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PI3K Inhibitor (Specialist Oncology Drug)

Alpelisib

Brand names: Piqray

Alpelisib is an oral PI3K-alpha selective inhibitor used, in combination with endocrine therapy, for certain hormone-receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancers.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It selectively inhibits the alpha isoform of phosphatidylinositol-3-kinase (PI3Kalpha), blocking downstream signalling that drives tumour cell proliferation and survival in PIK3CA-mutated tumours.

Prescribing in practice

  • Severe hyperglycaemia, sometimes leading to ketoacidosis, is a key risk, so assess and optimise glycaemic control before starting and monitor blood glucose closely during treatment.
  • Severe cutaneous reactions, including hypersensitivity and potentially serious skin reactions, can occur and may require interruption or discontinuation.
  • Patient selection requires a confirmed PIK3CA mutation by a validated test.

Monitoring

Monitor fasting blood glucose and glycated haemoglobin regularly, and watch for rash, diarrhoea, and pneumonitis.

Counselling the patient

  • Report excessive thirst, frequent urination, or symptoms of high blood sugar promptly.
  • Report any new or worsening rash, mouth ulcers, or breathing problems.
  • Take as directed with food and attend regular blood tests.

Evidence & guidelines

Use in PIK3CA-mutated advanced breast cancer follows the SOLAR-1 evidence base and relevant NICE guidance; consult the SPC for detail.

Reference: NICE TA890 (Alpelisib with fulvestrant for PIK3CA-mutated HR+/HER2- advanced breast cancer, 2023); SOLAR-1 trial (NEJM 2019); ESMO Breast Cancer Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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