Alpelisib

  • TRADE NAME: Piqray (Novartis)
  • INDICATIONS: 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.
  • CLASS: Kinase inhibitor, Phosphoinositide 3-kinase (PI3K) inhibitor
  • HALF-LIFE: 8–9 hours

FDA APPROVAL DATE: 05/24/2019

CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:

Breast Cancer Resistance Protein inhibitors, CYP2C9 substrates, CYP3A4 inducers

PREGNANCY CATEGORY: N/A
Based on animal data and mechanism of action can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug associated risk. When used in combination with fulvestrant, refer to the prescribing information of fulvestrant for pregnancy information.

Our database has 41 adverse reactions for this drug across the following areas

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SKIN
HAIR
MUCOSAL
CENTRAL NERVOUS SYSTEM
ENDOCRINE/METABOLIC
GASTROINTESTINAL/HEPATIC
GENITOURINARY
HEMATOLOGIC
NEUROMUSCULAR/SKELETAL


Page last updated 08/01/2019

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Incidence info

  • <1%
  • 1-5%
  • 5-10%
  • 10-15%
  • 15-20%
  • 20-30%
  • >30%

Seriousness info

  • Hospitalization possible
  • Life threatening
  • Fatal

Warnings in other populations info

  • Breast feeding
  • Geriatric
  • Pediatric
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