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alpelisib (Piqray)

Indications: - treatment or postmenopausal women & men, with ER & PR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer * used in combination with fulvestran Monitor: - serum glucose, hemoglobin A1c Adverse effects: - hyperglycemia, increase in serum creatinine, hypocalcemia - lymphopenia, anemia, prolonged aPTT prolonged - elevated liver enzymes, increase in serum lipase - diarrhea, nausea/vomiting, decreased appetite, stomatitis - pneumonitis/interstitial lung disease - weight loss, fatigue - rash, hair loss - potentially severe skin reactions - Stevens-Johnson Syndrome, erythema multiforme, toxic epidermal necrolysis Laboratory: - used in combination with approved the companion diagnostic test, therascreen PIK3CA RGQ PCR Kit* * detects the PIK3CA mutation in a tissue &/or a liquid biopsy * patients who are negative by the therascreen test using a liquid biopsy should undergo tumor biopsy for PIK3CA mutation testing. Mechanism of action: - PIK3 inhibitor

General

small inhibitory antineoplastic agent (ib drug)

Database Correlations

PUBCHEM cid=56649450

References

  1. FDA News Release. May 24, 2019 FDA approves first PI3K inhibitor for breast cancer https://www.fda.gov/news-events/press-announcements/fda-approves-first-pi3k-inhibitor-breast-cancer