Source: Australian Department of Health
Treatment with Piqray should be initiated by a physician experienced in the use of anticancer Patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer should be selected for treatment with Piqray, based on the presence of a phosphatidylinositol 3-kinase catalytic alpha subunit (PIK3CA) mutation in tumour or plasma specimens, using a validated test. If a mutation is not detected in a plasma specimen, test tumour tissue if available.
The safety and efficacy of alpelisib in combination with a gonadotropin-releasing hormone (GnRH) agonist in pre- or peri-menopausal women has not been established. There was no treatment benefit demonstrated in patients without PIK3CA mutations, in the Phase III clinical study (see Section 5.1 Pharmacodynamic properties).
The recommended dose of Piqray is 300 mg (two 150 mg film coated tablets) taken orally, once daily. Piqray should be taken immediately following food, at approximately the same time each day (see Section 5.1 Pharmacodynamic properties and Section 4.5 Interactions). The maximum recommended daily dose of Piqray is 300 mg. If patient vomits after taking the Piqray 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.
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. Please refer to the full product information of fulvestrant.
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. Dosing modifications may be necessary to improve tolerability.
For further information refer to the Product Information.