SYMDEKO 150 MG
IVACAFTOR : 150 MG TEZACAFTOR : 100 MG IVACAFTOR : 150 MG · DIN 02478080 · VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
Health Canada status: MARKETED
What is SYMDEKO?
SYMDEKO 150 MG contains IVACAFTOR : 150 MG TEZACAFTOR : 100 MG IVACAFTOR : 150 MG. It is listed in the Health Canada Drug Product Database under DIN 02478080, held by VERTEX PHARMACEUTICALS (CANADA) INCORPORATED, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 28-Jun-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 SYMDEKO used for?
Treatment of cystic fibrosis (CF) in patients 12+ years homozygous for F508del mutation or heterozygous for F508del with specific responsive mutations (e.g., P67L, D110H, R117C, etc.).
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 | 02478080 |
|---|---|
| Brand name | SYMDEKO |
| Generic / active ingredient | IVACAFTOR : 150 MG TEZACAFTOR : 100 MG IVACAFTOR : 150 MG |
| Manufacturer | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED |
| Strength | 150 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | R07AX31 IVACAFTOR AND TEZACAFTOR |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 28-Jun-2018 |
How is it administered?
One tezacaftor 100 mg/ivacaftor 150 mg tablet in the morning and one ivacaftor 150 mg tablet in the evening, ~12 hours apart with fat-containing food. Swallow whole.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly stated in provided text (Section 11 header present but content missing).
How is it supplied?
Monthly pack of 56 tablets (4 weekly blister cards, each with 14 tablets). Blister consists of PCTFE/PVC with aluminum foil lidding.
Contraindications
Hypersensitivity to tezacaftor, ivacaftor or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Dizziness may affect driving. Monitor transaminases (ALT/AST) prior to start, every 3 months for 1 year, then annually. Risk of cataracts in pediatrics; baseline/follow-up eye exams recommended.
Who else supplies IVACAFTOR AND TEZACAFTOR worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. IVACAFTOR AND TEZACAFTOR 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.