Indications for PIQRAY:
In combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Swallow whole. Take with food. 300mg once daily (in combination with fulvestrant 500mg on Days 1, 15, and 29, then once monthly thereafter); continue until disease progression or unacceptable toxicity. Dose modifications and management of adverse reactions: see full labeling.
Risk of severe hyperglycemia; obtain fasting blood glucose (FBG) and HbA1c prior to initiation. After initiating, monitor blood glucose and/or FBG at least once weekly for the first 2 weeks, then at least once every 4 weeks, and as indicated. Monitor HbA1c every 3 months and as indicated. Interrupt, reduce dose, or discontinue therapy based on severity of the hyperglycemia. Permanently discontinue if severe hypersensitivity occurs. History of severe cutaneous reactions (eg, SJS, EM, TEN): do not initiate. Interrupt therapy if signs/symptoms of severe cutaneous reactions occur; permanently discontinue if confirmed. Interrupt and evaluate if new or worsening respiratory symptoms occur; permanently discontinue if pneumonitis is confirmed. Risk of severe diarrhea; interrupt, reduce dose, or discontinue therapy based on severity. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after last dose. Nursing mothers: not recommended (during and for 1 week after last dose).
Phosphatidylinositol 3-kinase inhibitor.
May be antagonized by strong CYP3A4 inducers; avoid. May be potentiated by BCRP inhibitors; avoid or use alternatives; if unavoidable, monitor closely for toxicity. May antagonize CYP2C9 substrates (eg, warfarin); monitor closely.
Lab abnormalities (eg, glucose increased, creatinine increased, lymphocyte count decreased, GGT increased, ALT increased, hemoglobin decreased, lipase increased, calcium decreased, glucose decreased, aPTT prolonged), diarrhea, rash, nausea, fatigue, decreased appetite, stomatitis, vomiting, weight decreased, and alopecia; ketoacidosis, hypersensitivity reactions, interstitial lung disease, dehydration, acute kidney injury.
Blister pack—1×28 (200mg tabs); 2×28 (200mg + 50mg tabs); 2×28 (150mg tabs)