PIQRAY
As listed in the register: PIQRAY
50 mg · tablet
- Prescription only
- Cancer treatments and immune-system medicines
- Active substance
- Alpelisib
- Made by
- Novartis Pharmaceuticals Canada Inc
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (PIQRAY). It describes the substance, not this exact product.
Alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα.
Gain-of-function mutations in the gene encoding the catalytic α-subunit of PI3K (PIK3CA) lead to activation of PI3Kα and Akt-signaling, cellular transformation and the generation of tumors in in vitro and in vivo models.
Alpelisib is primarily metabolized by chemical and enzymatic hydrolysis to form its metabolite BZG791 and followed by CYP3A4 mediated hydroxylation.
Effect of food A high-fat high-calorie meal (985 calories with 58.1 g of fat) increased alpelisib AUC by 73% and C max by 84%, and a low-fat low-calorie meal (334 calories with 8.7 g of fat) increased alpelisib AUC by 77% and C max by 145% following a single dose of PIQRAY.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-12-15
Safety of the active substance
From the US prescribing label for the same active substance (PIQRAY). It describes the substance, not this exact product.
- PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components [see Warnings and Precautions (5.1)].
- Severe hypersensitivity to PIQRAY or to any of its components.
The most frequent adverse reactions leading to treatment discontinuation of PIQRAY in > 2% patients receiving PIQRAY plus fulvestrant were hyperglycemia (6%), rash (4.2%), diarrhea (2.8%), and fatigue (2.5%).
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
SpainNo exact match for this strength and form
Netherlands2 matching products
SwitzerlandNo exact match for this strength and form
Details
| Made by | Novartis Pharmaceuticals Canada Inc |
|---|---|
| Active substance | Alpelisib |
| Used in | Cancer treatments and immune-system medicines |
| Strength | 50 mg |
| Form | tablet |
| Classification | L01EM03 · Cancer treatments and immune-system medicines |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Approved |
| Marketed | No — authorised but not currently marketed, according to the register |
| DIN | 02497042 |
| DPD drug code | 98685 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Other strengths and forms
4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- tablet3 products
- tablet, kit1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.