PIQRAY 200 MG
ALPELISIB : 200 MG · DIN 02497077 · NOVARTIS PHARMACEUTICALS CANADA INC
Health Canada status: MARKETED
What is PIQRAY?
PIQRAY 200 MG contains ALPELISIB : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02497077, held by NOVARTIS PHARMACEUTICALS CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 29-Jun-2020. 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 PIQRAY used for?
In combination with fulvestrant for postmenopausal women and men with HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer after progression on endocrine-based regimen.
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 | 02497077 |
|---|---|
| Brand name | PIQRAY |
| Generic / active ingredient | ALPELISIB : 200 MG |
| Manufacturer | NOVARTIS PHARMACEUTICALS CANADA INC |
| Strength | 200 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L01EM03 ALPELISIB |
| AHFS class | 10:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 29-Jun-2020 |
| Original market date | 2020-06-29 00:00:00 |
How is it administered?
Recommended dose: 300 mg (2 x 150 mg tablets) orally once daily with food. Continue until disease progression or unacceptable toxicity. Max 2 dose reductions permitted for ADRs.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly stated in the provided text (refer to section 11 of full monograph).
How is it supplied?
Aluminium PVC/PCTFE blisters. 300mg dose: 56 x 150mg tablets. 250mg dose: 28 x 200mg + 28 x 50mg tablets. 200mg dose: 28 x 200mg tablets.
Contraindications
Hypersensitivity to alpelisib or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container.
Warnings and precautions
Serious warnings: Hypersensitivity/anaphylaxis, severe cutaneous adverse reactions (SJS, DRESS, EM), severe hyperglycemia (including fatal ketoacidosis), and pneumonitis.
What can be used instead?
Other Canadian products sharing ATC code L01EM03 ALPELISIB. 3 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 |
|---|---|---|---|---|---|
| PIQRAY | 150 MG | TABLET | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02497069 |
| PIQRAY | 50 MG | TABLET | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02497085 |
| PIQRAY | 50 MG | TABLET | NOVARTIS PHARMACEUTICALS CANADA INC | APPROVED | DIN 02497042 |
Who else supplies ALPELISIB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ALPELISIB appears in 28 registered pack listings across 9 markets, published on 7 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.