NUCALA 100 MG
MEPOLIZUMAB : 100 MG · DIN 02449781 · GLAXOSMITHKLINE INC
Health Canada status: CANCELLED POST MARKET
What is NUCALA?
NUCALA 100 MG contains MEPOLIZUMAB : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02449781, held by GLAXOSMITHKLINE INC, supplied as POWDER FOR SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as cancelled post market, status dated 06-Dec-2023. 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 NUCALA used for?
Add-on maintenance for severe eosinophilic asthma (≥6 years), chronic rhinosinusitis with nasal polyps (adults), eosinophilic granulomatosis with polyangiitis (adults), and hypereosinophilic syndrome.
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
| DIN | 02449781 |
|---|---|
| Brand name | NUCALA |
| Generic / active ingredient | MEPOLIZUMAB : 100 MG |
| Manufacturer | GLAXOSMITHKLINE INC |
| Strength | 100 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | SUBCUTANEOUS |
| Schedule | Prescription |
| ATC code | R03DX09 MEPOLIZUMAB |
| AHFS class | 90:28.00 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 06-Dec-2023 |
| Original market date | 2016-03-14 00:00:00 |
How is it administered?
Adults/Adolescents (≥12): 100 mg SC every 4 weeks. Children (6-11): 40 mg SC every 4 weeks. EGPA/HES: 300 mg (as 3 x 100 mg injections) SC every 4 weeks.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Lyophilized powder: Store below 25°C. Reconstituted solution: Store below 30°C (do not freeze, discard after 8h). Pre-filled formats: Store at 2-8°C, do not freeze.
How is it supplied?
10 mL glass vial (lyophilized powder); 1 mL pre-filled autoinjector; 1 mL pre-filled syringe; 0.4 mL pre-filled syringe.
Contraindications
Hypersensitivity to mepolizumab, to any ingredient in the formulations, or component of the containers.
Warnings and precautions
Not for acute asthma/status asthmaticus. Risk of hypersensitivity/anaphylaxis. Treat pre-existing helminth infections. Consider varicella vaccination for herpes zoster risk.
What can be used instead?
Other Canadian products sharing ATC code R03DX09 MEPOLIZUMAB. 3 of 4 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.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| NUCALA | 100 MG | SOLUTION | GLAXOSMITHKLINE INC | MARKETED | DIN 02492989 |
| NUCALA | 100 MG | SOLUTION | GLAXOSMITHKLINE INC | MARKETED | DIN 02492997 |
| NUCALA | 40 MG / 0.4 ML | SOLUTION | GLAXOSMITHKLINE INC | MARKETED | DIN 02530821 |
Who else supplies MEPOLIZUMAB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. MEPOLIZUMAB appears in 53 registered pack listings across 12 markets, published on 9 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.
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.
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.