Prescribing information


This page/content is for Great Britain Healthcare professionals only. If you require information for Northern Ireland please refer to the Northern Ireland PI



PIQRAY® (alpelisib) is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine-based therapy.1

PIQRAY® is given in combination with fulvestrant.1

Dosing and administration1

Dosing and administration dosing guide chart

Continue treatment until disease progression or until unacceptable toxicity occurs.

Accounting for missed PIQRAY® doses1

  • If a dose is missed, it can be taken immediately following food and within 9 hours after the time it is usually administered. After more than 9 hours, the dose should be skipped for that day. The next day, PIQRAY® should be taken at its usual time
  • If the patient vomits after taking the dose, the patient should not take an additional dose on that day, and should resume the usual dosing schedule the next day at the usual time

Certain AEs may require dose modifications1

Image detailing dose modifications


Caution should be used in patients with severe renal impairment as there is no experience with PIQRAY® in this population.


Thumbnail of PIQRAY Management Guide document


Please see the therapy management guide for more details on dosing and administration.

View resources 


The blister pack is designed to help patients stay on track with treatment1

Dosing table. The recommended starting dose of PIQRAY: 300 mg daily + Fulvestrant recommended dose 500 mg


*Tablets should not be chewed, crushed or split prior to swallowing. No tablet should be ingested if it is broken, cracked, or otherwise not intact.

AE, adverse event.


  1. PIQRAY® (alpelisib) Summary of Product Characteristics.
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UK | July 2023 | 186029-1

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.



Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]