Piqray’s Safety Label is Updated


Some fatal cases of ketoacidosis have occurred, and high-risk patients should be monitored when starting treatment.

The FDA has approved an update to safety labeling for Piqray (alpelisib), Novartis’ therapy for patients with advanced or metastatic breast cancer, saying there have been some fatal cases of ketoacidosis in the postmarket setting.

The Warnings and Precautions section of the label, under hyperglycemia, now reads: “Severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar non-ketotic syndrome (HHNKS) or ketoacidosis has occurred in patients treated with PIQRAY. Some fatal cases of ketoacidosis have occurred in the postmarketing setting …” (Additions/changes are in italics.)

HHNKS is a serious complication of type 2 diabetes resulting from high blood glucose levels, which can result in a coma or seizures. Ketoacidosis is a serious complication of diabetes that occurs when liver metabolizes fat for fuel, resulting in high levels of ketones, a byproduct of that process.

The FDA approved Piqray in 2019 for use in combination with Faslodex (fulvestrant) for postmenopausal women, and men, with HR+/HER2- PIK3CA-mutated advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

A Novartis spokesperson said the company continues to learn more about the therapy as additional patients are treated. In the postmarketing setting, it is a regulatory requirement to continue to collect real-world safety data.

This process showed increased severity of an already known adverse reaction ketoacidosis, which triggered the prescribing Information update, the spokesperson said in an email. “At Novartis, patient safety is our utmost priority. The updated guidance for additional safety monitoring is to help physicians appropriately manage potential serious side effects,” she said.

That guidance suggests that, in addition to monitoring HbA1C every three months, physicians monitor fasting glucose more frequently for the first few weeks of treatment in patients with high risk factors for hyperglycemia such as obesity, elevated fasting plasma glucose and HbA1c levels, use of systemic corticosteroids, and those over the age of 75.

Piqray continues to demonstrate that it is an important treatment option to address the needs of about 40% of patients with HR+/HER2- advanced breast cancer whose tumors harbor a PIK3CA mutation, which is linked to a poorer prognosis in the metastatic setting, the spokesperson said.

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