE FUROATE : 200 MCG VILANTEROL (VILANTEROL TRIFENATATE) : 25 MCG. It is listed in the Health Canada Drug Product Database under DIN 02515776, held by GLAXOSMITHKLINE INC, supplied as POWDER for INHALATION administration. Health Canada currently lists it as marketed, status dated 13-Sep-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is TRELEGY ELLIPTA used for?

TRELEGY ELLIPTA (fluticasone furoate/umeclidinium/vilanterol) is a combination of an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA). COPD TRELEGY ELLIPTA 100/62.5/25 mcg is indicated in adult patients who are not adequately treated by a combination of an ICS/LABA or a combination of a LAMA/LABA: • for the long-term, once daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema (see 14 CLINICAL TRIALS). • to reduce exacerbations of COPD in patients with a history of exacerbations (see 14 CLINICAL TRIALS). TRELEGY ELLIPTA is not indicated for the relief of acute bronchospasm (see 7 WARNINGS AND PRECAUTIONS, General). Asthma TRELEGY ELLIPTA 100/62.5/25 mcg and 200/62.5/25 mcg are indicated for the long-term, once-daily, maintenance treatment of asthma in patients aged 18 years and older who are not adequately controlled with a maintenance combination of a medium or high dose of an ICS and a LABA (see 14 CLINICAL TRIALS). TRELEGY ELLIPTA is not indicated for the relief of acute bronchospasm (see 7 WARNINGS AND PRECAUTIONS, General).

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

TRELEGY ELLIPTA is for oral inhalation only. TRELEGY ELLIPTA should be administered as a single dose once-daily at the same time of the day each day. After inhalation, patients should rinse their mouth with water (without swallowing). Do not use TRELEGY ELLIPTA more than once every 24 hours. COPD: The recommended and maximum dose is one inhalation of TRELEGY ELLIPTA 100/62.5/25 mcg once daily. TRELEGY ELLIPTA 200/62.5/25 mcg is not indicated for the treatment of COPD. Asthma: The recommended dose is one inhalation of TRELEGY ELLIPTA 100/62.5/25 mcg or 200/62.5/25 mcg once daily. A starting dose of TRELEGY ELLIPTA 100/62.5/25 mcg should be considered for patients who require a low to mid dose of inhaled corticosteroid in combination with a LAMA and a LABA. TRELEGY ELLIPTA 200/62.5/25 mcg should be considered for patients who require a higher dose of inhaled corticosteroid in combination with a LAMA and a LABA. For patients who do not respond adequately to TRELEGY ELLIPTA 100/62.5/25 mcg once daily, consider increasing the dose to 200/62.5/25 mcg once daily, which may provide improvement in asthma control. The maximum recommended dose is 1 inhalation of TRELEGY ELLIPTA 200/62.5/25 mcg once daily. Missed Dose: If a dose is missed, the patient should be instructed to take the next dose when it is due. The patient should be instructed not to take an extra dose.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Do not store above 30°C. Store in a dry place away from direct heat or sunlight. If stored in the refrigerator, allow the inhaler to return to room temperature for at least an hour before use. Keep out of sight and reach of children. Patients should be instructed to write the date the inhaler should be discarded on the label in the space provided. The date (6 weeks after the date of opening) should be added as soon as the inhaler has been removed from the tray. TRELEGY ELLIPTA should be safely discarded when the dose counter reads “0” or 6 weeks after it was removed from the foil tray, whichever comes first.

How is it supplied?

TRELEGY ELLIPTA is available in 2 pack sizes, delivering either 14 or 30 inhalations per ELLIPTA inhaler.

Contraindications

TRELEGY ELLIPTA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. TRELEGY ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity Reactions).

Warnings and precautions

Serious Asthma-Related Events – Hospitalizations, Intubations, Death: Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death (see Salmeterol Multicenter Asthma Research Trial (SMART)). Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone (see Serious Asthma-Related Events with Inhaled Corticosteroid/Long-acting Beta2-adrenergic Agonist Combination Products). Not for Acute Use: TRELEGY ELLIPTA should not be used for the relief of acute symptoms of COPD or asthma (i.e., as rescue therapy for the treatment of acute episodes of bronchospasm). Patients should be prescribed a rapid onset, short duration inhaled bronchodilator (e.g., salbutamol) to relieve acute symptoms such as shortness of breath, and advised to have this available for use at all times. Deterioration of Disease and Acute Episodes: TRELEGY ELLIPTA should not be initiated in patients with acutely deteriorating COPD or asthma which may be a life-threatening condition. The use of TRELEGY ELLIPTA in this setting has not been studied and is not considered appropriate. Pneumonia: COPD: In line with the known class effect of inhaled corticosteroids, pneumonia events (including pneumonias resulting in hospitalization) were observed in patients with COPD receiving TRELEGY ELLIPTA. In some instances, fatal events of pneumonia have been reported with use of inhaled corticosteroid fluticasone furoate-containing drugs, including TRELEGY ELLIPTA (see 8 ADVERSE REACTIONS). Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia in patients with COPD receiving inhaled corticosteroid-containing drugs include current smokers, patients with a history of prior pneumonia, patients with low body mass index and patients with severe COPD. These factors should be considered when TRELEGY ELLIPTA is prescribed, and treatment should be re-evaluated if pneumonia occurs.

What can be used instead?

Other Canadian products sharing ATC code R03AL08 VILANTEROL, UMECLIDINIUM BROMIDE AND FLUTICASONE FUROATE. 2 of 2 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.