Quick answers
- What is Alpelisib used for?
- The FDA-approved label (Piqray, Novartis Pharmaceuticals Corporation, December 15, 2025) says: “PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Alpelisib have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Alpelisib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Alpelisib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Alpelisib?
- 1 company lists prescription products of Alpelisib in the FDA NDC Directory, including Novartis Pharmaceuticals Corporation.
What Alpelisib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. …
— FDA label: Piqray, Novartis Pharmaceuticals Corporation, effective December 15, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Novartis Pharmaceuticals Corporation5 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA212526 PIQRAY | Novartis | May 24, 2019 | 5, latest January 18, 2024 2024: Efficacy · 2022: Efficacy · 2022: Labeling |
| NDA215039 VIJOICE | Novartis | April 5, 2022 | 3, latest July 22, 2025 2025: Labeling · 2024: Efficacy · 2022: Labeling |
| NDA218466 VIJOICE | Novartis | April 24, 2024 | 1, latest July 22, 2025 2025: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Piqray, Novartis Pharmaceuticals Corporation, effective December 15, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →