ORKAMBI 125 MG
IVACAFTOR : 125 MG LUMACAFTOR : 100 MG · DIN 02463040 · VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
Health Canada status: MARKETED
What is ORKAMBI?
ORKAMBI 125 MG contains IVACAFTOR : 125 MG LUMACAFTOR : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02463040, held by VERTEX PHARMACEUTICALS (CANADA) INCORPORATED, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 03-May-2017. 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 ORKAMBI used for?
Treatment of cystic fibrosis (CF) in patients 1 year of age and older who are homozygous for the F508del mutation in the CFTR gene.
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 | 02463040 |
|---|---|
| Brand name | ORKAMBI |
| Generic / active ingredient | IVACAFTOR : 125 MG LUMACAFTOR : 100 MG |
| Manufacturer | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED |
| Strength | 125 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | R07AX30 IVACAFTOR AND LUMACAFTOR |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 03-May-2017 |
How is it administered?
Taken orally every 12 hours with fat-containing food. Dosage is weight and age-dependent. Tablets must be swallowed whole; granules mixed with soft food/liquid.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 5 to 25ºC (for granules once mixed). [General storage not explicitly detailed in provided text snippet, though stability for mixed granules is 1 hour].
How is it supplied?
Tablets: Blister packs (112 count). Granules: Unit dose packets (56 count).
Contraindications
Hypersensitivity to lumacaftor, ivacaftor, or any ingredient in the formulation or component of the container.
Warnings and precautions
Risk of elevated transaminases (ALT/AST); monitor liver function. Respiratory events (dyspnea/chest discomfort) common at initiation. Increased blood pressure. Risk of cataracts in pediatrics.
What can be used instead?
Other Canadian products sharing ATC code R07AX30 IVACAFTOR AND LUMACAFTOR. 5 of 5 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 |
|---|---|---|---|---|---|
| ORKAMBI | 100 MG | GRANULES | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | DIN 02483831 |
| ORKAMBI | 125 MG | TABLET | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | DIN 02451379 |
| ORKAMBI | 150 MG | GRANULES | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | DIN 02483858 |
| ORKAMBI | 94 MG | GRANULES | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | DIN 02537087 |
Who else supplies IVACAFTOR AND LUMACAFTOR worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. IVACAFTOR AND LUMACAFTOR appears in 23 registered pack listings across 2 markets, published on 2 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.