BYLVAY 400 MCG
ODEVIXIBAT : 400 MCG · DIN 02542676 · MEDISON PHARMA CANADA INC.
Health Canada status: MARKETED
What is BYLVAY?
BYLVAY 400 MCG contains ODEVIXIBAT : 400 MCG. It is listed in the Health Canada Drug Product Database under DIN 02542676, held by MEDISON PHARMA CANADA INC., supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 07-Feb-2024. 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 BYLVAY used for?
Treatment of pruritus in patients aged 6 months+ with Progressive Familial Intrahepatic Cholestasis (PFIC) and cholestatic pruritus in patients aged 12 months+ with Alagille syndrome (ALGS).
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 | 02542676 |
|---|---|
| Brand name | BYLVAY |
| Generic / active ingredient | ODEVIXIBAT : 400 MCG |
| Manufacturer | MEDISON PHARMA CANADA INC. |
| Strength | 400 MCG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | A05AX05 ODEVIXIBAT |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 07-Feb-2024 |
How is it administered?
PFIC: 40 mcg/kg once daily; may increase to 120 mcg/kg after 3 months. ALGS: 120 mcg/kg once daily. Administer in the morning with a meal. Capsules may be swallowed whole or sprinkled on soft food.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at room temperature (implied by standard HDPE packaging, though specific range not explicitly stated in provided text, usually 15-30°C).
How is it supplied?
High-density polyethylene (HDPE) bottles of 30 capsules with child-resistant closures.
Contraindications
Hypersensitivity to odevixibat or any ingredient in the formulation or component of the container.
Warnings and precautions
Risk of diarrhea/dehydration, liver test abnormalities, and fat-soluble vitamin (A, D, E, K) deficiencies. May not be effective in PFIC type 2 with complete absence of BSEP protein.
What can be used instead?
Other Canadian products sharing ATC code A05AX05 ODEVIXIBAT. 4 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 |
|---|---|---|---|---|---|
| BYLVAY | 1200 MCG | CAPSULE | MEDISON PHARMA CANADA INC. | MARKETED | DIN 02542692 |
| BYLVAY | 200 MCG | CAPSULE | MEDISON PHARMA CANADA INC. | MARKETED | DIN 02542641 |
| BYLVAY | 600 MCG | CAPSULE | MEDISON PHARMA CANADA INC. | MARKETED | DIN 02542684 |
Who else supplies ODEVIXIBAT worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ODEVIXIBAT appears in 59 registered pack listings across 8 markets, published on 6 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.