PALYNZIQ 10 MG / 0.5 ML
PEGVALIASE : 10 MG / 0.5 ML · DIN 02526255 · BIOMARIN INTERNATIONAL LIMITED
Health Canada status: MARKETED
What is PALYNZIQ?
PALYNZIQ 10 MG / 0.5 ML contains PEGVALIASE : 10 MG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02526255, held by BIOMARIN INTERNATIONAL LIMITED, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 26-Aug-2022. 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 PALYNZIQ used for?
To reduce blood phenylalanine concentrations in patients with phenylketonuria (PKU) aged 16 years and older with inadequate control (> 600 micromol/L) despite dietary management.
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 | 02526255 |
|---|---|
| Brand name | PALYNZIQ |
| Generic / active ingredient | PEGVALIASE : 10 MG / 0.5 ML |
| Manufacturer | BIOMARIN INTERNATIONAL LIMITED |
| Strength | 10 MG / 0.5 ML |
| Dosage form | SOLUTION |
| Route of administration | SUBCUTANEOUS |
| Schedule | Prescription |
| ATC code | A16AB19 PEGVALIASE |
| AHFS class | 44:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 26-Aug-2022 |
| Original market date | 2022-08-26 00:00:00 |
How is it administered?
Induction: 2.5 mg once weekly for 4 weeks. Titrate gradually to maintenance (20 mg, 40 mg, or 60 mg daily) to achieve blood Phe ≤ 600 micromol/L. Premedication required during induction/titration.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text snippet (section 11 mentioned but content not shown), though typically refrigerated for biologics.
How is it supplied?
2.5 mg, 10 mg, or 20 mg pre-filled syringes. Available in cartons of 1 or 10 (for 20 mg strength).
Contraindications
Severe systemic hypersensitivity or recurrent mild-to-moderate anaphylaxis to Palynziq or its ingredients; anaphylaxis to PEG or PEGylated products.
Warnings and precautions
Serious risk of systemic hypersensitivity/anaphylaxis; requires auto-injectable epinephrine, initial supervision by health professional, and a trained observer for first 6 months.
What can be used instead?
Other Canadian products sharing ATC code A16AB19 PEGVALIASE. 3 of 3 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 |
|---|---|---|---|---|---|
| PALYNZIQ | 2.5 MG / 0.5 ML | SOLUTION | BIOMARIN INTERNATIONAL LIMITED | MARKETED | DIN 02526247 |
| PALYNZIQ | 20 MG | SOLUTION | BIOMARIN INTERNATIONAL LIMITED | MARKETED | DIN 02526263 |
Who else supplies PEGVALIASE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. PEGVALIASE appears in 10 registered pack listings across 3 markets, published on 3 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.