Concise Prescribing Info
In combination w/ fulvestrant for the treatment of postmenopausal women w/ hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer w/ a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.
Dosage/Direction for Use
300 mg (2 x 150 mg) once daily on a continuous basis. Max daily dose: 300 mg. Should be co-administered w/ fulvestrant 500 mg IM on days 1, 15 & 29, & once mthly thereafter.
Should be taken with food: Take immediately after meals.
Special Precautions
Hypersensitivity reactions (including anaphylactic reaction & shock). Permanently discontinue & should not be reintroduced in patients w/ serious hypersensitivity reactions. Do not initiate in patients w/ a history of severe cutaneous reactions; permanently discontinue if severe cutaneous reactions is confirmed. Patients w/ type 1 & uncontrolled type 2 diabetes. Hyperglycemia w/ rapid onset after starting treatment; frequently self-monitor in the 1st 4 wk & especially w/in the 1st 2 wk of treatment, as clinically indicated. May require dose interruption, reduction or discontinuation based on severity of hyperglycaemia. Permanently discontinue in all patients w/ confirmed pneumonitis. Risk of severe diarrhoea & clinical consequences eg, dehydration & acute kidney injury. Exercise caution when used either simultaneously or sequentially w/ bisphosphonates or denosumab. Do not initiate in patients w/ ongoing osteonecrosis of the jaw from previous or concurrent treatment w/ bisphosphonates/denosumab. Patients w/ prior fulvestrant use; symptomatic visceral disease. Minor influence on the ability to drive & use machines. Patients w/ severe renal impairment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Women should not breast-feed during treatment & for at least 1 wk after the last dose. Elderly ≥75 yr. Childn 0-18 yr.
Adverse Reactions
UTI; anaemia, decreased lymphocyte & platelet count; increased or decreased glucose plasma, decreased appetite, decreased Mg, hypokalaemia, hypocalcaemia; headache, dysgeusia; diarrhoea, nausea, stomatitis, vomiting, abdominal pain, dyspepsia; rash, alopecia, pruritus, dry skin; fatigue, mucosal inflammation, oedema peripheral, pyrexia, mucosal dryness; decreased wt, decreased albumin, increased blood creatinine, γ-glutamyltransferase, ALT & lipase, prolonged aPTT. Hypersensitivity; dehydration; insomnia; blurred vision, dry eye; HTN, lymphoedema; pneumonitis; toothache, gingivitis, gingival pain, cheilitis; erythema, dermatitis, palmar-plantar erythrodysaesthesia syndrome, erythema multiforme; muscle spasms, myalgia, osteonecrosis of jaw; acute kidney injury; oedema; increased HbA1c.
Drug Interactions
Increased systemic exposure w/ BCRP inhibitors (eg, eltrombopag, lapatinib, pantoprazole). Caution when used in combination w/ CYP3A4 substrates that also possess an additional time-dependent inhibition & induction potential on CYP3A4 that affects their own metabolism (eg, rifampicin, ribociclib, encorafenib); CYP2C9 substrates w/ a narrow therapeutic index eg, warfarin; sensitive CYP2B6 substrates (eg, bupropion) or CYP2B6 substrates w/ a narrow therapeutic window, as alpelisib may reduce the clinical activity of such medicinal products. Potential to increase systemic exposure of OAT3, BCRP & P-gp substrates.
ATC Classification
L01EM03 - alpelisib ; Belongs to the class of phosphatidylinositol-3-kinase (Pi3K) inhibitors. Used in the treatment of cancer.
Piqray FC tab 150 mg
Piqray FC tab 200 mg + 50 mg
Piqray FC tab 200 mg
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