ORKAMBI 150 MG
LUMACAFTOR : 150 MG IVACAFTOR : 188 MG · DIN 02483858 · VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
Health Canada status: MARKETED
What is ORKAMBI?
ORKAMBI 150 MG contains LUMACAFTOR : 150 MG IVACAFTOR : 188 MG. It is listed in the Health Canada Drug Product Database under DIN 02483858, held by VERTEX PHARMACEUTICALS (CANADA) INCORPORATED, supplied as GRANULES for ORAL administration. Health Canada currently lists it as marketed, status dated 14-Dec-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 ORKAMBI used for?
ORKAMBI (lumacaftor/ivacaftor) is indicated for the treatment of cystic fibrosis (CF) in patients 1 year of age and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation.
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 | 02483858 |
|---|---|
| Brand name | ORKAMBI |
| Generic / active ingredient | LUMACAFTOR : 150 MG IVACAFTOR : 188 MG |
| Manufacturer | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED |
| Strength | 150 MG |
| Dosage form | GRANULES |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | R07AX30 IVACAFTOR AND LUMACAFTOR |
| AHFS class | 48:14.04 ; 48:14.12 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 14-Dec-2018 |
| Original market date | 2018-12-14 00:00:00 |
How is it stored and handled?
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How is it supplied?
Orkambi Tablets (100 mg / 125 mg): 112 tablets (supplied in a box containing 4 cartons, with each carton containing 7 blister strips with 4 tablets per strip). Orkambi Tablets (200 mg / 125 mg): 112 tablets (supplied in a box containing 4 cartons, with each carton containing 7 blister strips, with 4 tablets per strip). Orkambi Granules (75 mg / 94 mg) 56 packets (supplied in a box containing 4 wallets, with each wallet containing 14 packets of 75 mg/94 mg granules per printed foil laminate packet). Orkambi Granules (100 mg / 125 mg): 56 packets (supplied in a box containing 4 wallets, with each wallet containing 14 packets of 100 mg / 125 mg granules per printed foil laminate packet). Orkambi Granules (150 mg / 188 mg): 56 packets (supplied in a box containing 4 wallets, with each wallet containing 14 packets of 150 mg / 188 mg granules per printed foil laminate packet).
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 | 125 MG | TABLET | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | DIN 02463040 |
| 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.