TRELEGY ELLIPTA 62.5 MCG — DIN 02474522
UMECLIDINIUM (UMECLIDINIUM BROMIDE) : 62.5 MCG VILANTEROL (VILANTEROL TRIFENATATE) : 25 MCG FLUTICASONE FUROATE : 100 MCG · GLAXOSMITHKLINE INC · POWDER · wholesale supply in Canada
Health Canada status: MARKETED
What is TRELEGY ELLIPTA?
TRELEGY ELLIPTA 62.5 MCG contains UMECLIDINIUM (UMECLIDINIUM BROMIDE) : 62.5 MCG VILANTEROL (VILANTEROL TRIFENATATE) : 25 MCG FLUTICASONE FUROATE : 100 MCG. It is listed in the Health Canada Drug Product Database under DIN 02474522, held by GLAXOSMITHKLINE INC, supplied as POWDER for INHALATION administration. Health Canada currently lists it as marketed, status dated 30-May-2018. 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.
Is there a generic Vilanterol, Umeclidinium Bromide And Fluticasone Furoate in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
Only one market authorization holder has a Canadian DIN containing Vilanterol, Umeclidinium Bromide And Fluticasone Furoate — 2 DINs, of which 2 are currently marketed. There is no second Canadian source today, so a supply interruption on this holder has no domestic substitute at the same molecule.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| GLAXOSMITHKLINE INC | 2 | 2 | TRELEGY ELLIPTA | Sourceable in Canada |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 62.5 MCG |
|---|---|
| Dosage form | POWDER |
| Route | INHALATION |
| Pack configuration (monograph) | TRELEGY ELLIPTA is available in 2 pack sizes, delivering either 14 or 30 inhalations per ELLIPTA inhaler. |
| Storage | 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. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Vilanterol, Umeclidinium Bromide And Fluticasone Furoate |
|---|---|
| ATC code | R03AL08 |
| AHFS class | 84:80.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02474522 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2474522 |
| Brand name | TRELEGY ELLIPTA |
| Generic / active ingredient | UMECLIDINIUM (UMECLIDINIUM BROMIDE) : 62.5 MCG VILANTEROL (VILANTEROL TRIFENATATE) : 25 MCG FLUTICASONE FUROATE : 100 MCG |
| Market authorization holder | GLAXOSMITHKLINE INC |
| Health Canada schedule | Prescription |
| ATC code | R03AL08 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R03AL |
| Current status | MARKETED |
| Status date | 30-May-2018 |
| Original market date | 2019-05-13 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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.
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?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
2 of 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| TRELEGY ELLIPTA | 62.5 MCG | POWDER | GLAXOSMITHKLINE INC | MARKETED | 02515776 |
2 · Same class — other molecules in ATC R03AL
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Salbutamol And Ipratropium Bromide | APO-SALVENT-IPRAVENT STERULES · COMBIVENT RESPIMAT · COMBIVENT UDV · IPRAMOL · +3 more | 7 | 3 | Yes |
| Vilanterol, Umeclidinium Bromide And Fluticasone Furoate | TRELEGY ELLIPTA | 2 | 2 | Yes |
| Formoterol, Glycopyrronium Bromide And Budesonide | BREZTRI AEROSPHERE | 1 | 1 | Yes |
| Indacaterol And Glycopyrronium Bromide | ULTIBRO BREEZHALER | 1 | 1 | Yes |
| Formoterol And Aclidinium Bromide | DUAKLIR GENUAIR | 1 | 1 | Yes |
| Indacaterol, Glycopyrronium Bromide And Mometasone | ENERZAIR BREEZHALER | 1 | 1 | Yes |
| Olodaterol And Tiotropium Bromide | INSPIOLTO RESPIMAT | 1 | 1 | Yes |
| Vilanterol And Umeclidinium Bromide | ANORO ELLIPTA | 1 | 1 | Yes |
| Fenoterol And Ipratropium Bromide | DUOVENT UDV | 1 | 0 | Not in Canada |
| Formoterol, Glycopyrronium Bromide And Beclometasone | TRIMBOW | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC R03A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R03AK | Formoterol And Budesonide · Formoterol And Mometasone · Indacaterol And Mometasone · Salbutamol And Sodium Cromoglicate · Salmeterol And Fluticasone · +1 more | 26 | 20 |
| R03AC | Fenoterol · Formoterol · Indacaterol · Olodaterol · Pirbuterol · +4 more | 81 | 15 |
| R03AA | Epinephrine | 4 | 0 |
| R03AB | Isoprenaline · Orciprenaline | 6 | 0 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is TRELEGY ELLIPTA called?
Also recorded in Canada as: UMECLIDINIUM BROMIDE (GLOBAL), UMECLIDINIUM BROMIDE (US), UMECLIDINIUM BROMIDE (UK), TRELEGY ELLIPTA 100/62.5/25 (GLOBAL), TRELEGY ELLIPTA 200/62.5/25 (GLOBAL).
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.