PIQRAY® (alpelisib) | PIK3CA-mutated advanced breast cancer

For Healthcare Professionals Outside the US

Keeping TRAQ with PIQRAY: Patient Management Tool

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This tool is designed to provide information on the safety profile of PIQRAY and guidance on dose modifications and management of selected adverse reactions (adverse reactions)
Keeping TRAQ with PIQRAY patient management tool Keeping TRAQ with PIQRAY patient management tool
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Manageable safety profile

Serious adverse reactions associated with PIQRAY include severe hypersensitivity (including anaphylactic reaction), severe cutaneous reactions, hyperglycemia, pneumonitis, diarrhea, and embryo-fetal toxicity1 Among patients treated with PIQRAY + fulvestrant, 25% of patients discontinued treatment due to adverse reactions compared with 5% treated with placebo + fulvestrant2,3
  • The most common adverse reactions leading to discontinuation of PIQRAY were hyperglycemia (6% of patients), rash (4%), diarrhea (3%), and fatigue (3%)1
Adverse reactions and laboratory abnormalities
occurring in >20% and >30% of the total population, respectively1
Adverse reactions Any grade
n (%) 		Grade 3/4
n (%)
Blood and lymphatic system disorders
Anemia 125 (44.0) 14 (4.9)*
Lymphocyte count decreased 157 (55.3) 26 (9.2)
Metabolism and nutrition disorders
Glucose plasma increased 225 (79.2) 111 (39.1)
Decreased appetite 102 (35.9) 2 (0.7)*
Gastrointestinal disorders
Diarrhea 169 (59.5) 20 (7.0)*
Nausea 133 (46.8) 8 (2.8)*
Stomatitisa 86 (30.3) 7 (2.5)*
Vomiting 81 (28.5) 2 (0.7)*
Skin and subcutaneous tissue disorders
Rashb 147 (51.8) 55 (19.4)*
Alopecia 58 (20.4)
General disorders and administration site conditions
Fatiguec 123 (43.3) 16 (5.6)*
Investigations
Weight decreased 79 (27.8) 15 (5.3)*
Blood creatinine increased 192 (67.6) 8 (2.8)*
Gamma-glutamyl transferase increased 151 (53.2) 34 (12.0)
Alanine aminotransferase increased 125 (44.0) 12 (4.2)*
Lipase increased 121 (42.6) 20 (7.0)
*No grade 4 adverse reactions were observed.
aStomatitis: also includes aphthous ulcer and mouth ulceration.
bRash: also includes rash maculopapular, rash generalized, rash papular, rash pruritic.
cFatigue: also includes asthenia.

Managing adverse reactions

Choose an adverse reaction from the list below to explore considerations for monitoring and management before and during treatment with PIQRAY


References: 1. Piqray® (alpelisib): EU Summary of Product Characteristics. Novartis; 2022. 2. André F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med. 2019;380(20):1929-1940. 3. Rugo H, André F, Yamashita T, et al. Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer. Ann Oncol. 2020;31(8):1001-1010.