Alpelisib

Piqray is indicated 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, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine-based therapy.

, Table 4-2). g. metformin), 40% of patients with dose interruption, 43% of patients with dose reduction, and 10% of patients with permanent discontinuation. In patients with hyperglycemia, 166/191 (87%) were managed with anti-diabetic medication and 145/191 (76%) reported use of metformin as single agent or in combination with other anti-diabetic medication.

The maximum dose of metformin recommended in phase III clinical study was 2,000 mg per day. In the phase III clinical study, patients with a history of diabetes mellitus intensified anti-diabetic medication(s) while on treatment with PIQRAY; therefore, these patients require monitoring and possibly intensified anti-diabetic treatment.

Patients with poor glycemic control may be at a higher risk of developing severe hyperglycemia and associated complications. Patients with risk factors for hyperglycemia such as obesity (BMI ≥30), elevated FPG or HbA1c at or above the upper limit of normal, or age ≥75 are at a higher risk of developing severe hyperglycemia.

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