Product Dossier
PIQRAY
Product Dossier for PIQRAY (alpelisib, Novartis Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Novartis Pharmaceuticals
- Active ingredient: alpelisib
- Therapeutic area: Oncology
- Same area: TALZENNA
- Same area: ZARZIO
What it is
PIQRAY contains alpelisib. PIQRAY is available as film-coated tablets in three strengths: 50 mg, 150 mg, and 200 mg.
Approved indications
— Treatment of postmenopausal women and men with hormone receptor positive, HER2-negative, advanced or metastatic breast cancer with a PIK3CA mutation as detected by a validated test following progression on or after an endocrine-based regimen, in combination with fulvestrant.
Dosing overview
The recommended dose of PIQRAY is 300 mg taken orally once daily. PIQRAY should be taken immediately following food, at approximately the same time each day. When co-administered with PIQRAY, the recommended dose of fulvestrant is 500 mg administered intramuscularly on days 1, 15 and 29, and once monthly thereafter. Management of severe or intolerable adverse drug reactions may require temporary dosing interruption, reduction, and/or discontinuation of PIQRAY. A maximum of two dosing reductions are recommended, after which the patient should be discontinued from treatment. Dosing reduction options are 250 mg daily or 200 mg daily continuously.
Key safety warnings
The safety and efficacy of alpelisib in combination with a GnRH agonist in pre- or peri-menopausal women has not been established. Consultation with a healthcare professional experienced in the management of hyperglycaemia should be considered. Premedication with metformin may decrease the incidence and severity of hyperglycaemia when metformin is initiated seven days prior to the start of treatment with PIQRAY and metformin dose titrated to the maximum tolerated dose.
Regulatory history
The TGA approved PIQRAY for registration on 19 March 2020. The TGA's evaluation of the quality, nonclinical, and clinical data, including the pivotal Phase III SOLAR-1 trial, supported the efficacy and safety of alpelisib. PIQRAY was first listed on the ARTG on 20 March 2020 in three variant presentations: the 150 mg tablet for 300 mg daily dosing, the 200 mg tablet for 200 mg daily dosing, and a composite pack of 200 mg and 50 mg tablets for 250 mg daily dosing.