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alpelisib

Piqray, Vijoice · ATC code L01XE

Key facts
Active substance
alpelisib
Drug class
ALK inhibitor
ATC code
L01XE
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Piqray 50 mg film-coated tablets / Piqray 150 mg film-coated tablets / Piqray 200 mg film-coated tablets · Vijoice 50 mg film-coated tablets / Vijoice 125 mg film-coated tablets / Vijoice 200 mg film-coated tablets · Vijoice 50 mg granules in sachet
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-29

Key facts

Alpelisib is a phosphatidylinositol-3-kinase (PI3K) inhibitor. It is used in PIK3CA-mutated breast cancer (Piqray) and in PIK3CA-related overgrowth spectrum, PROS (Vijoice).

What it is used for

  • Piqray: with fulvestrant in postmenopausal women and men with HR-positive, HER2-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after progression on an endocrine-based regimen.
  • Vijoice: adults and children aged 2 years and older with severe or life-threatening manifestations of PROS who require systemic therapy.

Dosing

  • Piqray: 300 mg (2 x 150 mg tablets) once daily continuously, with fulvestrant 500 mg intramuscularly; dose reductions for adverse reactions to 250 mg and then 200 mg daily (only one reduction for pancreatitis).
  • Piqray: patients are selected based on a PIK3CA mutation in tumour or plasma specimens.
  • Vijoice adults: 250 mg once daily; reduce to 125 mg and then 50 mg for adverse reactions.
  • Vijoice children (2 to < 18 years): 50 mg once daily; from 6 years, an increase to 125 mg once daily may be considered after 24 weeks.
  • Missed dose: take with food within 9 hours, otherwise skip; no extra dose after vomiting.
  • See the full text for dose modifications for hyperglycaemia, rash, diarrhoea and other adverse reactions.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.

Important warnings

  • Hyperglycaemia: monitor glucose; patients with a history of diabetes may need intensified treatment; safety in type 1 and uncontrolled type 2 diabetes is not established.
  • Serious hypersensitivity reactions (including anaphylaxis, angioedema): discontinue permanently.
  • Severe cutaneous reactions (SJS, erythema multiforme, TEN, DRESS): do not start in patients with such a history; interrupt if signs occur.
  • Pneumonitis, including serious cases: interrupt immediately and evaluate if respiratory symptoms appear or worsen.
  • Piqray: efficacy after prior fulvestrant is not established due to limited data.

Side effects

  • Piqray, very common: plasma glucose increased (77.4%), creatinine increased (68.9%), diarrhoea (57.7%), lymphocyte count decreased (56.4%), rash (50.0%), nausea (46.3%), anaemia (45.7%), fatigue (43.4%), decreased appetite (35.4%), stomatitis (27.1%).
  • Piqray, grade 3 or 4: including plasma glucose increased (35.6%) and rash (20.2%); also osteonecrosis of the jaw and acute kidney injury.
  • Vijoice, adults: hyperglycaemia (27.8%), diarrhoea (27.8%), headache (22.2%); children: stomatitis (23.1%) and diarrhoea (12.8%).

Interactions

  • BCRP inhibitors (e.g. eltrombopag, lapatinib, pantoprazole, ciclosporin) may increase alpelisib exposure; use caution and monitor for toxicity.
  • Acid-reducing agents such as ranitidine decreased alpelisib exposure.
  • Alpelisib may increase exposure to narrow-therapeutic-index substrates of BCRP and P-gp. See the full text for more.

Pregnancy and breastfeeding

  • Can harm the foetus: effective contraception during treatment and for at least 1 week after; Piqray is not for pregnant women, Vijoice only if the woman's condition requires it.
  • Do not breast-feed during treatment and for at least 1 week after the last dose.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • PiqrayNovartis Europharm Limited · EMEA/H/C/004804
  • VijoiceNovartis Europharm Limited · EMEA/H/C/006539

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Piqray, Vijoice
Liechtenstein
Piqray, Vijoice
Norway
Piqray, Vijoice

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Piqray – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/piqray-epar-product-information_en.pdf
  2. European Medicines Agency. Vijoice – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/vijoice-epar-product-information_en.pdf
  3. Wikidata (CC0): ATC L01XE.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.