KALYDECO 75 MG
IVACAFTOR : 75 MG · DIN 02442620 · VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
Health Canada status: MARKETED
What is KALYDECO?
KALYDECO 75 MG contains IVACAFTOR : 75 MG. It is listed in the Health Canada Drug Product Database under DIN 02442620, held by VERTEX PHARMACEUTICALS (CANADA) INCORPORATED, supplied as GRANULES for ORAL administration. Health Canada currently lists it as marketed, status dated 14-Sep-2015. 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 KALYDECO used for?
Treatment of cystic fibrosis (CF) in patients aged 2 months and older with specific CFTR mutations (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H).
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 | 02442620 |
|---|---|
| Brand name | KALYDECO |
| Generic / active ingredient | IVACAFTOR : 75 MG |
| Manufacturer | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED |
| Strength | 75 MG |
| Dosage form | GRANULES |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | R07AX02 IVACAFTOR |
| AHFS class | 48:14.12 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 14-Sep-2015 |
| Original market date | 2015-09-14 00:00:00 |
How is it administered?
Take orally approx. 12 hours apart with fat-containing food. Tablets: 150 mg twice daily. Granules: Dose based on age/weight (13.4 mg to 75 mg) twice daily. Mix granules with soft food/liquid.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text snippet (refer to section 11). Standard packaging includes desiccant for bottles.
How is it supplied?
Tablets: Blister pack (56) or HDPE bottle (60). Granules: 56-count carton containing unit dose packets.
Contraindications
Hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Elevated transaminases (ALT/AST) reported; monitor liver function. Risk of non-congenital cataracts in pediatrics. Dizziness may affect driving/operating machinery.
What can be used instead?
Other Canadian products sharing ATC code R07AX02 IVACAFTOR. 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 |
|---|---|---|---|---|---|
| KALYDECO | 13.4 MG | GRANULES | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | DIN 02543451 |
| KALYDECO | 150 MG | TABLET | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | DIN 02397412 |
| KALYDECO | 25 MG | GRANULES | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | DIN 02519364 |
| KALYDECO | 50 MG | GRANULES | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | DIN 02442612 |
Who else supplies IVACAFTOR worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. IVACAFTOR 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.