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Serious and common adverse reactions (ARs)

Serious ARs associated with PIQRAY include severe hypersensitivity, severe cutaneous adverse reactions (SCARs), hyperglycemia, pneumonitis, diarrhea or colitis, and embryo-fetal toxicity.1

ARs occurring in >20% of the total population1
Table for ARs occurring in >20% of the total population

*No grade 4 ARs were reported.
aIncluding stomatitis, aphthous ulcer, mouth ulceration.
bIncluding fatigue, asthenia.
cIncluding rash, rash maculo-papular, rash macular, rash generalized, rash papular, rash pruritic.


Laboratory abnormalities occurring in >30% of the total population1
Table for laboratory abnormalities occurring in >30% of the total population

No grade 4 laboratory abnormalities were reported.
aGlucose increase is an expected laboratory abnormality of PI3K inhibition. Hyperglycemia, a laboratory-related AR, was reported in 65% of patients treated with PIQRAY (grade 3=33%; grade 4=3.9%).

  • Glucose increase, including hyperglycemia, is an expected, on-target effect of PI3K inhibition1,2

  • Prophylactic use of metformin 7 days prior to initiating PIQRAY was observed to decrease the incidence and severity of hyperglycemia1

Ketoacidosis was reported in 0.7% of patients (n=2) treated with PIQRAY1

  • Among patients treated with PIQRAY and fulvestrant, 5% permanently discontinued both therapies and 21% permanently discontinued PIQRAY alone due to ARs1

The most common ARs leading to discontinuation of PIQRAY were hyperglycemia (6% of patients), rash (4%), diarrhea (3%), and fatigue (3%)1

  • Dose reductions due to ARs occurred in 55% of patients receiving PIQRAY and fulvestrant1

The most common ARs leading to a dose reduction of PIQRAY were hyperglycemia (29% of patients), rash (9%), diarrhea (6%), stomatitis (4%), and mucosal inflammation (2%)

Patient management resources
PIQRAY Monitoring AR Checklist


Monitoring AR Checklist
Monitor for ARs before and during treatment

PIQRAY patient management brochure


Managing Patients on PIQRAY
Take an in-depth look at managing selected ARs

Important Safety Information

PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.

Severe Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, can occur in patients treated with PIQRAY. Severe hypersensitivity reactions were manifested by symptoms, including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia...


PIQRAY® (alpelisib) tablets is indicated in combination with fulvestrant for the treatment of adults 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...

References: 1. Piqray. Prescribing information. Novartis Pharmaceuticals Corp. 2. Goncalves MD, Hopkins BD, Cantley LC. Phosphatidylinositol 3-kinase, growth disorders, and cancer. N Engl J Med. 2018;379(21):2052-2062.